Pfizer and BioNTech Submit COVID-19 Vaccine for EU Emergency Approval - COVID-19 Clinical Trial
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Pfizer and BioNTech Submit COVID-19 Vaccine for EU Emergency Approval

US pharma giant Pfizer (PFE) and its German partner BioNTech (BNTX) have submitted their COVID-19 vaccine for conditional approval with the European Medicines Agency (EMA), the companies said today. This follows their application for emergency approval to the US Food and Drugs Administration on 20 November and to the UK’s Medicines and Healthcare Regulatory Agency on 23 November.

Pfizer/BioNTech announced on 18 November that their vaccine protected 95% of people over 65-years-old from COVID-19, and that the results indicated it was equally effective across all ethnicities. The EMA said it plans to decide on authorisation of the Pfizer/BioNTech vaccine by 29 December. The European Commission also said that it is poised to issue final authorisation of the vaccine days after its EMA approval. The US-German partners’ application for EU authorisation comes one day after US-based Moderna (MRNA) submitted its vaccine to the European and US drug regulators for emergency approval. Final data analysis from Moderna’s large-scale trial found its vaccine to be 94.1% effective at protecting people from the virus – and 100% when it came to preventing severe cases of COVID-19.

AstraZeneca Nears Temporary OK for COVID-19 Vaccine, Plots Extra Trial

The U.K. government has asked the national regulator to consider clearing AstraZeneca’s COVID-19 vaccine for temporary supply as soon as it receives safety, quality and efficacy data. Requesting use of the fast track positions the U.K. to be among the first countries to begin a COVID-19 vaccination campaign. 

Officials at the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) have already begun assessing some of the data on the viral vector vaccine, AZD1222, under a rolling review scheme. However, typically the MHRA would wait until conducting a full review of the late-phase data, which AstraZeneca shared a glimpse of last week, before authorizing the vaccine for use in the U.K. The temporary supply of the vaccine would position the rollout to start before the MHRA completes its review of the full data set. Under pressure to bring COVID-19 cases down without further harming the economy, the U.K. government has formally asked the MHRA to assess whether AZD1222 is suitable for temporary supply.

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