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BioNTech (BNTX) and Pfizer’s (PFE) Coronavirus Vaccine Received Greenlight from EMA

BioNTech-Pfizer’s coronavirus vaccine was approved by the European Medicines Agency (EMA) and the European Commission on Monday. This means 450 million people across the EU will be vaccinated. The positive assessment by the EMA of the vaccine was widely anticipated. Europe is in the midst of a fierce second wave of the virus. Several European countries, including Germany, urged the Amsterdam-based drug regulator to expedite its decision, originally scheduled for December 29.

European Commission President Ursula von der Leyen said, “We gave conditional authorization to the vaccine produced by BioNTech and Pfizer.”  “We’re all in this together,” she added.

The European Medicines Agency has indicated that the drug has demonstrated an efficacy of 95% and may be used by people aged 16 and older.

“Today’s good news represents an important step in the fight against the pandemic, which has caused so much pain and suffering for so many,” said the EMA’s Emer Cooke.

And Ms. Cooke said: “Our comprehensive inspection has enabled us to confidently assure people in the EU that this vaccine is safe and proves effective and that it meets the necessary quality standards.

“We will continue to investigate the safety and effectiveness of this vaccine to protect people from being vaccinated in the EU.” She added.

 Jens Spahn, the German Health Minister, described the approval as “a milestone in fighting the pandemic.” He tweeted that more than 1.3 million doses of the vaccine will be delivered by the end of this year to all 16 German states. Those over the age of 80, nursing home staff and residents, and health care workers at very high risk of infection will be the first to be vaccinated in a vaccination campaign starting December 27.

The rollout of the vaccine comes as many counties cut travel relations with the UK and disrupt trade ahead of the Christmas holiday after identifying a highly infectious strain of the coronavirus in Britain.

The European Medicines Agency (EMA) said at a press briefing that it was highly likely that the vaccine would work against the coronavirus’s new variant. Marco Cavaleri, EMA’s Head of Biological Health Threats and Vaccines Strategy, believes that the vaccine is likely to still protect against the new variant. The vaccine generated antibodies that could neutralize different strains with mutations, even though the agency could not provide any proof concerning the new strain.

Follow-up data will be required from pharmaceutical companies and the vaccine they manufacture for the next year. The European Medicines Agency said it had worked around the clock to determine the vaccine’s safety and efficacy before approving it.

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