Oxford-AstraZeneca vaccine SUSPENDED!

[Hypocrite-The]

US may not need AstraZeneca COVID-19 vaccine: Anthony Fauci
Public health officials testify at U.S. Senate hearing on COVID-19 response in Washington
Public health officials testify at U.S. Senate hearing on COVID-19 response in Washington
02 Apr 2021 08:13AM
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CHICAGO: The United States may not need AstraZeneca's COVID-19 vaccine, even if it wins US regulatory approval, Anthony Fauci, the nation's top infectious disease doctor told Reuters on Thursday (Apr 1).

The vaccine, once hailed as another milestone in the fight against the COVID-19 pandemic, has been dogged by questions since late last year, even as it has been authorised for use by dozens of countries, not including United States.

Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the White House, said the United States has enough contracts with other vaccine makers to vaccinate its entire population, and possibly enough for booster shots in the fall.

READ: AstraZeneca says vaccine 80% effective for elderly, no blood clot risk
Asked whether the United States will use the AstraZeneca vaccine doses, he said, "That's still up in the air. My general feeling is that given the contractual relationships that we have with a number of companies, that we have enough vaccine to fulfil all of our needs without invoking AstraZeneca."

Late last year, the drugmaker and Oxford University published data from an earlier trial with two different efficacy readings as a result of a dosing error. Then in March, more than a dozen countries temporarily suspended the use of AstraZeneca's vaccine after reports linked it to a rare blood clotting disorder.

READ: No reason to stop using AstraZeneca COVID-19 vaccine: WHO
Also in March, a US health agency said data from the company gave an incomplete picture of its efficacy. Days later AstraZeneca published results showing diminished, though still strong, efficacy.

Fauci said that "If you look at the numbers (of doses) that we're going to be getting, the amount that you can get from J&J, from Novavax from Moderna if we contract for more, it is likely that we can handle any boost that we need, but I can't say definitely for sure."

 

[Hypocrite-The]

UK logs 30 cases of clots after AstraZeneca COVID-19 jab
FILE PHOTO: Oxford/AstraZeneca's COVID-19 vaccine at a vaccination centre in Antwerp
FILE PHOTO: Empty vials of Oxford/AstraZeneca's COVID-19 vaccine are seen at a vaccination centre in Antwerp, Belgium March 18, 2021. REUTERS/Yves Herman/File Photo
03 Apr 2021 01:39AM
(Updated: 03 Apr 2021 01:47AM)
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LONDON: Thirty cases of rare blood clotting have been recorded in Britain among more than 18 million people who have had the AstraZeneca vaccination, the national medicines regulator said Friday (Apr 2).

"The benefits of the vaccines against COVID-19 continue to outweigh any risks," the Medicines and Healthcare products Regulatory Agency (MHRA) said, urging the public to keep taking the vaccine.

Up to Mar 24, 22 reports of cerebral venous sinus thrombosis (CVST) and eight of other thrombosis events with low platelets were logged.

"The risk of having this specific type of blood clot is very small," the agency noted.

"The number and nature of suspected adverse reactions reported so far are not unusual in comparison to other types of routinely used vaccines," the MHRA online statement said.

However there were no such reports for the Pfizer/BioNTech vaccine.

The agency said vaccination was the most efficient way to reduce the number of deaths and serious illness from coronavirus.

The Netherlands on Friday became the latest in a line of European countries to halt vaccinations with the AstraZeneca jab for people under the age of 60 amid fears of links to rare blood clots.

The move came after five new cases in the Netherlands affecting women between 25 and 65 years of age, one of whom died.

Germany had taken a similar decision earlier this week.

The European Medicines Agency (EMA), which has also previously declared the AstraZeneca vaccine safe, as has the World Health Organization, is expected to announce updated advice on the issue on Apr 7.

The EMA said again on Wednesday it believes the vaccine is safe and that experts have found no specific risk factors such as age, gender or medical history.

Britain, where the vaccine was developed with the University of Oxford, has been one of the countries worst-hit by coronavirus with nearly 127,000 dead.

 

[Hypocrite-The]

Blood-clotting case in AstraZeneca vaccine recipient being taken 'very seriously'
Posted Yesterday at 9:47am, updated Yesterday at 9:19pm
Play Video. Duration: 5 minutes 45 seconds
Dr Norman Swan says health authorities are closely examining the blood-clotting case in Melbourne.
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Australia's Acting Chief Medical Officer Michael Kidd has confirmed authorities are investigating a "probable" case of a rare clotting disorder in an Australian man who received the AstraZeneca vaccine.

Key points:
It is not clear whether the clots are linked to the man receiving the vaccine
The Therapeutic Goods Administration says there is no proven link between the AstraZeneca jab and blood clots
The majority of Australians will receive a dose of the AstraZeneca vaccine, which is being manufactured in Melbourne
Professor Kidd said the matter was being taken "very seriously" and was being investigated by the Therapeutic Goods Administration (TGA).

The TGA's vaccine safety investigation group will meet on Saturday and will seek to determine whether the disorder is linked to the AstraZeneca vaccine.

The blood clots were recorded in a 44-year-old man who is now being treated in Melbourne's Box Hill Hospital.

The man received the AstraZeneca vaccine on or around March 22 and was admitted to hospital with serious thrombosis and a low platelet count.

"He had low platelets, but he had clots in his liver, in his spleen and in his gut in general," Coronacast host Dr Norman Swan told ABC News.

"So, he fits the description of vaccine-induced pro-thrombotic thrombocytopenia. He fits the case description."

Professor Kidd said medical officials were taking the case very seriously.

"This case is currently being investigated by the TGA and a meeting will be held tomorrow morning … which will examine this report and determine whether it could be linked to the AstraZeneca vaccine," he said.

The Acting Chief Medical Officer said investigators had not yet confirmed a "causal link" with the vaccine.

The exterior sign of the Box Hill Hospital, underneath which a bush of white flowers blooms next to a concrete staircase.
The man has been admitted to Box Hill Hospital in Melbourne's east.( ABC News: Patrick Rocca )
Warning to seek medical advice about 'persistent' headaches
But he did issue a note of caution.

"People should be particularly alert to severe persistent headaches occurring four to 20 days after vaccination and which are different to the usual pattern of headaches and do not settle with over-the-counter painkillers," he said.

"If you received the AstraZeneca vaccine and experience symptoms of persistent headaches or other worrying symptoms four to 20 days after the vaccine, you should seek medical advice."

Professor Kidd said anyone getting vaccinated in coming days should bear in mind that clotting disorders were "extremely rare" and had only been reported in a small number of cases.

"The serious risk disease and death from COVID-19, if we experience another severe outbreak, … is far greater than the very small potential risk of a very rare clotting disorder associated with the vaccine," he said.

Play Video. Duration: 2 minutes 39 seconds
Professor Michael Kidd says no causal link has been made between the blood clot case and the AstraZenica vaccine.
Small number of cases makes link to vaccine hard to determine
Earlier, Australian Medical Association vice-president Chris Moy told the ABC European authorities had been investigating whether there was a link between the AstraZeneca vaccine and blood clots.

"What they found was there was definitely no overall risk of clotting throughout the community that was given the vaccine," he said.

"And that the risk was so low, the benefits of the vaccine would far outweigh any potential risk.

"But they were still looking at this little group where you have this very rare occurrence.

"The rate was somewhere in the order of one in maybe several hundred thousand to one in a million or so.

"I know right throughout the world everyone is looking at this very carefully."

The TGA updated its guidance on the AstraZeneca jab last month, saying there was no proven link between the vaccine and the development of blood clots.

A pair of gloved hands uses a syringe to measure a vaccine.
Most Australians will receive the AstraZeneca vaccine as part of the national rollout.( ABC News: Isabella Higgins )
Use of AstraZeneca jab under close scrutiny overseas
The majority of Australians will receive the AstraZeneca vaccine, rather than the Pzifer BioNTech jab, as it is being locally produced in Melbourne.

Millions of people in the UK and Europe have received the AstraZeneca vaccine without reporting any major adverse side effects.

Overnight, British health regulators reported 30 cases of blood clots in people who had received the vaccine.

The UK's Medicines and Healthcare Products Regulatory Agency received reports of two types of clots in those who received the AstraZeneca vaccine but none for those who had received the Pfizer vaccine.

It followed data from the European Medicines Agency (EMA) which suggested the risk of blood clots following the vaccine was potentially as high as one in 100,000.

Most of the documented cases were people under the age of 55.

The EMA has said that the vaccine is not associated with an increase in blood clot risks, and its benefits outweigh any risk of side effects.

The World Health Organization has declared the vaccine safe.

Play Video. Duration: 4 minutes 2 seconds
How will the coronavirus vaccines work?
Federal Health Department information sheets tell recipients of the AstraZeneca vaccine that less common side effects, such as dizziness and stomach pain, are usually mild and subside in one or two days.

As with other vaccines, such as the flu jab, common side effects include pain and tenderness in the injection area, fatigue, headaches and fever.

Findings recently published in The Lancet found the AstraZeneca vaccine had an 81 per cent efficacy rate when its second dose was given three months after the first.

More than 541,700 people had been vaccinated across Australia by March 28, federal data shows.

More than 115,000 doses had been administered in Victoria by Friday morning, with the majority of those being the AstraZeneca shot.

 

[Hypocrite-The]

 

[Leongsam]

 

[Leongsam]

I think cow dung works better than vaccines.

 

[Hypocrite-The]

Seven blood clot deaths in UK after vaccine
QLD Health's warning on AstraZeneca side effects: "Seek urgent advice"
Queensland Chief Health Officer Dr Jeannette Young said people need to be aware of the symptoms of rare vaccine side effects. Picture: NCA NewsWire / Dan PeledSource:News Corp Australia

Seven people in the UK have died from a rare blood clotting condition, after receiving the AstraZeneca COVID-19 vaccine. Picture: Loic Venance/AFPSource:AFP

Australia’s acting chief medical officer Michael Kidd has assured people health officials are taking the “potential risk very seriously”. Picture: NCA NewsWire/Gary RamageSource:News Corp Australia

Yesterday, acting chief medical officer Michael Kidd urged Aussies to stay calm.

“Investigators have not at this time confirmed a casual link with the COVID-19 AstraZeneca vaccine but investigations are ongoing,” Professor Kidd told reporters.

The “very rare disorder” has “previously not been known to be associated with the vaccine, however it has been noted as a complication of people who have contracted COVID-19”, Professor Kidd said.

Before reassuring Australians that health officials are taking the “potential risk” of the clotting disorder “very seriously”, Prof Kidd also reinforced the importance of people getting vaccinated against coronavirus.

“We continue in Australia to be at risk of another serious outbreak of COVID-19 at a time when most of our population has no immunity from either past infection or from vaccination,” he said.

“We do have low risk of transmission of COVID-19 in Australia at this time but we are being open about possible risks and acknowledge the uncertainty that this will cause. We are taking this potential risk very seriously.

“At this time, the risk of serious disease and death from COVID-19, if we experience another severe outbreak, especially among older Australians and those with severe health conditions, is far greater than the very small potential risk of a very rare clotting disorder associated with the vaccine.”

While health officials in the UK and the European Medicines Agency (EMA) repeated a similar sentiment, overnight the Netherlands joined a growing number of countries in halting its use of the AstraZeneca vaccine.

“We must err on the side of caution, which is why it is wise to press the pause button now as a precaution,” Health Minister Hugo de Jone said.

The Netherlands follows Canada and France, where the vaccine has been suspended to people aged under 55, and Germany, where use of the vaccine has been restricted to those aged over 60, among others – prompting the Australian Technical Advisory Group on Immunisation (ATAGI) to also reassess its position.

ATAGI found no link between the vaccine and blood clots but, in a new warning, told patients who received of the COVID-19 vaccines (Pfizer or AstraZeneca) to be aware of common side effects which include fever, sore muscles, tiredness and headaches usually 24 hours after the dose.

The “benefits of vaccination in protecting people in Australia from COVID-19 outweigh the rare potential risk of these rare blood clotting events”, ATAGI said. Picture: Loic Venance/AFPSource:AFP

“The reports from overseas of rare clotting disorders have occurred later than this. Before day four and day 20, after vaccination, and have generally caused severe symptoms requiring hospitalisation,” the warning reads.

“People should be particularly alert to severe persistent headaches occurring 4-20 days after vaccination and which are different to the usual pattern of headaches that people may experience at other times and which do not settle with paracetamol or other over the counter painkillers.”

In a statement, ATAGI said there would be no change to the clinical guidance on the use of the AstraZeneca vaccine, following findings by the EMA that the condition may be associated with clots linked to thromocytopenia, a rare but serious condition involving low levels of blood platelets.

“ATAGI considers the benefits of vaccination in protecting people in Australia from COVID-19 outweigh the rare potential risk of these rare blood clotting events, and supports the continued rollout of the AstraZeneca vaccine in Australia,” they said.

 

[Hypocrite-The]

Medical experts urge calm as TGA investigates 'probable' blood clots after AstraZeneca shot
Posted 4h
The front entrance and sign of Box Hill Hospital.
The man was admitted to Box Hill Hospital with serious thrombosis and a low platelet count.( ABC News: Jessica Longbottom )
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Medical experts say there is no need to panic as Australia's medical regulator reviews the case of a man who was hospitalised with blood clots after receiving the AstraZeneca vaccine.

Key points:
The Therapeutic Goods Administration is meeting to determine whether the man has a very rare form of blood clotting, and whether that is linked to the vaccine
Authorities and doctors say the benefits of the vaccine far outweigh any potential risks
Haemotologist Nada Hamad says there's no need to panic but it's important people are aware of potential symptoms
The 44-year-old man was being treated at Melbourne's Box Hill Hospital after being admitted with serious thrombosis and a low platelet count.

The man had received a dose of the AstraZeneca vaccine nearly two weeks earlier. A causal link between the vaccine and the clotting has not been established.

About 30,000 people develop blood clots each year in Australia, and hundreds of thousands of people across the country have received the AstraZeneca vaccine without any recorded major side effects.

The man's symptoms appear to fit the diagnostic criteria for vaccine-induced pro-thrombotic thrombocytopenia, a very rare condition which has not been recorded in Australia to date.

Professor Kidd said the matter was being taken "very seriously" and was being investigated by the Therapeutic Goods Administration (TGA).

The regulator is meeting this morning and the Australian Health Protection Principal Committee (AHPPC) is expected to convene after that.

Worker looks at AstraZeneca vaccine
The majority of Australians will receive the AstraZeneca vaccine, with 50 million doses being produced in Melbourne.( ABC News )
Queensland's Chief Health Officer Jeannette Young, a member of the AHPPC, said "all vaccines have some very, very rare side effects".

"At this point in time, people shouldn't be concerned and we expect rare side effects," Dr Young said.

"We just need to be aware of them and individuals need to be aware of them."

Victorian minister Luke Donnellan said the state government would continue to take its advice from the TGA and the immunisation working group, "who are continually monitoring this and ensuring that it's fit and safe for use".

Doctors urge calm
Emergency physician Stephen Parnis, a former president of the Australian Medical Association (AMA) Victoria, said the appropriate investigations were taking place.

"But it's important to avoid the sense of mass panic as well, with regards to COVID vaccinations," he said.

A man in a blue shirt and blue trousers sits on a hospital bed with a stethoscope around his neck and hospital equipment behind
Stephen Parnis says people need to listen to Australia's medical regulator when it comes to the vaccine.( Supplied )
Dr Parnis said he had treated more blood clots in three months than have been discovered in AstraZeneca recipients worldwide.

"What is being talked about with this case is a possible rare syndrome, which is a form of thromboembolism but very different to, if you like, your garden variety clots in veins of the legs or in the chest," he said.

"The point I'm making is that it's not an easy proposition to differentiate things that happen in a population who is unvaccinated versus things that happen in a vaccinated population."

An advisory note from the Australian Technical Advisory Group on Immunisation (ATAGI) on March 25, following temporary pauses enacted in Europe, emphasised "that the benefits of the COVID-19 vaccine far outweigh this potential risk".

A further ATAGI note on Friday, following the man being admitted to hospital, said providers should be aware of warning signs and symptoms of rare clotting disorders.

It noted most of the international cases involved a blod clot in the brain, called cerebral venous sinus thrombosis (CVST), which is similar to a condition associated with taking the drug heparin.

Play Video. Duration: 2 minutes 50 seconds
Haematologist Nada Hamad says it's important to separate normal clotting and the rare symptoms displayed by the patient.
Doctor Nada Hamad, a member of the Haematology Society of Australia and New Zealand, said while information was still being gathered it had "intrigued the medical community enough to want to understand this process, and to try and figure out how to minimise it".

