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Oxford-AstraZeneca vaccine SUSPENDED!

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3 health workers who received AstraZeneca COVID-19 vaccine in hospital with 'unusual' symptoms, Norway says
FILE PHOTO: A vial of AstraZeneca coronavirus vaccine
FILE PHOTO: A vial of AstraZeneca coronavirus vaccine is seen at a vaccination centre in Westfield Stratford City shopping centre, in London, on Feb 18, 2021. (Photo: REUTERS/Henry Nicholls)
14 Mar 2021 12:11AM
(Updated: 14 Mar 2021 12:21AM)
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OSLO: Three health workers in Norway who recently received the AstraZeneca vaccine against COVID-19 are being treated in hospital for bleeding, blood clots and a low count of blood platelets, Norwegian health authorities said on Saturday (Mar 13).

Norway halted on Thursday the roll-out of that vaccine, following a similar move by Denmark. Iceland later followed suit.

"We do not know if the cases are linked to the vaccine," Sigurd Hortemo, a senior doctor at the Norwegian Medicines Agency told a news conference held jointly with the Norwegian Institute of Public Health.

All three individuals were under the age of 50.

The European medicine regulator EMA would investigate the three incidents, Hortemo added.

"They have very unusual symptoms: bleeding, blood clots and a low count of blood platelets," Steinar Madsen, Medical Director at the Norwegian Medicines Agency told broadcaster NRK.

"They are quite sick ... We take this very seriously," he said, adding authorities had received notification of the cases on Saturday.

AstraZeneca was not immediately available for comment.

Before Denmark's and Norway's move, Austria stopped using a batch of AstraZeneca shots while investigating a death from coagulation disorders and an illness from a pulmonary embolism.

READ: Denmark, Norway temporarily suspend AstraZeneca COVID shots after blood clot reports
Still, EMA on Thursday said the vaccine's benefits outweighed its risks and could continue to be administered.

Europe is struggling to speed up a vaccine roll-out after delivery delays from Pfizer and AstraZeneca, even as a spike in cases amid a more contagious virus variant has triggered fresh lockdowns in countries like Italy and France.
 

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AstraZeneca finds no evidence showing increased risk of blood clots with COVID-19 vaccine
A medical worker administers a dose of the AstraZeneca/Oxford Covid-19 vaccine at a vaccination cen
A medical worker administers a dose of the AstraZeneca-Oxford COVID-19 vaccine at a vaccination centre in a public hospital in Brasilia, Brazil, on Feb 2, 2021. (Photo: REUTERS/Ueslei Marcelino)
15 Mar 2021 06:17AM
(Updated: 15 Mar 2021 06:59AM)
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LONDON: AstraZeneca said on Sunday (Mar 11) a review of safety data of people vaccinated with its COVID-19 vaccine has shown no evidence of an increased risk of blood clots.

AstraZeneca's review, which covered more than 17 million people vaccinated in the United Kingdom and European Union, comes after health authorities in some countries suspended the use of its vaccine over clotting issues.

"A careful review of all available safety data of more than 17 million people vaccinated in the European Union and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country," the company said.

Authorities in Ireland, Denmark, Norway, Iceland and the Netherlands have suspended the use of the vaccine over clotting issues, while Austria stopped using a batch of AstraZeneca shots last week while investigating a death from coagulation disorders.

"It is most regrettable that countries have stopped vaccination on such 'precautionary' grounds: it risks doing real harm to the goal of vaccinating enough people to slow the spread of the virus, and to end the pandemic," Peter English, a retired British government consultant in communicable disease control, told Reuters.

European Medicines Agency has said there is no indication that the events were caused by the vaccination, a view that was echoed by the World Health Organisation on Friday.

The drugmaker said, 15 events of deep vein thrombosis and 22 events of pulmonary embolism have been reported so far, which is similar across other licensed COVID-19 vaccines.

The company said additional testing has and is being conducted by the company and the European health authorities and none of the re-tests have shown cause for concern. The monthly safety report will be made public on the EMA website in the following week, AstraZeneca said.

The AstraZeneca vaccine, developed in collaboration with Oxford University, has been authorised for use in the European Union and many countries but not yet by US regulators.

The company is preparing to file for US emergency use authorisation and is expecting data from its US Phase III trial to be available in the coming weeks.
 

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Another great day for big farma. Not every day the government pays you to conduct clinical trials on their citizenry instead of paying the participants our selves. :sneaky:
 

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Right now...the AstraZeneca vaccine is more dangerous than the mrna vaccines

Italy's Piedmont region stops use of AstraZeneca COVID-19 vaccine batch
FILE PHOTO: Vials labelled "AstraZeneca COVID-19 Coronavirus Vaccine" and a syringe are s
Vials labelled "AstraZeneca COVID-19 Coronavirus Vaccine" and a syringe are seen in front of a displayed AstraZeneca logo in this illustration taken on Mar 10, 2021. (Photo: REUTERS/Dado Ruvic)
15 Mar 2021 03:04AM
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ROME: Italy's northern region of Piedmont said on Sunday (Mar 14) said it would stop using a batch of AstraZeneca coronavirus shots after a teacher died following his vaccination on Saturday.

The region, around the northern city of Turin, had initially suspended all AstraZeneca vaccines in order to identify and isolate the batch from which the jab administered to the teacher, from the town of Biella, came.

The decision, following similar moves elsewhere in Europe, was precautionary and the region is awaiting the results of checks which will verify whether there is a connection between the death and the vaccination, the regional government said in an online statement.

The statement did not specify what batch it had banned nor did it say how the teacher died. Italian newspapers reported it was batch ABV5811. A source close to the regional government confirmed it was batch ABV5811.

The regional government's statement said that the Piedmont region was also awaiting decisions from Italy's medicine's agency Aifa and a regional health commission on the issue.

"It is an act of extreme prudence, while we verify whether there is a connection. There have been no critical issues with the administration of vaccines to date," Luigi Genesio Icardi, head of regional health services, said in the statement.

Italy's medicine authority Aifa on Thursday banned the use of doses of the AstraZeneca vaccine belonging to the ABV2856 batch. Sources told Reuters the decision had been taken after the deaths of two men in Sicily.

Aifa had said that the ban was precautionary, adding that no link had been established between the vaccine and subsequent "serious adverse events".

Authorities in Denmark, Norway and Iceland have suspended the use of the vaccine over blood clotting issues, while Austria stopped using a batch of AstraZeneca shots last week while investigating a death from coagulation disorders.

The European Medicines Agency has said there is no indication that the events were caused by the vaccination, a view that was echoed by the World Health Organisation on Friday. AstraZeneca also said it had found no evidence of increased risk of deep-vein thrombosis.

