A crucial FDA panel group advisory unanimously decided to support the use of Pfizer-coronavirus BioNTech’s vaccine in children aged 5 to 11, bringing the vaccine one step closer to reaching about 28 million youngsters. Shots might be available as soon as next week.
The panel recommended that the age group get one-third of the amount provided to adults 12 and older in two shots three weeks apart. The committee’s recommendations on whether to approve vaccinations are not legally binding, but the FDA panel usually follows them in the days after the decision. This will refer the case to the C.D.C., which has its own expert panel expected to rule next week.
The FDA’s experts voted after authorities stated that hundreds of children aged 5 to 11 had been hospitalised with Covid-19, and almost 100 had died during the epidemic.
During a lengthy debate previously, several committee members questioned whether the vaccination was truly necessary for every kid in the age group or whether it should be restricted to those at high risk of severe Covid-19.
Dr. Paul Offit, a panellist who directs the Vaccine Education Center at Children’s Hospital of Philadelphia, described it as “nerve racking” to make judgments impacting millions of children based on research with only a few thousand participants.
“The question is when do you know enough?” he added. And I believe we can all agree that there are many children between the ages of 5 and 11 who are vulnerable to this sickness and might become ill, be hospitalised, or die as a result of it.”
Dr. Peter Marks, who heads the agency’s vaccine licencing section, told the committee that Covid-19 is now one of the top 10 causes of mortality among children aged 5 to 11. According to him, about two million people in that age bracket have been infected, and 8,300 have been hospitalised, with a third requiring acute care.
Federal authorities expect that the paediatric dose would help address a significant gap in the United States’ immunisation campaign, which has concerned parents, educators, and public health experts. If the FDA panel gives approval, around 28 million youngsters will be eligible. Only the youngest, children under the age of five, would be left unprotected.
According to Dr. Fiona Havers, a viral infections specialist at the CDC, children aged 5 to 11 account for 10.6 percent of all illnesses but only 8.7 percent of the population. She claims that children have larger levels of neutralising antibodies than adults, yet they are just as prone as adults to become sick.
Covid hospitalisation rates for children aged 5 to 11 are three times higher for Black, Hispanic, or Native American children than for white children, she claims. Between early August and October, more than 2,000 schools with over one million pupils were forced to close due to epidemics, she claimed.
The C.D.C. also released blood test results showing that 42 percent of young children had antibodies, raising concerns about how many of them had been infected and developed natural immunity. However, Dr. Havers emphasised that the children studied were already receiving therapeutic treatment and may not be representative of the entire community.
It is unknown how many parents would immediately vaccinate their primary school-aged children if given the opportunity. According to polling, around one-third of these parents are keen to do so right soon, while the other third want to wait. Since May, when federal authorities approved Pfizer injections for youngsters aged 12 to 15, 46 percent of that age group has been completely vaccinated, compared to around 69 percent of adults.
Scientists at the Food and Drug Administration evaluated their own research and concluded that the advantages of avoiding Covid-19 with a paediatric dosage exceeded the dangers of the most concerning side effects. According to Hong Yang, an FDA panel expert, even if the risk of infection is minimal, as it was in June, the advantages of immunisation may exceed the dangers of potential side effects. This is due to the fact that persons hospitalised with Covid-19 likely to be sicker and for a longer period of time than those with particular cardiac issues linked to the vaccination.
According to federal health experts, incidences of the heart disorders reviewed by the FDA panel — myocarditis, or inflammation of the heart muscle, and pericarditis, or inflammation of the lining around the heart — following the second dose of a vaccination are usually minor and recover rapidly. None of the children in Pfizer’s clinical study had those problems, which was to be expected given the small size of the trial and the rarity of those disorders.