But she said it was "important for us to take it seriously enough to warn and advise patients to look out for symptoms".

Federal Health Department information sheets tell recipients of the AstraZeneca vaccine that less common side effects, such as dizziness and stomach pain, are usually mild and subside in one or two days.

As with other vaccines, such as the flu jab, common side effects include pain and tenderness in the injection area, fatigue, headaches and fever.

The symptoms possibly linked to the rare clotting disorder include persistent headaches, nausea and visual disturbances for four to 20 days after the vaccination.

Play Video. Duration: 4 minutes 2 seconds
How will the coronavirus vaccines work?
Research has found patients with severe COVID-19 infection appear to be at greater risk of developing blood clots in the veins and arteries.

"It's important to recognise there are significant risks in not vaccinating the population as well," Dr Parnis said.

Dr Parnis said it "would be a tragedy" if people withdrew from the vaccine on the basis of the case, and urged people to listen to the advice from the TGA and ATAGI.

TGA investigation follows European action
Findings recently published in The Lancet found the AstraZeneca vaccine had an 81 per cent efficacy rate when its second dose was given three months after the first.

The shot has been in the spotlight in recent weeks as European nations have reviewed data from their vaccination rollouts.

Millions of people have received the AstraZeneca vaccine without reporting any major adverse side effects.

However, British health regulators recently reported 30 cases of blood clots in people who had received the vaccine.

The UK's Medicines and Healthcare Products Regulatory Agency received reports of two types of clots in those who received the AstraZeneca vaccine but none for those who had received the Pfizer vaccine.

It followed data from the European Medicines Agency (EMA) which suggested the risk of blood clots following the vaccine was potentially as high as one in 100,000.

Most of the documented cases were people under the age of 55.

The EMA has said that the vaccine is not associated with an increase in blood clot risks, and its benefits outweigh any risk of side effects.

The World Health Organization has declared the vaccine safe.

 

[Hypocrite-The]

Blood-clotting case 'likely' linked to AstraZeneca vaccine, Deputy CMO says
Play Video. Duration: 3 minutes 25 seconds
Deputy Chief Medical Officer says the blood-clotting case is consistent with other international experiences.
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Australia's Deputy Chief Medical Officer says it is "likely" there is a link between the AstraZeneca vaccine and a Melbourne man being hospitalised with blood clots.

Key points:
The Deputy Chief Medical Officer says there is currently no evidence of a link between the AstraZeneca vaccine and blood clotting
This follows a 44-year-old man who developed thrombosis after receiving the jab
Both the TGA and the ATIGA have recommended that no change to the vaccine rollout
However, Professor Michael Kidd told media on Saturday there was currently no definitive evidence to prove the link.

“Given how consist of the clinical features are in this case, with some similar cases which have been seen overseas, it is likely that this case, which is reported, is related to the vaccine,” he said.

He said investigations were ongoing.

“I acknowledge that these reports lead to uncertainty and anxiety and we will continue to provide more information to you as soon as we have it available,” Professor Kidd said.

While investigations continue, both the TGA and the Australian Technical Advisory Group on Immunisation (ATAGI) have said no change to Australia's vaccine rollout was needed.

Youtube Professor Michael Kidd's press conference
"The risks of serious side effects remain very low," Professor Kidd said.

"But safety is paramount, which is why ATAGI and the TGA continue to do due diligence on this case.

"We have not been advised at this time by ATAGI or the TGA to pause the rollout of the AstraZeneca vaccine in Australia.

"We continue to follow the medical advice of our national experts."

He was then admitted to Box Hill Hospital with what was described as a rare clotting disorder, thrombosis.

 

[Hypocrite-The]

Seven deaths in UK among AstraZeneca jab recipients after blood clots: Medical regulator
Vials with Covid-19 Vaccine stickers attached and syringes with the logo of British pharmaceutical
Vials with COVID-19 Vaccine stickers attached and syringes with the logo of British pharmaceutical company AstraZeneca. (Photo: AFP/Justin Tallis)
03 Apr 2021 08:00PM
(Updated: 03 Apr 2021 08:00PM)
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LONDON: The UK medical regulator said Saturday (Apr 3) that out of 30 people who suffered blood clots after receiving the Oxford-AstraZeneca vaccine, seven have died.

The British acknowledgement of deaths comes as several European countries have paused the use of the AstraZeneca jab over a potential link to blood clots.

The UK's Medicines and Healthcare products Regulatory Agency said in a statement: "Out of the 30 reports up to and including Mar 24, sadly seven have died."

READ: UK logs 30 cases of blood clots after AstraZeneca COVID-19 vaccine
The Netherlands on Friday halted vaccinations with the AstraZeneca jab for people under the age of 60 after five new cases among women, one of whom died.

Germany took a similar decision earlier this week.

The European Medicines Agency (EMA), which like the World Health Organization previously declared the AstraZeneca vaccine safe, is expected to announce updated advice on the issue on Apr 7.

READ: Netherlands halts use of AstraZeneca COVID-19 vaccine for people under 60
The EMA said again on Wednesday it believes the vaccine is safe and that experts have found no specific risk factors such as age, gender or medical history.

The UK regulator said that the 30 reports of thrombosis, submitted by medics or members of the public via a government website, came after 18.1 million doses of the vaccine had been administered in the country.

Most of the cases (22) were cerebral venous sinus thrombosis, a rare condition when a blood clot forms in the brain.

Eight other cases saw people suffer thrombosis and low levels of blood platelets, which help blood clot.

There were no reports of blood clots from the Pfizer-BioNTech vaccine it said, adding that "our thorough review into these reports is ongoing:.

The regulator's website says that on the basis of current data, the benefits of the vaccines against COVID-19 "continue to outweigh any risks".

AstraZeneca said last month following US efficiency trials that its vaccine is 79 per cent effective at preventing the disease and does not increase the risk of blood clots.

The UK has administered more than 31 million first vaccine doses, using both the Oxford-AstraZeneca and the Pfizer-BioNTech jabs. People cannot choose which one they get.

The UK in June last year ordered 100 million doses of the Oxford-AstraZeneca vaccine and supported its development. It also ordered 30 million doses of the Pfizer-BioNTech vaccine the same year.

 

[Hypocrite-The]

US stops AstraZeneca vaccine production at Baltimore plant | Malay Mail
Vials labelled ‘Astra Zeneca Covid-19 Coronavirus Vaccine’ and a syringe are seen in front of a displayed AstraZeneca logo, in this illustration photo taken March 14, 2021. — Reuters pic
Vials labelled ‘Astra Zeneca Covid-19 Coronavirus Vaccine’ and a syringe are seen in front of a displayed AstraZeneca logo, in this illustration photo taken March 14, 2021. — Reuters pic
Subscribe to our Telegram channel for the latest updates on news you need to know.

NEW YORK, April 3 — The United States has put Johnson and Johnson in charge of a plant that ruined 15 million doses of its Covid-19 vaccine and has stopped British drugmaker AstraZeneca Plc from using the facility, a senior health official said today.

J&J said it was “assuming full responsibility” of the Emergent BioSolutions facility in Baltimore, reiterating that it will deliver 100 million doses to the government by the end of May.

The Department of Health & Human Services facilitated the move, the health official said in an email, asking not to be named due to the sensitivity of the matter.

AstraZeneca, whose vaccine has not been approved in the United States, said it will work with President Joe Biden’s administration to find an alternative site to produce its vaccine.

White House officials did not immediately respond to a request for comment.

The development, first reported by the New York Times, further hampers AstraZeneca’s efforts in the United States. The government has criticized the drugmaker for using outdated data in the results of its vaccine trial. It later revised its study.

Workers at the Emergent BioSolutions plant several weeks ago conflated ingredients for the J&J and AstraZeneca vaccines, the Times said earlier in the week. J&J said at the time the ruined batch had not advanced to the fill-and-finish stage.

The government’s move to have the facility make only the J&J single-dose vaccine is meant to avoid future mix-ups, the Times said, citing two senior federal health officials.

The top US infectious disease doctor told Reuters on Thursday the country may not need AstraZeneca’s vaccine even if it wins approval.

