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Pfizer and BioNtech start submitting for full FDA approval for his or her Covid vaccine

Vial of the Pfizer BioNTech Covid-19 vaccine on Thursday, February 11, 2021 at the vaccination site of the Sun City Anthem Community Center in Henderson, Nevada, USA.

Roger Kisby | Bloomberg | Getty Images

Pfizer and German drug maker BioNTech have started filing for full approval of the Covid-19 vaccine for people aged 16 and over in the United States. This makes the companies the first in the nation to apply for full regulatory approval.

The Food and Drug Administration issued emergency approval for their Covid vaccine at the end of December. Since then, Pfizer has distributed 170 million doses in the US, with the goal of dispensing 300 million doses by the end of July.

“We are proud of the tremendous progress we have made in working with the US government to deliver vaccines to millions of Americans since December,” said Albert Bourla, CEO of Pfizer, in a statement. “We look forward to working with the FDA to complete this ongoing filing and support its review with the aim of ensuring full regulatory approval for the vaccine in the months ahead.”

Pfizer needs to demonstrate that it can reliably manufacture the vaccines in order to get full clearance. If approved, companies could market their shots directly to consumers and potentially change the pricing of the cans. It also allows the shot to stay in the market once the pandemic is over and the US is no longer considered an “emergency”.

It usually takes the FDA about a year or more to determine whether a drug is safe and effective for the general public. Due to the one-off pandemic that killed nearly 600,000 people in the United States, the FDA allowed the gunshots to be used as part of an emergency clearance.

The permit grants conditional approval based on data for two months. It’s not the same as a biological license application that requires six months of data and ensures full approval. Companies apply for approval on a “rolling filing” basis, which speeds the review process by allowing the FDA to review new data as soon as the company receives it.

“The BLA filing is an important cornerstone in achieving long-term herd immunity and future COVID-19 containment,” said Dr. Ugur Sahin, CEO and Co-Founder of BioNTech, in a statement. “We are excited to work with US regulators to apply for approval of our COVID-19 vaccine based on our key Phase 3 study and follow-up data.”

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