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Following rapid FDA approval, the European pharmaceutical authority EMA recommended conditional approval of BioNTech’s mRNA vaccine BNT162b2 in the EU.
It is the first time that the European Medicines Agency (EMA) has recommended an mRNA vaccine. On Monday, the pharmaceutical agency cleared the way for BNT162b2, which Pfizer Inc. will market globally, except in China, under the Comirnaty brand.
The CHMP recommendation is based on phase III data published in The New England Journal of Medicine on 10 December 2020. If the European Commission grants a conditional marketing authorization, it will take effect immediately in the 27 member states of the the European Union. The vaccine is currently temporarily approved or has emergency approval in more than 15 countries, according to BioNTech. Additional regulatory filings are being reviewed in several countries, he said, and additional filings are planned.
The German Pharmaceutical Association VFA, which stressed that the approval of new candidate vaccines against SARS-CoV-1 will be crucial to “overcome the pandemic” and “meet global demand.” According to VDA Director Han Steutel, it is not yet known which vaccines will provide the longest protection, which ones are also suitable for minors, and which further reduce the risk of infection for others when vaccinated. While BioNTech is a biotech company, the VFA celebrated the EMA’s recommendation as a success for Germany “as a pharmaceutical location.”
BioNTech stated that its vaccine has been shown to protect against various mutations of the new coronavirus. More recently, a new mutation, which is up to 70 percent more contagious than the most common form of SARS-CoV-2, spread from the UK to Germany and Italy. Since this is not a cause for panic, it shows that the virus is adapting to its host to speed up its spread, which means a selection advantage. In contrast, higher mortality is a selection disadvantage because high mortality reduces the number of potential hosts for the virus.
However, there are exceptions to this general rule. A mutated poultry virus called Marek virus accelerated its spread so extremely through interaction with host transcription factors in the 1980s that it became resistant against an existing vaccine. However, it took 20 years before the Marek virus became so infectious that it flooded the blood of its host, thus breaking the vaccine’s protection and becoming 7 times more deadly than before.
