Pfizer and BioNTech have begun seeking the go-ahead for children as young as six months old to receive their Covid-19 vaccine.
The two companies started submitting data for the application on Tuesday, they said in a statement, seeking an emergency authorization from the US Food and Drug Administration.
“Our vaccine has already demonstrated a favorable safety, tolerability and efficacy profile in multiple clinical trials and real-world studies for all age groups starting from 5 years old,” said BioNTech’s CEO, Ugur Sahin. “If authorized, we are very excited about the prospect of offering parents the opportunity to help protect their children 6 months through 4 years of age from COVID-19 and the potentially severe consequences of infection.”
So far, the Pfizer-BioNTech vaccine has only been authorised for children aged five years and older. If the new authorisation is granted, babies and toddlers even younger than that could start getting the shot by late February.
The news comes as the US death toll from Covid creeps closer to a million. As of Tuesday afternoon, more than 888,400 Americans had died of the virus.
Severe Covid cases among children are still relatively rare, but the Omicron variant has upended any sense that kids are invulnerable. In the final week of December, as the Omicron wave reached its peak, the US saw an average of 521 patients under 18 being hospitalised with Covid per day.
“Sadly, we are seeing the rates of hospitalisations increasing for children zero to four, children who are not yet currently eligible for Covid-19 vaccination,” Dr Rochelle Walensky, director of the Centers for Disease Control and Prevention, lamented earlier this month.
The Omicron wave also showed that a third vaccine shot, or “booster,” is crucial to fighting off Covid with minimal symptoms. On Tuesday, Pfizer and BioNTech said the new FDA authorisation would be for a two-shot vaccine, but the companies hope it will eventually cover a booster as well.
“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants,” said Albert Bourla, Pfizer’s CEO. “If two doses are authorised, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorisation of a third dose.”
Dr Anthony Fauci, President Biden’s chief medical adviser, said last week that this was the direction Pfizer was moving in.
“It looks like it will be a three-dose regimen,” Dr Fauci said at a White House Covid briefing. “I don’t think we can predict when we will see an EAU [emergency use authorisation] with that, because the company is still putting the data before the FDA … I think we just need to be patient and know one thing for sure that that’s why the system works.”
