Pfizer’s Covid-19 vaccine is more than 90% effective in preventing symptomatic illness in children aged 5 to 11, according to a document issued Friday that lays out the company’s case for approval.
The additional information was posted on the FDA’s website, and the agency has convened an advisory group of independent specialists to vote on whether or not to approve the injection on Tuesday.
The study included data from around 2,250 trial participants who were randomly assigned to receive either the vaccination or a placebo, with data collected until October 8. When the Delta variety was popular in the United States and across the world, the majority of positive instances occurred.
“VE (Vaccine Efficacy) against laboratory-confirmed symptomatic Covid-19 occurring at least 7 days after Dose 2 in evaluable participants without evidence of prior SARS-CoV-2 infection was 90.7%,” the document said.
The vaccine was tested with a 10 microgram dose, while older age groups have received 30 micrograms. The doses were administered three weeks apart.
There were no cases of severe Covid and no cases of multisystem inflammatory syndrome in children (MIS-C), a rare but serious post viral condition.
Overall, 158 children aged 5 to 11 have died from Covid in the United States since the start of the pandemic, according to official data.
Pfizer argued that “although the mortality rate for Covid-19 in children is substantially lower than that in adults, Covid-19 was among the top 10 leading causes of death for children 5 to 14 years of age between January and May 2021 in the US.”
Safety data was examined among a total of 3,000 vaccinated participants, with a low incidence of severe events.
There were no cases of myocarditis or pericarditis — inflammation or inflammation around the heart — but there were not enough study volunteers to be able to detect highly rare side effects.
In any case, male adolescents and young men are thought to be a higher risk group for these conditions.
This is the first time Pfizer has released an efficacy estimate for its Covid vaccine in younger children, along with a detailed dataset.
Its earlier press statements only said the vaccine produced a robust immune response and was safe.
Throughout the pandemic, pharmaceutical companies have been making major announcements through press releases with scant data, a situation that has frustrated some experts.
A document containing the FDA’s own analysis should be released soon, and will give an indication of the agency’s own view on whether the benefits of the vaccine outweigh the risks for this group.
The administration of President Joe Biden has said it stands ready to roll out shots for the country’s 28 million 5 to 11-year-olds as soon as the vaccine is authorized by science agencies.
The FDA panel meeting will be followed by a panel convened by the Centers for Disease Control and Prevention (CDC) on November 2-3. If both committees vote in favor, authorization could follow within days or weeks.