Pfizer to seek vaccine approval this month

Pfizer plans to get full approval from the U.S. Food and Drug Administration for its Covid-19 vaccine for ages 16 to 85 by the end of May, Bourla said.

“While we are currently distributing our vaccine in the United States under Emergency Use Authorization (EUA), we plan to submit a Biologics License Application (BLA) to the Food this month. and Drug Administration (FDA) of the United States to obtain full approval of our Covid-19 vaccine for people 16 years of age and older, ”said Bourla.

Moving from authorization to approval allows vaccine manufacturers to market and distribute their vaccines directly. It could also impact vaccination mandates – and perhaps help sway skeptics hesitant to get vaccinated now.

Some organizations say they plan to require the Covid-19 vaccine, but have chosen not to do so while it is cleared and not yet fully approved.

“People, when they hear it’s still emergency use, they still have a little bit of worry about how far you can go with it,” said Dr Anthony Fauci, director of the National Institute. of allergies and infectious diseases, to CNN’s Jim Sciutto last week.

The three Covid-19 vaccines distributed in the United States – manufactured by Pfizer / BioNTech, Moderna and Johnson & Johnson – are licensed, but not approved. Emergency Use Clearance is what the name suggests – a medical product, such as a vaccine, that gets special clearance from the FDA for use in an emergency.

There is strong demand for Pfizer’s vaccine – Bourla said on Tuesday the company had been hired to deliver 1.6 billion doses of its Covid-19 vaccine to the world this year, and the company plans to produce at least 3 billion doses of the vaccine in 2022.

A gesture to facilitate the distribution of vaccines

Pfizer also said on Tuesday that it had submitted information to the FDA that could allow its Covid-19 vaccine to be stored at standard refrigerator temperatures. Such a change could help simplify vaccine distribution.

Bourla said the company submitted new data to the FDA on Friday and may “soon” have emergency use clearance to allow standard refrigeration for up to four weeks.

Currently, Pfizer’s vaccine is allowed to be stored at ultra-cold temperatures, between -80 and -60 degrees Celsius, or in a cold room, between -25 and -15 degrees Celsius, for a maximum of two weeks, which may complicate the 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 was working on additional formulations that could further extend the storage life of the vaccine in standard and ultra-cold refrigerators.