Ireland also temporarily suspended AstraZeneca's vaccine "out of an abundance of caution" on Sunday, citing reports from the Norwegian Medicines Agency regarding a cluster of serious blood clotting in some recipients there. Earlier on Sunday, Italian Health Minister Roberto Speranza said vaccines in Italy and Europe were "effective and safe", with all checks being carried out, when asked in an interview about the ban.
 

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AstraZeneca says vaccine safe after Ireland joins nations pausing rollout
Posted 2h
Vials labelled "Astra Zeneca COVID-19 Coronavirus Vaccine" and a syringe are seen in front of a displayed Ireland flag
Irish authorities say the vaccination program could resume once safety tests are completed.( Reuters: Dado Ruvic )
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AstraZeneca says a review of safety data of people vaccinated with its COVID-19 vaccine has shown no evidence of an increased risk of blood clots.

Key points:
Ireland is the latest country to suspend the use of the AstraZeneca vaccine
AstraZeneca, the European Medicines Agency and the World Health Organization all say the vaccine is safe
Irish authorities concede they "may be overreacting"
AstraZeneca's review, which covered more than 17 million people vaccinated in the United Kingdom and European Union, came after health authorities in some countries suspended the use of the vaccine over clotting issues.

"A careful review of all available safety data … has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country," the company said.

Italy's northern region of Piedmont also said it would stop using a batch of AstraZeneca coronavirus shots after a teacher died following his vaccination on Saturday.

The region, around the northern city of Turin, had initially suspended all AstraZeneca vaccinations in order to identify and isolate the batch from which the jab administered to the teacher came.

The statement did not specify what batch it had banned, and did not say how the teacher died. Italian newspapers reported it was batch ABV5811, and a source close to the regional government confirmed it to Reuters.

The European Medicines Agency has said there is no indication that blood clotting issues were caused by the vaccination, a view echoed by the World Health Organization.

AstraZeneca said 15 events of deep vein thrombosis and 22 events of pulmonary embolism had been reported so far. Other licensed COVID-19 vaccines have reported similar rates of clotting in patients who have been vaccinated, according to AstraZeneca.

The company said additional tests were being carried out and said none of the re-tests had shown cause for concern.

Play Video. Duration: 3 minutes 50 seconds
Can vaccinated people still transmit the virus?
A monthly safety report would be made public in the next week, AstraZeneca said.

The AstraZeneca vaccine, developed in collaboration with Oxford University, has been authorised for use in the European Union and many countries, including Australia, but has not yet been approved by US regulators.

The company is preparing to file for US emergency use authorisation and is expecting data from its US phase 3 trial to be available in the coming weeks.

'We may be overreacting': Irish authorities
Irish authorities have received some reports of clotting similar to those seen in Europe last week but nothing as serious as the cases in Norway, Deputy Chief Medical Officer Ronan Glynn said.

Dr Glynn said the fact that the Norwegian cases related to a cluster of four unusual clotting events involving the brain in 30 to 40 year-olds raised the level of concern.

He said Ireland was suspending the rollout because it was due to administer the AstraZeneca vaccine to people of a similar age with serious underlying conditions next week.

"Hopefully we will have data to reassure us in a few short days and we will be back up and running with this."

AstraZeneca vaccinations make up 20 per cent of the 590,000 shots administered among Ireland's 4.9 million population, mainly to healthcare workers, after its use was not initially recommended for those over 70 and the company supplied far fewer vaccines to the EU than agreed.

There have been 4,534 COVID-related deaths in Ireland. The number of cases per 100,000 people in the past 14 days fell to 151 from a high of over 1,500 in January, although officials are concerned over a slight rise in new cases in recent days.

In response to Ireland's decision, the UK's medicine regulator said the available evidence did not suggest the vaccine was the cause of the clots.
 

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AstraZeneca jab not linked to clotting: co-developer - The Online Citizen Asia

The director of the Oxford Vaccine Group on Monday said there was no link between the jab it developed with AstraZeneca and blood clotting, after several countries suspended its use.

Andrew Pollard said there was “very reassuring evidence that there is no increase in a blood clot phenomenon here in the UK, where most of the doses in Europe been given so far”.

“It’s absolutely critical that we don’t have a problem of not vaccinating people and have the balance of a huge risk, a known risk of COVID, against what appears so far from the data that we’ve got from the regulators — no signal of a problem,” he told BBC radio.

Ireland and the Netherlands on Sunday became the latest countries to suspend their use of the Oxford/AstraZeneca vaccine out of precaution.

Denmark, Norway and Iceland have also paused their rollout of the jab.

AstraZeneca said on Sunday there was no evidence of increased blood clots from the jab after outcomes from 17 million doses were analysed.

The pharmaceutical company said the 15 incidences of deep vein thrombosis (DVT) and 22 events of pulmonary embolism reported among those given the vaccine was “much lower than would be expected to occur naturally in a general population”.

“The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety,” chief medical officer Ann Taylor said.

“In terms of quality, there are also no confirmed issues related to any batch of our vaccine used across Europe, or the rest of the world.”

The World Health Organization and the European Medicines Agency have both said there is no evidence the use of the jab should be suspended.

Ireland said it had “temporarily deferred” use of the vaccine on the advice of its advisory panel following the move by Norway.

The Dutch health ministry also said it was suspending the rollout as a precaution.

– AFP
 

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WHO experts to meet on AstraZeneca shot as virus cases surge - The Online Citizen Asia
by Nina Larson, with AFP bureaus

WHO safety experts prepared to meet Tuesday over the AstraZeneca coronavirus vaccine whose rollout has been halted in several European countries over blood clot fears, imperilling the pandemic fight as infection rates surge.

The three largest EU nations — Germany, Italy and France — joined others in suspending the shot Monday, dealing a blow to the global immunisation campaign against a disease that has killed more than 2.6 million people.

The World Health Organization, AstraZeneca, and the European Medicines Agency have insisted the shot is safe, and that there is no link between the vaccine and reported blood clots.

“We do not want people to panic and we would, for the time being, recommend that countries continue vaccinating with AstraZeneca,” WHO chief scientist Soumya Swaminathan said Monday.

“So far, we do not find an association between these events and the vaccine.”

WHO and EMA experts on Tuesday will separately discuss data from AstraZeneca vaccinations, and the European regulator will hold an extraordinary meeting two days later to decide on any further action.

AstraZeneca‘s shot, among the cheapest available, was billed as the vaccine of choice for poorer nations and the clot reports have had an impact beyond Europe.

Indonesia delayed its AstraZeneca rollout on Monday, and Venezuela announced it would not authorise the jab over fears of “complications”.

The vaccine was developed by AstraZeneca and the University of Oxford in Britain, where more than 11 million doses have been administered apparently without any major problems.

Prime Minister Justin Trudeau on Monday also urged Canadians to get the AstraZeneca shot after reports of hesitancy based on the suspensions in Europe.

