FDA panel supports Pfizer’s low-dose COVID-19 vaccine for children
WASHINGTON (AP) – The United States took another step towards expanding COVID-19 vaccinations to millions more children as government advisers approved doses of Pfizer for children ages 5 to 11 on Tuesday years.
A Food and Drug Administration advisory group voted unanimously, with one abstention, that the vaccine’s benefits in preventing COVID-19 in this age group outweigh the potential risks. This includes questions about a heart-related side effect that has been very rare in adolescents and young adults despite their use of a much higher dose of the vaccine.
While children are much less likely than older people to contract severe COVID-19, many panelists ultimately decided it was important to give parents the choice to protect their young – especially those at high risk of sickness or who live in places where other precautions, such as masks in schools are not used.
“This is an age group that deserves and should be given the same opportunity to be vaccinated as any other age,” said Dr Amanda Cohn, panel member, Centers for Disease Control and Prevention.
The FDA is not bound by the panel’s recommendation and is expected to make its own decision within days. If the FDA agrees, there’s yet another step: Next week, the CDC will have to decide whether to recommend the injections and which young people should get them.
Full strength injections made by Pfizer and its partner BioNTech are already recommended for all ages 12 and up, but pediatricians and many parents are calling for protection for young children. The extra-contagious delta variant has caused an alarming rise in pediatric infections – and families are frustrated with school quarantines and have to say no to sleepovers and other childhood rites to keep the virus at bay.
In the 5-11 age group, more than 8,300 hospitalizations have been reported, with about a third requiring intensive care and nearly 100 deaths.
States are preparing to roll out the injections – only a third of the amount given to adolescents and adults – which will come in special orange-capped vials to avoid dosage mix-ups. More than 25,000 pediatricians and other primary care providers have signed up so far to offer the vaccination, which will also be available at pharmacies and other locations.
But despite all of this anticipation, there are also people who strongly oppose immunization of young children, and the FDA and its advisers have been inundated with an email campaign aimed at blocking the firing of Pfizer.
Dr Jay Portnoy of the Children’s Mercy Hospital in Kansas City, Missouri, said that despite more than 4,000 emails urging him to vote against the vaccine, he was convinced by the data showing it worked. Portnoy said he also represents “parents who I see every day at the clinic and who are terrified of sending their children to school.â¦ They also need a voice.”
Panelists stressed that they do not support vaccination mandates for young children – and the FDA does not make mandate decisions. FDA chief vaccine officer Dr Peter Marks also said it would be highly unusual for other groups to mandate something that is only cleared for emergency use. Several advisers said they wanted to be able to tailor shooting for young people most at risk, a decision that would rest with the CDC.
Dr James Hildreth of Meharry Medical College said he ultimately voted for the vaccine “to make sure the kids who really need this vaccine – mainly black and brown kids in our country – get it” .
Pfizer studied 2,268 elementary school children who received two injections three weeks apart of a placebo or a children’s dose. Young people vaccinated developed anti-virus antibody levels as strong as adolescents and young adults who received the injections at full strength. More importantly, the vaccine was found to be nearly 91% effective in preventing symptomatic infection – based on 16 cases of COVID-19 in children who received dummy injections, compared to only three who were vaccinated.
The dosage for children was also found to be safe, with similar or fewer temporary side effects, such as arm pain, fever, or body aches, experienced by adolescents. At the request of the FDA, Pfizer recently recruited another 2,300 young people into the study, and preliminary safety data showed no red flags.
But this study is not large enough to detect extremely rare side effects, such as heart inflammation that occasionally occurs after the second full dose, mostly in young men and adolescents. The panel spent hours discussing whether young children, receiving a lower dose, might also experience this side effect.
Statistical models developed by FDA scientists have shown that in most continuing pandemic scenarios, the vaccine would prevent many more COVID-19-related hospitalizations in this age group than would potentially be caused by this problem. rare cardiac.
FDA models suggest the vaccine could prevent 200 to 250 hospitalizations per 1 million young people vaccinated – assuming the spread of the virus remains high, which is difficult to predict. FDA scientists also said young children probably wouldn’t have as much risk of heart inflammation as teenagers, but if they did, it could lead to about 58 hospitalizations per million vaccinations.
âI think it’s a relatively close call,â said counselor Dr. Eric Rubin of Harvard University. “It will really be a question of what the conditions are, but we will never learn how safe this vaccine is unless we start giving it.”
Moderna is also studying its vaccine in young children, and Pfizer has additional studies underway in children under 5.