Pfizer seeks US approval to vaccinate children under 5 years old

Pfizer is seeking approval in the United States to vaccinate children under five years old, with hopes it could be available this month.

Pfizer and BioNTech have begun submitting a formal request to US health regulators for emergency use of their Covid vaccine for children aged over six months and under five years.

The request is currently for two doses of a three-microgram shot, which will give parents “the opportunity to begin a Covid-19 vaccination series for their children while awaiting potential authorisation of a third dose,” Pfizer CEO Albert Bourla said in a statement.

The under 5s are the last age group in the United States not yet eligible for coronavirus shots.

Australia is also yet to approve Pfizer for use in under 5s but did recently roll out the vaccines for those aged 5 to 11.

Currently vaccinations are not mandatory for students attending public schools but authorities are encouraging them to get the jab.

Therapeutic Goods Administration head John Skerritt explained there were “a lot of reasons” why children under 12 should get the jab.

Professor Skerritt noted children were a major transmitter of the virus to older people at risk of dying from Covid-19.

“Even though (kids) don’t get as sick as adults, they have a pretty strong role in spreading it back to family members,” he told the ABC.

The mental health effects of the pandemic on children was another issue that made vaccinating the under 12s age group important.

“The other reason is just so kids can do what kids are meant to do – go to the school, play with their friends, do sport, do exercise, do social things,” Prof Skerritt said.

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Parents may soon be able to vaccination children under 5 years old against Covid. Picture: Brendan Radke

As they seek the green light for children under five to receive two doses of the vaccine, Pfizer and BioNTech will also continue studies on a three-shot regimen, the The New York Times is reporting.

The US Food and Drug Administration hopes to approve shots for young kids as early as late February. Data on a three-dose regimen would not be submitted until late March, the paper added.

The companies concluded last fall that low doses of the vaccine provided protection in children up to two years old but not in kids aged two to five, announcing in December they would add a third dose to their trials.

“We know that two doses isn’t enough, and we get that,” a source told The Washington Post.

“The idea is, let’s go ahead and start the review of two doses. If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don’t do anything until the third-dose data comes in.”