Pfizer-BioNTech Apply for EU Emergency Vaccine Authorisation

Moderna had said that it would apply for emergency authorisation of its vaccine candidate on Monday, 30 November

Pfizer had said that a final analysis of clinical-trial data from its COVID-19 vaccine trial shows that the shot is 95 percent effective.

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Pfizer Inc and BioNTech on Tuesday, 1 December, informed that they have applied to the European drugs regulator for conditional authorisation of their COVID-19 vaccine, following similar steps in the United States and Britain, according to Reuters.

The companies had applied in the United States for approval on 20 November.

United States’ Pfizer and Germany’s BioNTech, according to Reuters, reported final trial results on 18 November that showed that their vaccine candidate was 95% effective in preventing COVID-19. No major safety concerns were also reported, according to Reuters.

The European filing completes what was referred to as the rolling review process, according to Reuters.

The US-German partners had reported the data from their clinical trials to the UK Medicines and Healthcare products Regulatory Agency (MHRA), reported Reuters, citing the British government.

Meanwhile, following a late-stage study claiming that the vaccine developed by Moderna was 94.1 percent effective in preventing COVID-19, the US drug-maker said that it would apply for emergency authorisation of its vaccine candidate on Monday, 30 November.

The announcement by Moderna comes after its vaccine candidate was found to be 100 percent successful in preventing severe cases of coronavirus.