The Medicines and Health Products Regulatory Agency on Wednesday approved a vaccine developed by Pfizer Inc. and Germany’s BioNTech SE, which launched its launch in the United Kingdom. and the European Medicines Agency.
It is the highest-profile move by the British agency before the end of December 31 of the UK’s transition out of the EU. After that date, the MHRA will be the regulator with primary responsibility for medicines authorized for use in the UK, stepping out of the shadow of the EMA, which had that role for the past 16 years.
“The MHRA has a huge incentive to appear very fluid and to ensure that, starting in 2021, companies come to them with new drugs, new vaccines,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine. Dress rehearsal with everyone watching, he said, and the message is, “We’ll do it fast.”
June Raine, director of the MHRA, said in a televised briefing on Wednesday that the agency followed international standards for vaccine review, from deciding obstacles to safety and effectiveness in the summer to monitoring the quality of Pfizer doses. -BioNTech coming out of the factories in recent years. days. When asked about any concerns that the regulator had rushed the process, Dr. Raine said: “Everyone can be absolutely sure that no corners have been cut.”
The FDA and the EMA have defended their slower approach. Both agencies have quickly shortened their own typical vaccine approval deadlines, and both are expected to make a decision on the Pfizer vaccine this month.
The FDA will hold a public online meeting with expert advisers on December 10 to discuss the emergency use authorization of the vaccine. Scientists and other members of the public can submit comments in advance. The following day, the EMA will host a virtual public meeting to discuss vaccine development and regulatory reviews.
Such meetings, designed to reinforce confidence in the regulatory process, take a lot of time and planning. Researchers say they could help address people’s hesitancy to get vaccinated. The FDA is expected to make a decision on Pfizer’s vaccine a few days after the December 10 meeting. FDA Commissioner Stephen Hahn told ABC News on Tuesday that the agency would take the time to conduct its own analysis.
The FDA scheduled the public meeting for November 20, in part to assure the public that it was not being rushed by political considerations. He is expected to comment on a Moderna Inc. vaccine shortly after he places a call about the Pfizer vaccine.
The EMA said on Wednesday it was seeking a broader category of authorization, which would be broader and more permanent than the British decision. EU law does not allow the EMA to achieve the kind of temporary emergency use authorization that the UK was seeking, agency officials said. As such, they needed more testing and assurance that manufacturing controls will remain in effect after authorization, they said.
“These are essential elements to guarantee a high level of protection to citizens during the course of a mass vaccination campaign,” said an EMA spokeswoman.
The EMA is set to announce a decision on Pfizer’s vaccine by December 29 and Moderna’s vaccine by January 12. In each case, the agency will have to convene its high-level scientific committee for human drugs before rendering a judgment. Communication between drug manufacturers and the EMA has been slowed by data format and software compatibility issues, according to people familiar with the matter. Last week, the agency said it was willing to consider ways to speed up its system and asked drug companies for suggestions.
The UK agency has the advantage of having been an EMA workhorse during the country’s time in the EU, handling evaluations for a large portion of the bloc’s new drugs overall. Individual EU countries oversee clinical trials; the EMA enforces safety, efficacy and quality guidelines, and coordinates decisions across the block, through a committee, on authorized use.
The UK’s decision to leave the EU led the EMA last year to move out of its London headquarters and settle in Amsterdam.
By then, the EMA had already been distributing the UK regulator’s huge portfolio of drug evaluations across Europe to other EU countries. The 370 drugs that were part of the UK’s responsibility at the time were redistributed among 27 EU nations plus Iceland and Norway, the EMA said.
With its workload reduced, the MHRA “has had relatively little work,” said Professor Evans. That has given it additional bandwidth to act quickly, the researchers said. The London-based MHRA also gained experienced staff who left the EMA and stayed in the city.
UK regulators and ministers don’t need to go through the EU committee system either. “There is an advantage to being small,” said George Freeman, a former UK life sciences minister who oversaw changes to the MHRA to speed up drug reviews.
The agency, which is not a household name even in its home country, was founded in 2003 with the merger of separate UK regulators for drugs and medical devices, and has a staff of 1,320 people. The EMA has around 900 employees, although it does not evaluate medical devices or supervise clinical trials. The FDA has a staff of about 17,000 people.
For the green light on the vaccine, the UK government used a long-standing power of attorney to authorize drugs on its own in an emergency, allowing the MHRA to review the drug outside the EMA framework even before the end of the period. Brexit transition. All other EU members have the same power, but none have publicly declared plans to exercise it.
Pfizer executive Ralf Rene Reinert said during a press conference on Wednesday that he was receiving emails about other countries that were considering seeking faster authorization, following the lead of the United Kingdom. “The world is looking at the UK right now,” he said, without mentioning the countries.
Like the FDA and EMA, the British agency used data from large-scale human trials delivered in successive batches as the trials progressed. People who have been working with the MHRA in recent months say it has been more proactive in working with drug companies as they provide data, ask additional questions and request more information that could expedite a review.
Recently, the “ongoing review of the MHRA is a much more interactive experience,” said Sarah Blagden, associate professor of experimental cancer therapies at the University of Oxford, who oversees cancer trials. “Regulators become part of the discussion very, very early. “
In the run-up to Pfizer’s vaccine authorization in the UK, teams from the company and its partner BioNTech worked 24 hours a day with their counterparts at the MHRA, answering individual inquiries and providing additional, personalized data where required. necessary, according to people familiar with the process. They said the MHRA was sending questions to the companies until last weekend.
Professor Reinert, a Pfizer executive, said the MHRA would respond quickly, sometimes after just 10 minutes, to the data it sent.
BioNTech praised the UK regulator. “The MHRA has asked questions with the same level of detail as any agency,” said Sean Marett, BioNTech’s business and commercial director.
The UK government has also asked the agency to review a vaccine that is being jointly developed by AstraZeneca PLC and the University of Oxford before possible emergency use authorization. The UK has said that it is also making continuous reviews of the Moderna injection test data, and that the vaccine, if licensed, could be available in the UK as early as spring, similar to the rest of Europe.
Write Jenny Strasburg at [email protected], Drew Hinshaw at [email protected] and Bojan Pancevski at [email protected]
.
