Coronavirus pandemic: the vaccines are coming | PZ – Pharmaceutical Newspaper

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Four vaccine candidates against Covid-19 are already in the approval process of the European Medicines Agency EMA. This checks the vaccines in an accelerated process known as a “rolling review”. In this case, the study data are not submitted collectively at the end of the studies, but interim results are continuously provided so that they can be checked in parallel to ongoing studies. Clinical phases are not skipped and there are no other changes to the regular test sequence. The EMA website says: “The EMA will make its assessment in accordance with the usual standards of quality, safety and effectiveness.”The companies Moderna and Biontech / Pfizer have applied for a conditional marketing authorization. This is granted for medicinal products that meet an »unmet medical need«, even if the complete data are not yet available. This applies, for example, to active substances against severely restrictive or life-threatening diseases without treatment options, as well as to drugs that are to be used in emergency situations. The conditional approval is only valid for one year, but can be renewed annually or become a full approval, the PEI informs the PZ upon request.

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.



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