A panel of independent vaccine experts appointed by the US Food and Drug Administration (FDA) to extend the authorization of Pfizer-BioNtech COVID-19 Vaccine to include children aged five to 11 years.
The Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0 to recommend Jabs for children, with one person abstaining.
While the panel’s recommendation, made up of people outside the regulatory agency, is not binding, it is an important first step toward expanding vaccine access in the US.
The shot will now require approval from the FDA and the Centers for Disease Control and Prevention (CDC) to obtain emergency use authorization.
If it crosses the last hurdle, it will be the first jab available to children in that age group.
The authorization of shots for children has become a controversial topic among many, with almost half of parents saying they would not give shots to their children, even if approved.
Studies have found that even children are less likely to experience symptoms of the virus.
The Pfizer-BioNTech COVID-19 vaccine was recommended for authorization in children ages 5 to 11 on Tuesday, clearing the first hurdle in expanding JABS eligibility. Pictured: A child receives a shot of the COVID-19 vaccine in Pasadena, California
The jab for children aged five to 11 years would be ten micrograms, which would be one-third the size of the 30 microgram dose given to adults.
Pfizer said in one of the presentation slides, ‘The 10ug dosage level was chosen as optimal to achieve a robust immune response with an acceptable safety profile.
Like the dosage for adults, this will be a two-shot vaccine with doses spaced at least three weeks apart.
The company also presented clinical trial data in the meeting, which showed that the vaccine is effective in children of this age.
The data showed the vaccine is 90 percent effective at preventing Covid in children aged five to 11 years for at least four months, without any notable serious side effects other than a rare myocarditis case.
Pfizer is 91% effective in children aged five to 11 years for the first four months after the vaccine is administered
Cases of myocarditis, or inflammation of the heart, have been reported in young men who have received an mRNA vaccine, like Pfizer.
While the chances of developing the condition – which is often not very serious, but can be potentially fatal in a small fraction of cases – after catching the virus is much higher than after vaccination, the risk still exists.
Pfizer established six estimates to determine the risk-reward consequences of vaccinating children to prevent COVID-19 cases, while also highlighting the small chance of them suffering from heartburn.
Scenario 1: Vaccine is 70% effective against infection and 80% effective against hospitalization, only men aged between five and 11 who are most at risk for covid, assuming virus status as on September 11 happened
Scenario 2: Effectiveness similar to scenario one, although there is a 20% increase in cases, and a 30% increase in hospitalizations
Scenario 3: 95% reduction in covid cases and 90% reduction in hospitalizations
Scenario 4: The vaccine is 90% effective against cases, and 100% effective against hospitalizations
Scenario 5: Using the Current Mortality Rate Listed on the CDC Tracker
Scenario 6: Myocarditis risk halved to 50%
The model found that the vaccine could potentially prevent thousands of COVID-19 cases, hundreds of hospitalizations, and very few deaths.
Vaccines, on the other hand, can cause dozens of severe cases of myocarditis.
In scenario three, where there was a 95 per cent reduction in the number of Covid cases and a 90 per cent reduction in hospitalizations, the risk of myocarditis was more severe than that of the vaccine.
Pfizer officials and FDA panel members both noted that the estimates are using higher rates of heart inflammation than the actual rates found in other countries, with young children eligible for the vaccine.
They also determined that those rare cases of myocarditis often resolve quickly and do not pose a significant risk to children.
Still, these fears have made parents afraid to forcibly kill their young children.
Nearly half of parents with a child under 12 say they are unlikely to get their child vaccinated. Survey from the University of Michigan In July.
This is because some people are afraid of possible side effects such as myocarditis – while children are less likely to suffer serious symptoms – if any – from the virus itself.
A recent CDC study found that 50 percent children Those who contract the virus will experience an asymptomatic case.
Shots are likely to be available for the younger age group in early November, with the first hurdle to the vaccine now extended authorization removed.
Dr Anthony Fauci, the country’s top infectious disease specialist, believes shots could begin for the age group five to 11 from November 4.
Currently, the Pfizer vaccine is the most commonly used jab in the United States, and is only available to minors.
The jab has received emergency use authorization for children 12 to 17 years of age and full FDA approval for adults 18 years of age or older.
The vaccine has been administered 243 million times and 105 million people have been fully vaccinated.
Moderna, which also makes a two-shot Covid vaccine similar to Pfizer, is also hoping to expand the authorization of its jab to minors in the coming weeks.
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