US Food and Drug Administration staff reviewers on Sunday said Pfizer-BioNTech’s Covid-19 vaccines were effective and safe for use in children aged six months to four years.
The FDA reviewers said in briefing documents published on Sunday evening that their evaluation did not reveal any new safety concerns related to the use of the vaccine in young children.
The FDA analysis of data from Pfizer’s trial was published ahead of a meeting of its outside advisers on Wednesday. Recommendations from the external advisers will determine the FDA’s decision on the vaccines.
“Available data support the effectiveness of the Pfizer-BioNTech Covid-19 vaccine three-dose primary series in preventing Covid-19 in the age group of six months through four years,” FDA staff said in the review.
An early analysis of data from Pfizer-BioNTech’s vaccine based on 10 symptomatic Covid-19 cases identified when the Omicron coronavirus variant was dominant suggested a vaccine efficacy of 80.3 per cent in the under-five age group.
Covid-19 shots for children under six are yet not approved in most parts of the world. It remains unclear how many parents will get their children vaccinated as demand has been low for children aged five to 11.
US president Joe Biden’s administration expects vaccinations for young children to begin in earnest as early as June 21st if the FDA and the US Centers for Disease Control and Prevention approve the vaccines.
Government officials say pre-orders for use in the under-six age group has been low but demand is expected to pick up once the vaccines gain authorisation.
The FDA on Friday released a staff review of Moderna’s Covid-19 vaccine that said the doses were safe and effective for use in children aged six months to 17 years.
Separately, French drug maker Sanofi on Monday said the Covid-19 vaccine candidate it had developed jointly with GlaxoSmithKline in two trials showed a potential to protect against the virus’s main variants of concern, including the Omicron BA.1 and BA.2 strains, when used as a booster jab.
“Across both studies, the Sanofi-GSK next-generation vaccine candidate was well-tolerated, with a favourable safety profile,” Sanofi said in a statement, adding that it would publish the complete findings of the studies later this year.
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