Why the U.K. Approved a Coronavirus Vaccine First
When early results from the final trials began to roll
in, scientists were well prepared. Now, they face the logistical challenge of
putting the vaccine to work.
Benjamin
Mueller
By Benjamin
Mueller
Dec. 2,
2020
Updated
11:51 a.m. ET
LONDON —
The first rigorously tested coronavirus vaccine was given a green light for use
on Wednesday in Britain. Doses of the vaccine, made by the American
pharmaceutical giant Pfizer and a small German company, BioNTech, will be
injected starting next week, the government said.
In leaping
ahead of the United States to allow mass inoculations, Britain added to the
pressure on American drug regulators, who were summoned to the White House on
Tuesday by President 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, American 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,
the commissioner of the Food and Drug Administration, called the United States
an outlier when it comes to the rigor of its vaccine reviews, saying on Tuesday
that the F.D.A. “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.
Still,
scientists and industry experts said the British regulators maintained high
standards, often acting as a bellwether for other countries’ rulings. The
regulators themselves said on Wednesday that experts had “unprecedented access”
to raw trial data; tested vaccines for quality, batch by batch; and read more
than 1,000 pages of documentation.
American
and British regulators also have different ways of soliciting outside views.
The F.D.A.
consults an independent panel of experts before it decides. In the case of
Pfizer’s vaccine, that panel will meet on Dec. 10. 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. In
all, the committee met for more than 40 hours about the Pfizer vaccine, its
chairman said on Wednesday.
Like
American regulators, their British counterparts have been reviewing vaccine
data as it arrived. And different teams worked in parallel, rather than waiting
for other parts of the review to finish.
“If you’re
climbing a mountain, you prepare and prepare,” Dr. June Raine, the chief
executive of Britain’s Medicines and Healthcare Products Regulatory Agency,
said on Wednesday. “We started that in June.”
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 F.D.A., 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 on Dec.
29.
The
agency’s job is complicated by its obligation to solicit the views of all 27
E.U. 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
plans to ship 800,000 doses to Britain in the coming days. Starting Tuesday
night, those doses were being prepared for shipping at 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. They will arrive in government
distribution warehouses by the weekend, Pfizer said on Wednesday.
British
hospitals have already begun emailing staff members to schedule vaccinations,
with a London hospital system indicating that its first doses will be given at
7 a.m. on Monday. Britain placed advance orders for 40 million doses of the
Pfizer vaccine but most of those are expected to be administered next year.
Each patient needs two, a month apart.
Who will be
vaccinated first in Britain?
A
government advisory body released its list of vaccine priority groups on
Wednesday. At the top of the list are nursing home residents and workers,
followed by people older than 80 and health and social care workers.
In
practice, though, government officials have indicated that frontline hospital
workers may be quicker to receive vaccines because of the difficulties of
storing and moving the Pfizer vaccine to nursing homes and other sites. It has
to be stored at around minus 70 degrees Celsius (minus 94 Fahrenheit) until
days before injection.
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 in 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 on Wednesday that they had already heard from other countries
that, in light of Britain’s go-ahead, were looking to accelerate their own
approval processes.
American
regulators, despite months of pressure from Mr. Trump, have maintained that
they will follow their plan and review Pfizer’s vaccine to the F.D.A.’s
standards.
The United
States has pre-ordered 100 million doses of the Pfizer vaccine. Most of its
supply will come from a separate factory in Kalamazoo, Mich. Still, many
questions remain about how vaccine makers like Pfizer will fulfill the orders
of wealthier nations that have procured supplies in advance.
Britain’s
ruling offered little relief to poorer countries that could not afford to buy
supplies in advance and may struggle to pay for both the vaccines and the
exceptional demands of distributing them.
Benjamin
Mueller is a United Kingdom correspondent for The New York Times. Before that,
he had been a police and law enforcement reporter on the Metro desk since 2014.
@benjmueller
Sem comentários:
Enviar um comentário