Pfizer on fast track to getting its vaccine for under-fives approved

Pfizer and partner BioNTech say they have started submitting data to US regulators for authorisation of their Covid-19 vaccine for younger children, hastening an effort to get shots to more of them after the Omicron wave caused paediatric infections to jump.

The companies said they have started a rolling submission with the US Food and Drug Administration (FDA) seeking an emergency authorisation for the vaccine in children aged six months to four years. A panel of outside advisers is scheduled to meet on February 15 to consider the request, according to the agency.  

“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we’re committed to a timely review of the data,” acting commissioner Janet Woodcock said. 

The clearance request came earlier than expected. Data released by the companies in December suggested the ability of two doses to prevent infection was mixed and that more evidence would be needed before asking for an authorisation. The companies said at the time they would study a third dose and, if successful, seek authorisation in the first half of 2022.

However, Pfizer and BioNTech accelerated that timetable at the request of regulators. The FDA asked the drugmakers to submit data on two doses of the shot as part of a three-dose series. Data on a third dose given eight weeks after the second shot are expected in coming months and will also be sent to regulators, the companies said. 

Parents have been pushing US President Joe Biden’s administration and the companies to move faster to get shots cleared for younger children. With cases surging, more youngsters have been infected with the virus, complicating childcare and parents’ efforts to remain at work. At the same time, however, there are signs families are more wary of getting shots for their children.

While a faster clearance is likely to satisfy parents who are eager to vaccinate their kids, it could exacerbate uneasiness among those who have been more uncertain about shots for children.

While vaccines have been available for children aged five to 11 for several months, vaccination rates in that group remain lower than in older demographics, even amid signs that the Omicron strain leaves of them at greater risk of disease. Virus cases among children have risen since Omicron was first detected in the US in December, with paediatric hospitalisations reaching a record at the end of last year.

In December, Pfizer vaccine executive Kathrin Jansen said limiting the spread of the more infectious Omicron variant, which now accounts for almost all Covid-19 cases, “may only be possible with three or more doses”.

Three shots are now recommended by the US Centers for Disease Control and Prevention (CDC) for everyone aged 12 and older, and it is expected that third shots will be cleared for those aged five and up soon. While US regulators consider anyone who has received two doses of a messenger RNA (mRNA) shot to be fully vaccinated, studies have shown three doses are more effective at shielding against an Omicron infection.

Anthony Fauci, Biden’s top adviser on the pandemic, said last week he thought the Pfizer vaccine for younger children would be a three-shot regimen. Fauci said at a news conference that the FDA is “very scrupulous” in reviewing vaccines, especially for children, and that if shots were to be cleared, “we can be certain that they will be safe and that they will be effective”.

While a faster clearance is likely to satisfy parents who are eager to vaccinate their offspring, it could worsen uneasiness among those who have been more uncertain about shots for children. Recent CDC studies show the shots caused few side effects in the five-to-11 age group and were overwhelmingly effective at keeping adolescents out of the hospital.

The US immunisation effort has been levelling off for all ages. About 68% of people five years and older are considered fully vaccinated, according to CDC data, while by Monday 42% of those who eligible received a booster shot.

The FDA is expected to convene a panel of expert advisers to consider the evidence on the Pfizer shot for younger children later this month. The agency isn’t bound by the group’s advice, but generally adheres to it. Experts who advise the CDC on vaccine policies are also likely to meet.

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— Bloomberg