‘Critical situation’
The AstraZeneca crisis comes as a number of countries battle worrying surges in coronavirus infections, a grim reminder that the battle against COVID-19 is far from over.

Norway’s capital Oslo announced tougher measures to stop the spread of the virus, including closing secondary schools, as it reported a record number of cases last week.

“These will be the most intrusive measures taken by Oslo during the pandemic,” said mayor Raymond Johansen.

“It’s tough, it’s difficult but it’s necessary”.

And a fresh spike pushed the main COVID-19 hospital in Bosnia to the edge, forcing it to declare a state of emergency.

“The staff is exhausted,” hospital director Sebija Izetbegovic wrote on Facebook.

“We will continue to do what is possible to save lives, but the situation is really critical. More and more of our employees are sick.”

Most of Italy re-entered lockdown on Monday, with schools, restaurants, shops and museums closed, while intensive care doctors in Germany issued an urgent appeal for new restrictions to avoid a third wave in the country.

Brazil’s President Jair Bolsonaro — widely panned for his coronavirus scepticism — appointed a new health minister Monday as the South American nation reeled from another deadly surge in infections and deaths.

Vaccine options
The pandemic spurred unprecedented efforts to develop vaccines, with a number of successful options now available.

Rollouts have been hampered, however, by export controls, bitter diplomatic spats and production issues — in addition to the AstraZeneca suspension.

But a new agreement for Germany’s IDT Biologika to help produce the single-shot Johnson & Johnson vaccine would offer Europe greater certainty, Germany’s economy minister said Monday.

And the developers of Russia’s successful Sputnik V vaccine said Monday they had reached production agreements in key European countries.

China, where the virus first emerged in late 2019, has also developed COVID-19 vaccines and begun exporting them across the world — including to Europe, the Middle East and South America.

On Monday, it pledged 300,000 doses to protect United Nations peacekeepers, adding to the 200,000 doses already pledged by India. Neither country specified which type of vaccines would be donated.

China has largely brought its outbreak under control, but maintains strict travel restrictions to avoid importing cases.

But on Monday it said restrictions have been relaxed for some visitors from the Philippines who have been inoculated — but only if they received a Chinese-made shot.

– AFP
 

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Several European countries have paused their roll out of the Astra Zeneca vaccine after dozens of reports of blood clots and some deaths among the millions who have received it. As Dr Norman Swan reports, both the World Health Organization and local medical authorities insist there's no evidence of any link to the vaccine and are concerned by any suggestion of a pause.
 

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AstraZeneca's vaccine rollout has been paused across Europe amid blood clot reports. Should Australia follow suit?
ABC Health & Wellbeing
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By health reporter Lauren Roberts
Posted Yesterday at 3:00am, updated Yesterday at 1:07pm
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Duration: 1 minute1m

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AstraZeneca rollout shouldn't be suspended, say experts
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Australia's medicines regulator insists there's "no evidence" the AstraZeneca COVID-19 vaccine is the cause of blood clots which has seen its use suspended by several leading European nations, including Germany and France.
Key points:
  • A blood clot is when a clump of blood changes from liquid to semisolid
  • Of the 17 million people vaccinated in Europe and the UK, there have been 15 reports of deep-vein thrombosis and 22 of pulmonary embolisms
  • Australian experts say vaccinations should not be halted, but closely monitored
Chief medical officer Paul Kelly said while he was aware of countries in Europe pausing rollout of the vaccine, other countries, including Canada and the UK were still continuing to use AstraZeneca as planned.
"With a vaccine rollout like this, we need to monitor carefully for any unusual events," Professor Kelly said.
"We will find them, but this does not mean that every event following a vaccination is caused by the vaccine.
"The Australian Government remains confident in the AstraZeneca COVID-19 vaccine and there is currently no evidence that it causes blood clots."
The AstraZeneca vaccine is the jab most people in Australia will get, with 53.8 million doses of the AstraZeneca secured by the Department of Health.
But what exactly are blood clots? Are the numbers we're seeing in vaccinated populations higher than expected? And should Australia halt its rollout of the AstraZeneca vaccine?
A healthcare worker holds the COVID-19 AstraZeneca vaccine.

Australia's regulator insists there's "no evidence" the AstraZeneca COVID-19 vaccine is the cause of blood clots.(
Getty Images: Antonio Masiello
)What are blood clots?
In the simplest terms, a blood clot is when a clump of blood changes from a liquid to a semisolid state.
Most of the time, blood clots are totally harmless and can be really useful if you scratch yourself and they can prevent you from losing too much blood.
But if a blood clot forms in your veins, it can travel to your organs and stop blood flow — leading to potentially deadly consequences.
So you have questions about the COVID vaccines? We have answers
A graphic of hands piecing together a puzzle that has the word vaccine on it
Confused about Australia's vaccine rollout? We've tracked down the answers to the questions you've been asking.
Read more

The Therapeutic Goods Administration (TGA) says venous thromboembolism (VTE), a clot which starts in the vein, is the third-most common cardiovascular disease in the world — with more than 10 million reports a year.
People who are over the age of 65, smoke, have cancer, are pregnant or have a family history of blood clots are more at risk of getting them.
In Australia, at least 17,000 people annually — roughly 50 people every day — develop VTE. So far, there have been no reports of blood clots following the vaccine's rollout in Australia.
In a statement, the TGA said it had not seen any evidence of a "biologically plausible relationship" that would suggest a cause-and-effect relationship between the vaccines and blood clots.
More than 17 million people have been vaccinated with the AstraZeneca vaccine across Europe and the United Kingdom, and there have been 15 reports of deep-vein thrombosis and 22 of pulmonary embolisms following vaccinations.
"This is much lower than would be expected in a population of this size," said Paul Griffin, a professor of medicine at the University of Queensland.
The European Medicines Agency has also said there is no indication that blood clotting issues were caused by the vaccination, a view echoed by the World Health Organization.
And according to AstraZeneca, a review of safety data of people vaccinated with its COVID-19 vaccine has shown no evidence of an increased risk of blood clots.
RECAP: Look back on the latest news on the COVID-19 pandemic.
Professor Griffin described the suspension of the vaccine in parts of Europe as an "overreaction".
"In my opinion, this response is an overreaction and while this is perhaps how these countries prefer to respond, we should make sure we don't overreact in our country and that we continue to make evidence-based decisions based on the available data at hand," he said.
"This vaccine has proven very safe and effective in large clinical trials."
'It's too early to be worried'
Coronacast co-host Norman Swan said although the rate of blood clots in the vaccinated population was lower than the background rate, the "worrying thing" was that there had been a number of reports of younger people with clotting.
"Age is a risk factor — the older you are, the more likely you are to get clots," he said.
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Duration: 6 minutes 46 seconds6m

