Pfizer announced Tuesday it is preparing to file for full FDA approval of its COVID-19 vaccine by the end of this month. The pharmaceutical giant, along with its German partner BioNTech, received emergency use authorization by the Food and Drug Administration late December.
According to CNBC, Pfizer said that its first-quarter sales of the COVID-19 vaccine was $3.5 billion, exceeding Wall Street expectations. The drug company predicts that revenues for the full year will top $26 million from sales of their vaccine, more than the previous forecast of $15 billion.
If the FDA gives full approval to the vaccine, Pfizer will be able to distribute the drug on its own. It is expected that Pfizer will deliver 300 million doses of the vaccine to the U.S. by the end of July, says CNBC.
The FDA normally takes at least a year to grant full approval to a new drug, but the pandemic fast-tracked the process. The FDA issued emergency use authorization or EUA status to the current COVID-19 vaccines in an effort to stem the tide of the pandemic that has already claimed nearly 600,000 American lives.
Pfizer will need to submit a Biological License Application or BLA to the FDA to secure licensing and full approval of their product. The process could take up to six months, according to CNBC.
“FDA’s Center for Biologics Evaluation and Research (CBER) ensures that FDA’s rigorous scientific and regulatory processes are followed by those who pursue the development of vaccines,” says the FDA website, adding that their evaluation of the safety and effectiveness of vaccines is “among the most robust in the world.”
Pfizer also announced that it plans to apply for EUA for its COVID-19 booster shot to guard against variants this summer and for vaccines that will protect children and infants later this the fall.
According to CNN, since all phases of clinical trials have already been done for the COVID-19 vaccines currently on the market, and the FDA has reviewed the safety and manufacturing data provided by the pharmaceutical companies, the formal approval process should be “very soon,” said Dr. Anthony Fauci.
Fauci, the director of the National Institute of Allergy and Infectious Diseases, told CNN that the FDA will work “as expeditiously as possible” on approval applications when they come in. Moving from EUA to full approval means that the drug companies will have the power to distribute their products themselves.
“When you are getting a formal approval, you have to have a certain amount of time just observing predominantly the safety — and obviously, the safety looks really, really good in well over 140 million people having been vaccinated with at least a single dose,” said Fauci.
Once their vaccine received formal approval, Pfizer and BioNTech can begin marketing their vaccine directly to the public and changing its prices, says CNBC.
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