As the first vaccine in the US, the product is fully approved by Biontech and Pfizer. What sounds like a purely formal step could have a big impact.
Silver Spring – The US drug authority FDA has granted full approval to the drug from German manufacturer Biontech and its US partner Pfizer as the first corona vaccine in the US.
It applies to people aged 16 and over, the FDA announced and called the decision a “milestone” in the fight against the pandemic. The emergency authorization for people aged twelve and over will continue to exist.
The vaccine has been used in the US with emergency approval since December; Biontech and Pfizer applied for full approval in May. To do this, the FDA, which used an accelerated process, 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 the country in recent months.
According to the expectations of many experts, full approval could result in further vaccination obligations – for example, from city administrations, universities or health facilities that wanted to wait for full approval for such a step for legal reasons, among other things.
New York obliges school staff to vaccinate
Apart from this, experts also hope that the vaccination campaign will be boosted, as many people who have not yet had themselves vaccinated named the lack of full approval as the reason for this in surveys. However, this could possibly only have been given as a pretext.
US President Joe Biden used the FDA’s decision to appeal to all unvaccinated people: The approval should “give additional confidence in the safety and effectiveness of this vaccine. If you haven’t been vaccinated, now is the right time, ”said Biden on Twitter.
The metropolis of New York, meanwhile, announced the compulsory vaccination of all school employees including teachers – a decision that could pave the way for similar steps in other cities in view of the increasing numbers of infections from the Delta variant. It was initially unclear what would happen to those who refuse to be vaccinated anyway.
“Conditional Marketing Authorization” in the EU
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 the necessary documents. Johnson & Johnson plans to submit such an application later this year.
In the EU, the Biontech / Pfizer vaccine has “conditional marketing approval”, which is practically one notch above the “emergency approval” that the vaccine previously had in the US.
On request, the European Medicines Agency (EMA) stated that a conditional approval could be converted into a standard marketing approval. The prerequisite is the fulfillment of all requirements associated with the conditional approval to the satisfaction of the EMA. This is checked annually. The drug agency initially did not announce when exactly this procedure would allow the Biontech vaccine to be fully approved in the EU. dpa
