FDA Advisory Panel Recommends Pfizer-BioNTech Boosters for Adults 65+, Others at High Risk

FDA Advisory Panel Recommends Pfizer-BioNTech Boosters for Adults 65+, Others at High Risk

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FDA Advisory Panel Recommends Pfizer-BioNTech Boosters for Adults 65+, Others at High Risk
People aged 65 and over and those at high risk of severe COVID-19 or infection may soon be eligible for a third dose of Pfizer-BioNTech’s COVID-19 vaccine.
The Vaccine Advisory Board of the Food and Drug Administration (FDA) today unanimously approved a recommendation to recommend a booster vaccination for people aged 65 and over who received two doses of the Pfizer BioNTech vaccine at least six months ago.
People over the age of 16 who are at high risk of severe COVID-19 are also included in the recommendations.
If the FDA follows the recommendations of the Commission, the approval is granted as an emergency approval (EUA) instead of a full approval.
Pfizer BioNTech vaccine is now a fully approved TrustedSource vaccine as a double-dose regimen for people aged 16 and older under the Comirnaty brand in the United States.
In the US, starting doses of the vaccine are available from 12 to 15 years of age. This group is currently not eligible for boosters.
Originally used for all COVID-19 vaccines, emergency approval is a faster regulatory route for public health emergencies such as pandemics.
As part of the EEA, the FDA will continue to monitor data on the safety and effectiveness of booster vaccines in these groups.
After the vote, a committee of independent experts also informally recommended that the EEA be supplemented with “Healthcare workers or other persons at high risk of occupational exposure”.
All members have accepted this addition.
“This is a really overwhelming vote for those at serious risk of COVID, d Korn, Centers for the Medical Director of Disease Control and Prevention (CDC) Commissioner, said:
He said many people in these high-risk groups were vaccinated in December 2020 or January this year, which could increase their risk of infection due to weakened immunity after vaccination.
What we know about how easily delta variants spread:
The Delta variant identified in December 2020 quickly spread around the world and became the dominant strain in India, Great Britain and now the United States.
Scientists believe that delta variants spread up to 60% faster than alpha variants. The alpha variety was believed to spread 50 percent faster than the original variety, which launched in 2019.
How contagious are Delta variants?
Dr. Sharon Nackman, a pediatric infectious disease expert and chair of the pediatric infectious disease division at Stony Brook Children’s Hospital in Stony Brook, New York, said the Delta variant was up to 60% more contagious than the original coronavirus. high. It was discovered in 2019.
Nackman thinks Delta is much more contagious than influenza and comparable to measles.
The biggest indication that this variant is more contagious than influenza, according to Neuman, is this year’s data on seasonal illnesses.
Thanks to all the precautions we’re taking to prevent COVID-19, there has been virtually no flu season this year.
However, despite the precautionary measures, the alpha and delta variants continued to shrink, affecting millions of people.
“The fact that COVID-19 spreads more widely in situations where influenza is rarely detected shows how infectious SARS-CoV-2 compares to influenza A and B viruses,” said Neuman.
The level of innate immunity in our population also affects the infectivity of the virus.
There is widespread immunity in measles thanks to high vaccination rates and highly effective vaccines.
He also has great immunity to chickenpox and flu.
However, with COVID-19, unvaccinated people who have never been sick remain vulnerable.
“When your cells see it, they get infected and, as we’ve seen, the infections (from unvaccinated people) are more people in the hospital and more. That means a lot of people are going to die,” Nackman said.
These differences are also due to the virus’ ability to spread remotely, according to Nachman.
Measles is spread from a distance of 60 feet. You can get measles by entering the room within an hour or two of someone having measles.
Measles is so contagious that there is a 90 percent chance of developing measles if a person with measles is exposed to a non-immune person.

Chickenpox is contagious from 6 meters away, and flu is mainly transmitted through close contact.
The extent to which a virus is suspended in the air depends on its size, Nachman said. The measles virus is very small and can stay airborne for a long time to remain contagious.
Pfizer manufactures booster can cases:
During the full-day session, the FDA advisory group reviewed Pfizer’s evidence on the safety and effectiveness of the third dose of the vaccine.
The panel also heard from two Israeli researchers who presented data from that country suggesting a reduction in the protection provided by the vaccine months after the second dose.
The data showed that all age groups had weakened protection against infection 6 months after vaccination.
Protection against serious illnesses has also decreased in people over the age of 60. This trend was less evident in the younger age group.
Pfizer scientists cited recent Israeli data and data from laboratory studies and clinical trials in order to claim the approval.
Laboratory data showed that antibody levels rose after the third dose, at least 6 months after the second dose.
Clinical trial data showed that the side effects of the third dose were similar to the first two doses. In some cases, the side effects were less severe after the third dose.
“These data and other scientific evidence presented at the conference underscore our belief that drivers will be an important tool in our ongoing efforts to contain the spread of this virus,” said Dr. Katrin U. Janssen, Senior Vice President and Director. of vaccine research and development at Pfizer in a press release.
People with weakened immunity can already receive a third mRNA vaccine in the USA. These are not considered booster doses, but they are a way to boost people’s initial immune responses.
The FDA does not have to follow the panel’s advice, but generally does.
The CDC Advisory Committee on the Implementation of Immunizations (ACIP) will meet to discuss whether the CDC should recommend the use of Pfizer BioNTech boosters for these groups.
Clearer booster benefits for the elderly
The FDA advisory board initially voted on whether boosters should be recommended to everyone over the age of 16.
The vote failed because two members agreed and 16 members disagreed.
Some members felt that while there is strong evidence that older people have the benefits of boosters, younger age groups need more safety data.

In particular, they focused on the risk of heart inflammation: myocarditis and pericarditis. These conditions can occur after vaccination with the mRNA vaccine.
They are more common after the second dose and in adolescent men and young adults. Most people recover quickly with treatment.
Israel recently started rolling out Pfizer BioNTech vaccine boosters for the younger age group.
Dr. Sharon Alroy Price, director of public health at Israel’s Ministry of Health, said more than 6,000 children between the ages of 16 and 18 received a third dose during the meeting.
The Israeli Ministry of Health is actively monitoring all cases of heart inflammation in this group.
So far, the incidence of myocarditis or pericarditis seems to be lower after the third dose than after the second. However, Alroy-Price added that the follow-up time for these young adults is less than 30 days.
Some members of the FDA committee felt that a longer follow-up was needed to know the true risk of heart inflammation after the booster.
Clearer booster benefits for the elderly:
The FDA advisory board initially voted on whether boosters should be recommended to everyone over the age of 16.
The vote failed because two members agreed and 16 members disagreed.
Some members felt that while there is strong evidence that older people have the benefits of boosters, younger age groups need more safety data.
In particular, they focused on the risk of heart inflammation: myocarditis and pericarditis. These conditions can occur after vaccination with the mRNA vaccine.
They are more common after the second dose and in adolescent men and young adults. Most people recover quickly with treatment.
Israel recently started rolling out Pfizer BioNTech vaccine boosters for the younger age group.
Dr. Sharon Alroy Price, director of public health at Israel’s Ministry of Health, said more than 6,000 children between the ages of 16 and 18 received a third dose during the meeting.
The Israeli Ministry of Health is actively monitoring all cases of heart inflammation in this group.
So far, the incidence of myocarditis or pericarditis seems to be lower after the third dose than after the second. However, Alroy-Price added that the follow-up time for these young adults is less than 30 days.

Some members of the FDA committee felt that a longer follow-up was needed to know the true risk of heart inflammation after the booster.