The United States has loan deals to send Mexico and Canada roughly 4 million doses of the AstraZeneca vaccine, made at its US facility. — Reuters

 

[Hypocrite-The]

Government announces Pfizer as the preferred vaccine for people under the age of 50
Posted 5h

Prime Minister Scott Morrison said the government accepted the recommendations from ATAGI to prioritise Pfizer in adults under the age of 50.
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Australian health authorities have advised the Pfizer vaccine should be given to Australians aged under 50, amid concerns of rare blood clots potentially linked to the AstraZeneca vaccination.
Key points:

• The European Union's medical regulator found blood clots were a rare occurrence in young adult recipients of the AstraZeneca vaccine
• One Australian was hospitalised after developing blood clots after being vaccinated
• People who have safely received their first dose of AstraZeneca are advised it is safe to have their second

The Federal Government's expert medical taskforce met on Wednesday to consider use of the AstraZeneca vaccine, following advice from the European Union's medical regulator that "very rare cases of blood clots" were a side-effect in the weeks after the vaccine was administered.
The United Kingdom decided to offer other vaccines, such as the one produced by Pfizer, to people aged under 30.
Chief Medical Officer Paul Kelly made the announcement, flanked by the Prime Minister Scott Morrison, in an unexpected press conference on Thursday night.
"The use of the Pfizer vaccine is preferred over the AstraZeneca vaccine in adults aged less than 50 years who have not already received a first dose of AstraZeneca vaccine," Professor Kelly said.
"This is based both on the increased risk of complications from COVID-19 with increasing age, and thus increased benefit of the vaccination, and the potentially lower, but not zero risk, of this rare event with increasing age.
Professor Kelly said people who have had their first dose of the AstraZeneca vaccine, and had not experienced any "adverse side effects", can be given their second dose.

Professor Brendan Murphy explains the changes to Australia's vaccine rollout.
"People who have had blood clots associated with low platelet levels after their first dose of COVID-19 AstraZeneca should not be given the second dose," he said.
"That's the all but one person that we've had so far in Australia are in that category."
A Melbourne man was hospitalised last week, developing blood clots almost a fortnight after receiving the AstraZeneca vaccine.

The European Medicines Agency says the risk of dying from COVID-19 is far greater than the risk from vaccine side effects.Announcement brings changes to national vaccine rollout
Prime Minister Scott Morrison said planning would continue through the night to consider how the advice from the Australian Technical Advisory Group on Immunisation (ATAGI) would change the national vaccine rollout.
"There are, of course, Pfizer vaccines that are in Australia, and we are getting a regular supply of those," Mr Morrison said.
"They can be prioritised against the individuals for whom that will be the more appropriate vaccine for them.
"But we will just have to work through the logistics of that and the calibration of how that is done."
The matter will also be discussed by state and territory leaders at Friday's national cabinet meeting.
The Chief Medical Officer said the decision was made to ensure confidence in the coronavirus vaccine program.
"We've taken very rapid decisions to look at that data carefully and to make the decision that has been made today, and the advice has come from medical experts on that basis," Professor Kelly said.
"We're sharing that with the Australian public so that they can be aware and know that, if we ever get that information, we will immediately and fully be transparent about it."
Australia's vaccination program is currently only in phase 1a and 1b, which focuses on frontline healthcare and quarantine workers, aged care residents and staff, older and vulnerable Australians.
The Prime Minister was asked whether the advice about the AstraZeneca vaccine would blow out the Commonwealth timeframe for all Australians to receive at least one dose of the COVID-19 jab by the end of the year.
"I think we have to take the time to assess the implications for the program," Mr Morrison said.
"When we've done that, we may be able to form a view, but I don't think anyone should expect that any time soon.
"But it won't stop the work that we're doing in rolling out the vaccination program right now with the doses that we have, particularly from Pfizer, but also rolling out from AstraZeneca, which are predominantly for older Australians above 50 in phases 1a and 1b."

The AstraZeneca vaccine presents minimal risk for a profound reward.

 

[Hypocrite-The]

Philippines suspends AstraZeneca vaccine for under 60s - The Online Citizen Asia

The Philippine health department suspended Thursday the use of the AstraZeneca COVID-19 jab for people under 60 after reports of blood clots overseas, in a setback for the country’s already slow vaccine rollout.
It comes amid a record surge in coronavirus infections that has forced more than 24 million people in the capital and surrounding provinces into a lockdown.
Several European countries have suspended the use of AstraZeneca’s vaccine for younger populations after it was earlier banned outright in several places over blood clot scares.
The EU’s medicines regulator said Wednesday blood clots should be listed as rare side effects of the jab, but the benefits continue to outweigh the risks.
“While we have not seen such incidents in the country, the FDA has recommended to temporarily suspend the use of the vaccine for persons below 60 years old as we await results of the review being done by our local experts, as well as the official guidance of the WHO,” Food and Drug Administration director-general Eric Domingo said.
The Philippines has received around 2.5 million doses of COVID-19 vaccines so far — the majority from China’s Sinovac.
It also got 525,600 AstraZeneca doses through the Covax programme, most of which have been administered already, according to official data.
The country expects another three million AstraZeneca doses in the coming months.
President Rodrigo Duterte’s government has been skewered by critics over its handling of the pandemic and efforts to secure vaccines.
The 2.5 million doses received so far represent a fraction of the shots Manila has been negotiating with seven manufacturers to secure.
The bulk of the supply is not expected until later this year.
But the challenge is not limited to stock.
Low public confidence in vaccines remains after the country became the first to deploy the dengue vaccine Dengvaxia in 2016.
A botched rollout led to unfounded claims that several dozen children had died from the jab, and a recent survey showed about 60 percent of the population were unwilling to be inoculated against Covid-19.
“I want to emphasize that this temporary suspension DOES NOT MEAN that the vaccine is unsafe or ineffective — it just means that we are taking precautionary measures to ensure the safety of every Filipino,” Domingo said in the statement.
The World Health Organization’s Western Pacific office on Wednesday backed the use of the AstraZeneca vaccine in the region.
“Available data do not suggest any overall increase in the clotting conditions in the vaccinated population as compared to the general population,” Socorro Escalante, WHO essential medicines coordinator, told reporters.
The European Medicines Agency examined 86 blood clotting cases, 18 of which were fatal, out of around 25 million people in Europe who received the AstraZeneca vaccine. Most of the cases were in women aged under 60.
– AFP

 

[Hypocrite-The]

AstraZeneca: Who is using the jab, and who is not
The fallout over the AstraZeneca jab continued Thursday with several countries halting its use among younger people, as nations raced to secure much-needed vaccines in the face of fresh virus surges.

The European Medicines Agency says blood clots should be listed as a "very rare" side
The European Medicines Agency says blood clots should be listed as a "very rare" side effect of the AstraZeneca vaccine. (Photo: AFP/Joel Saget)
08 Apr 2021 11:57PM
(Updated: 09 Apr 2021 10:31PM)
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PARIS: The AstraZeneca vaccine's rollercoaster ride has taken another twist with a growing list of countries restricting its use over "very rare" blood clots.

While Britain, whose Oxford University developed it, now no longer recommends it for the under 30s, South Africa has rejected it outright.

READ: How worried should we be about links of blood clots to AstraZeneca's COVID-19 vaccine?
Nevertheless, the vaccine is still the most widely used in the world and remains cheaper and easier to store than its competitors.

It has already been given in some 111 countries - more than its competitors Pfizer-BioNTech and Moderna put together - according to an AFP database from official sources.

Here is an overview of where the jab is now being restricted:

DITCHED

South Africa suspended its vaccine rollout - meant to begin with AstraZeneca in February - after a study found the jab failed to prevent mild and moderate illness caused by a variant found there.

Instead it offered its doses to the African Union.

SUSPENDED

More than a dozen countries including the biggest European Union nations suspended AstraZeneca shots in mid-March because of fears over blood clots and other possible side effects.

Most then restarted using it after Europe's drugs regulator said it was "safe and effective".

But some other countries continued their suspensions, including Norway and Denmark.

Hong Kong said on Friday it had asked AstraZeneca to suspend delivery of its vaccine.

"We think it is not necessary for AstraZeneca to deliver the vaccines to the city within this year," said the city's health chief, adding Hong Kong wanted "to avoid any waste as vaccines are in short supply globally".

RESTRICTED

Many countries have resumed the vaccine's use only for older people, aged 55 and above, because the clots tend to affect younger people more.

These include France, Canada, Germany, the Netherlands, Finland, Iceland and Sweden.

READ: Covax backs AstraZeneca as COVID-19 vaccines reach 100 territories
But the doubts about blood clots did not go away, and the EU and British drugs regulators said Wednesday that it was linked to clotting in some rare cases.