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Dr Norman Swan says issues surrounding AstraZeneca vaccine are complicated
Dr Swan also explained that some people who had presented with blood clots also had low levels of platelets — cells which help blood to clot.
"It's just possible that the vaccines as a whole have a problem with creating antibodies in some people to the platelets and paradoxically causing blood clots," he said.
Theoretically, platelet levels could drop because of a blood clot in the lung.
Professor Griffin said although young people were less likely to get blood clots, it wasn't without precedent and the number of people who had them after being vaccinated was still very small.
"We do still see people in those [younger] demographics who very occasionally get blood clots," he said.
When questioned about the low platelet levels some people had presented with, Professor Griffin said while it wasn't common, it wasn't necessarily cause for alarm.
"We do see that in populations from time to time," he said.
"It's too early to be worried about these numbers."
Should Australia halt its rollout?
No, according to our experts. Although, they say there is a need for more research and monitoring of the situation.
"Nobody wants any link to the vaccine, but if there is one, you've got to find it soon," Dr Swan said.
"If it is linked to the vaccine, which is very unlikely, it may be that there's a group of people who should not get the vaccine … it's got to be taken seriously."
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Nigel Crawford, director of a vaccine safety and clinical immunisation research group based at Murdoch Children's Research Institute, urged "extreme caution in pausing rollouts" while investigations were underway.
"Because once a vaccine rollout is paused, it can sometimes dent vaccine confidence so much that it struggles to recover, as seen in Japan with the human papillomavirus vaccine," Dr Crawford said.
Robert Booy, senior professorial fellow at the National Centre for Immunisation Research, added that Australia had an "excellent system" for the surveillance of rare events, such as blood clots, which can occur after vaccination.
"The issue of blood clots appearing to occur after use of the AstraZeneca COVID vaccine is being taken very seriously and is being carefully investigated," he said.
"The data collected so far suggests that blood clots are not occurring any more often than would be expected by coincidence."
 

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Commentary: Blood clot fears of the AstraZeneca vaccine will only deepen vaccine hesitancy
In erring on the side of caution, despite little hard data of serious side effects, the suspension of the AstraZeneca vaccine will bring greater harm, says a drug specialist.

Fears over blood clots prompted many countries to suspend distribution of the AstraZeneca vaccine
Fears over blood clots prompted many countries to suspend distribution of the AstraZeneca vaccine AFP/Martin BUREAU
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BIRMINGHAM, United Kingdom: The arrival of effective vaccines against COVID-19 has been one of the few good news stories of the pandemic.

However, communicating the safety of vaccines has long been difficult, as shown by most countries having some level of vaccine hesitancy, including hesitancy towards COVID-19 vaccines specifically.

Just as regulatory authorities – such as the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) – had systems in place to assess if the vaccines worked, so too did they create carefully thought through vaccine safety plans to deal with any safety signals arising after the vaccines’ deployment.

However, this week the EU’s plan for vaccine safety was thrown into confusion. At least 12 EU states have suspended use of the AstraZeneca COVID-19 vaccine because of concerns of a possible link between the vaccine and blood clots.

These concerns are registered in spontaneous reports, where a patient or healthcare professional suspects a link between an adverse event they’ve witnessed and the vaccine.

Reporters do not have to be sure of a link, and these reports do not prove there’s any association between the vaccine and the event.

The number of blood clots reported among people taking the vaccine, assuming even a fairly high level of under-reporting, does not seem to be higher than would be expected in the general population.

A woman receives a vaccine as Vietnam starts its official rollout of AstraZeneca's COVID-19 va
A woman receives a COVID-19 vaccine at Hai Duong Hospital for Tropical Diseases, Hai Duong province, Vietnam, Mar 8, 2021. (File photo: REUTERS/Thanh Hue)
Many things happen after vaccination that would have happened without the vaccine.

That said, in some countries, such as Norway and Germany, an extremely rare form of blood clot in the brain called cerebral venous sinus thrombosis (CVST) has been reported.

Incidence of CVST in the normal population is hard to measure, although Johns Hopkins Medicine has said it may affect around one in every 200,000 people each year.

In Germany, the incidence of CVST post vaccination has exceeded this rate, so the EMA is carefully examining each case to look for possible contributing factors.

READ: Commentary: Here’s why taking the vaccine is necessary even if it’s optional
But so far, the World Health Organization, EMA, MHRA and AstraZeneca have all said that there is no evidence of a causal link between the vaccine and clots, and the EMA has said it is firmly convinced that the benefits of the vaccine far outweigh the risks.

Yet if this is the case, why have the advisory committees of some EU states decided to suspend the vaccine?

A GOOD TOOL BADLY USED

A major reason appears to be the misapplication of the precautionary principle. This is where you take anticipatory action to avoid potential harm, even when the evidence around that harm is uncertain.

It can be a useful tool when needing to make a decision in a situation that includes risk and uncertainty.

The precautionary principle evolved from critiques of risk assessments that were based on scientific methods. These, it was argued, were too conservative, requiring too much evidence to prove risk, and so perhaps biased towards seeing an absence of harms.

The earliest forms of the principle are thought to have arisen in West Germany in the 1970s, where “Vorsorgeprinzip” was used in environmental policy to limit actions that were suspected but not proven to cause ecological damage.

Past case studies of harms for which there were early warnings but only later actual evidence – such as asbestos – show the sorts of outcomes that the principle can potentially help avoid.

READ: Commentary: Concerns over long-term side effects could hold back Singapore’s COVID-19 vaccination programme
Regarding pausing the AstraZeneca vaccine, the principle has been cited explicitly by some EU states. Others have invoked it implicitly in interviews, saying they will “err on the side of caution”.

However, there are trade-offs – and that’s the primary reason why we can say the principle has been misapplied.

The AstraZeneca COVID-19 vaccine suspended in France
Vials of the AstraZeneca COVID-19 vaccine are seen at a medical center in Champigny, near Paris, as France's decision to suspend temporarily the AstraZeneca COVID-19 vaccine was taken in co-ordination with other European countries, March 16, 2021. REUTERS/Gonzalo Fuentes
COVID-19 vaccines are being used to prevent deaths. Decisions to suspend their use will slow vaccination campaigns by reducing vaccine availability.

Suspensions might also affect vaccine uptake by sparking wider concerns about safety among the public. Confidence in the AstraZeneca vaccine is already relatively low in Europe, with high-profile comments about its effectiveness having dented uptake.

So rather than avoiding risk, the principle has instead moved countries away from one risk (blood clots) towards another (lower vaccine coverage). The impact of the latter could be much larger.

Even if this weren’t the case, the principle has still, arguably, been misapplied.

Plans for COVID-19 vaccine safety monitoring until now have been based around rigorous scientific evaluation of safety signals, careful communications to ensure vaccine hesitancy is not increased, and ensuring that signals are investigated to examine if any risk requires regulatory action.
 

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Benefits outweigh the risks of AstraZeneca shot as review continues: WHO
FILE PHOTO: FILE PHOTO: Vial and sryinge are seen in front of displayed AstraZeneca logo
FILE PHOTO: A vial and sryinge are seen in front of a displayed AstraZeneca logo in this illustration taken January 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo/File Photo
17 Mar 2021 10:26PM
(Updated: 17 Mar 2021 10:28PM)
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GENEVA: A World Health Organization (WHO) vaccine safety panel said on Wednesday (Mar 17) that it considers that the benefits of the AstraZeneca COVID-19 vaccine outweigh its risks and recommends that vaccinations continue.

The WHO listed AstraZeneca and Oxford University's vaccine for emergency use last month, widening access to the relatively inexpensive shot in the developing world.

More than a dozen European countries have suspended the use of the vaccine this week amid concerns.

READ: Sweden, Latvia suspend use of AstraZeneca's COVID-19 vaccine
The European Medicines Agency (EMA) has said it was investigating reports of 30 cases of unusual blood disorders out of 5 million recipients of the AstraZeneca vaccine. In total, 45 million COVID-19 shots have been delivered across the region.

The EU regulator will release its findings on Thursday but its head, Emer Cooke, said she saw no reason to change its recommendation of AstraZeneca - one of four vaccines that it has approved for use.

READ: WHO urges world not to halt COVID-19 vaccinations as AstraZeneca shot divides Europe
The WHO said its Global Advisory Committee on Vaccine Safety is carefully assessing the latest available safety data for the AstraZeneca vaccine.

"Once that review is completed, WHO will immediately communicate the findings to the public," WHO said in its statement a day after its experts held a closed-door meeting.

"At this time, WHO considers that the benefits of the AstraZeneca vaccine outweigh its risks and recommends that vaccinations continue," it added.
 

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How safe are the coronavirus vaccines?
The vaccines against COVID-19 have been developed in record time and there are still many things experts don’t yet understand about them.

Vaccinating against coronavirus is the easiest way for Australians to get their normal lives back, but millions are hesitant to get the jab.

Our Best Shot is news.com.au’s campaign answering your questions about the COVID-19 vaccine roll out.

We’ll debunk myths about vaccines, answer your concerns about the jab and tell you when you can get the COVID-19 vaccine.

With two vaccines set to be rolled out in Australia, here is everything we know and don’t know about them.

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WHAT WE DO KNOW: THEY ARE SAFE

While there are many unknowns, people can be assured of one thing: the vaccines are safe.

“Where shortcuts have been taken, they are not in terms of monitoring safety,” Professor of immunology at RMIT University, Magdalena Plebanski told news.com.au.

“There’s just been a huge amount of scrutiny.”

All the vaccines have been through Phase III trials that each saw between 20,000 and 40,000 people given the jab and monitored for health issues.

While this does not pick up rare side effects (those occurring in less than 1 in 10,000 people) it does exclude uncommon side effects. However, this is not any different for other new vaccines that are developed.

“The eyes of the world are on this and that means shortcuts on safety cannot be taken, which is great,” Prof Plebanski said.

“Everything’s been transparent so I wouldn’t be worried personally on the safety.”

Professor Allen Cheng, who leads the government’s Australian Technical Advisory Group on Immunisation, told news.com.au’s Samantha Maiden in January that no major side effects had been found despite the vaccines being rolled out to millions around the world.

“Obviously millions of people now have got it in the US and Europe and other countries and we’re not finding anything majorly unexpected,” he said.

He noted that severe allergic reactions from those getting the Pfizer vaccine had been observed in 1 in 100,000 people, which is why those with severe allergies have been advised to not to get the vaccine if possible, but that means 999,000 people hadn’t had serious side effects.

So far there have been 19 cases of anaphylaxis in Australia from 183,000 doses of COVID-19 vaccine administered, 14 happened after the person got the Pfizer vaccine and five were in people who got the AstraZeneca vaccine.

The Therapeutic Goods Administration (TGA) is monitoring this and will also look at whether these rates are unusual.

TGA head Professor John Skerritt said any vaccine could cause an anaphylactic reaction in a small number of people.

“We certainly don’t believe there is any specific problem around AstraZeneca (and) Pfizer COVID vaccines. These are rare events that do happen in patients,” he told reporters on Wednesday.

Concerns have also been raised about the AstraZeneca vaccine and a possible link to blood clots but the TGA said there was no evidence the clots were linked to the vaccine.

Prime Minister Scott Morrison has also noted that Australia is one of the few countries in the world to give the Pfizer vaccine “formal approval” and not just an emergency approval.

“We are one of only a handful of countries to have gone through such a comprehensive and thorough level of oversight to ensure the vaccines are safe,” he told the National Press Club of Australia on February 1.

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SO WHAT ARE THE SHORTCUTS?

Where shortcuts were taken, Prof Plebanski said, this was more around optimising the immune response to the vaccine.

Scientists would normally have more time to test the effectiveness of different dosages and work out how much vaccine gets the best immune response, and how far apart the doses should be.

Giving a smaller dose of the AstraZeneca vaccine may prove to be more effective against the coronavirus. Picture: Oli Scarff/AFPSource:AFP

“Because everything is so accelerated, a lot of studies that would have been done in terms of making the vaccine work optimally are being done now, rather than before it was given to a lot of people,” Prof Plebanski said.

“More studies could have been done with different doses and different gaps between doses.”

For example, authorities are now recommending the two doses of the AstraZeneca vaccine be given 12 weeks apart after it was found during trials that this produced the best immune response.

Prof Cheng said the quick development of the vaccines was due to the different phases being done at the same time instead of one after the other. Normally scientists also have to wait for funding to be approved and regulators usually take around 255 business days to consider the results of Phase III trials. Instead, priority has been given to COVID vaccines so this is done as soon as possible.

There is also a lot of funding that is being put on the line in the race for a cure.

“You would never think in a million years … that we would make vaccines before we knew that they were effective,” Prof Cheng said.

However, this is being done for COVID vaccines so they can be ready for shipping as soon as they are found to be safe and effective.

Australia is also in a fortunate position when it comes to these unknowns as the mass rollout of vaccines overseas mean that rare events, such as the possibility of an allergic reaction, will likely be picked up before Australians get the vaccine.

“We are in such a luxurious position as we will see what happens in the rest of the world,” Prof Plebanski said.

“It’s an amazing position to see that and the safety of it, so we can be confident in the vaccination.”

CAN WE TAKE TWO VACCINES?

This is another question that scientists don’t have the answer to: whether it is safe to take two different vaccines.

When it comes to the two doses each vaccine requires, authorities don’t recommend mixing and matching. If your first injection is for the Pfizer vaccine for example, you must also get a second dose of Pfizer, not AstraZeneca.

However, there are now trials being undertaken to look at whether it’s safe to mix vaccines.

