FDA Says Pfizer-BioNTech Covid Vaccine 90.7% Effective For Children Aged 5-11

The efficacy of Pfizer-BioNTech Covid-19 vaccines shown in children's clinical trials is 90.7 per cent, implying that the vaccines could be safe and have a significant impact on children.

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New Delhi: The US Food and Drug Administration (USFDA) made some documents public on Friday that show the Pfizer-BioNTech vaccine is more than 90 per cent effective in children aged 5 to 11. 

The efficacy shown in the clinical trials is 90.7 per cent, implying that the vaccines could be safe and have a significant impact on children.

The vaccines and related biological products advisory committee briefing document was submitted by Pfizer to USFDA ahead of a meeting to be held on October 26. 

The document mentions a total of 2,268 participants, 1,500 of whom received the active vaccine, while the rest received placebos. Out of the total participants, only 19 were infected with Covid-19 following the vaccination. Three children belonged to the vaccinated group, while 16 belonged to the placebo group. 

There were no severe cases or deaths from Covid-19 in either the active vaccine group or placebo group. 

The number of children given the active vaccine in the clinical trials is twice the number of children in the placebo group.

Scientists at the FDA later said that the likely benefits of giving the Pfizer-BioNTech vaccine to 5 to 11-year-olds clearly outweigh the risks of rare cases of heart inflammation.

Pfizer had also conducted a clinical trial on adults. The US drugmaker compared the amount of neutralising antibodies induced by the vaccine in children to the amount induced in older participants. This implies the clinical trial in the children was not primarily designed to measure efficacy against the virus.

The children received two shots of a 10-microgram dose of the vaccine. 

Data From Clinical Trial To Be Examined

Outside advisors to the FDA are scheduled to meet on Tuesday to decide whether the vaccine should be authorised for the age group of 5-1, Reuters reported. 

Pfizer said it doubled the number of children enrolled to improve its safety data, the report mentions.

There are no new safety concerns from the vaccine for the children, according to the documents. 

Rare cases of heart inflammation, called myocarditis, have been observed in individuals who received Pfizer/BioNTech or Moderna vaccines. 

Myocarditis rate in vaccinated children belonging to the age group of 5-11 was likely to lower than the rate in vaccinated children aged 12-15.

The US has given regulatory authorisation to the Pfizer-BioNTech vaccine for people who are at least 12 years of age. The vaccines have full FDA approval for people aged 16 and above.

More than 11 million fully vaccinated people aged 12 to 17 in the US have received the Pfizer vaccine.

The US Centers for Disease Control and Prevention (CDC) will meet on November 2 and 3, if the FDA authorises the vaccine for children aged 5 to 11. CDC will provide recommendations about the manner in which the doses should be administered.