Coronavirus: EU medicines regulator says first vaccine could be approved by Dec. 29

An illustration picture shows vials with Covid-19 Vaccine stickers attached and syringes with the logo of US pharmaceutical company Pfizer, on November 17, 2020. (AFP)

The European Medicines Agency said on Tuesday that if its experts have received enough data from drugmakers Pfizer and Moderna about their candidate vaccines against the coronavirus, the agency would complete its reviews by Dec. 29 and Jan. 12, respectively, at latest.

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The companies said earlier on Tuesday that they had submitted approval requests for their vaccine candidates to the European Medicines Agency (EMA).

The application comes after the companies applied for US approval on November 20, taking them a step closer to launching their vaccine.

A logo for Pfizer is displayed on a monitor on the floor at the New York Stock Exchange in New York, US. (File photo: Reuters)

A logo for Pfizer is displayed on a monitor on the floor at the New York Stock Exchange in New York, US. (File photo: Reuters)

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.

US drugmaker Pfizer and Germany's BioNTech reported final trial results on November 18 that showed their vaccine candidate was 95 percent effective in preventing COVID-19, with no major safety concerns, raising the prospect of US and European approval as early as December.

The European filing completes the so-called rolling review process, which was initiated with the EMA on October 6.

Vaccine trial participant David Rach is prepared to test coronavirus disease (COVID-19) vaccine candidate BNT162b2, developed by Pfizer and BioNTech, at the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine in Baltimore on May 24, 2020. (Reuters)

Vaccine trial participant David Rach is prepared to test coronavirus disease (COVID-19) vaccine candidate BNT162b2, developed by Pfizer and BioNTech, at the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine in Baltimore on May 24, 2020. (Reuters)

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).

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Last Update: Tuesday, 01 December 2020 KSA 14:40 - GMT 11:40
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