Once people complete the two shots for a vaccine, it’s also not clear whether they can change to a different vaccine if they need a booster next year for example.

It’s not clear yet whether it will be safe to combine different vaccines. Picture: Geoff Caddick/AFPSource:AFP

HOW LONG DOES IMMUNITY LAST FOR?

It’s still unclear how long people who get vaccinated or who have recovered COVID-19, will remain immune from the disease.

However, there are some promising signs.

A British study found those who have already had COVID-19 and recovered appear to be immune for at least five months, while a study published in January found those who got the Moderna vaccine still showed good immune responses four months after getting the jab.

“The vaccines have only been around for a number of months so we know that they work for at least how long people have been followed up with a call, which is generally not that long,” Prof Cheng said.

This could have implications for our chances of achieving herd immunity.

But only time will tell.

DO VACCINES STOP TRANSMISSION?

The available vaccines are very effective at stopping people from getting severely ill or dying but it’s still unclear how good they are at stopping people from spreading the disease.

The available vaccines work by teaching the body how to recognise and fight off the disease but it’s unclear how quickly this response works and whether it will stop the virus multiplying in the nose (where it first enters) and being sneezed out.

It’s possible some vaccinated people could be infected with the coronavirus but not have symptoms and then pass the virus on to others.

It’s unclear at the moment if this is the case but if this is proven, it could have implications for achieving herd immunity.

This is one reason that people are being advised to continue social distancing and wearing masks even if they have been vaccinated.

However, other types of vaccines may prove effective at stopping transmission in the future.

IS HERD IMMUNITY ACHIEVABLE?

If enough of the population is vaccinated, “herd immunity” can be achieved because the virus won’t be able spread in the population as the people you come into contact with are likely to be immune.

“At this stage we really just don’t have enough information to say how much (of the population needs to be vaccinated for) that might occur,” Prof Cheng said.

It does look like the AstraZeneca vaccine, which the majority of Australians is likely to receive, is extremely effective at protecting against severe disease but it may not be as good at protecting against infection.

“But we just don’t know that for sure at this stage,” Prof Cheng said.

Authorities may soon get some idea about how effective vaccination is at preventing transmission, for the Pfizer vaccine at least, as results begin to emerge from Israel’s fast-tracked vaccination program.

But Prof Cheng warned that vaccinating the whole population was going to take a bit of time, and there was also no vaccine available for children yet.

“So we have at least, you know, 20 per cent of the population that can’t get vaccinated, because (of) the children,” he said.

There will also be around 10 to 20 per cent of the population who don’t want to be vaccinated.

“If half the population is vaccinated and they don’t get sick and die then that changes things immediately,” Prof Cheng said.

“But we’ll need to wait a bit longer to know fine details about mask wearing, what we’ll do during an outbreak and hotel quarantine arrangements.”

SHOULD PREGNANT WOMEN GET THE VACCINE?

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) has not recommended the routine use of COVID-19 vaccines for women who are pregnant because not enough information is available about safety impacts, although there’s no evidence of any harm.

“Based on known data from other similar vaccines, it is unlikely that COVID-19 vaccines pose a risk to a pregnant woman or her foetus,” a RANZCOG statement said.

“However, as pregnant and breastfeeding women have not been included in initial trials, data are very limited and our current knowledge is based on inadvertently exposed patients and the impact of the disease in an unvaccinated population.”

Prof Cheng has advised women to speak to their doctor about the potential risk or benefits of getting vaccinated.
 

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AstraZeneca COVID vaccine bans 'have cost lives' as Europe struggles with looming third wave
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A red-headed nurse in a face mask injects a needle into the arm of a man wearing a boater hat
The WHO says there is currently no evidence to suggest a link between the AstraZeneca vaccine and an increased risk of developing blood clots( Reuters: Eric Gaillard )
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The suspension of the Oxford-AstraZeneca vaccine rollout across much of Europe will likely be lifted soon.

Key points:
Four of the EU's largest nations suspended the use of the Oxford-AstraZeneca vaccine after reports of illnesses among some recipients
The pause on the vaccine has coincided with a rise in coronavirus infections in Italy, France and Germany
Health experts fear the damage done to public confidence will lead to unnecessary deaths from COVID-19
But some experts believe the damage to public confidence will be long-lasting and result in unnecessary deaths.

Fears about blood clots haven't yet been backed up by evidence, but doctors say they are likely to fuel further public concern about the vaccine at a time when Europe can ill afford it.

Countries like Italy, France and Germany are all experiencing dangerous spikes in COVID-19 cases, yet they have all paused their rollouts of the AstraZeneca product.

In Australia, the federal government says the rollout of the AstraZeneca vaccine will continue, despite the concerns in Europe.

The European Medicines Agency looks likely to endorse the safety of the vaccine on Thursday (European time).

But Anthony Harnden, deputy chair of the UK’s Joint Committee on Vaccination and Immunisation (JCVI), said the damage was done.

"You cannot stop and start vaccination programs without losing some public confidence," he told the ABC.

"There will be many, many people in Europe, [who] feel now that the Oxford AstraZeneca vaccine is second best ... which is patently untrue."

Professor Harnden, who is also an expert in primary care at the University of Oxford, which helped develop the vaccine, said the decision would compound mistrust in the vaccine, which some European countries previously withheld from their older populations, citing a lack of data.

"I have no doubt that Europeans have died because of some of these decisions," he said.

"If you don't get a vaccine and you're vulnerable and you're exposed to it [coronavirus], you may die as a result."

Vaccine suspension a 'disaster'
An elderly man and woman hold hands while lying in hospital beds
The AstraZeneca ban comes as Italy enters another lockdown amid a recent surge of coronavirus across the nation.( LaPresse Via AP: Cecilia Fabiano )
Cases have risen sharply in Italy, which has entered another lockdown.

On Tuesday, Italy recorded 20,396 new cases and 502 deaths.

Stefano Nava, chief of respiratory and critical care at Bologna's Sant' Orsola hospital — Italy's biggest — said the last four weeks had been "out of control".

He said the third wave had presented new challenges, which he partly blamed on the UK variant.

"The patients are younger and sometimes sicker," Professor Nava told the ABC.

Italy has administered more than 6.6 million vaccine doses, according to the European Centre for Disease Prevention and Control (ECDC).

Professor Nava said vaccines were showing encouraging signs of reducing hospital admissions in the elderly.

However, he said the suspension of the AstraZeneca vaccine would undermine public confidence.

"It will have a huge effect," he said.

Italy has been given access to 1,512,000 doses of the AstraZeneca vaccine, according to the ECDC.

So far, it has administered 1,077,868 doses from that supply, a significantly higher proportion than when the country blocked exports of 250,000 doses to Australia earlier this month.

Professor Nava is worried that having increased their uptake of the Oxford-AstraZeneca vaccine, Italians won't want their second dose.

"Now people are really convinced that the AstraZeneca vaccine kills people," he said.

