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New COVID Vaccines Coming From Pfizer, Moderna Amid 'Very High' US Spread

Houri

Stupidman
Loyal

New COVID Vaccines Coming From Pfizer, Moderna Amid 'Very High' US Spread​


The U.S. Food and Drug Administration (FDA) on Thursday approved Pfizer and Moderna's updated COVID-19 vaccines amid a summer wave of "very high" coronavirus levels in wastewater, according to the Centers for Disease Control and Prevention (CDC).

The approval allows the pharmaceutical giants to begin shipping out millions of doses that "more closely target currently circulating variants," according to the FDA, including the KP.2 strain.

"Shipping will begin immediately to ensure robust supply and rapid access of this season's vaccine in pharmacies, hospitals, and clinics across the country," a spokesperson for Pfizer told Newsweek in an email.

Moderna said in a news release that the "approval is timely, as COVID-19 remains a significant health risk and is the leading cause of respiratory illness-related hospitalization, regardless of age or health condition." It noted that the updated vaccines should appear in "pharmacies and care settings in the coming days."

An FDA press officer told Newsweek that the "FDA approves or authorizes a product when FDA's standards have been met," and noted that the agency "will review any additional COVID-19 vaccine applications submitted to the agency and take appropriate regulatory action," on an ongoing basis.

The statement noted that, "Novavax has announced it anticipates that the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) to be available sometime this fall."

Newsweek reached out to Moderna's press team for comment via email on Thursday.

LINK

COVID-19 infections have surged this summer, with the CDC reporting "very high" viral activity in national wastewater, which can detect traces of the virus.

According to recent CDC data, KP.3.1.1 Omicron strain accounts for over a third of infections in the U.S. The analysis also reveals that the highest rates of infection in the past two weeks are found in five Southern/Southwestern states, with nearly 1 in 4 COVID tests coming out positive across the region comprised of Arkansas, Louisiana, New Mexico, Oklahoma and Texas.

In a Thursday news release announcing the approval, Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said, "Vaccination continues to be the cornerstone of COVID-19 prevention." He urged eligible individuals to get the updated vaccines and noted a "waning immunity of the population."

The FDA said individuals who receive the updated vaccines "may experience similar side effects" as previous coronavirus vaccines. "The FDA anticipates that the composition of COVID-19 vaccines will need to be assessed annually, as occurs for seasonal influenza vaccines," the agency said.

It approved the vaccines for people age 12 and older, and granted emergency use authorization for those age 6 months through 11 years old.

The statement sought to assuage concerns over the vaccines: "The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the U.S., and the benefits of these vaccines continue to outweigh their risks." CDC officials have previously stated that while vaccines don't completely protect against the virus, they can prevent severe cases and hospitalization.

The virus is expected to surge in winter as people gather indoors. The CDC previously stated that "It is safe to receive COVID-19 and flu vaccines at the same visit."

www.newsweek.com

New COVID vaccines coming from Pfizer, Moderna amid "very high" US spread

The U.S. Food and Drug Administration approved Pfizer and Moderna's updated COVID-19 vaccines amid a summer surge and ahead of an expected winter spike.
www.newsweek.com
www.newsweek.com
 

laksaboy

Alfrescian (Inf)
Asset
You know the drill, you've seen the script before. Add 2 to 3 months and something similar will happen here. MOH, Ratface Ong and the propaganda media (including a certain doctor) will get featured. :cool:
 

DiMana

Alfrescian
Loyal
You know the drill, you've seen the script before. Add 2 to 3 months and something similar will happen here. MOH, Ratface Ong and the propaganda media (including a certain doctor) will get featured. :cool:
2020 redux.......
https://www.straitstimes.com/singap...sidents-70-and-older-front-line-workers-to-be

Healthcare workers to receive Covid-19 vaccine from Dec 30, S’pore residents aged 70 and older from Feb ’21: MOH​


yq-sgvaccine-27122020.jpg

The committee has also assessed that the Pfizer-BioNTech vaccine is suitable for use in people aged 16 and above.
ST PHOTO: CHONG JUN LIANG

limminzhang.png

Lim Min Zhang
China Correspondent

Updated
Dec 28, 2020, 09:08 PM

SINGAPORE - Singapore's Covid-19 vaccination exercise will begin on Dec 30 with healthcare workers at the National Centre for Infectious Diseases, followed by the elderly aged 70 and older next February.

