fda: FDA panel supports Pfizer’s low-dose Covid-19 vaccine for children

WASHINGTON: US took a step closer to expanding Covid-19 vaccinations for another million children when government advisers on Tuesday approved child-sized doses Pfizers shots for 5- to 11-year-olds.
An advisory panel from the Food and Drug Administration voted unanimously, with one abstention, that the benefits of the Covid-19 vaccine in that age group outweigh any potential risks. It includes questions about a heart-related side effect that have been very rare in teens and young adults despite their use of a much higher vaccine dose.
Although children are much less likely than older people to get serious Covid-19, many panelists ultimately decided that it is important to give parents the choice to protect their young people – especially those at high risk of illness or living in places where others precautionary measures, such as masks in schools, are not used.
“This is an age group that deserves and should have the same opportunity to be vaccinated as any other age,” said panelist Dr Amanda Cohn of the 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 a few days. If the FDA agrees, there is another step: Next week, the CDC must decide whether to recommend the shots and which young people should get them.
Full-strength shots made by Pfizer and its partner BioNTech are already recommended for all 12 years and older, but pediatricians and many parents are calling for protection for younger children. The extra contagious delta variant has caused an alarming increase in pediatric infections – and families are frustrated with school quarantines and having to say no to overnight stays and other childhood rites to keep the virus in check.
In the age group 5 to 11 years, more than 8,300 hospital admissions have been reported, about a third requiring intensive care and almost 100 deaths.
States are getting ready to roll out the shots – just a third of the amount given to teenagers and adults – that come in special orange-filled bottles to avoid confusing the dosage. More than 25,000 pediatricians and other primary care providers have so far signed up to offer vaccinations, which will also be available in pharmacies and other places.
But despite all that expectation, there are also people who strongly oppose vaccinating younger children, and both the FDA and its advisers were inundated with an email campaign that tried to block the Pfizer shot.
Dr. Jay Portnoy of the Children’s Mercy Hospital in Kansas City, Missouri, said despite more than 4,000 emails urging him to vote against the vaccine, he was persuaded by the evidence that it worked. Portnoy said he also represented “parents I see every day at the clinic who are terrified of sending their children to school … They also need a voice.”
Panelists stressed that they did not support vaccine mandates for young children – and the FDA does not make mandate decisions. FDA Vaccine Director Dr. Peter Marks also said that it would be very unusual for other groups to mandate something that is only approved for emergency use. Several advisers said they wished they could tailor the shots for young people at highest risk, a decision that would fall on the CDC.
Dr James Hildreth of Meharry Medical College said he finally voted for the vaccine “to ensure that the children who really need this vaccine – mainly black and brown children in our country – get it.”
Pfizer studied 2,268 primary school children who received two injections at three-week intervals of either placebo or the child dose. Vaccinated adolescents developed levels of antiviral antibodies as strong as adolescents and young adults who received full-strength shots. More importantly, the vaccine proved almost 91% effective in preventing symptomatic infection – based on 16 cases of Covid-19 among children who received dummy shots compared to only three who were vaccinated.
The child dose was also shown to be safe, with similar or fewer temporary side effects – such as sore arms, fever or pain – that teenagers experience. At the request of the FDA, Pfizer recently registered an additional 2,300 adolescents in the study, and preliminary safety data have not shown any red flags.
However, that study is not large enough to detect any extremely rare side effects, such as heart inflammation that sometimes occurs after the second full-strength dose, mostly in young men and teenage boys. The panel spent hours discussing whether younger children, who are given a smaller dose, can also face that side effect.
Statistical models developed by FDA researchers showed that in most scenarios of the continuing pandemic, the vaccine would prevent far more Covid-19 hospitalizations in this age group than could potentially be caused by the rare heart problem.
FDA models suggested that the vaccine could prevent 200 to 250 hospitalizations for every million young people vaccinated – provided the virus spread remained high, which is difficult to predict. FDA researchers also said that younger children are unlikely to have the same risk of heart inflammation as teenagers, but if they did, it could cause about 58 hospitalizations per million vaccinations.
“I think it’s a relatively close conversation,” said Harvard University advisor Dr. Eric Rubin. “It will certainly be a question of what the prevailing conditions are, but we will never learn how safe this vaccine is if we do not start giving it.”
Modern is also studying its vaccine in young children, and Pfizer has further studies in progress on those younger than 5.

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