An advisory panel voted to recommend the Pfizer-BioNTech COVID-19 vaccine for authorization children aged 5 to 11Jab will still need approval from the FDA and CDC to have its authorization expandedShot for younger children will be ten micrograms, one-third of the standard dose for adultsClinical trial data found that the shit was 90% effective at preventing infection from the virus Main concern regarding the vaccine is the potential for the jab to cause myocarditis in young males, though risk is very low
A panel of independent vaccine experts has recommended the U.S. Food and Drug Administration (FDA) to expand authorization of the Pfizer-BioNTech COVID-19 vaccine to include children aged five to 11.
The Vaccines and Related Biological Products Advisory Committee voted on Tuesday to recommend the jabs for children by a 17-0 vote with one person abstaining.
While the recommendation from the panel, made up of people outside of the regulatory agency, is not binding, it is a key first step towards expanding the vaccine’s access in America.
The shot will now need approval from the FDA and the Centers for Disease Control and Prevention (CDC) to gain emergency use authorization.
If it gets through the final hurdles, it would be the first jab available for children within that age group.
The Pfizer-BioNTech COVID-19 vaccine was recommended for authorization in children aged 5 to 11 on Tuesday, clearing the first hurdle towards expanding the jabs eligibility. Pictured: A child in Pasadena, California, receives a shot of a COVID-19 vaccine
The jab for children aged five to 11 will be ten micrograms, a third of the size of the 30 microgram dose given to adults.
’10ug dose level was selected as optimal to elicit robust immune responses with an acceptable safety profile,’ Pfizer said in one of the presentation slides.
Just like the doses for adults, it will be a two-shot vaccine with the doses at least three weeks apart.
The company presented data from clinical trials at the meeting as well, showing the vaccine to be effective in children of that age group.
Data showed the vaccine to be 90 percent effective at preventing Covid in children aged five to 11 for at least four months, without any notable serious side-effects other than the rare myocarditis case.
The Pfizer vaccine is 91% effective in children aged five to 11 for the first four months after it is administered
Myocarditis, or heart inflammation, cases have appeared in young males who have received mRNA vaccine like Pfizer’s.
While the likelihood of developing the condition – which is often not very serious but could be potentially deadly in a small portion of cases – is much higher after catching the virus than it is getting vaccinated, the risk still exists.
Pfizer set up six projections to determine the risk-reward outcomes of vaccinating children to prevent COVID-19 cases, while also exposing them to the small likelihood of suffering heart inflammation.
Scenario 1: Vaccine is 70% effective against infection and 80% effective against hospitalizations, only males between five to 11, who are most at risk for Covid, assuming the virus situation as of September 11 holds
Scenario 2: Same effectiveness as scenario one, though cases increase by 20%, and hospitalizations by 30%
Scenario 3: Covid cases decrease 95% and hospitalizations decrease 90%
Scenario 4: Vaccine is 90% effective against cases, and 100% effective against hospitalizations
Scenario 5: Using the current death rate listed on the CDC tracker
Scenario 6: Risk of myocarditis is halved by 50%
The model found that the vaccine could potentially prevent thousands of COVID-19 cases, hundreds of hospitalizations and a very small amount of deaths.
On the other hand, the vaccine could cause dozens of serious myocarditis cases.
In scenario three, where the amount of Covid cases was slashed by 95 percent and hospitalizations by 90 percent, was the risk of myocarditis more severe than that of the vaccine.
Both the Pfizer officials and members of the FDA panel noted that the projections are using much higher rates of heart inflammation than the actual rates being found in other nations were young children are eligible for the vaccine.
They also determined that those rare cases of myocarditis often resolve quickly and do not pose significant danger to the children.
With the vaccine now having cleared the first hurdle to expanded authorization, it is likely to shots will be available to the younger age group in early November.
Currently, the Pfizer vaccine is the most commonly used jab in the United States, and the only one available to minors.
The jab has received emergency use authorization for children aged 12 to 17, and full FDA approval for adults 18 or older.
The vaccine has been adminsitered 243 million times and fully vaccinated 105 million people.
Moderna, who also produces a two-shot Covid vaccine similar to Pfizer’s, is also hoping to expand authorization of its jab to minors in the coming weeks.