U.K. Prime Minister Boris Johnson speaks during a news conference on the continuing situation with COVID-19, at Downing Street on Dec. 2, 2020 in London, England.
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The U.K. has become the first country in the world to approve the COVID-19 vaccine developed by U.S. drugmaker Pfizer PFE, +3.43% and its German partner BioNTech BNTX, +5.83%, paving the way for the shot to be distributed to people who need it most within days.
The two-shot vaccine was authorized by the U.K. medicines regulator the Medicines and Healthcare products Regulatory Agency ahead of the U.S. and Europe, and will become available from next week, the government said on Wednesday. People over the age of 80, care home residents, and health and social-care workers are at the top of the priority list for the vaccine.
U.K. Prime Minister Boris Johnson said it was a “huge moment” but that an “immense logistical challenge” lay ahead. He said it would be a number of months before all the most vulnerable people are protected and urged the public to follow the new tier system, which came into force in England on Wednesday.
Large vaccination centers, in venues such as conference centers, are being set up to rollout the mass immunization program, while around 50 hospitals are also ready to administer the jab, said health secretary Matt Hancock. The vaccine would also be available from some general practitioners and pharmacies if they have cold-storage facilities.
Hancock admitted that rolling out the vaccine across the U.K. would be “challenging” because the shot requires a storage temperature of minus 94 degrees Fahrenheit. By comparison, the vaccine being developed by biotech Moderna MRNA, +1.42% needs to be stored at minus 4 degrees Fahrenheit. Pfizer said shippers can maintain the temperature for 10 days unopened, which allows for transportation to markets globally.
Read: Europeans may be waiting until next year for a COVID-19 vaccine
Shares in Pfizer rose more than 3% and BioNTech’s stock was 6% up into afternoon trading.
The U.S. Food and Drug Administration is planning to meet on Dec. 10 to review the Pfizer-BioNTech vaccine, and could authorize use of the shot soon after.
The U.K. has already secured 40 million doses of the Pfizer-BioNTech vaccine, which was shown to have an efficacy rate of 95% in people over 65 years in a Phase 3 trial, with no major safety concerns.
Around 10 million doses will be available soon, with the first 800,000 — enough to vaccinate 400,000 people — arriving in the country in the coming days.
The vaccine is one of the fastest to be developed — taking just 10 months to come to market compared with the years it typically takes — and marks a major step in fighting the pandemic that has killed more than 1.4 million people worldwide.
Read: The timeline for vaccine approval around the world, as U.K. authorizes COVID-19 shot
“The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer/BioNTech’s COVID-19 vaccine for use,” the U.K. government said in a statement. “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.”
It added that the NHS — the U.K.’s state-funded health system — “has decades of experience” in delivering large-scale vaccination programs, and will begin putting its extensive preparations into action to provide care and support to all those eligible for vaccination.
The Joint Committee on Vaccination and Immunization has published its advice on which groups of people will be eligible for the shot.
“Help is on the way”, said Hancock on Twitter TWTR, +1.32%.
He said there would be “three modes of delivery” of the vaccine. “The first is hospitals themselves, which of course we’ve got facilities like this,” he told Sky News, adding that 50 hospitals across the country are already set up and waiting to receive the vaccine.
“Also vaccination centers, which will be big centers where people can go to get vaccinated. They are being set up now,” Hancock said, adding that GP surgeries and pharmacies could also be used.
Read: Moderna asking U.S. and European regulators to authorize COVID-19 vaccine for emergency use
CMC Markets analyst Michael Hewson said: “Ultimately even if a vaccination program was to start this month, the fact that two jabs are required means that it’s likely to be several months before we start to see a possible economic benefit in terms of an easing of restrictions, given that medical staff, along with more vulnerable people are likely to be the first to benefit, with the general population at the back of the queue.”
On Sunday, the Department of Health said it had increased its order for a vaccine developed by Moderna from 5 million to 7 million doses, enough for 3.5 million people. Moderna’s experimental shot has shown to be 95% effective in Phase 3 trials.
Pfizer Chief Executive Albert Bourla said today’s emergency-use authorization in the U.K. marks a “historic moment” in the fight against COVID-19.
“This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K.,” Bourla said.
“As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world,” he added.
The Pfizer-BioNTech vaccine uses the so-called messenger RNA (mRNA) approach, which instructs cells to create proteins to generate an immune response protecting against a virus.
The U.K. has now secured access to a total of 357 million doses of vaccines from seven different developers. This includes 100 million doses of the vaccine being developed by drugmaker AstraZeneca AZN, +0.70% and the University of Oxford.
Last week, the U.K. government formally asked the MHRA to assess AstraZeneca’s experimental shot vaccine candidate, despite some experts raising questions about its trial data.
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