U.K. Accelerates Reviews of Pfizer and Astra-Oxford Vaccines
Britain is getting ready to approve the first successful shot as quickly as possible.
(Bloomberg) -- The U.K.’s drug regulator has started accelerated reviews of Covid-19 vaccines under development from Pfizer Inc. and AstraZeneca Plc, as Britain gets ready to approve the first successful shot as quickly as possible.
The U.K. Medicines and Healthcare Products Regulatory Agency started a so-called rolling review of the Pfizer vaccine in recent weeks, according to a person with knowledge of the situation who didn’t want to be identified because the procedure hasn’t been announced publicly. The agency is also conducting an expedited review of Astra’s vaccine, which the company is co-developing with the University of Oxford, a spokesman for Astra confirmed.
Astra shares erased losses, trading 0.2% higher in London. Pfizer rose 0.5% in premarket trading in New York.
Rolling reviews allow regulators to see clinical data in real time and have discussions with companies about ongoing trials and manufacturing processes so that approvals can be granted more quickly. The approach is designed to speed up access to drugs and vaccines when there is a public health need.
The move supports the U.K.’s plans to potentially move ahead of the European Union on clearing a vaccine. While the U.K. is still subject to the approval process of the European Medicines Agency until the end of the Brexit transition process this year, the government has said that if there was a compelling case to move more quickly than the EMA, it would look at granting a temporary authorization for an unlicensed vaccine.
Pfizer declined to comment. A spokeswoman for the MHRA said the agency couldn’t comment on rolling reviews due to commercial confidentiality.
Pfizer and Astra are among a vanguard of vaccine developers that could have shots cleared for use this year. The U.S. company, which is co-developing its vaccine with Germany’s BioNTech SE, expects to release initial late-stage trial data next month and may apply for an emergency-use authorization in the U.S. shortly after.
Pfizer said this week that it hadn’t yet reached a key milestone that will help researchers know how effective the shot is. Astra and Oxford are also targeting publication of advanced-stage trial data this year.
Moderna Inc., another frontrunner in the vaccine race, also said this week it had started an expedited review of its shot in the U.K. Rolling reviews of the Pfizer and Astra jabs in Europe were announced by the EMA earlier this month.
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