Status: 23.08.2021 6:19 p.m.
So far, all corona vaccines have only had an emergency approval in the USA. BioNTech / Pfizer is the first vaccine to have received full approval. Experts hope for a boost for the US vaccination campaign.
The US Food and Drug Administration (FDA) has granted full approval to the drug from the German manufacturer BioNTech and its US partner Pfizer as the first corona vaccine in the US. This upgrade is a “milestone” that has the potential to change the course of the pandemic, the FDA said.
The public can be assured that the vaccine “meets the high standards of safety, efficacy and manufacturing quality that the FDA requires of an approved product,” said FDA chief Janet Woodcock. She was confident that even more people will now be vaccinated against the coronavirus because regular approval should create “additional trust”.
The decision of the US drug agency caused price jumps: Pfizer shares rose more than five percent on Wall Street, BioNTech rose by more than nine percent.
Comprehensive data sets
The vaccine has been in use in the US since December with an emergency approval; BioNTech and Pfizer applied for full approval in May. To do this, the FDA, which used an accelerated procedure, had to review about ten times as much data as for the emergency approval – including much that was gained from the massive use of the vaccine in recent months.
More than 200 million doses of the vaccine have been given in the United States since December, and hundreds of millions more worldwide. In their opinion, the FDA had sufficient data to guarantee the safety of the vaccine.
The regular permit is valid for people over the age of 16 years. For people over the age of twelve, it can still be vaccinated in the USA as part of the emergency approval. US President Joe Biden used the FDA’s decision to appeal to unvaccinated people. “If you haven’t been vaccinated, now is the time,” he wrote on Twitter.
New York announces compulsory vaccination for teachers
The US is the first country in the world to give the vaccine full approval, according to Pfizer. This could lead to more companies and institutions increasingly requiring their employees to have vaccinations. The City of New York took such a step. Mayor Bill de Blasio announced that the 148,000 school workers and contractors in schools will need to be vaccinated at least once by September 27th.
In general, experts hope that the vaccination campaign will be boosted, as many people who have not yet been vaccinated stated in surveys that the reason for this was the lack of full approval. However, this could possibly only have been given as a pretext.
Upgrading of Moderna is pending
The vaccines from Moderna and Johnson & Johnson have also been used in the USA for months on the basis of emergency approvals. Moderna applied for full approval from the FDA at the beginning of June, but has not yet submitted all of the necessary documents. Johnson & Johnson plans to submit such an application later this year.
In the European Union, the preparation from Biontech / Pfizer has so far received conditional marketing approval, which is practically one step above the emergency approval that the vaccine previously had in the USA. On request, the European Medicines Agency (EMA) stated that a conditional approval could be converted into a standard marketing approval. But she did not want to give any information about when this step could take place.