Spain, the Philippines and Italy reacted by suspending the jab for people under 60 while Belgium restricted it to over 55s.

Australia says it should no longer be given to people under 50 unless they had already received a first dose without ill effects.

Oxford University has suspended trials on children following the new concerns.

Britain, which has already given more than 20 million doses of jab, says it will now offer alternative vaccines to young people.

France said on Friday that people under 55 who received a first dose of AstraZeneca's COVID-19 vaccine should receive a new-style messenger RNA (mRNA) vaccine for their second dose.

Two mRNA vaccines, one from Pfizer and BioNTech, and another from Moderna, have been approved for use in France.

MOST WIDELY USED

Despite criticisms over supply difficulties and safety concerns, the AstraZeneca vaccine is today being administered in around 111 countries and territories.

The jab also forms the bulk of those being given for free to poorer countries under the Covax scheme led by the WHO, the Gavi vaccine alliance and the Coalition for Epidemic Preparedness Innovations.

 

[Hypocrite-The]

How worried should we be about links of blood clots to AstraZeneca's COVID-19 vaccine?
COVID-19 vaccinations in Madrid
A vial containing the AstraZeneca COVID-19 vaccine is seen at a vaccination centre in Madrid, Spain, Apr 9, 2021. (Photo: REUTERS/Sergio Perez)
09 Apr 2021 06:47PM
Bookmark
ZURICH: Europe's drug regulator on Wednesday (Apr 7) said it had found a possible link between AstraZeneca's COVID-19 vaccine and very rare blood clots in adults who received the shot. Britain recommended people under 30 get an alternative COVID-19 vaccine if possible.

Here's what we know so far.

WHAT HAS HAPPENED?

The European Medicines Agency (EMA) said its vaccine side effects monitoring system, as of Apr 4, had received 169 reports of cases of cerebral venous sinus thrombosis (CVST), or clots in blood vessels exiting the brain, and 53 cases of splanchnic vein thrombosis (SVT), or clotting in veins in the abdomen.

That's out of about 34 million AstraZeneca vaccine doses administered in Britain and the European Economic Area since vaccinations started almost three months ago.

Its safety committee carried out a review of 62 cases of CVST and 24 cases of SVT, of which 18 were fatal.

READ: AstraZeneca - Who is using the jab, and who is not
Most of the cases reported have occurred in women under 60, though that could be misleading. Germany and Britain say many more women received AstraZeneca's shot than men.

Most cases occurred within two weeks of the person receiving their first dose.

German vaccination officials who recorded 29 cases of CVST in women aged 20 to 59 who got the AstraZeneca vaccine said the occurrence rate in that group was 20 times higher within 16 days of vaccination than what would have typically been expected.

Germany's health ministry has said one to 1.4 cases of CVST would have been expected during that time.

WHAT HAS BRITAIN'S REGULATOR SAID?

The Medicines and Healthcare products Regulatory Agency reviewed 79 cases of rare clotting coupled with low platelets, with 19 fatalities - 13 women and six men. Eleven of the deaths were of people under the age of 50 and three under 30.

All 79 cases occurred after a first dose of the vaccine.

READ: French under-55s given AstraZeneca COVID-19 jab to get different second vaccine
HOW DID REGULATORS COME TO THEIR DECISION?

British officials drew on statistics from the University of Cambridge's Winton Centre for Risk and Evidence Communication to explain their recommendations that young people get an alternative shot while older people still get AstraZeneca's.

According to the centre, vaccination with the AstraZeneca shot would reduce admissions to intensive care units by nearly seven in 100,000 people in the group aged 20 to 29 years old with high risk of exposure to the virus, while 1.1 people per 100,000 people in the same group were estimated as likely to suffer serious vaccine-related harms.

The risk of serious harm due to vaccination falls further the older people get, and intensive care unit admissions prevented by vaccination rise sharply, boosting the AstraZeneca shot's benefit-to-risk ratio.

The centre concluded only 0.4 people for every 100,000 in the 50 to 59 age group would suffer vaccine-linked harm, while 95.6 ICU admissions per 100,000 people would be prevented.

READ: AstraZeneca woes grow as Australia, Philippines, African Union curb COVID-19 shots
Syringes with AstraZeneca vaccine against the coronavirus disease (COVID-19) are pictured in Helsin
Syringes filled with the AstraZeneca vaccine against COVID-19. (File photo: REUTERS/Essi Lehto)
EMA investigators checked if the frequency of events was higher in the vaccinated population than normal background rates drawn from public health statistics or insurance records. This would be combined with a medical analysis of each case and insight from scientific literature.

In its findings, the EMA said on Mar 18 that, on average, just 1.35 cases of CVST might normally have been expected among people under 50 within 14 days of receiving AstraZeneca's vaccine, whereas by the same cut-off date 12 cases had been recorded.

By comparison, four women out of 10,000 would get a blood clot from taking oral contraception.

Key to the EMA's assessment that benefits continue to outweigh risks are its conclusions about likelihood of an increased risk from clotting, compared with the benefits of preventing COVID-19 and reducing hospitalisations and deaths.

READ: WHO says AstraZeneca COVID-19 vaccine benefits outweigh risks; assessing latest data
WHAT'S THE EU DOING NOW?

The EMA said that unusual blood clots with low blood platelets should be listed as very rare side effects and countries should decide on how to proceed with their national COVID-19 immunisation campaigns.

These may vary from nation to nation, the EMA said, depending on factors like how quickly infections are spreading and whether vaccines are available. Its safety committee requested new studies, and changes to ongoing ones, to provide more information about the mechanism behind the rare clots.

AstraZeneca and European regulators have said concerns about blood disorders did not emerge during clinical trials.

READ: Malaysia deliberating over use of AstraZeneca COVID-19 vaccine after EU findings
ARE THERE ANY THEORIES FOR WHAT MAY BE LEADING TO THE CLOTS?

Among possible causes for these rare cerebral sinous vein clots being investigated are that the vaccine triggers an unusual antibody in rare cases.

The EMA said the vaccine may trigger an immune response leading to the unusual clotting, though it acknowledged that scientists have yet to identify any risk factors that might predispose somebody to clotting combined with low platelets.

German scientists at Greifswald University concluded the vaccine is linked to the side effects, though their work still requires peer review. Andreas Greinacher, an expert on drug-induced immune responses, said specimens he has examined exhibited unusual antibodies that activate blood platelets, prompting the clots.

Greinacher is still seeking clues about why some people had clots and others did not.

 

[Hypocrite-The]

Johnson & Johnson COVID-19 vaccine under EU review over blood clots
Posted 1h
A health worker loads syringes with the vaccine on the first day of the Johnson & Johnson vaccine being made available.
Nearly 5 million people in the United States had received J&J's vaccine as of Thursday morning.
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Europe’s drug regulator says it is reviewing rare blood clots in four people in the United States who received Johnson & Johnson’s COVID-19 vaccine.

Key points:
Johnson & Johnson said it was aware of the rare reports of blood clots, and was working with regulators to assess the data
The US Food and Drug Administration said it was aware of the reports, but they had "not found a causal relationship with vaccination"
It follows an investigation of blood clots reported by some people given the AstraZeneca vaccine, which has prompted some countries to change their vaccine recommendations
The European Medicines Agency’s safety committee has also been looking at how AstraZeneca’s COVID-19 vaccine is associated with very rare cases of unusual blood clots and said it was now reviewing reports of capillary leak syndrome in people given AstraZeneca’s vaccine.

Johnson & Johnson (J&J) said it was aware of the rare reports of blood clots in individuals given its COVID-19 vaccine, and was working with regulators to assess the data and provide relevant information.

“At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine,” the company said in an emailed statement.

Of the four serious cases of clotting and low platelets, three occurred in the United States during the rollout of J&J’s vaccine from its Janssen unit, the European Medicines Agency (EMA) said.

That was in addition to one person who died from a clotting disorder reported in J&J’s clinical trial.

The US Food and Drug Administration said it was aware of a few reports of individuals who had serious blood clots — sometimes linked with low levels of blood platelets — after they received the J&J vaccine, and noted that these conditions could have many different causes.

“We have not found a causal relationship with vaccination and we are continuing our investigation and assessment of these cases. Our analysis of the data will inform the potential need for regulatory action,” the agency said in an emailed statement.

Review part of normal process
Nearly 5 million people in the United States had received J&J’s vaccine as of Thursday morning, according to the US Centers for Disease Control and Prevention.

