- The UK approved Pfizer and BioNTech’s COVID-19 vaccine Wednesday morning, making it the first Western country to authorize a shot against the virus.
- In the US, the drugmakers will have to wait until at least December 10 for approval from the Food and Drug Administration (FDA), which is still analyzing data on the vaccine.
- Approval in the EU will likely take even longer.
- Regulators in the US and UK do things differently: The FDA asks drugmakers for raw data, which it reanalyzes itself, while British regulators rely more heavily on reports produced by the drugmakers.
- The FDA has come under fire for not approving the vaccine sooner, and news of the UK’s approval could intensify criticism.
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The UK has approved Pfizer and its German partner BioNTech’s COVID-19 vaccine — but regulators in the US are yet to make a decision on authorization.
The UK’s vaccine regulator approved the shot Wednesday morning, making it the first western country to authorize a COVID-19 vaccine. Vaccinations will start next week, the government said.
But the US, which has a different regulatory process, will have to wait until at least December 10 for approval.
Why has the UK approved Pfizer’s COVID-19 vaccine before the US?
In the US, the Food and Drug Administration (FDA) has to approve vaccines for them to be rolled out.
Pfizer, a US company, applied for an emergency use authorization (EUA) on November 20. The FDA has set a December 10 date for an independent expert panel to gather and evaluate the vaccine. The vaccine — which trials have suggested is 95% effective — could be approved the same day, and then vaccinations could begin within “a day or two”, Dr Moncef Slaoui, head of the government’s Operation Warp Speed vaccine drive, said.
The approval process involves experts reviewing “thousands of pages” of technical information, an FDA spokesperson told Axios Tuesday.
The agency also has to evaluate the manufacturing process, check statistical analyses, and look at the effect of the vaccine on groups of people with high side effect risk, the spokesperson said.
The FDA and the Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulator, have different processes to review vaccines, Dr Penny Ward, a visiting professor in pharmaceutical medicine at King’s College London, told The New York Times.
The FDA asks drugmakers for raw data, which it reanalyzes itself, while British regulators rely more heavily on reports produced by the drugmakers.
The FDA is coming under fire for not approving the vaccine sooner, and news of the UK’s approval could exacerbate this.
On Tuesday, Mark Meadows, chief of staff at the White House, asked FDA commissioner Stephen Hahn why he hasn’t moved faster to approve Pfizer’s vaccine, two senior administration officials told Axios.
“We want to move quickly because this is a national emergency, but we will make sure that our scientists take the time they need to make an appropriate decision,” Hahn told Axios.
“It is our job to get this right and make the correct decision regarding vaccine safety and efficacy.”
What does the UK’s fast approval mean about the safety of the vaccine?
Though the UK approval process has been faster, the MHRA remains confident it has fully assessed the vaccine.
Wednesday’s announcement followed “the most rigorous scientific assessment of every piece of data” to meet safety, effectiveness, and quality standards, MHRA CEO Dr June Raine said at a press conference.
“The safety of the public will always come first,” she said.
She added that the MHRA’s standards are equivalent to all international ones.
Peter Openshaw, professor of experimental medicine at Imperial College London, told the BBC that there had been “no short cut” in the regulatory processes.
The MHRA reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling, and testing of the final vaccine, the UK government said. The agency also considered the conditions for its safe supply and distribution.
The National Institute for Biological Standards and Control will continue independent laboratory testing “so that every batch of the vaccine meets the expected standards of safety and quality,” the government added.
Why has the UK approved a vaccine faster than the EU?
Across the world, authorities in other countries are still analyzing data.
Until January 1, 2021, the UK still has to follow EU rules, so vaccines in the UK would usually have to be approved by the Amsterdam-based European Medicines Agency (EMA). In the past, the agency has worked closely with UK regulator the Medicines and Healthcare Products Regulatory Agency (MHRA).
But as COVID-19 cases in the UK continued to climb, the government activated emergency powers that allow the MHRA to bypass EU regulation during a crisis. The MHRA launched an accelerated review independent from the EMA.
The EMA has said it hopes to authorize at least one vaccine by the end of the year. Pfizer said Tuesday it had asked the EU to approve its vaccine, and the EMA said its scientific committee will decide whether Pfizer’s vaccine is safe and effective enough on or before December 29.
The approval process could be slowed by Britain’s withdrawal from the EU on January 1: The MHRA often took the lead in assessing medicines and vaccines for the EMA.
Pfizer’s CEO Albert Bourla praised the UK’s authorization, and said: “We applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK.”
“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.