Pfizer To File for Full Approval from FDA for COVID-19 Vaccine


On Tuesday, pharma giant Pfizer said that it would be filing for full approval for its COVID-19 vaccine from the US FDA. Although the company has been rolling out its vaccine, which is a collaboration with BioNTech Germany from the past few months, it has been under Emergency Use Authorization (EUA). It is applying for final approval by end May and if it gets it, then the Pfizer-BioNTech vaccine for the coronavirus can be marketed directly to consumers.


Pfizer released its first quarter earnings report and its Covid-19 vaccine sales were $3.5 billion. This amounted to about 24 percent of its total revenue. Pfizer’s earnings from oncology, internal medicine,  hospital and rare diseases were above 10 percent. A 9 percent increase from 2020 was also seen in revenues from the inflammation and immunology unit and was approximately a billion dollars. Its earnings were much higher than expectations from Wall Street.


On April 1, the two companies reported new findings from their clinical trials. The Pfizer-BioNTech vaccine was safe and over 91 percent effective for six months after the second dose. Pfizer CEO Albert Bourla said that this data makes it possible for them to put in a Biologics License Application to the U.S. FDA reported by CNBC.


This license will give the company a lot of leeway. It can advertise the shots directly, change the cost  of the price, and remain in the market after the pandemic ends


The company is also looking for EAU for its booster shots that are being developed to offer protection against the new and emerging variants of the coronavirus. The earnings report included a slide representation of the booster shot which is expected to be released by mid-July. Pfizer is also looking at obtaining data on the safety of its vaccines for pregnant women in the same period of time.


The pharmaceutical company is waiting for authorization for use with children in the age group of 12 to 15 years by the end of the month. It is also expected to apply for using its vaccine in toddlers and young children sometime in September, and for infants sometime in November.



Photo Credit: Marco Verch Professional Photographer




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