A panel of independent vaccine experts recommended that the U.S. Food and Drug Administration (FDA), expand the authorization of the Pfizer BioNTech COVID-19 vaccine for children aged 5 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.
The panel’s recommendation is not binding but is a critical first step towards increasing vaccine access in America.
To obtain emergency use authorization, the shot will need to be approved by the FDA and the Centers for Disease Control and Prevention.
If it can get past the last hurdles, it could be the first jab for children in that age range.
Many parents are unsure whether their children will be allowed to have shots. Around half of parents say they won’t give their kids the shots even if they are approved.
Studies show that the virus is less likely to affect children.
The Pfizer BioNTech COVID-19 vaccine was approved for children 5-11 years old on Tuesday. This cleared the first hurdle to expanding jabs eligibility. Pictured: A COVID-19 shot is given to a Pasadena, California child.
The jab for children five to 11 years old will be ten milligrams. This is one-third of the adult dose of 30 milligrams.
Pfizer stated that the optimal dose to elicit strong immune responses and a safe profile was 10ug.
It will be the same as the adult doses, but it will be a 2-shot vaccine with doses at least 3 weeks apart.
The company also presented data from clinical trials that showed the vaccine was effective in children under the age of 5.
The vaccine was found to be 90% effective in preventing Covid in children between five and eleven years old for at least four month, with no notable side effects other than myocarditis.
For the first four months following its administration, the Pfizer vaccine is 91% efficacious in children five to eleven years old
Myocarditis, also known as heart inflammation, has been reported in young men who have received the mRNA vaccine, such as Pfizer’s.
Although the chance of contracting the condition, which is usually not very serious but could lead to death in a small percentage of cases, is higher after getting the virus than after getting vaccinated for it, there is still a risk.
Pfizer has created six projections that will help determine the risk-reward outcome of vaccinating children in order to prevent COVID-19. However, they also expose them to the small chance of suffering from heart inflammation.
Scenario 1 – Vaccine is 70% effective against infection, 80% against hospitalizations. Only males aged 5-11 are most at risk of Covid, assuming that the virus situation as of September 11 remains.
Scenario 2 – Same effectiveness as scenario 1, but hospitalizations rise by 30% and cases by 20%.
Scenario 3
Scenario 4 : Vaccine is 90% effective in fighting cases and 100% effective against hospitalizations
Scenario 5 : Using the current death rates listed on the CDC tracker
Scenario 6 – Myocarditis risk is reduced by 50%
The model showed that the vaccine could prevent thousands of COVID-19-related deaths, hundreds of hospitalizations, and very few deaths.
On the other side, the vaccine could lead to dozens of severe myocarditis cases.
Scenario three, where the number of Covid cases were slashed to 95 percent and hospitalizations reduced to 90 percent, had a higher risk of myocarditis than the vaccine.
Both FDA panel members as well as officials at Pfizer pointed out that the projections used higher rates of heart inflammation to make the vaccine than what was actually found in other countries.
They also found that myocarditis is rare and often heals quickly.
Parents are afraid to poke their children.
According to a University of Michigan poll in July, approximately half of parents of children under 12 years old believe it is unlikely that their child will be vaccinated.
This is because people fear side-effects such as myocarditis, while children are less likely to experience severe symptoms (if any) from the virus.
A recent CDC study has shown that half of all children who get the virus will develop an asymptomatic condition.
The vaccine has now cleared the first hurdle for expanded authorization. This means that shots will likely be available to younger age groups in November.
Dr. Anthony Fauci, the nation’s foremost infectious disease expert, believes that shots could be given to children aged five to eleven as soon as November 4.
The Pfizer vaccine is currently the most widely used jab in the United States and the only one that is available to minors.
The jab has been granted emergency use authorization for children 12-17 years old, and full FDA approval for adults 18 years or older.
The vaccine has been administered 243,000,000 times and fully vaccinated 105,000,000 people.
Moderna, which also makes a two-shot Covid vaccination similar to Pfizer, is also looking to expand the authorization for its jab to minors over time.