With coronavirus cases around the world now at over 63 million, scientists have been working around the clock to develop a vaccine.
Jabs from Pfizer, Moderna and AstraZeneca are undergoing Phase 3 clinical trials, and now it seems that Pfizer’s offering could be one step closer to launching.
Pfizer and BioNTech have applied to the European drugs regulator for conditional authorization of their COVID-19 vaccine, following similar steps in the United States and Britain, the companies said on Tuesday.
The application to the European Medicines Agency (EMA) comes after the companies applied for U.S. approval on Nov. 20, taking them a step closer to launching their vaccine.
In their pursuit of a European launch, potentially this year, the partners are neck-and-neck with rival Moderna, which said on Monday it would ask the EU regulator to recommend conditional approval for its shot.
U.S. drugmaker Pfizer and Germany’s BioNTech reported final trial results on Nov. 18 that showed their vaccine candidate was 95% effective in preventing COVID-19, with no major safety concerns, raising the prospect of U.S. and European approval as early as December.
The European filing completes the so-called rolling review process, which was initiated with the EMA on Oct. 6.
The British government said last week that the US-German partners had reported the data from their clinical trials to the UK Medicines and Healthcare products Regulatory Agency (MHRA).
The UK has access to a total of 357 million doses of vaccines from 7 different developers.
This includes 40 million doses of BioNTech and Pfizer’s Covid-19 vaccine.
NHS hospitals have been told to be ready to deploy a coronavirus vaccine from as early as Wednesday this week, according to sources speaking to The Daily Telegraph.
Sources said trusts ‘have been asked to mobilise’, amid widespread anticipation that the Pfizer vaccine will get regulatory approval this week.