"This is not what you should say when you don't have any proof."

The vast majority of Italy's vaccinations are performed using Pfizer-BioNTech jabs, which are not affected by the suspension.

Does the Oxford-AstraZeneca vaccine cause blood clots?
A needle balanced on a vial of the AstraZeneca vaccine
Countries including Germany, France, Spain, Italy and Ireland, Sweden and Latvia have temporarily banned the use of AstraZeneca.( Reuters: Dado Ruvic )
AstraZeneca says that out of 17 million people vaccinated with its product in the UK and European Union, just 37 cases of blood clots have been reported.

There were 15 cases of deep vein thrombosis, and 22 cases of pulmonary embolism.

The company insists there is no link between the vaccine and the clots, and the European Medicines Agency appears to agree.

"At present, there is no indication that vaccination has caused these conditions," the EMA's executive director Emer Cooke said this week.

Both the EMA and the World Health Organization say the benefits outweigh the risks.

However, the EMA's expert committee is reviewing each case and will announce its findings on Thursday.

"This requires a very rigorous analysis of all the data," Ms Cooke said.

In Germany, nearly half the 3 million AstraZeneca doses it has secured remain unused.

The health ministry said there were eight blood clotting cases potentially connected to the AstraZeneca vaccine, three of which were fatal.

German health minister Jens Spahn said the suspension was a necessary precautionary measure.

"All of us are very aware of the consequences of this decision and we did not take this decision lightly," he said on Tuesday.

Could the suspension lead to more deaths?
Other European countries suspending the AstraZeneca rollout include Austria, Bulgaria, Cyprus, Denmark, Iceland, Ireland, Latvia, Sweden, the Netherlands, Norway, Romania and Spain.

"I think that once one [country] stops doing it, then they get a collective anxiety," Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, told the ABC.

"They don't want to be standing out."

A woman in a face mask pulls her top down from her shoulder in a car while a nurse injects her through the window
Vaccine uptake is already lagging in parts of Europe, and experts fear recent bans on AstraZeneca will make matters worse.( Reuters: Flavio Lo Scalzo )
In Germany, case numbers have surged 20 per cent in a week, according to the Robert Koch Institute.

On Wednesday, the country recorded 13,435 new cases and 249 deaths.

France is also grappling with rising case numbers.

Almost 30,000 were reported on Tuesday, and Prime Minister John Castex said the country was facing a "sort of third wave".

Professor Evans said he did not believe there was any link between the blood clots and the AstraZeneca vaccine.

And he warned that the suspensions in Europe could do more harm than good.

"If you pause this vaccine and there is a lot of the COVID disease about ... then you're going to increase the death rate.”

What's behind Europe's mistrust of the vaccine?
Graph shows vaccine doses administered.
This graph shows the total number of vaccine doses administered per 100 people in the total population. March 17, 2021.( Our World In Data )
The UK has vastly outperformed Europe in its vaccination rollout.

It has administered 39 doses per 100 people, according to figures compiled by Our World in Data.

That's compared with 11 doses per 100 in France, Germany, and Italy.

European leaders are under pressure to accelerate the rollout, and many blame AstraZeneca for not providing enough doses.

And this isn't the first time some have questioned the quality of the UK-developed vaccine.

In February, French president Emmanuel Macron described it as "quasi-effective" in the over-65s, and France recommended that it not be given to people in that age group.

Germany, Italy, Norway, the Netherlands and Spain made similar recommendations, citing a lack of older participants in clinical trials.

However, they reversed those decisions once real-world data became available from the UK, where more than 11 million people have been vaccinated with the AstraZeneca product.

A woman in a black face mask walks through Trafalgar Square
UK health bosses say the AstraZeneca injection is "safe" and the government won't change its rollout strategy.( Reuters: Henry Nicholls )
UK studies showed that a single dose of either the Pfizer or AstraZeneca vaccines reduced the risk of hospital admissions by more than 80 per cent in people aged 80 or over.

Professor Harnden said while he respected the decisions of European governments, they would have serious consequences.

"They have large portions of their vulnerable elderly population unprotected because of an incorrect decision that they made about delaying the AstraZeneca dose in the elderly population," he said.

And he warned that the effects of European decisions would not be confined to the continent.

"It's going to affect us all, ultimately, if we have a huge amount of transmission and infection within Europe."
 

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EU, UK drug regulators rally behind AstraZeneca vaccine after safety concerns
Oxford/AstraZeneca's COVID-19 vaccine at a vaccination centre in Antwerp
A person receives a dose of Oxford/AstraZeneca's COVID-19 vaccine at a vaccination centre in Antwerp, Belgium March 18, 2021. REUTERS/Yves Herman
19 Mar 2021 12:44AM
(Updated: 19 Mar 2021 04:59AM)
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AMSTERDAM/LONDON: Germany, France and other European nations announced plans to resume using AstraZeneca's COVID-19 vaccine on Thursday after EU and British regulators moved to shore up confidence in the shot, saying its benefits outweigh the risks.

Reports of rare brain blood clots had prompted more than a dozen nations to suspend use of the shot, the latest challenge for AstraZeneca's ambition to produce a "vaccine for the world", as the global death toll from the coronavirus passes 2.8 million.

The European Medicines Agency's (EMA) "clear" conclusion following an investigation into 30 cases of unusual blood disorders was that the vaccine's benefits in protecting people from coronavirus-related death or hospitalisation outweighs the possible risks, though it said a link between blood clots in the brain and the shot could not be definitively ruled out.

"This is a safe and effective vaccine," EMA director Emer Cooke told a briefing. "If it were me, I would be vaccinated tomorrow."

Within hours, Germany said it would resume administering the AstraZeneca vaccine from Friday morning. Health Minister Jens Spahn said suspending the vaccine out of caution had been the right call "until the clustering of this very rare type of thrombosis had been examined."

France too said it would resume use of the vaccine, with Prime Minister Jean Castex saying he would receive the shot himself on Friday afternoon.

Italian Prime Minister Mario Draghi said Italy would do the same, and that his government's priority remained to vaccinate as many people as quickly as possible.

Spain said it was evaluating a possible resumption, while Cyprus, Latvia and Lithuania said they would restart administering the vaccine.

Many governments had said the decision to pause inoculations was out of an abundance of caution. But experts have warned political interference could undermine public confidence in vaccinations as governments struggle to tame more infectious virus variants.

"We trust that, after the regulators’ careful decisions, vaccinations can once again resume across Europe," said AstraZeneca Chief Medical Officer Ann Taylor in a statement.

READ: India backs AstraZeneca shot as COVID-19 cases hit three-month high
EUROPE LAGS BRITAIN, US

The EMA's review covered 20 million people given the AstraZeneca shot in the UK and the European Economic Area (EEA), which links 30 European countries.

