Vials containing 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 announced that they have begun filing for full approval of their 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 having 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, Pfizer CEO, 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 once in a century 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.
rival Modern said it Thursday plans to initiate an ongoing filing to the FDA for their vaccine this month.
“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 be working with US regulators to apply for approval of our COVID-19 vaccine based on our key Phase 3 study and follow-up data.”
Early data from 12,000 vaccinated people aged 16 and over in this Phase 3 study showed that the shots were 91.3% effective at getting the disease up for up to six months after the second dose and 95.3% effective against severe Covid as defined by the FDA. The companies said on April 1st. The data also showed “a favorable safety and tolerability profile,” they said at the time.
Dr. White House chief medical officer Anthony Fauci told CNN on April 28 that US regulators would act “as soon as possible” once companies submit their requests for full approval.
“When you get formal approval, you have to have some amount of time to do mostly safety observations, and obviously safety looks really, really good in well over 140 million people who have been vaccinated with at least a single dose.” he told CNN. “”Hope you make it quick because … people who hear it’s still an emergency still have a little bit of concern about how far you can go with it. “
The companies are awaiting FDA emergency approval to use their vaccine in children ages 12-15 and intend to apply for a full license once they have six months of data.
They said in late March that the vaccine was 100% effective in a clinical study involving more than 2,000 adolescents. They also said the vaccine produced a “robust” antibody response in the children that outperformed that in a previous study in older teenagers and young adults. The side effects were generally consistent with those seen in adults, they added.