Vaccine vetting
Britain’s approval puts pressure on U.S. drug regulators.
LONDON — The first rigorously tested coronavirus vaccine was given a green light for use last week in Britain. Doses of the vaccine, made by U.S. pharmaceutical giant Pfizer and a small German company, BioNTech, will be injected starting this week, the government said.
In leaping ahead of the United States to allow mass inoculations, Britain added to the pressure on U.S. drug regulators, who were summoned to the White House by President Donald Trump’s chief of staff to explain why they were not ready to do the same.
Why did Britain authorize a vaccine before the U.S.?
The two countries vet vaccines differently.
Rather than accepting the findings of vaccine makers, U.S. regulators painstakingly reanalyze raw data from the trials to validate the results, poring over what regulators have described as thousands of pages of documents. Dr. Stephen Hahn, commissioner of the Food and Drug Administration, said Tuesday that the FDA “is one of the few regulatory agencies in the world that actually looks at the raw data.”
Regulators in Britain and elsewhere in Europe lean more heavily on companies’ own analyses. Instead of sifting through raw trial data and crunching the numbers themselves, regulatory agencies often will study a drugmaker’s reports and — unless there are anomalies — ground their decisions in company-provided documents.
The question of whether Britain had authorized a vaccine in haste, or the United States was wasting valuable time as the virus was killing about 1,500 Americans a day, provoked a spirited debate among scientists and industry experts. European regulators said that Britain’s authorization was so limited that it only applied to specific batches of the vaccine, a claim that Pfizer denied and that British officials did not address.
Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the FDA’s vaccine advisory panel, said that regulators’ success in approving vaccines, while minimizing unforeseen errors, justified a rigorous approach.
“That we’ve been able to get on top of viruses with such a minimal amount of casualties is remarkable,” he said, adding that American regulators were only days away from finishing their own review.
The FDA has scheduled a meeting of an independent panel of experts for Thursday to review Pfizer’s vaccine. British regulators seek opinions from a specialist committee, too, but that group has the flexibility to review data and meet as it needs to, allowing it to move more quickly.
To speed the process, Britain’s Medicines and Healthcare Products Regulatory Agency had its experts review vaccine data as it became available, and separate teams worked in parallel on different parts of the process, rather than one waiting for another to finish.
What about the rest of Europe?
Britain broke from the European Union’s regulatory orbit to approve a vaccine early, owing to emergency powers that the bloc gives countries in the case of a pandemic. Once Britain consummates its split from the European Union on Dec. 31, those powers to approve vaccines on its own will become permanent.
The countries that remain in the European Union are waiting for its regulator, the European Medicines Agency, to authorize a vaccine. Like the FDA, the European regulator has scheduled a meeting during which it will consult outside experts and offer an opinion on the Pfizer vaccine. That will happen Dec. 29.
The agency’s job is complicated by its obligation to solicit the views of all 27 EU countries. That process has been accelerated during the pandemic, but it will still take several days for countries to weigh in after the Dec. 29 meeting, which is likely to delay vaccinations until early January.
When will the first doses arrive in Britain?
Pfizer planned to ship 800,000 doses to Britain in the coming days. The doses are being prepared for shipping from a factory in Puurs, Belgium, BioNTech said.
The doses will be packaged in boxes of several thousand doses each, with dry ice keeping them at the South Pole-like temperatures they require, before they are put on trucks or planes and taken to Britain.
Who will be vaccinated first in Britain?
At the top of a list released by a government advisory body are nursing home residents and workers, followed by people older than 80 and health and social care workers.
In practice, though, government officials say that, because of the difficulties of storing and moving the Pfizer vaccine, they would initially restrict vaccinations to a network of 50 hospitals. As a result, nurses, doctors, nursing home staff and people age 80 or over who had scheduled appointments would be first in line for the vaccine, ahead of nursing home residents.
Pfizer has said that the vaccine can survive for five days in a normal refrigerator. But Britain’s National Health Service still has to consider issues like staffing at non-hospital sites and transport difficulties within the country when deciding how to administer the vaccine.
The National Health Service has roughly 150,000 doctors and more than 330,000 nurses and midwives.
Does authorization in Britain affect other countries’ supply of the vaccine?
The British decision will not in itself bring vaccinations closer anywhere else. But Pfizer executives said they had already heard from other countries that, in light of Britain’s goahead, were looking to accelerate their own approval processes.
U.S. regulators, despite months of pressure from Trump, have maintained that they will follow their plan and review Pfizer’s vaccine to the FDA’s standards.
The United States has preordered 100 million doses of the Pfizer vaccine. Most of its supply will come from a separate factory in Kalamazoo, Michigan. Still, many questions remain about how vaccine makers like Pfizer will fulfill the orders of wealthier nations that have procured supplies in advance.