FDA advisors to rule on Pfizer vax in younger childrentext_fields
Washington: An expert panel on Tuesday voted unanimously to recommend the U.S. Food and Drug Administration authorise the Pfizer Inc and BioNTech SE COVID-19 vaccine for children ages 5 to 11, saying the benefits of inoculation outweigh the risks.
The FDA's Vaccines and Related Biological Products Advisory Committee will discuss whether to approve the vaccine. If authorised, it would be the first Covid-19 vaccine for younger children, reports Xinhua news agency.
While children are at lower risk of severe COVID-19 than older people, ultimately many panellists decided it was important to give parents the choice to protect their youngsters – especially those at high risk of illness or who live in places where other precautions, like masks in schools, aren't being used.
Anthony Fauci, the nation's top infectious disease expert, said some 28 million children aged 5 to 11 in the US may be able to receive their Covid-19 vaccine in the first two weeks of November.
"You never want to get ahead of the FDA in their regulatory decisions, nor do you want to get ahead of the CDC and their advisers on what the recommended would be," Fauci said in an interview with ABC News.
"But if you look at the data that's been made public and announced by the company, the data looked good as to the efficacy and the safety."
Pfizer and its partner BioNTech said their vaccine is safe and 90.7 per cent effective against symptomatic Covid-19 in children the particular age group, according to a document posted on the FDA website on Monday.
Pfizer and BioNTech are applying FDA emergency use authorization (EUA) of a two-dose regimen of 10-microgram dose for children ages 5 to 11, which would be administered three weeks apart.
The most common side effects occurred after the second dose and included pain at the injection site, fatigue and headache.
There were no serious adverse events associated with the vaccine, according to the FDA.
Health experts have stressed to get children vaccinated against Covid as soon as possible in an effort to curb the increase in cases, and prevent the virus from spreading to other vulnerable groups.