According tomedia BGR, the UK has stepped up its review of AstraZeneta, Pfizer and Moderna, the three leading companies in the new crown vaccine. The Government is conducting a rolling review, which will enable it to see the data in real time and has the potential to expedite the approval of emergency use of vaccine candidates that prove safe and effective. By contrast, the U.S. Food and Drug Administration (FDA) has strict requirements for emergency approval, making it impossible for any of the three drugs to be approved before the presidential election.
The UK is reportedly speeding up the vetting process for three new crown vaccine front-runners, with approval likely to be issued before the rest of Europe. Phase 3 trials of the three experimental drugs, AstraZeneta/Oxford, Moderna and Pfizer/BioNTech, are coming to an end. The FDA made it clear that none of the vaccines would seek an emergency use authorization (EUA) in the U.S. before the presidential election because the agency wants at least half of the volunteers in each study to have at least two months of safety data.
Pfizer appears most likely to get the U.S. EUA this year, but the company announced earlier this week that it had no data on the efficacy of the early vaccine to share with the public as it waits for a milestone to be reached. All companies’ COVID-19 vaccine studies are double-blind, and only an independent review board can see some of the data. Once 32 of the 42,000 registered volunteers received a positive COVID-19 diagnosis, Pfizer will receive the first batch of information about the drug’s efficacy.
But if the U.S. and Europe do approve any drug before the U.S., that means the drugs have shown efficacy and safety, making it only a matter of time before the FDA issues its own approval.
The UK’s drug and healthcare regulator (MHRA) has begun a rolling review of Pfizer’s drugs, a person familiar with the matter told Bloomberg. An AstraZeneia spokesman also confirmed that the MHRA was conducting a rapid review of the drug. AstraZeneta’s Phase 3 trial has just resumed in the US after a weeks-long pause over a safety incident. The British trial resumed shortly after the incident in early September. Moderna confirmed earlier this week that the MHRA had begun a rolling review of its vaccine candidates.
Rolling reviews are processes in which regulators have real-time access to clinical data and discuss trials and production processes with companies. In this way, the approval and promotion of drugs can be accelerated.
Bloomberg points out that the UK remains part of the EU as the Brexit process is not yet final. As a result, the UK still has to comply with the European Medicines Agency’s (EMA) drug approval process. But the BRITISH government says it is willing to bypass the EMA and move faster if there are compelling reasons to do so. The EMA announced its rolling review of Pfizer and AstraZeneta a few weeks ago.
Pfizer, AstraZeneta and Moderna have announced deals with the US, EU and UK to prepare tens to hundreds of millions of doses of the new crown vaccine this year.