[Ip-health] New York Time: U.K. Approves Pfizer Coronavirus Vaccine, a First in the West

Thiru Balasubramaniam thiru at keionline.org
Thu Dec 3 00:15:00 PST 2020


https://www.nytimes.com/2020/12/02/world/europe/pfizer-coronavirus-vaccine-approved-uk.html?smid=tw-share

U.K. Approves Pfizer Coronavirus Vaccine, a First in the West

The emergency approval, ahead of the United States and the European Union,
clears the way for Britain to begin mass inoculations. “Help is on its
way,” one official said.

By Benjamin Mueller

Dec. 2, 2020

--

<SNIP>


Britain’s beating the United States to authorization — on a vaccine
codeveloped by an American company, no less — intensified pressure on U.S.
regulators, who are under fire from the White House for not moving faster
to get doses to people. But it also fueled concerns that Britain was acting
in haste for political reasons or trying to muscle its way to the front of
the line for deliveries.

European regulators on Wednesday cast doubt on the rigor of Britain’s
review and said that the authorization was limited to specific batches of
the vaccine, a claim that Pfizer denied and British officials did not
address.

Britain’s move provoked a spirited debate among American scientists about
whether U.S. regulators, who are known to be unusually meticulous, could
afford to hold off any longer on authorizing a vaccine against a virus that
is claiming more than 10,000 lives a day worldwide.

American regulators have argued that they lag behind — if only by a matter
of days — because they are virtually alone in reanalyzing thousands of
pages of raw data from vaccine trials before approval. Backers of that
approach say it is the only way to minimize unintended damage, in lives and
in public trust, from vaccines not working.

British and European regulators lean more heavily on the companies’ own
analyses, auditing their figures occasionally but otherwise grounding their
decisions on vaccine makers’ reports. While the more cautious American
approach can be valuable, some scientists said the Europeans subject
vaccine makers to considerable scrutiny, and it is imperative to move
quickly to curb the suffering wrought by the pandemic.

<SNIP>

While the go-ahead bodes well for Britain, which broke from the European
Union’s regulatory orbit to approve the vaccine early, it will have no
effect on the distribution of the hundreds of millions of doses that the
United States and other wealthy countries have procured in prepaid
contracts.

It also offers 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.


--

U.K. Approves Pfizer Coronavirus Vaccine, a First in the West

The emergency approval, ahead of the United States and the European Union,
clears the way for Britain to begin mass inoculations. “Help is on its
way,” one official said.

By Benjamin Mueller

Dec. 2, 2020

LONDON — Britain gave emergency authorization on Wednesday to Pfizer’s
coronavirus vaccine, leaping ahead of the United States to become the first
Western country to allow mass inoculations against a disease that has
killed more than 1.4 million people worldwide.

The decision cleared the way for a vaccination campaign with little
precedent in modern medicine, encompassing not only ultracold dry ice but
also a crusade against anti-vaccine misinformation.

Britain’s beating the United States to authorization — on a vaccine
codeveloped by an American company, no less — intensified pressure on U.S.
regulators, who are under fire from the White House for not moving faster
to get doses to people. But it also fueled concerns that Britain was acting
in haste for political reasons or trying to muscle its way to the front of
the line for deliveries.

European regulators on Wednesday cast doubt on the rigor of Britain’s
review and said that the authorization was limited to specific batches of
the vaccine, a claim that Pfizer denied and British officials did not
address.

Britain’s move provoked a spirited debate among American scientists about
whether U.S. regulators, who are known to be unusually meticulous, could
afford to hold off any longer on authorizing a vaccine against a virus that
is claiming more than 10,000 lives a day worldwide.

American regulators have argued that they lag behind — if only by a matter
of days — because they are virtually alone in reanalyzing thousands of
pages of raw data from vaccine trials before approval. Backers of that
approach say it is the only way to minimize unintended damage, in lives and
in public trust, from vaccines not working.

British and European regulators lean more heavily on the companies’ own
analyses, auditing their figures occasionally but otherwise grounding their
decisions on vaccine makers’ reports. While the more cautious American
approach can be valuable, some scientists said the Europeans subject
vaccine makers to considerable scrutiny, and it is imperative to move
quickly to curb the suffering wrought by the pandemic.

“When you say it’s OK to wait another week or two, you’re saying it’s OK
that many thousands of people are going to die,” said Dr. Walid F. Gellad,
who leads the Center for Pharmaceutical Policy and Prescribing at the
University of Pittsburgh.

No country until Wednesday had authorized a fully tested coronavirus
vaccine; Russia and China approved vaccines without waiting for large-scale
efficacy tests.

“Help is on its way with this vaccine — and we can now say that with
certainty, rather than with all the caveats,” the British health secretary,
Matt Hancock, said Wednesday.

While the go-ahead bodes well for Britain, which broke from the European
Union’s regulatory orbit to approve the vaccine early, it will have no
effect on the distribution of the hundreds of millions of doses that the
United States and other wealthy countries have procured in prepaid
contracts.

It also offers 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.

Roughly 800,000 doses of the Pfizer vaccine, developed with BioNTech, a
smaller German firm, were being packaged at the company’s Belgian
manufacturing plant on Wednesday for shipment to Britain. How and when they
will arrive is a secret for security reasons, the company said.

