The European Medicines Agency, or EMA, said on Tuesday that it has received a conditional marketing-authorization application from drug company AstraZeneca AZN, -0.02% for the COVID-19 vaccine it developed with the University of Oxford.
A decision on marketing authorization of the AstraZeneca–Oxford shot could be issued by Jan. 29 during a scheduled review by the EMA’s scientific committee for human medicines, the regulator said in a statement.
The European Commission will then fast-track its decision-making process, with a view to granting a conditional marketing authorization “within days,” the EMA said.
If authorized, the AstraZeneca–Oxford vaccine would be the third to be given the go-ahead in the European Union, after the shot developed by U.S. drug company Pfizer PFE, -1.93% and its German partner BioNTech BNTX, -4.89%, as well as the one developed by U.S. biotech Moderna MRNA, +0.55%.
Shares in AstraZeneca were down 2.09% in early-afternoon London trading.
European Commission President Ursula von der Leyen welcomed the news, saying on Twitter TWTR, -0.91% that, once the vaccine receives a positive scientific opinion, “we will work full speed to authorize its use in Europe.”
The EU struck a deal in June last year to buy up to 400 million doses of the AstraZeneca–Oxford shot and hopes to receive the first delivery of the doses two weeks after authorization, European Commission director-general for health Sandra Gallina told Brussels lawmakers on Tuesday.
The EMA has come under pressure in recent weeks to accelerate the authorization of new vaccines as coronavirus cases have surged in the region, while some EU leaders have faced criticism for the slow pace of their inoculation programs, which began on Dec. 27 using the Pfizer–BioNTech shot.
Earlier on Tuesday, the EU reached its eighth supply deal for vaccine doses as it said it had concluded exploratory talks with French biotech Valneva VLA, +15.49% for the supply of up to 60 million doses of its experimental COVID-19 shot.
“The envisaged contract with Valneva would provide for the possibility for all EU member states to purchase together 30 million doses, and they could further purchase up to 30 million more doses,” the European Commission said in a statement.
The EU has already signed contracts with six companies for COVID-19 vaccines, taking its total stockpile to almost 2.3 billion doses. Last week, the Commission secured an extra 300 million doses of the Pfizer–BioNTech COVID-19 vaccine, doubling its current stockpile of the shot.
Valneva’s vaccine candidate entered Phase 1 and Phase 2 clinical studies in December 2020 and the company expects to report initial safety and immunogenicity data in April this year. If successful, Valneva INRLF, +12.61% will carry out a larger study in April 2021, with more than 4,000 volunteers testing two doses of the vaccine in two groups: those aged between 18-65 years and over 65s.
“If clinical development is successful, an initial approval may be granted in the second half of 2021,” the company said in a statement on Tuesday.