US drugmaker Pfizer on Thursday said it has formally requested emergency use authorization for its COVID-19 vaccine in children aged five to 11.
Children have been infected in greater numbers in the latest wave of infections driven by the Delta variant of SARS-CoV-2, and inoculating young people is seen as key to keeping schools open and helping end the COVID-19 pandemic.
In late September, Pfizer and BioNTech, a German firm that codeveloped the vaccine, began submitting data to US Food and Drug Administration (FDA) regulators for the highly anticipated authorization.
Pfizer early on Thursday wrote on Twitter 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 last week said that it had scheduled a meeting of an advisory committee to review the data on Oct. 26, before giving its opinion on whether authorization should be granted.
The agency has previously said that once the formal submission was completed, it would complete its review “likely in a matter of weeks rather than months.”
The US Centers for Disease Control and Prevention (CDC) would subsequently publish recommendations for use for healthcare providers administering COVID-19 vaccines.
“If there is approval or authorization, and a CDC recommendation, we are ready, we have the supply,” Jeff Zients, an adviser to US President Joe Biden and White House coronavirus response coordinator, told CNN following the announcement. “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.”
In clinical trials, children in the five-to-11 age group received a two-dose regimen of 10 micrograms, 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 aged 16 or older, and the FDA in May authorized its emergency use in children aged 12 to 15.
Experts say that children are essential to vaccinate to help achieve population immunity against the disease.
While younger children are less likely to develop severe cases, they can still become sick and transmit the virus to the general population.
“We’re working with states to set up convenient locations for parents and kids to get vaccinated, including pediatricians’ offices and community sites,” Zients said.
As of Thursday last week, nearly 5.9 million US children had tested positive for COVID-19, American Academy of Pediatrics data showed.
Vaccines, masks and other mitigation measures against COVID-19 have become deeply political issues in the US — especially for children.
California last week announced that vaccinations would be compulsory for all students, a first in the US.
About one-third of US parents with a child aged five to 11 say that they would vaccinate their children as soon as possible, a survey conducted by the Kaiser Family Foundation showed last month.
However, one-third say they would wait before making a decision, and one-quarter say they would not get their child vaccinated.
The Pfizer-BioNTech 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 available.
Health officials are focusing in particular on the risk of myocarditis, an inflammation of the heart muscle that has been found to be more common in young adults and adolescents after vaccination, with an aim of determining whether benefits outweigh risks.
Pfizer and BioNTech are also trialing their vaccine on infants aged six months to two years, and on children aged two to five. Initial data for these groups are expected before the end of the year.
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