The US drug agency is due to rule on whether or not Pfizer / BioNTech’s serum is allowed for this age group in the United States in the near future.
The anti-Covid-19 vaccine developed by Pfizer and BioNTech is 90.7% effective against symptomatic forms of the disease in children aged 5 to 11 years, said the pharmaceutical group in a document relayed by the Wall Street Journal.
These new data were published on the site of the United States Medicines Agency (FDA), whose advisory committee is due to meet on Tuesday to study this request for authorization.
“The vaccine’s efficacy against confirmed symptomatic forms of Covid-19 at least 7 days after the second dose (…) was 90.7%,” Pfizer wrote in this document.
“No serious case of the disease”
These are the results of a study of around 2,250 children aged 5 to 11, of whom more than 1,500 received the vaccine and 750 received a placebo. The participants were followed for at least two months after the injections. The results mean that by comparing the two groups, the risk of getting sick from Covid-19 was reduced by more than 90% for the vaccinated group.
“There have been no severe cases of the disease or cases of MIS-C” (pediatric multisystem inflammatory syndrome) observed, Pfizer also said.
The laboratory also clarified that no case of myocarditis, an inflammation of the heart muscle, had been observed in these children after vaccination. The dosage for children has been adjusted to 10 micrograms per injection, compared to 30 micrograms for the older groups.
The first injections for early November in case of green light
The vaccine “demonstrated a favorable safety profile, a robust immune response against all variants of concern and high efficacy against symptomatic forms of Covid-19 during a period when the Delta variant was dominant,” summarized the business.
So far, Pfizer had only reported results on the immune response observed in children, based on the levels of antibodies detected, but not on the effectiveness of the remedy.
In the event of a green light from the American health authorities, injections could begin as early as November in the United States, the White House having announced earlier this week its plan for the ultra-rapid distribution of millions of doses throughout the country. The United States has 28 million children between the ages of 5 and 11.