The report from the EMA is the first to mention a probe of blood clots associated with the J&J vaccine.

The FDA said it was aware of the EMA’s statement and provided the agency with the data that formed the basis of its report.

The EMA’s statement follows an investigation of blood clots in the brain reported by some people given the AstraZeneca vaccine, which has prompted some European countries to change their vaccine recommendations.

In its report on Friday, EMA’s safety committee said unusual blood clots linked with low blood platelets should be listed as very rare side effects of the AstraZeneca vaccine.

It has also started to investigate reports of capillary leak syndrome — which causes blood vessel swelling and a drop in blood pressure — in five people who received the AstraZeneca vaccine.

The safety panel said it was not clear whether these were linked with the vaccine. AstraZeneca did not immediately respond to a request for comment.

AstraZeneca vaccine in a lab
The EMA’s statement follows an investigation of blood clots in the brain reported by some people given the AstraZeneca vaccine.( Supplied )
Ian Douglas, a professor of pharmacoepidemiology at London School of Hygiene and Tropical Medicine, said the reports were part of a normal process in which the EMA’s safety committee reviews important safety signals as they arise.

“It’s too early to comment on the signal of capillary leak with the AZ vaccine, or clots with the Janssen vaccine, but from what we’ve seen in the last few weeks, the EMA’s PRAC (Pharmacovigilance Risk Assessment Committee) will doubtless assess all the evidence they have as thoroughly and quickly as possible,” he said.

Use of AstraZeneca restricted
Some countries have restricted the use of AstraZeneca’s vaccine, Vaxzevria, in younger people following an update by EU and UK regulators this week that found a link between the events and the shot.

Following the update, Australian health authorities advised the Pfizer vaccine should be given to Australians aged under 50, instead of the AstraZeneca vaccination.

Play Video. Duration: 1 minute 11 seconds
Scott Morrison stressed the AstraZeneca vaccine was safe.
Regulators have said the benefits of the vaccine outweigh the risks.

J&J’s single-dose vaccine has been approved for EU use, but a rollout is yet to begin. It is mainly being used in the United States currently.

The J&J and AstraZeneca shots are two of the four approved COVID-19 vaccinations in Europe.

Reuters

 

[Hypocrite-The]

AstraZeneca’s vaccine: your questions answered
What is the new advice regarding vaccination in Australia?
On Thursday night, the federal government’s Australian Technical Advisory Group on Immunisation (ATAGI) issued new advice recommending Pfizer’s vaccine be “preferred” over AstraZeneca’s vaccine for people under 50.

Professor Allen Cheng, left, co-chair of ATAGI, received the Pfizer vaccine at The Alfred hospital in March.
Professor Allen Cheng, left, co-chair of ATAGI, received the Pfizer vaccine at The Alfred hospital in March. SUPPLIED
That recommendation is based on the reduced risk people under 50 face from COVID-19 compared to older people, and the potentially increased risk people under 50 face from a new blood-clotting side-effect linked to AstraZeneca’s vaccine.

AstraZeneca’s vaccine is still recommended for people aged over 50. People who have already had their first dose of AstraZeneca’s vaccine can have the second.

ATAGI offers advice, but is not an official decision-making body. However, on Thursday night Prime Minister Scott Morrison indicated he would accept their advice.

The decision does not ban the use of AstraZeneca for people aged under 50. ATAGI’s advice is the vaccine is highly effective against COVID-19 and can still be used for people under 50 when the benefits outweigh the risks.

“We also carefully used the word ‘prefer’ (Pfizer over AZ) in younger people. We respect patient autonomy – that people have a choice about the vaccines and treatments they get,” ATAGI co-chair Professor Allen Cheng wrote on Twitter.

What is this rare side-effect, and how much of a risk does it pose?
The side-effect linked to AstraZeneca’s vaccine is an extremely rare and unusual blood-clotting disorder, during which blood platelet levels fall and tiny blood clots form in unusual places in the body, like in veins that drain blood from the brain or gut.

It typically occurs between four and 20 days after injection with AstraZeneca’s vaccine. It remains unclear how the vaccine causes VIPIT, but so far suspicion has focused on an unusual antibody some people with the syndrome have. The antibody appears to activate platelets in the blood, causing clots to form.

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It remains unclear how rare this side-effect is. Current evidence suggests between four and six people in every million vaccinated will develop the syndrome, ATAGI says, with higher rates reported in some countries like Norway.

There are no specific risk factors known, nor any medical conditions proven to increase the risk of VIPIT.

At this stage, it has a roughly 25 per cent fatality rate, although experts think that is likely to fall as doctors become more aware of the risk.

What is the evidence that AstraZeneca actually causes this syndrome, and it’s not just random chance?
That has been hotly debated since cases first started showing up.

It is very, very difficult to conclusively prove a vaccine causes a rare side-effect outside a clinical trial, and AstraZeneca’s clinical trial did not show this risk, which is to be expected for very rare side-effects. Events that seem to happen in a pattern can often be caused by random chance. As late as Monday, Thrombosis and Haemostasis Society Australia and New Zealand told The Age “we cannot say there is a causal link”.

After reviewing the evidence, ATAGI concluded AstraZeneca’s vaccine “appears likely to be causally-linked” to the syndrome.

The evidence suggesting a link comes primarily from two sources: the number of people reporting cases, and the time they are reporting them after receiving AstraZeneca’s vaccine.

Data from Europe suggests between four and six people in every million vaccinated will suffer from the syndrome, which is more than would be expected if the vaccine was not causing an increased risk. And most of these cases happen between four and 20 days after vaccination.

“The overwhelming evidence really just relates to the timing. The events are happening between four and 20 days post-first dose of vaccine. And that’s been relatively consistent in all the cases that have been described,” says Professor Paul Monagle, a paediatric haematologist at the University of Melbourne who is studying the syndrome.

What have other countries done?
Every country faces a different epidemic, and therefore they have come to different responses.

Britain has opted to offer people aged under 30 an alternative vaccine if available. Germany decided on an age cut-off of 60, and recommended people who have had their first dose of AstraZeneca receive a second dose of a different vaccine – despite a lack of clinical evidence showing this is safe and effective.

France chose to limit the second jab to people over 55, with second doses being switched out for mRNA vaccines. The Philippines suspended the use of AstraZeneca for people younger than 60 this week, as did South Korea, Portugal and the Netherlands.

What does this mean for AstraZeneca’s vaccine?
At this stage, that remains unclear. On the basis of ATAGI’s advice, the vaccine appears likely to still be given to Australians aged over 50, of which there are several million.

Doses will continue to be delivered from CSL’s Broadmeadows plant. If there is surplus, that opens the possibility for Australia to rapidly supply them to other countries – like our Pacific neighbours – who are dealing with urgent outbreaks.

CSL’s AstraZeneca lab in Melbourne. Jason South

ATAGI’s advice also leaves the door open for administering AstraZeneca’s vaccine to Australians under 50 in the event of a major local outbreak.

Can I get one if I am under 50?
On ATAGI’s advice, it would appear likely: “AstraZeneca can be used in adults aged under 50 years where the benefits are likely to outweigh the risks for that individual and the person has made an informed decision based on an understanding of the risks and benefits,” the advisory group recommends.

Do we have enough alternatives to vaccinate the under 50s?
Make no mistake, onshore production of AstraZeneca’s vaccine was the foundational centrepiece of Australia’s vaccine strategy. The government had initially purchased 20 million doses of Pfizer’s two-dose vaccine, 53.8 million doses of AstraZeneca’s vaccine, and another 51 million doses of Novavax’s vaccine.

On Thursday night, Australia managed to secure another 20 million doses of Pfizer’s vaccine, which are likely to be available in the final quarter of this year. All up, that should be enough to fully cover Australia.

It is not yet clear if Novavax’s vaccine will be approved for use in Australia, despite encouraging data so far. The vaccine remains in late-stage clinical trials. If those trials succeed, the government has said it expects all 51 million doses will be delivered by the end of the year.

Will this mean Australia’s rollout will be delayed and by how long?
ATAGI co-chair Professor Allen Cheng wrote on Twitter there was “no question that this decision will slow things down – having on-shore capacity to produce vaccine is very valuable”.

The federal government’s current goal is to offer all Australians their first jab by October.

“Tomorrow, and over the weekend, there will be a recalibration of how the program will need to be adjusted to take into account decisions the government’s taken tonight to accept those recommendations from ATAGI,” Prime Minister Morrison said on Thursday night.

