- The UK has accelerated the review of the three coronavirus vaccine frontrunners: AstraZeneca, Moderna, and Pfizer.
- The country’s government is conducting rolling reviews, which allow it to see data in real-time and potentially hasten emergency use approval for the vaccine candidates that prove to be safe and effective.
- The US FDA has strict requirements for emergency approvals, making it impossible for any of the three drugs to be approved before the presidential election.
- Pfizer seems to be the closest to having its drug approved in the US.
The UK is reportedly accelerating the review process for three coronavirus vaccine frontrunners, and it might issue approvals even before the rest of Europe does. AstraZeneca/Oxford, Moderna, and Pfizer/BioNTech are the three experimental drugs that are nearing the end of Phase 3 trials. The FDA made it clear that none of these vaccines will be able to seek emergency use authorization (EUA) in the US before the presidential election, as the agency wants safety data for at least two months for at least half of the volunteers in each study.
Of the three efforts, Pfizer seems the most likely to get a EUA this year in the US, but the company announced earlier this week that it has no early vaccine efficacy data to share with the public as it’s still waiting for a milestone to be reached. All companies are blinded to their COVID-19 vaccine studies, and only independent review boards get to see the partial data. Pfizer will receive the first information about the drug’s efficacy once 32 people out of the 42,000 registered volunteers get a positive COVID-19 diagnosis.
But if the UK and Europe do approve any of the drugs before America does, it would imply that the drugs have shown efficacy and safety, making it only a matter of time before the FDA issues its own approvals.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) started a rolling review process of the Pfizer drug, a person familiar with the matter told Bloomberg. An AstraZeneca spokesperson also confirmed that the MHRA is conducting an expedited review of the drug. The AstraZeneca Phase 3 trial has just been resumed in the US after a temporary pause that lasted several weeks as officials investigated a safety incident. The UK trial was resumed soon after that incident in early September. Moderna confirmed earlier this week that the MHRA has begun a rolling review of its vaccine candidate.
Rolling reviews are processes in which regulators have access to clinical data in real-time and have discussions with companies about the trials and manufacturing processes. That way, the approvals and roll out of a drug can be sped up.
Bloomberg points out that the UK is still part of the EU as the Brexit process hasn’t been finalized. As a result, the UK is still subject to the European Medicines Agency’s (EMA) drug approval process. But the British government has said it’s willing to sidestep the EMA in case there’s a compelling case to move more quickly. EMA announced its own rolling reviews of the Pfizer and AstraZeneca drugs a few weeks ago.
Even though the EU and UK are on an accelerated path to approve coronavirus vaccines, there’s no telling when that will happen. The drugmakers and regulators are still waiting for the events needed to occur before approvals can be granted. Vaccine candidates still have to prove to be effective and safe to use. Multiple regulators will likely approve the same drugs, no matter who is first to do it. Pfizer, AstraZeneca, and Moderna have already announced various deals with the US, EU, and the UK, and they’ll have ready tens to hundreds of millions of doses this year.