Originally Published: 04 MAY 21 15:41 ET
By Naomi Thomas, NCS
(NCS) — Pfizer expects to file for full US Food and Drug Administration approval for its Covid-19 vaccine for folks ages 16 to 85 this month, and can seek emergency use authorization for its vaccine for children ages 2 to 11 in September, the corporate stated throughout an earnings name on Tuesday.
The firm’s vaccine security and efficacy examine in children age 6 months to 11 years previous remains to be 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 stated, including that the readout and submission for children 6 months to 2 years is predicted in the fourth quarter of 2021.
Pfizer has already utilized for emergency use authorization for its coronavirus vaccine for teenagers and children ages 12 to 15. The FDA is poised to authorize Pfizer’s coronavirus vaccine in that age group by early subsequent week, a federal authorities official instructed NCS on Monday.
Bourla additionally stated on Tuesday that Phase 2 security knowledge from Pfizer’s ongoing examine in pregnant ladies is predicted 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 top of May, Bourla stated.
“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 stated.
Progressing from licensed to authorized permits vaccine makers to market and immediately distribute their vaccines. It might additionally have an effect on vaccine mandates — and maybe assist sway skeptics hesitant to get the vaccines now.
Some organizations say they anticipate to require the Covid-19 vaccine, however have opted not to whereas it’s licensed and never but totally authorized.
“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 (*11*) Diseases, instructed NCS’s Jim Sciutto final week.
The three Covid-19 vaccines distributed in the United States — made by Pfizer/BioNTech, Moderna and Johnson & Johnson — are licensed, however not authorized. Emergency use authorization is what its title suggests — a medical product, akin to a vaccine, that will get particular FDA authorization to be used throughout an emergency.
There’s excessive demand for Pfizer’s vaccine — Bourla stated Tuesday the corporate has been contracted to ship 1.6 billion doses of its Covid-19 vaccine globally this yr, and the corporate expects to produce a minimum of 3 billion doses of the vaccine in 2022.
A transfer to ease vaccine distribution
Pfizer additionally stated Tuesday it has submitted info to the FDA that will enable its Covid-19 vaccine to be saved at customary fridge temperatures. Such a change might assist simplify distribution of the vaccine.
Bourla stated the corporate submitted new knowledge to the FDA on Friday, and it might “soon” have an emergency use authorization to enable customary refrigeration for up to 4 weeks.
Currently, Pfizer’s vaccine is allowed to be saved at ultra-cold temperatures, between -80 and -60 levels Celsius, or in chilly storage, between -25 and -15 levels Celsius, for a most of two weeks, which may complicate distribution of the vaccine.
According to Bourla, new knowledge might enable the vaccine to be saved at customary temperatures, between 2 and eight levels Celsius, for up to 4 weeks.
Bourla stated Pfizer is engaged on extra formulations that would additional lengthen the storage time of the vaccine in each customary and ultra-cold fridges.
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