Prime Minister Scott Morrison announces that Pfizer is the preferred vaccine for Australians under 50. Alex Ellinghausen

Chief Medical Officer Paul Kelly said on Friday that deals with other vaccine manufacturers were possible. So far, Australia has received 870,000 doses of Pfizer’s vaccine, with about 130,000 to 150,000 doses arriving on our shore every week; the federal government says it has received assurances this number will increase.

Why are younger people believed to be more susceptible than older people?
On the data we have, there is a slightly higher incidence of VIPIT in younger people. British data suggests for every 100,000 people aged 20 to 29 given the vaccine, 1.1 will suffer from blood-clotting problems.

That risk falls to 1 in 500,000 for people aged 60 to 69. It remains unclear why this might be.

Professor Paul Monagle points out that autoimmune conditions – one hypothetical cause of VIPIT – are more common in younger people. But the rare condition that most closely-resembles VIPIT, heparin-induced thrombocytopenia, is far more common in adults than children.

“Your immune system clearly changes with age. During childhood, you’re meeting lots of antigens for the first time. As you get older, your immune system has previously been exposed. All of those things will have an impact.”

Was ATAGI’s advice overly cautious?
The risk of dying from a complication from the AstraZeneca vaccine is smaller than other commonly encountered risks, like drowning while swimming, being in a car crash, or binge drinking.

“I accept the call by ATAGI,” wrote Dr Stephen Parnis, former president of AMA Victoria, on Twitter. “But I’ll make the observation that if every therapeutic agent was pulled because of a vanishingly rare complication, there would be nothing left to prescribe.”

Scientists on Friday differed on whether ATAGI’s advice was too risk-adverse.

“Genuinely surprised by ATAGI decision, but understand made with patient safety in mind,” Professor Greg Dore, an infectious diseases physician and epidemiologist at the Kirby Institute, wrote on Twitter (he declined an interview request).

“Believe narrow framework of individual patient risk – incredibly small in this case – that most doctors use is the wrong perspective when achieving broader public health goals is key objective.

“Doctors don’t tell vast majority of their patients not to drive, not to go on holidays.”

Professor Fiona Russell, a vaccine expert at the Murdoch Children’s Research Institute, pointed out there were three to four serious side-effects per million doses for the polio vaccine “but we still gave it to all Australian babies even though there was no polio in Australia”.

“At the moment there is not a COVID alternative vaccine to the scale that is required. However, this will change over time but we have no timeline.

“The public should be able to make their own decision, in consultation with their GP after a discussion on risk and the unknown about alternatives.”

Dr Jose Perdomo, senior officer at the Haematology Research Unit at the University of NSW, said ATAGI’s call was the right one.

“Even though the risk of serious thrombosis following AstraZeneca’s vaccination is extremely low, I believe that restoring public confidence in vaccination was a key consideration by ATAGI.”

I’ve already had the first dose of AstraZeneca. Is it OK for me to get the Pfizer jab now instead of getting a second dose of AstraZeneca?
ATAGI’s advice on this question is as follows: “People who have had the first dose of COVID-19 vaccine AstraZeneca without any serious adverse effects can be given the second dose, including adults under 50 years.”

Are people who have blood-clotting conditions, or are using blood-thinning medication, at any greater or lesser risk?
So far, no underlying medical conditions or biological risk factors have been linked to an increased or decreased risk, ATAGI advises.

Can I choose which vaccine I get?
Yesterday, the answer would have been a clear no. But things are less clear now. ATAGI’s advice is merely to “prefer” Pfizer over AstraZeneca for people aged under 50, while still allowing them to access it where the benefits outweigh the risks. It remains unclear if people under 50 will be offered a choice of vaccine.

 

[Hypocrite-The]

Blood clot concerns over second vaccine
APRIL 10, 20213:36pm
NSW resumes AstraZeneca vaccine rollout to over 50s
James Hall
NCA NewsWire
The European drug regulator has revealed it is reviewing rare blood clots suffered by recipients of the Johnson and Johnson vaccine in the United States.

The European Medicines Agency (EMA) said it was investigating four serious cases but it was unclear at this stage if the clots were related to the vaccine or another medical issue.

Three of the cases occurred during the US rollout where nearly five million had been given the vaccine by Thursday, while one was during a clinical trial.

In one of the cases, the person died from the complication.

Johnson and Johnson said it was aware of the review and was working with regulators to assess the issue, but insisted “no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine”.

Johnson and Johnson vaccine, known as the Janssen COVID-19 Vaccine, has suffered a setback. Picture: Joseph Prezioso / AFPSource:AFP

The major pharmaceutical’s jab is currently only available in the US and was scheduled to be issued in the European Union in coming weeks.

Australia has not yet committed to the Johnson and Johnson vaccine but the complication comes amid concerns with the AstraZeneca shot, which is threatening to derail confidence in the rollout.

Professor Mary-Louise McLaws, an epidemiologist at the University of New South Wales, insisted the extremely rare complications in each of the vaccines far outweighed the threat of COVID-19.

“It's all about putting into proportion the risk of death to our elderly group who represent 100 per cent of all coronavirus deaths in Australia,” she told NCA NewsWire.

“They only die if they get COVID, so to keep them from getting infected we have to ring-fence them.

“In the context of a pandemic, there’s this enormous risk of this older group dying so you want to protect them by vaccinating everybody, but particularly the young ones who have a greater risk of acquiring it and transmitting it.”

Despite Australia not yet committing to the Johnson and Johnson vaccine, the hiccup from the EMA this week threatens to complicate an already increasing supply issue across the globe.

Prime Minister Scott Morrison on Thursday refused to commit to the nation’s jab rollout being completed this year as Professor McLaws offered a far more gloomy timeline — she expects delays to vaccine supply leading to Australia’s borders remaining closed up until the end 2022.

The AstraZeneca shot won’t be offered to Australians under the age of 50 following advice from the Australian Technical Advisory Group on Immunisation, which will free-up supply for the older cohort.

“So now that we have less people requiring AstraZeneca, we've got a little bit more (supply) space,” the professor said.

“But if we want to open up anytime soon next year, that supply of AstraZeneca is going to have to be increased to get people vaccinated in time because there's a three-month delay between the first and the second shot.

“So just because fewer people need it, doesn't mean we’re out of the woods yet because the government is going to have to run two cohorts and they’re going to have to match the speed so we can open up our borders.”

 

[Hypocrite-The]

Can Australia produce mRNA COVID-19 vaccines such as Pfizer?
Posted Yesterday at 7:00pm, updated Yesterday at 9:34pm
Glass vials in the foreground, masked people in background
Australia is already making one type of COVID-19 vaccine. What's stopping us from expanding our repertoire?(Getty Images: Thomas Kienzle/AFP)
Vaccine experts say Australia has the potential to make mRNA vaccines such as Pfizer on home soil — but it will take time and investment to ramp up domestic manufacturing capabilities.

Key points:
Australia is producing 20 million AstraZeneca COVID vaccines
New medical advice recommends under-50s should be given the Pfizer mRNA vaccine, and not AstraZeneca, unless benefits outweigh risks
Experts say Australia could and should eventually start making mRNA vaccines. given the resources to do so
This follows health authorities advising that the Pfizer vaccine should be given to Australians aged under 50, amid concerns of rare blood clots potentially linked to the AstraZeneca vaccine.

Archa Fox, an mRNA researcher at the University of Western Australia, says there is nothing stopping us from making the Pfizer vaccine here.

"This is what we've been saying for almost a year. We could be making it. We just need investment," she says.

"It is actually not that complicated to do from a scientific point of view.

"The technology, the equipment — it exists, we can buy it, we just need, essentially, the will."

RMIT University professor of immunology Magdalena Plebanski agrees.

"Scientifically, we are mature and ready to take on a challenge like that as a country," she says.

Dr Fox says it's frustrating knowing the Pfizer vaccine wasn't backed harder by the federal government last year, but admits it would have been difficult for experts weighing up the options.

"It's all very well and good to say with the benefit of hindsight that we should have invested in this one early on," she said.

"Because at the start of the pandemic, and middle of last year, there were so many vaccines being developed that it was hard to know which one was going to be the right one."

So, why aren't mRNA vaccines such as Pfizer already being made in Australia?

And why did Australia choose to manufacture AstraZeneca in the first place?

Here's what we know so far.

Watch
Duration: 3 minutes 13 seconds
3m 13s
Pfizer vs AstraZeneca
Both Pfizer and AstraZeneca COVID-19 vaccines work in the same basic way.

