Conditional admission is tied to conditions. It can be granted if the benefit-risk balance is positive, i.e. the benefit to public health from the immediate availability of the drug or vaccine outweighs the risks that exist due to the planned subsequent submission of further data. The applicant must provide comprehensive data at a later date.
The conditional approval differs from an Emergency Use Authorization (EUA), an emergency approval that enables a drug that has not been approved to be placed on the market in the USA. An EUA therefore does not allow permanent placing on the market.
Approvals generally only apply to the groups of people who were represented in the clinical trials, i.e. in the case of the SARS-CoV-2 vaccines not to children and pregnant women. As Moderna announced to the PZ, corresponding studies are planned on these groups of people. In the case of pregnant women, additional toxicity tests on animals would have to be awaited.
The mRNA vaccine from Biontech and Pfizer (photo) was the first in the world to receive emergency approval from the British Medicines Agency MHRA on December 2nd. It is approved for people aged 16 and over because young people were represented in the studies. Here, too, no data is available on children and pregnant women.