The U.K. has approved the COVID-19 vaccine from Pfizer and BioNTech for emergency use, paving the way for vaccinations to begin weeks ahead of most of the world.The approval by U.K. medical regulators comes as their counterparts in the U.S., European Union, and other countries around the world prepare to deliver their own verdict on promising COVID-19 vaccines.
The vaccine from U.S. drugmaker Pfizer
and its German partner BioNTech
is scheduled for formal assessment in the U.S. and EU within the next month, while in the U.K. vaccinations with the two-shot jab will begin for priority populations across the country next week. Of the 40 million doses of the Pfizer-BioNTech vaccine that the U.K. has ordered, 800,000 — enough to vaccinate 400,000 people — will arrive in the U.K. in the coming days, with a total of around 10 million doses available soon. The first jabs will be targeted toward health-care workers, care home residents, the elderly, and the clinically extremely vulnerable. The U.K.’s Medicines and Healthcare products Regulatory Agency is the first regulator to approve a vaccine based on large-scale clinical trials for the coronavirus that causes COVID-19, and it may approve others soon. Read more: Pfizer-BioNTech COVID-19 vaccine wins approval in first country as U.K. prepares for rollout next week The government formally asked the MHRA last week to review the vaccine in development from British-Swedish drugmaker AstraZeneca
and the University of Oxford, while the vaccine from U.S. biotech Moderna
has also yet to be approved. When is regulatory approval likely to happen in other countries? The U.S. The U.S. Food and Drug Administration is set to meet on Dec. 10 to discuss whether the Pfizer-BioNTech vaccine should be authorized for use. On Monday, Moderna asked the FDA for emergency approval of its vaccine candidate. It is likely that any vaccine in the U.S. would be made available first to high-risk health-care workers as well as residents and staff of care homes, after an advisory panel to the Centers for Disease Control and Prevention voted to recommend that strategy on Tuesday. Top U.S. health officials have said that the first Americans would receive vaccinations against COVID-19 within two days of regulatory approval. According to media reports, President Donald Trump and his advisers have pushed FDA officials to move faster on authorization, in part because the administration feels like it is being outpaced by European countries. European Union The European Medicines Agency, the bloc’s regulator, said that its formal assessment of the Pfizer-BioNtech vaccine would come by Dec. 29, while the assessment for Moderna’s vaccine will happen by Jan. 12. These due dates represent a delay from the EU’s initial timeline, according to a report from the Financial Times, which said the bloc was supposed to assess both vaccines on Dec. 22. More: Europeans may be waiting until next year for COVID-19 vaccine, as EU regulators fall behind U.S. and U.K. Pfizer and BioNTech submitted their final application to the EU’s health authorities on Tuesday. The 27 member countries of the bloc will have to individually approve any vaccine after the EMA’s ruling, increasing the delay between approval and rollout. A wait of four to six weeks for an assessment means that countries like France, Germany, Spain, and Italy likely won’t begin vaccinations until the beginning of January, at the earliest. Australia, Canada, and New Zealand Australia’s health minister, Greg Hunt, welcomed the U.K.’s approval of the Pfizer-BioNTech vaccine on Wednesday, saying that it was “an important step for the world.” Hunt reiterated his government’s advice that the timeline for a decision on approval is expected by the end of January, with the first vaccines planned to be delivered in March. Australia has signed a deal for 10 million doses of the Pfizer-BioNTech vaccine. In Canada, Prime Minister Justin Trudeau said on Tuesday that independent scientists were reviewing the clinical trial data from four promising vaccine candidates, but didn’t provide a clear timeline for Health Canada’s regulatory approval. Health Canada’s chief medical adviser said last month that approval could come at some point in December. A minister in charge of procurement, Anita Anand, said on Tuesday that the government is planning for the first vaccines to come in the first quarter of 2021. Details of the timeline for vaccine approval and rollout in New Zealand are expected later this month. The country’s prime minister, Jacinda Ardern, said earlier this week that she expects the first vaccinations in the country to happen around March. Mexico Mexico’s foreign minister, Marcelo Ebrard, said on Tuesday that the first jabs of a COVID-19 vaccine could be given out in mid December, pending approval from Cofepris, the country’s health regulator. Pfizer and BioNTech were scheduled to submit details on their vaccine to the regulator by Wednesday. Ebrard said that, should this first vaccine be approved, it would be about five days before the first shipment arrived in Mexico. Read: Here are 5 things to know about BioNTech and the married couple behind the COVID-19 vaccine with Pfizer