KUALA LUMPUR, Oct 25 — The protection offered by Pfizer-BioNTech’s Covid-19 vaccine to children aged from 5 to 11 “clearly outweigh” the risk of myocarditis, or heart inflammation, according to scientists at the United States Food and Drug Administration (FDA).
An FDA briefing document that was made public ahead of an advisory committee meeting tomorrow showed that the Pfizer vaccine not only reduces the risk of coronavirus infection, but also cuts the risk of symptomatic Covid-19 cases in children.
Among the 1,518 children in the study who received the Pfizer vaccine, only three cases were symptomatic Covid-19. In comparison, among 750 children in the placebo group, 16 were symptomatic, which means the vaccine was 90.7 per cent effective.
Symptoms among the vaccinated children who developed Covid-19 were very mild, with none having any fevers. In contrast, 10 of the 16 unvaccinated children who contracted the virus developed fevers and had worse symptoms in general. Common side effects included fevers and headaches similar to those seen in adults.
“While benefits of vaccination were highly dependent on Covid-19 incidence, the overall analysis predicted that the numbers of clinically significant Covid-19-related outcomes prevented would clearly outweigh the numbers of vaccine-associated excess myocarditis cases over a range of assumptions for Covid-19 incidence,” researchers said.
However, they noted that if the rate of Covid-19 was to fall to levels seen in June 2021, there would be more vaccine-associated myocarditis cases than Covid-19 hospitalisations. Even then, FDA staff said, given the more severe nature of Covid-19 hospitalisation, “the overall benefits of the vaccine may still outweigh the risks under this low-incidence scenario.”
Pfizer last Friday said that its vaccine was about 91 per cent effective in preventing Covid-19 in children aged between 5 and 11.