They train the body's immune system to recognise the spike protein in SARS-CoV-2 (the virus that causes COVID-19).

But they do so using different technologies.

AstraZeneca uses a harmless chimpanzee adenovirus to deliver DNA into our cells.

Pfizer, on the other hand, uses messenger RNA (mRNA) encased in a lipid layer, which, until recently, had not been approved for use in a human vaccine.

The mRNA — the active ingredient — is very fragile, which is why it needs to be kept at between -60C and -90C.

Professor Plebanski says because only a few companies in the world manufactured these specialised lipids, it's led to a shortage of supply.

"Even Pfizer itself has acknowledged that some of the components are quite limited," she says.

Professor Plebanski compared building the vaccine to assembling a Lego structure, where one of the main blocks was hard to find.

Dr Fox agrees, explaining that single-use consumable plastic bags that went into the reactor vessels during vaccine production are in short supply.

Supply issues with essential components of the Pfizer vaccine are one reason why Australia wouldn't be able to start manufacturing this jab tomorrow.

So if Australia is to start producing its own mRNA vaccines, Dr Fox says it should also look to make the components as well, eliminating supply issues.

Why Australia's making AstraZeneca
It essentially comes down to already having the manufacturing capabilities.

To make the AstraZeneca vaccine, manufacturers must grow large volumes of mammalian cells, infect them with the adenovirus, filter the adenovirus out, then dilute, test and bottle it.

"There are facilities in Australia [with] the experience to grow safe viral-vector-based vaccines," Professor Plebanski says.

Professor Plebanski says at the moment, Australia simply does not have the manufacturing capability to make mRNA vaccines at the scale we'd need — but we could with enough investment.

As well as these logistical issues, AstraZeneca as a company simply doesn't subcontract in the same way Pfizer does.

"AstraZeneca is very happy to outsource supply," Professor Plebanski says.

However, Pfizer prefers to maintain its rights to the vaccine and manufacture it as well.

Pfizer doses purchased by the Australian government will be manufactured in the United States, Belgium and Germany.

And Pfizer will start closing down its Australian manufacturing facilities next year.

But Pfizer isn't the only COVID-19 mRNA vaccine on the market — Moderna, which is rolling out in the US, uses similar technology — which means there are potentially other avenues to getting a local licence.

'Potential' for future
Dr Fox says even though Australia-made mRNA vaccines aren't on the cards for the first generation of COVID-19 vaccines, they might be in future.

"I don't think it's too late. I don't think this technology is going away. It's here to stay," she says.

The other benefit of manufacturing mRNA vaccines is that it's easier to "tweak" the vaccine to target new and emerging variants, Dr Fox says.

"It's potentially much more straightforward to tweak the sequence for the variant," she says.

 

[Hypocrite-The]

What we know about VIPIT, the rare blood condition affecting the AstraZeneca rollout
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Watch how the AstraZeneca vaccine is made
The AstraZeneca shot was previously meant to be the cornerstone of Australia's rollout.( News Video )
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The federal government has announced the AstraZeneca COVID-19 vaccine is no longer the preferred option for Australians under 50.

This follows reports over recent weeks of blood clots in a small number of people around the world who had received the AstraZeneca vaccine, including one man who was hospitalised in Melbourne.

Scientists have termed the condition "vaccine induced prothrombotic immune thrombocytopenia" (VIPIT). But what does this actually mean, how significant is the risk, and what are the implications for Australia's vaccine rollout — which has been relying predominantly on the AstraZeneca jab?

Play Video. Duration: 2 minutes 25 seconds
Professor Brendan Murphy explains the changes to Australia's vaccine rollout.
A paucity of platelets
As indicated by its name, VIPIT is a form of something called thrombocytopenia.

Thrombocytopenia is a condition whereby the numbers of thrombocytes (very small blood particles, or platelets) are markedly reduced. Platelets form clots to stop bleeding, so when you don't have enough platelets in your blood, your body can't form clots. This can lead to excessive bleeding.

The condition has a genetic component, but can also arise from more than 300 common medicines, including penicillin and certain pain killers. Quinine, which is added to tonic water for flavour, can also very rarely cause thrombocytopenia.

The symptoms of VIPIT can include severe headaches, abdominal pain, seizures and visual changes. These are similar to the symptoms of thrombocytopenia unrelated to the vaccine.

In rare cases of thrombocytopenia, clots can develop in the vessels draining blood from the brain. The European Medicines Agency said it had received reports of 169 cases of brain blood clots in people who had been vaccinated with the AstraZeneca shot.

In severe cases, thrombocytopenia can be fatal. There have been deaths from blood clots reportedly associated with the AstraZeneca vaccine, including 19 in the United Kingdom.

Play Video. Duration: 2 minutes 8 seconds
The European Medicines Agency says the risk of dying from COVID-19 is far greater than the risk from vaccine side effects.
VIPIT appears to present 4-20 days after vaccination, and so far, the issue has been largely associated with women under the age of 65.

So how could this vaccine potentially cause thrombocytopenia? The "prothrombotic immune" part of the name denotes it's caused by an over-activation of the immune system, which gives us a clue.

Platelets and COVID-19
The AstraZeneca vaccine prompts cells to make a specific part of SARS-CoV-2 (the virus that causes COVID-19), called the spike protein, which the virus uses to attach to cells when infecting us.

The vaccine stimulates our immune system to generate antibodies against the spike protein, which then primes the body to mount an immune response against SARS-CoV-2, if it encounters the virus in the future.

But in some people, the AstraZeneca vaccine seems to produce antibodies that react with platelets, making them stick together, leading the blood to clot. This in turn reduces circulating platelet numbers, and hence the thrombocytopenia.

These antibodies are similar to those found in some people on a blood thinning drug called heparin. The immune response to heparin generates antibodies that bind to platelets. This can lead to blood clots in some people, called heparin induced thrombocytopenia. As many as one in 20 patients receiving heparin develop thrombocytopenia.

Keeping in mind we're yet to establish cause and effect, it's a possibility that the biological mechanism by which we believe heparin leads to thrombocytopenia could be the same biological mechanism by which the AstraZeneca vaccine might.

Play Video. Duration: 3 minutes 13 seconds
The AstraZeneca vaccine presents minimal risk for a profound reward.
How common is it?
Naturally occurring thrombocytopenia affects about one in 30,000 adults a year in the United States.

As for the suspected vaccine-induced kind, according to data collated by the Thrombosis and Haemostasis Society of Australia and New Zealand, VIPIT is as rare as one in 500,000 people. But the society notes the data are incomplete.

Different countries have reported different rates. Norway, for example, has so far reported one in 25,000 vaccinated adults under the age of 65 have experienced low platelet counts, bleeding, and widespread thromboses (blood clots).

Of course, the possibility that some of these cases of thrombocytopenia may have occurred regardless of the vaccine makes understanding vaccine-induced cases more complicated. But taken together, thrombocytopenia appears to be more common in the general population than among those who have been vaccinated.

As we continue to vaccinate the world, it's likely small subsets of people will continue to experience this complication. Whether we can establish a causal link between the AstraZeneca vaccine and thrombocytopenia is subject to continued investigation.

Be aware, but not alarmed
Amid this ongoing investigation, some countries, such as Norway, have paused their rollouts of the AstraZeneca vaccine. Others have restricted use of the vaccine in certain groups, like Canada, which is using it only for adults older than 55, who may have higher risks from COVID and lower risk of blood clots. Meanwhile, the UK has pledged to make other vaccine options available for younger people.

We will wait to see how the Australian experts respond. But for the general adult population, we agree with the current guidance from bodies including the European Medicines Agency and the World Health Organization that the benefits of the AstraZeneca vaccine outweigh the risks.

That said, it's not unreasonable to be cautious. You should monitor for these symptoms up to 28 days after receiving the jab:

breathlessness

pain in the chest or stomach

swelling or coldness in the leg

severe or worsening headache

blurred vision

persistent bleeding

multiple small bruises, reddish or purplish spots, or blood blisters under the skin.

If you're experiencing any of these symptoms and you're concerned, seek medical advice.

Anthony Zulli is associate professor, Maja Husaric is senior lecturer; MD, Maximilian de Courten is Professor in Global Public Health and Director of the Mitchell Institute and Vasso Apostolopoulos is Professor of Immunology and Associate Provost, Research Partnerships, at Victoria University. This piece first appeared on The Conversation.

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