Pfizer expects to file for full US Food and Drug Administration approval for its Covid-19 vaccine for people ages 16 to 85 this month, and will seek emergency use authorization for its vaccine for children ages 2 to 11 in September, the company said during an earnings call on Tuesday.
The company’s vaccine safety and efficacy study in children age 6 months to 11 years old is still going.
“We expect to have definitive readouts and submit for an EUA for two cohorts, including children age 2-5 years of age and 5-11 years of age, in September,” Pfizer CEO Albert Bourla said, adding that the readout and submission for children 6 months to 2 years is expected in the fourth quarter of 2021.
Pfizer has already applied for emergency use authorization for its coronavirus vaccine for teens and children ages 12 to 15. The FDA is poised to authorize Pfizer’s coronavirus vaccine in that age group by early next week, a federal government official told CNN on Monday.
Bourla also said on Tuesday that Phase 2 safety data from Pfizer’s ongoing study in pregnant women is expected by late July or early August.
Pfizer to seek approval for vaccine this month
Pfizer expects to seek full US Food and Drug Administration approval of its Covid-19 vaccine for 16-to-85-year-olds by the end of May, Bourla said.
“While we are currently distributing our vaccine in the US under an Emergency Use Authorization (EUA), we expect to submit this month a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking full approval for our Covid-19 vaccine for individuals 16 years of age and older,” Bourla said.
Progressing from authorized to approved allows vaccine makers to market and directly distribute their vaccines. It could also have an impact on vaccine mandates — and perhaps help sway skeptics hesitant to get the vaccines now.
Some organizations say they expect to require the Covid-19 vaccine, but have opted not to while it’s authorized and not yet fully approved.
“People, when they hear it’s still emergency use, they still have a little concern about how far you can go with it,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Jim Sciutto last week.
The three Covid-19 vaccines distributed in the United States — made by Pfizer/BioNTech, Moderna and Johnson & Johnson — are authorized, but not approved. Emergency use authorization is what its name suggests — a medical product, such as a vaccine, that gets special FDA authorization to be used during an emergency.
There’s high demand for Pfizer’s vaccine — Bourla said Tuesday the company has been contracted to deliver 1.6 billion doses of its Covid-19 vaccine globally this year, and the company expects to produce at least 3 billion doses of the vaccine in 2022.
A move to ease vaccine distribution
Pfizer also said Tuesday it has submitted information to the FDA that may allow its Covid-19 vaccine to be stored at standard refrigerator temperatures. Such a change could help simplify distribution of the vaccine.
Bourla said the company submitted new data to the FDA on Friday, and it may “soon” have an emergency use authorization to allow standard refrigeration for up to four weeks.
Currently, Pfizer’s vaccine is authorized to be stored at ultra-cold temperatures, between -80 and -60 degrees Celsius, or in cold storage, between -25 and -15 degrees Celsius, for a maximum of two weeks, which can complicate distribution of the vaccine.
According to Bourla, new data could allow the vaccine to be stored at standard temperatures, between 2 and 8 degrees Celsius, for up to four weeks.
Bourla said Pfizer is working on additional formulations that could further extend the storage time of the vaccine in both standard and ultra-cold refrigerators.