BRITAIN OKS VACCINE, WILL BEGIN SHOTS WITHIN DAYS

Pfizer wins emergency approval; health care workers given priority

Britain gave emergency authorization Wednesday to Pfizer’s coronavirus vaccine, becoming 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 co-developed by a U.S. company — 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 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 U.S. scientists about whether U.S. regulators 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.

U.S. regulators have argued that they lag behind — if only by a matter of days — because they are virtually alone in re-analyzing 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 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.

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 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 at the outset. The vaccine must be transported at South Polelike 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 or older 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 older 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 racetracks, 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 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.

Britain had preordered 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 regulators are also vetting a vaccine developed by the University of Oxford and AstraZeneca, a BritishSwedish 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 promising 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. U.S. 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 FDA 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 this month.

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.