Britain leaps ahead of US in race for vaccine
UK nod for Pfizer jab clears the way for sweeping campaign
Britain gave emergency authorisation yesterday 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 antivaccine misinformation.
Britain’s beating the US to authorisation — on a vaccine co-developed by a US company, no less — intensified pressure on US regulators, who are under fire from the White House for not moving faster to get doses out.
But it also fuelled 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 yesterday cast doubt on the rigour of Britain’s review and said the authorisation was limited to specific batches of the vaccine, a claim Pfizer denied and British officials did not address.
Britain’s move provoked a spirited debate among US scientists about whether US regulators, who are known to be unusually meticulous, could afford to hold off any longer on authorising a vaccine against a virus that is claiming more than 10,000 lives a day worldwide.
US regulators have argued that they lag behind — if only by a matter of days — because they are virtually alone in reanalysing thousands of pages of raw data from vaccine trials before approval. Backers of that approach say it is the only way to minimise 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 okay to wait another week or two, you’re saying it’s okay that many thousands of people are going to die,” said Dr Walid Gellad, who leads the Centre for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.
Before yesterday, no country had authorised a fully tested coronavirus vaccine; Russia and China approved vaccines without waiting for largescale 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 US and other wealthy countries have procured in prepaid contracts.
It also offers little relief to poorer nations that could not afford to buy supplies in advance and may struggle to pay for the jabs and the exceptional demands of distributing them.
About 800,000 doses of the Pfizer vaccine, developed with BioNTech, a smaller German firm, were being packaged at the company’s Belgian manufacturing plant yesterday 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 would be given only at 50 British hospitals to begin with. It must be moved at South Pole-like temperatures, 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 aged 80 and over with previously scheduled doctors’ appointments.
A government advisory committee has suggested older or more vulnerable health workers, and doctors and nurses working with fragile patients, would be among the first in line.
But the Government has not said when other employees of the NHS 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 centres 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 Minister Boris Johnson said yesterday.
“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 EU’s drug regulator until it splits from the bloc on December 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 per cent effective in a late-stage clinical trial. It had preordered 40 million doses of the vaccine and 315 million doses of competing vaccines, spreading its bets to assure it can inoculate its 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 EU.
UK 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 US is unclear after scientists and industry analysts questioned promising early results.
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.