PFE Pfizer Inc

By Jenny Strasburg, Drew Hinshaw and Bojan Pancevski 

LONDON -- Britain's first-in-the-West authorization of a Covid-19 vaccine thrusts its little-known medicines watchdog into the global spotlight -- weeks before the U.K.'s split from the European Union adds to the regulator's responsibilities.

The Medicines and Healthcare Products Regulatory Agency signed off Wednesday on a vaccine developed by Pfizer Inc. and Germany's BioNTech SE, setting in motion its rollout in the U.K. It reached a decision ahead of higher-profile watchdogs, such as the U.S. Food and Drug Administration and the European Medicines Agency.

It is the British agency's highest-profile move ahead of the Dec. 31 end to the U.K.'s transition out of the EU. After that date, the MHRA will be the regulator with the primary responsibility for drugs authorized for use in the U.K., stepping out of the shadow of the EMA, which had that role for the last 16 years.

"The MHRA has enormous incentive to appear very smooth to ensure that starting in 2021, companies will come to them with new drugs, new vaccines," said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine. It is a dress rehearsal with the whole world watching, he said, and the message is: "We'll do it quickly."

June Raine, head of the MHRA, said in a televised briefing on Wednesday that the agency followed international vaccine-review standards, from deciding hurdles for safety and effectiveness in the summer to monitoring the quality of Pfizer-BioNTech doses coming out of factories in recent days. Asked about any concerns that the regulator had rushed the process, Dr. Raine said, "Everyone can be absolutely confident that no corners whatsoever have been cut."

The FDA and the EMA have defended their slower approach. Both agencies have rapidly compressed their own typical vaccine-approval timelines, and both are expected to make a decision on the Pfizer vaccine this month.

The FDA on Dec. 10 will hold an online public meeting, with expert advisers, to discuss emergency-use authorization of the vaccine. Scientists and other members of the public can submit comments beforehand. The next day, the EMA will host a virtual public meeting to talk about vaccine development and regulatory reviews.

Such meetings -- designed to bolster confidence in the regulatory process -- require extensive time and planning. Researchers say they might help address people's hesitancy to take vaccines. The FDA is expected to make a decision on the Pfizer shot a few days after the Dec. 10 meeting. FDA Commissioner Stephen Hahn told ABC News on Tuesday that the agency would take the time necessary to perform its own analysis.

The FDA scheduled the public meeting on Nov. 20, in part to assure the public it wasn't being rushed by political considerations. It is expected to rule on a vaccine from Moderna Inc. a short time after it makes a call on the Pfizer shot.

The EMA said Wednesday that it was pursuing a broader category of authorization, which would be more sweeping and permanent than the British decision. EU law doesn't allow the EMA to reach the kind of temporary, emergency-use authorization that the U.K. pursued, agency officials said. As such they needed more evidence and assurances that manufacturing controls will remain in place after authorization, they said.

"These are essential elements to ensure a high level of protection to citizens during the course of a mass vaccination campaign," an EMA spokeswoman said.

The EMA is set to announce a decision about Pfizer's vaccine by Dec. 29 and Moderna's vaccine by Jan. 12. In each case, the agency will have to convene its high-level scientific committee for human medicines before reaching a judgment. Communication between drugmakers and the EMA has been slowed by data-formatting issues and software compatibility, 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 pharmaceutical companies to make suggestions.

The U.K. agency has the advantage of having been a workhorse of the EMA during the country's time in the EU, handling evaluations for a large chunk of the overall bloc's new medicines. Individual EU countries oversee clinical trials; the EMA enforces guidelines for safety, effectiveness and quality, and coordinates bloc-wide decisions, via committee, on authorized use.

The U.K.'s decision to leave the EU pushed the EMA last year to move out of its London headquarters and set up shop in Amsterdam.

The EMA by then had already been doling out the U.K. regulator's massive portfolio of Europe-wide medicine evaluations to other EU countries. The 370 medicines at the time that were part of the U.K.'s responsibility were redistributed among 27 EU nations plus Iceland and Norway, the EMA has said.

With its workload lessened, the MHRA "has been relatively underworked," said Prof. Evans. That has given it additional bandwidth to act quickly, researchers said. The London-based MHRA also gained experienced staff who left the EMA and stayed behind in the city.

British regulators and ministers also no longer need to go through the EU committee system. "There is an advantage in being small," said George Freeman, a former U.K. life-sciences minister who oversaw MHRA changes to speed up drug reviews.

The agency -- not a household name even in its home country -- was founded in 2003 with the merger of separate U.K. regulators for medicines and medical devices, and has a staff of 1,320. The EMA has about 900 employees, though it doesn't evaluate medical devices or oversee clinical trials. The FDA has a staff of around 17,000.

For the vaccine green light, the U.K. government used a long-held power 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 Brexit transition period. 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 media briefing on Wednesday he was receiving emails about other countries considering pursuing more-rapid authorization, following the U.K.'s lead. "The world is at the moment looking at the U.K.," he said. He didn't name the countries.

Like the FDA and the EMA, the British agency used data from large-scale human trials handed over in rolling 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, asking additional questions and requesting more information that could speed a review.

Recently, the MHRA's "rolling review is a much more interactive experience," said Sarah Blagden, associate professor of experimental cancer therapeutics at the University of Oxford, who oversees cancer trials. "The regulators become part of the discussion very, very early on."

In the run-up to the Pfizer vaccine authorization in the U.K., teams from the company and its partner BioNTech worked around the clock with counterparts at the MHRA, answering individual queries and providing extra, bespoke data when necessary, according to people familiar with the process. They said the MHRA was sending questions to the companies through last weekend.

Prof. Reinert, the Pfizer executive, said the MHRA would respond quickly, sometimes after just 10 minutes, to data it sent in.

BioNTech praised the U.K. regulator. "The MHRA has asked the same level of detail of questions as any agency," said Sean Marett, BioNTech's chief business and commercial officer.

The U.K. government has also asked the agency to review a vaccine being co-developed by AstraZeneca PLC and the University of Oxford ahead of a possible emergency-use authorization. The U.K. has said it is doing rolling reviews of trial data from the shot by Moderna, too, and that the vaccine, if authorized, could be available in the U.K. as early as the spring, similar to the rest of Europe.

Write to Jenny Strasburg at jenny.strasburg@wsj.com, Drew Hinshaw at drew.hinshaw@wsj.com and Bojan Pancevski at bojan.pancevski@wsj.com

(END) Dow Jones Newswires

December 02, 2020 11:04 ET (16:04 GMT)

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