Vaccinations will roll out to more healthcare institutions in the coming weeks, with public healthcare institutions and private hospitals to arrange for their staff to be vaccinated at their respective premises.

This is in line with recommendations by an expert committee that front-line and healthcare workers and those most vulnerable to severe complications if they contract Covid-19 should be vaccinated first, said the Ministry of Health (MOH) on Sunday (Dec 27).

The elderly will be vaccinated from February next year, followed by other Singaporeans and long-term residents who are medically eligible, said the MOH.
This follows the Government's full acceptance of a 14-member expert committee's recommendations that were submitted last Thursday.

"Vaccination is not a silver bullet that can end the pandemic immediately, but it is a key enabler to getting us back to a safer state of affairs," the ministry said.

The MOH said vaccination will complement other "key enablers", such as safe management measures, testing and contact tracing, to mitigate any spread and to keep community transmission low.

In its statement, the committee noted that Covid-19 patients aged 70 and older have worse health outcomes than those aged 60 to 69, and so it is recommended to start vaccination for the older group first.

Protecting older people minimises Covid-19-related mortality and morbidity, as well as the potential strain on the healthcare system.

The committee has also assessed that the Pfizer-BioNTech vaccine, which arrived in Singapore earlier this month, is suitable for use in people aged 16 and older for the prevention of Covid-19, it said, although taking the vaccine is still not recommended for pregnant women and immunocompromised individuals until more information is available.

This was after it conducted an independent review of the clinical data on the safety and efficacy of the vaccine, which has been approved by the Health Sciences Authority.

The committee said the vaccine has demonstrated a high efficacy of 95 per cent, and its safety profile is consistent with the high standards set for other registered vaccines used in immunisation against other diseases.

The recommendations follow Prime Minister Lee Hsien Loong's announcement on Dec 14 that Covid-19 vaccines will be free for all Singaporeans and long-term residents who are currently here, with plans to cover everyone who wants one by the end of next year.

Other recommendations by the expert committee include:

- Everyone living in Singapore who is medically eligible for vaccination should be vaccinated when vaccines become more widely available, although it should remain voluntary.
Achieving as high a level of population coverage for Covid-19 vaccination as possible can markedly reduce the overall proportion of the population that is susceptible to the disease and the likelihood of uncontrolled chains of transmission, said the committee.

A high vaccination coverage also indirectly protects others who may not be suitable for vaccination yet, it added.
- Set aside about 5 per cent of available vaccine stocks at any point in time for specific groups of people who are of critical importance to the functioning of Singapore.

These could include people involved in ensuring the country's water, utilities and other "nationally essential services" are not disrupted.

This is separate from public health considerations to prioritise certain population subgroups, so as to ensure Singapore would be able to continue functioning effectively amid a local outbreak, said the committee.

But the detailed identification of these groups is beyond the remit of the expert committee, it said, and will be left to the Government.
- Ongoing public health measures such as safe distancing, mask wearing and good hand hygiene should continue to be practised, until a significant proportion of the population is vaccinated and more data is available on the vaccine's duration of protection and its ability to prevent infections.

The committee was convened in October by the MOH to recommend a vaccination strategy for Singapore.

Chairman of the expert committee, Associate Professor Benjamin Ong, said that while Singapore currently has a low rate of local transmission of Covid-19, it remains vulnerable to the threat of a surge in cases.

"As such, it is important that we achieve as comprehensive a coverage of Covid-19 vaccination as possible across the entire population. We strongly encourage all persons who are medically eligible to be vaccinated when the vaccine is made available to them," he added.

