First EMA decision still in December

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The European Medicines Agency (EMA) wants to decide already in few weeks on a permission recommendation for two CoV vaccines, as the agency communicated on Tuesday. After the US pharmaceutical group Moderna, the German company Biontech and the US pharmaceutical giant Pfizer have now also applied for approval of their vaccine in the EU.

The EMA must now examine the applications, by 29 December at the latest a result for the Biontech Pfizer vaccine should be available, by 12 January for that of Moderna. The final decision will be made by the EU Commission, which, however, generally follows the EMA recommendation. A Commission spokesperson said on Tuesday that the procedure could be concluded within days following a recommendation.

Prior to the Commission’s decision, he said, a panel of experts in which all EU states are represented will be consulted. This must also agree by qualified majority. However, all parties involved would have the same interest that safe and effective vaccines become available quickly.

Delivery possible immediately after approval
Biontech had announced that it would be able to start delivering the first vaccines immediately after approval. Biontech/Pfizer and Moderna have also submitted applications to the US Food and Drug Administration (FDA) for emergency approval.

According to the companies, extensive testing of the Biontech/Pfizer vaccine, designated BNT162b2, has shown that it is effective in providing 95 percent protection against Covid-19 disease. The vaccine works similarly well across all age groups and other demographic differences and shows virtually no serious side effects, the companies reported after completion of the latest analyses. The vaccination protection in people over 65 years of age is over 94 percent.

Vaccine production is already in full swing even before approval
These positive results relate to protection against Covid-19 disease. To what extent the vaccine also protects against infection and possible virus transmission is not yet clear.

Preparations similar in effectiveness
The vaccine from Biontech and Pfizer is similar to the preparation from Moderna in its mode of action and also in its effectiveness. For both vaccines, a rolling review process is already underway at the EMA, which should speed up the approval process. Manufacturers can submit individual parts of the quality, safety and efficacy of a preparation even before the complete application for approval.

The preparation from Pfizer and Biontech is an RNA vaccine, like the one from Moderna. It contains genetic information of the pathogen, from which the body then produces a virus protein. The aim of the vaccination is to stimulate the immune system to produce antibodies in order to intercept the viruses. There is still no approved vaccine of this kind.

EU has framework agreements with both companies
According to Biontech, the vaccine doses should be distributed “fairly”. The company announced that “one country will not get everything”. The EU has already signed a framework agreement for the purchase of up to 300 million doses of the vaccine. Based on supply forecasts, Biontech expects to deliver up to 50 million doses of the vaccine worldwide this year and to produce up to 1.3 billion doses next year.

Last week, EU Commission President Ursula von der Leyen announced that a framework agreement for up to 160 million vaccine doses had also been concluded with Moderna. Initially, 80 million doses are to be supplied, with the option of 80 million additional units.

Application for approval in many countries
Biontech and Pfizer have also reportedly submitted an application to the UK regulatory authority MHRA. In addition, there are rolling procedures in Australia, Canada and Japan, among others. Further applications worldwide are planned.

Countries like Russia, China and recently Bahrain have already approved vaccines with restrictions and are already vaccinating parts of the population. But how well these vaccines actually protect and what side effects they can have is currently largely open.

hp, Source: ORF.at/agencies. picture: pixabay.com

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