It’s Donald Trump’s worst nightmare: The U.K. became the first country in the Western world to authorize a coronavirus vaccine on Wednesday.
The vaccine from BioNTech/Pfizer should start arriving in the U.K. within days, and could be used on British citizens from next week.
The first people to get the vaccine, which will be administered over two doses 21 days apart, will be “priority groups” including care home residents, health and care workers, the elderly and those who are medically vulnerable, based on a decision from the U.K.’s Joint Committee on Vaccination and Immunisation.
The U.K. has secured 40 million doses of the two-dose vaccine. U.K. Health Secretary Matt Hancock told the BBC’s Today radio program that “800,000” doses will available in the first instance, adding “this will start small and ramp up, the vast majority of vaccinations we expect to be in the new year.”
Hancock said the speed of the rollout will depend on how quickly the vaccinations can be manufactured in Belgium. He added that BioNTech/Pfizer had indicated the U.K. could get “many millions” of doses of the vaccine before the end of the year, “but we’re not putting a precise figure on it.”
That puts Britain ahead of EU countries in being authorized to start administering the vaccine. The head of the EU’s drug regulator, Emer Cooke, said Wednesday that a decision on approval from the European Medicines Agency (EMA) would come by December 29 at the “latest.”
BioNTech and Pfizer wrote in a press release that delivery of the vaccine “will occur throughout 2020 and 2021 in stages to ensure an equitable allocation of vaccines across the geographies with executed contracts,” adding that full delivery “is expected” in 2021.
Hancock sought to allay any fears over the vaccine’s safety, stating “the [U.K.] regulator is fiercely independent, and they’ve worked to ensure that they can insist on the highest of safety standards whilst also getting this approval through in the time that they have by doing the same checks that they normally do, but doing them in parallel rather than one after another.”
Hancock also tweeted: “Help is on its way,” adding that, “The NHS stands ready to start vaccinating early next week. The UK is the first country in the world to have a clinically approved vaccine for supply.” He told BBC Breakfast that the U.K.’s National Health Service will contact people when it is time for them to get the vaccine.
He said: “I’m confident now with the news today that from spring, from Easter onwards, things are going to be better and we’re going to have a summer next year that everybody can enjoy.”
The British government effectively worked around the EU to get the vaccine out sooner: The authorization followed a recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to allow the vaccine for emergency use before a conditional marketing authorization from the EMA.
Cooke, who took over the helm of the EMA last month, said Wednesday that she “noted” the decision made by U.K. authorities to approve the vaccine.
“This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness,” the U.K. government wrote in its press release.
The announcement came the morning after U.K. Prime Minister Boris Johnson suffered his largest rebellion since the general election, with 54 Tory MPs voting against the next phase of his coronavirus measures in parliament. The plan passed due to abstentions from opposition parties.
On Tuesday, U.S. President Trump admonished officials at America’s Food and Drug Administration (FDA) after reports the U.K. would approve a vaccine by December 7. The U.S. FDA predicted it would approve the BioNTech/Pfizer vaccine by December 10 at the earliest.
But the EMA’s approval is sure to take longer: The agency estimates it will approve the first vaccine “within weeks” by issuing a conditional marketing authorization — a more long-lasting type of approval that examines more evidence and requires more checks than emergency authorizations, according to the agency.
A CMA might take longer than America’s emergency use authorization, because the CMA looks at “all pharmacovigilance, manufacturing controls including batch controls for vaccines and other post-approval obligations apply in a legally binding manner and are evaluated and acted upon by EMA’s scientific committees on a continuous basis,” the agency’s press service wrote Tuesday. “These are essential elements to ensure a high level of protection to citizens during the course of a mass vaccination campaign.”
Technically, other EU countries can legally follow the U.K. and approve a vaccine for emergency use before the EMA gives the go-ahead, but the European Commission has encouraged countries to wait for the EMA’s stamp of approval. Even if they did approve the vaccine ahead of the EMA, EU countries would have to wait for the physical vaccine — the EU27 negotiated vaccine doses as a bloc with six producers.
The European Commission has secured up to 300 million doses of BioNTech/Pfizer’s vaccine.