The US Food and Drug Administration’s independent vaccine advisory panel will meet on Tuesday to decide whether the Pfizer/BioNTech Covid-19 vaccine should be licensed for children aged 5 to 11. Pfizer’s vaccine is already licensed for emergency use in children 12 to 15 years old, as well as for those 16 years old and older.
Members of the committee will hear from the Centers for Disease Control and Prevention on the effects of Covid-19 on children as part of their deliberations. They will also look at any potential safety problems with the vaccine.
Meeting Of FDA’s Independent Vaccination Committee To Review Pfizer’s
Additionally, Pfizer/BioNTech will talk about the company’s studies on this age group, which will be streamed live on the internet. Pfizer said in September that results from a Phase 2/3 research showed that children aged five to eleven years had a “robust” antibody response to its Covid-19 vaccines.
Before the FDA hearing on Friday, Pfizer produced a new document in which it claimed that their vaccine is safe and 90.7 percent effective in protecting children aged 5 to 11 years from symptoms of Covid-19.
According to the researchers, the immunization dose provided to children was one-third of the dose given to adults. Three of the children were unwell as a consequence of exposure to Covid-19.
Six hundred and sixty-three children were infected with Covid-19 after receiving a placebo injection, and sixteen of them died as a consequence. Covid-19 infected substantially more kids than the placebo, even though it was given to much fewer.
Pfizer/Covid-19 BioNTech’s vaccine, according to an FDA review issued late Friday night, has benefits that outweigh the hazards in the present pandemic context for children aged 5 to 11.
According to the FDA, the vaccine has a small but real risk of inducing myocarditis or pericarditis, which are both inflammations of the heart’s outer membrane that need medical attention and may necessitate hospitalization. There is an increased danger of Covid-19 infection if there is a large enough quantity of virus floating about.
Even while children are still less likely than adults to get Covid-19 and die as a result of it, the CDC estimates that 745 children have died in the United States since the epidemic started.
According to an American Academy of Pediatrics research published on Monday, nearly 118,000 children have tested positive for Covid-19 in the previous week alone. About 6.3 million children have tested positive for the virus since the Covid-19 epidemic began.
For the week ending October 21, children made up a disproportionate number of Covid-19 instances, making up moreover a quarter of all cases in the United States. About 22% of Americans are under the age of 18. FDA committee will determine whether or not to approve the vaccine for future use if they vote in favor of it being approved for emergency use by the FDA.
The committee will consider Pfizer’s findings on the vaccine’s safety and efficacy in protecting children in this age range when making its decision. This year’s vaccine recommendation for this age group will be voted on by the independent advisory committee of the Centers for Disease Control and Prevention (CDC) on November 2 and 3. In the end, the plan will be adopted or amended by Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention.