Pfizer Likely To Seek US FDA Nod In September For Use Of Its COVID-19 Vaccine In Kids Aged Between 2 To 11 Years
Pharmaceutical major Pfizer will likely seek the US Food and Drug Administration's emergency authorisation to administer its coronavirus vaccine among children between the ages of 2 and 11 in September, the media reported.
By early next week, the company is expected to get FDA approval for emergency use of its vaccine in children 12 to 15 years old.
It is planning to apply for full approval of the vaccine for use in people from ages 16 to 85, this month, The New York Times reported. The pharma major will also have clinical trial data on the safety of its vaccine in pregnant women by early August.
The FDA is preparing to make Covid vaccines "accessible to additional, younger populations", Jen Psaki, the White House press secretary, was quoted as saying at a news conference on Tuesday, the report said.
Currently, the Pfizer-BioNTech vaccine is given to adults under an emergency use authorization that the companies received in December. Obtaining full FDA approval will allow it to market the vaccine directly to consumers.
"Full approval is a welcome indicator of the continued safety and efficacy of the Pfizer vaccine," Saskia Popescu, an infectious disease epidemiologist at George Mason University, was quoted as saying.
Earlier in March, results of a clinical trial led by the companies showed that the Pfizer-BioNTech coronavirus vaccine is extremely effective in young adolescents, even more than in adults. The children produced strong antibody responses and experienced no serious side effects.
Vaccinating adolescents may also be key to boost immunity levels in the general population and thus reduce the number of hospitalisation and death.
A full approval may also make it easier for companies, government agencies, schools to get vaccinated and the jabs will stay in the market, even after the end of the pandemic, the report said.
(This story has been published from a wire agency feed without modifications to the text. Only the headline has been changed.)
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