US drugmaker Pfizer said Thursday it has formally requested emergency use authorization for its Covid-19 vaccine in children age five to 11.
Children have been infected in greater numbers in the latest coronavirus wave driven by the Delta variant, and inoculating young people is seen as key to keeping schools open and helping end the pandemic.
In late September, Pfizer and BioNTech, which co-developed the vaccine, began submitting data to the Food and Drug Administration regulators for the highly anticipated authorization.
Pfizer tweeted early Thursday that the two companies had “officially submitted our request” to the FDA “for Emergency Use Authorization (EUA) of our #COVID19 vaccine in children 5 to <12.”
“We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat,” Pfizer said.
The FDA said last week it had scheduled a meeting of an advisory committee to review the data on October 26, before giving its opinion on whether authorization should be granted.
– ‘Really important’ step –
Following the announcement, White House Covid coordinator Jeff Zients told CNN that “I think we can all agree that getting a safe and effective vaccine for kids five to 11 is a really important next step in our fight against the virus.”
The FDA has previously said that once the formal submission was completed, the agency would complete its review “likely in a matter of weeks rather than months.”
Children in the 5-11 age group received a two-dose regimen of 10 micrograms in the trial, compared with 30 micrograms for older age groups. The shots were given 21 days apart.
The Pfizer-BioNTech vaccine has been granted full FDA approval for those age 16 and up, and the FDA in May authorized its emergency use in children age 12 to 15.
– Youth vaccinations key –
Experts say children are essential to vaccinate to help achieve population immunity against the disease.
Nearly 5.9 million children have tested positive for Covid-19 as of September 30, according to the American Academy of Pediatrics.
Vaccines, masks, and other mitigation measures against Covid-19 have become deeply political issues in the United States — especially for children.
Early last month the Los Angeles school district, the second biggest in the country, voted that children age 12 and over who attend public schools will have to be fully vaccinated against Covid-19 by the start of next year, in the first such requirement by a major education board in the United States.
The Pfizer vaccine received full, formal approval in the US in August and is therefore technically available to children in younger age groups if prescribed by a doctor, but US authorities have cautioned against doing this until the safety data was in.
Pfizer and BioNTech are also trialling their vaccine on infants aged six months to two years, and on children aged two to five.
Initial data for these groups may come before the end of the year.
Source: AFP
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