The complicated logistics of moving, defrosting and preparing the vaccine
meant it was going to be given only at 50 British hospitals to begin with.
The vaccine must be transported at South Pole-like temperatures, and in
trays of 975 doses.

First to be vaccinated will be doctors and nurses in the country’s National
Health Service, along with nursing home workers and people 80 and over with
previously scheduled doctors’ appointments. A government advisory committee
has suggested that older or more vulnerable health workers, and doctors and
nurses who work with fragile patients, would be among the first in line.

But the government has not said when other employees of the National Health
Service would be eligible for vaccines. Essential workers, like teachers,
transport workers and first responders, would not be vaccinated until after
people 50 and over and those with underlying health problems received shots.

The advisory committee plans had made nursing home residents a top
priority, but they will have to wait until the government begins
distributing vaccines beyond hospitals. Pfizer and BioNTech have suggested
that is possible, given that the vaccine can be stored for five days in a
normal refrigerator.

Eventually, people will get their shots in mass vaccination centers being
set up by the military at soccer stadiums and racecourses, or at doctors’
offices and pharmacies.

“We’ve been waiting and hoping for the day when the searchlights of science
would pick out our invisible enemy, and give us the power to stop that
enemy from making us ill,” Prime Mister Boris Johnson said on Wednesday.
“And now the scientists have done it.”

For Britain, which has suffered one of Europe’s highest per capita death
tolls from the virus, the decision by its drug regulator was the latest
evidence of a vaccination strategy that has been the most aggressive in the
West.

Britain remains under the authority of the European Union’s drug regulator
until it consummates its split from the bloc on Dec. 31. But the government
recently strengthened an old law that allows it to step out from under the
bloc’s regulatory umbrella in public health emergencies. That allowed it to
fast-track a review of the Pfizer vaccine, which was 95 percent effective
in a late-stage clinical trial.

Britain had pre-ordered 40 million doses of the vaccine and 315 million
doses of competing vaccines, spreading its bets to assure it can inoculate
the country’s 67 million people.

British ministers cast the speed of the Pfizer approval as an early example
of the new flexibility the country will have once it fully untethers itself
from European regulation. Yet Brexit has also exacted costs, starving
Britain’s drug regulator of money it used to draw from contracts with the
European Union.

British regulators are also vetting a vaccine developed by the University
of Oxford and AstraZeneca, a British-Swedish company. It is cheaper and
easier to store than Pfizer’s, so much of the world could rely on it, but
its regulatory path forward in the United States is unclear after
scientists and industry analysts questioned promising early results.

The chemistry underlying Pfizer’s vaccine had never before produced an
approved shot, but scientists have experimented with it for years, testing
vaccines that did not make it to market. In order to coax cells to make a
viral protein, called a spike, and elicit an immune response, this class of
vaccine delivers genetic instructions, known as messenger RNA, encased in
tiny fat globules.

BioNTech made a prophetic bet on the technology and joined forces with
Pfizer, one of the world’s largest drug companies; they ended up delivering
stunning results, on a timeline that was unheard-of before this year.

The U.S. Food and Drug Administration plans to decide on emergency
authorization for the Pfizer vaccine shortly after a meeting of an advisory
panel on Dec. 10. American officials have said vaccinations could begin
within 24 hours after approval.

Another American company, Moderna, and the National Institutes of Health
have also developed a messenger RNA vaccine that has proved effective in
large trials. The F.D.A. will consider their application for emergency
authorization shortly after Pfizer’s.

The European Medicines Agency, which regulates vaccines across the European
Union, is expected to make a decision about the Pfizer vaccine later in
December.

Pfizer has said it expects to be able to produce up to 50 million doses
this year, about half of them going to the United States. Since each person
needs two doses, a month apart, up to 25 million people worldwide could
begin vaccination before 2021.

The United States has bought 100 million doses in advance from Pfizer, and
the European Union 200 million doses.

The approval arrived at a perilous moment in the pandemic in Britain, where
the virus has killed nearly 70,000 people, and hundreds more die each day.
A third of England’s hospital systems were caring for more Covid-19
patients in recent weeks than at the height of the first wave in the spring.

A monthlong shutdown of restaurants and pubs has stanched the spread of the
virus, but that is being replaced by a less stringent system of localized
restrictions, with allowances for Christmastime travel that scientists fear
will seed another uptick in infections.

In a clinical trial, the Pfizer-BioNTech vaccine proved highly effective
among older adults, who are more vulnerable to developing severe Covid-19
and who do not respond strongly to some types of vaccines. It caused no
serious side effects.

As vaccines become widely available, the scientific feat of developing them
will give way to the social and political problem of convincing people to
take them. In Britain, the source of some of the most virulent modern
disinformation about vaccines, just over half of people have said in
surveys they would definitely accept an inoculation.

Safety concerns have been accentuated by the speed of vaccine testing and
approval, despite Britain’s regulators saying repeatedly they were not
taking shortcuts.

Beyond those challenges, manufacturers will quickly need to eventually make
billions of doses and move them to hospitals, clinics and pharmacies.

The Pfizer vaccine makes this effort especially complex. It has to be
stored at around minus 70 degrees Celsius (minus 94 Fahrenheit) until
shortly before injection, requiring transportation in boxes stuffed with
dry ice.

Matina Stevis-Gridneff contributed reporting from Brussels, Katie Thomas
from Chicago and Rebecca Robbins from Bellingham, Wash.


-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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