Safety concerns had led at least 13 European countries to stop administering the shot, slowing an already faltering inoculation campaign in the EU, which lags Britain and the United States.

Britain's Medicines and Healthcare products Regulatory Agency (MHRA) said earlier that it was investigating five cases of the rare brain blood clot that had been reported out of 11 million shots administered in the UK.

It said it would investigate reports of clots in the cerebral veins (sinus vein thrombosis, or CSVT) occurring together with lowered platelets soon after vaccination. But the agency said use of the vaccine should continue and one official said Britain's rollout would likely continue even if a link was proved.

The AstraZeneca shot was among the first and cheapest of the COVID-19 vaccines to be developed and launched at volume and is set to be the mainstay of vaccination programmes in much of the developing world.

"The EMA's (verdict) now provides clarity about the safety of this vaccine, which should now be vaccinated at a high rate after this safety stop in order to efficiently prevent the actual risk, i.e. sometimes serious medical harm from COVID-19," said Clemens Wendtner, head of infectious diseases at Munich clinic Schwabing.

The drugmaker's own review covering more than 17 million people who have received its shot in the EU and Britain found no evidence of increased risk of blood clots.

The World Health Organization this week also reaffirmed its support for the shot.

The EMA said it would update its guidance on the AstraZeneca vaccine to include an explanation for patients about the potential risks and information for healthcare professionals.

The agency said it is in touch with regulators around the world to keep tabs on possible side effects of all COVID-19 vaccines.
 

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AstraZeneca COVID-19 vaccine is ‘haram’, but permissible due to urgent situation: Indonesia Islamic body
FILE PHOTO: A vial with the AstraZeneca's coronavirus disease (COVID-19) vaccine is pictured in Berlin, Germany, March 16, 2021. REUTERS/Hannibal HanschkeBookmark
JAKARTA: Indonesia’s most influential Islamic organisation said AstraZeneca’s COVID-19 vaccine is “haram” or forbidden for Muslims, but its use can be temporarily permitted due to a lack of alternatives.
The Indonesian Council of Ulema or MUI said it has conducted studies on the vaccine to see if it is “holy and halal” for Muslims to use.
The studies, said head of the council’s fatwa department Asorirun Niam Sholeh, showed that the AstraZeneca vaccine uses pork-derived trypsin – which is needed to break down proteins – in its production. Pork is considered unclean by Muslims.
“COVID-19 vaccine produced by AstraZeneca is haram because it uses pork-derived trypsin in its production,” Mr Sholeh told a press conference on Friday (Mar 19).
“Nevertheless, the use of COVID-19 vaccines produced by AstraZeneca is for now permissible.”
Mr Sholeh said the use of the vaccine is permissible by Islamic laws because there is an urgent need to get people vaccinated immediately and the clean and halal substitution is not yet sufficient.
The permission to use COVID-19 vaccines produced by AstraZeneca will no longer be valid, Mr Sholeh said, when there is a sufficient supply of clean and halal vaccines.
The MUI is an independent organisation but its fatwas, or religious edicts, are followed by millions of people living in this Muslim-majority country.
The decision could reduce confidence in the AstraZeneca vaccines, leaving Indonesia with just one approved vaccine, developed by China's Sinovac Biotech, for use in its nationwide vaccination drive.
Indonesia also has agreements with other vaccine companies, including Novavax and Pfizer, though none has arrived in the country yet.
Indonesia received 1.1 million doses of the AstraZeneca vaccine via the COVAX vaccine-alliance scheme this month and is set to receive some 10 million more in the next two months.
The MUI announcement on Friday came just as Indonesia's Food and Drug Regulatory Agency (BPOM) recommended that the administering of AstraZeneca vaccines should be resumed.
On Mar 15, Indonesian health minister Budi Gunadi Sadikin announced that Indonesia was delaying the administering of AstraZeneca's COVID-19 vaccine due to reports of blood clots among some recipients in Europe.
The BPOM’s recommendation came after the European Medicines Agency found that despite the vaccine may be associated with very rare cases of blood clots, the benefits still outweigh the risks.
The agency said on Friday: “Right now, COVID-19 infection is still high globally, including in Indonesia. Therefore, despite the fact that the vaccination can lead to post-vaccination events, the risk of death due to COVID-19 is still higher. Therefore, citizens must receive COVID-19 vaccinations as scheduled.”
READ: AstraZeneca finds no evidence showing increased risk of blood clots with COVID-19 vaccine

The BPOM warned that extra precautions must be taken when inoculating people with low or high platelet count. Platelets are cells that help the body form clots to stop bleeding.
Indonesia aims to inoculate 181.5 million people by mid-2022.
The Southeast Asian country has been grappling with the worst outbreak in the region, having recorded more than 1.4 million infections and 39,000 deaths.
Ms Siti Nadia Tarmizi, the government's spokesperson for COVID-19 vaccination, said the government welcomes the decisions by both the MUI and BPOM. She added that the government will start distributing AstraZeneca vaccines on Monday.
 

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Domestic production of AstraZeneca vaccine is approved
Posted 20m
A needle balanced on a vial of the AstraZeneca vaccine
Australia's Therapeutic Goods Administration said the approval was granted earlier today.( Reuters: Dado Ruvic )
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Australia's medical regulator has approved the domestic production of the Oxford-AstraZeneca COVID-19 vaccine, with the first batches expected to be released "in the next few days."
In a statement, the Therapeutic Goods Administration said the approval was granted "earlier today" and that it was a "critical and very exciting milestone" in Australia's response to the pandemic.
"Specific approval of Australian manufacturing by TGA was required to ensure that the locally-manufactured vaccine had exactly the same composition and performance as overseas-manufactured vaccine, was made to the same quality and is free of contaminants," the TGA said in a statement.
It said the final step for the locally-manufactured vaccine was "batch release", required for every batch of any vaccine supplied in Australia.
"This involves a review of documents supplied by the commercial sponsor describing how the vaccine batch was made, tested, shipped and stored as well as TGA's in-house laboratory testing to ensure the vaccine has been manufactured according to the required standards," the TGA said.
Australia's vaccination rollout depends on the locally-produced AstraZeneca vaccine, which will be manufactured at two sites in Melbourne.
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Leongsam

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I do not understand why those under 50 are being vaccinated in the first place because Covid is even milder than the flu for those in the 0 to 50 yr age bracket.

For those under 40 the risk is so low that it is almost non existent.

https://bestlifeonline.com/covid-fatality-by-age/

For infected people under 40, the mortality rate was remarkably low. Only about one in 10,000 COVID patients died, or an IFR of 0.01 percent, making COVID a terrifying 170 times deadlier for those over 60 than those under 40.

To risk the side effects of an experimental death in the under 40s for an illness that is only 1/10 as fatal as influenza is just absolute madness. It is far better to catch Covid and gain proper immunity the natural way.
 
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