Other members of the committee include MOH chief health scientist, Professor Tan Chorh Chuan, Associate Professor David Lye from the National Centre for Infectious Diseases, and Dr Anuradha Poonepalli from the HSA's Health Products Regulation Group.

The committee's report to the Singapore Government was based on information available as at last Wednesday.

It also said that while public health measures have been shown to be effective in containing outbreaks, the "fundamental challenge" is that the vast majority of people in Singapore and the world do not have any immunity to the novel virus.

"The development and availability of effective Covid-19 vaccines is a critically important milestone, providing the means to fundamentally contain the pandemic, diminish its impact in terms of morbidity and deaths from infection, and eventually allow societies to return to normalcy," the report added.

Singapore currently has a low rate of transmission, it noted, but the threat of an outbreak persists as the global pandemic intensifies and as the country resumes more activities.

It remains vulnerable to the disease and its spread, with the country's high population density and a significant proportion of older people, said the report, adding that there is great value in vaccinating the population widely to pre-emptively protect against the risk of Covid-19.

The committee said it considered four key criteria in assessing the suitability of vaccine candidates: Vaccine safety, efficacy, tolerability, and data adequacy of clinical trials.

It noted that the HSA's clinical assessment of the Pfizer-BioNTech vaccine includes how it has high efficacy of 95 per cent, with no significant safety concerns detected so far.

But continued monitoring for long-term efficacy of the vaccine will be needed to determine the duration of protection, as well as for rare and serious adverse effects.

As more vaccines become available, the committee will make further recommendations on other groups to be prioritised, it said, such as those who live or work in settings where there is potential for rapid transmission and large outbreaks.
 

cocobobo

Alfrescian
Loyal
The National Federation of State High School Associations said last week that six high school student athletes died within the past month, four of them from heart issues and two from being hit, according to the Associated Press. Gainer’s death brings that number to seven."
 

DiMana

Alfrescian
Loyal
https://www.koreatimes.co.kr/www/art/2024/09/398_381980.html

Akdong Club's Lee Tae-geun dies at 41 after suffering from alleged vaccine side effects
Posted : 2024-09-06 09:07
Updated : 2024-09-06 20:51

The late Lee Tae-geun, a former member of Akdong Club / Captured from MBC

The late Lee Tae-geun, a former member of Akdong Club / Captured from MBC By KTimes

Lee Tae-geun, a former member of the group Akdong Club, has died at 41.

According to the music industry, he was laid to rest at the Yaeun Memorial Park columbarium in Eumseong County, North Chungcheong Province.

Akdong Club, a five-member male idol group, debuted in 2002 after being selected through an MBC program. The group quickly gained attention, winning a rookie of the year award that year.

After the group disbanded, Lee re-debuted with Jung Yi-deun, Jung Yoon-don, and Yang Chi-hwan as part of the group The A.D.

However, in February 2022, Lee's wife posted a shocking petition on the Blue House petition board.

According to the family, Lee experienced severe side effects following his third dose of the Pfizer COVID-19 vaccine three years ago. He developed symptoms like headaches and vomiting, leading to a hospital visit where he was diagnosed with a subarachnoid hemorrhage and admitted to an intensive care unit (ICU).

At the time, his wife said, "The attending doctor explained that subarachnoid hemorrhages are usually caused by trauma, but in my husband's case, there was no trauma, and the cause of the bleeding couldn't be identified. There is no specific treatment plan or method."

She added, "It is frustrating that they cannot explain the connection between the vaccine and these symptoms, despite them occurring after the vaccination."

She described her husband's condition as critical in the ICU, having lost over 20 kilograms and being unable to eat or receive nutritional supplements. She made a desperate plea for help, asking for assistance to save her husband's life.

The late Lee reportedly did not receive compensation for his condition, as no causal link was confirmed between the vaccine and the subarachnoid hemorrhage.
Lee's tragic death has led to an outpouring of condolences from fans.

This article from the Hankook Ilbo, a sister publication of The Korea Times, is translated by a generative AI and edited by The Korea Times.
 
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