The UK has started vaccinating against COVID-19, but the US is still waiting. Here's why.
- The UK began rolling out Pfizer and BioNTech's COVID-19 vaccine Tuesday morning, making it the first Western country to vaccinate against the virus.
- In the US, the drugmakers will have to wait until at least Thursday for emergency authorization from the Food and Drug Administration, which is still analyzing data on the vaccine.
- Approval in the European Union will most likely take even longer.
- Regulators in the US and the 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 the UK's vaccination program could intensify criticism.
The UK has begun administering Pfizer and BioNTech's COVID-19 vaccine - but regulators in the US are yet to make a decision on whether to authorize the shot.
A 90-year-old British grandmother became the first person in the West to receive a COVID-19 vaccine outside clinical trials on Tuesday, after the UK's vaccine regulator approved the shot on December 2.
But the US, which has a different regulatory process, will have to wait until at least Thursday for emergency authorization.
Why has the UK rolled out 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 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 authorized the same day, and then vaccinations could begin as early as Friday, according to James Hildreth, an FDA vaccines advisor.
The regulatory process involves experts reviewing "thousands of pages" of technical information, an FDA representative told Axios.
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 risk of side effects, the representative 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, 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.
Two senior officials in the Trump administration told Axios that the White House chief of staff, Mark Meadows, asked FDA Commissioner Stephen Hahn why Hahn hadn't moved faster to clear Pfizer's vaccine for use.
"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 UK regulator remains confident it has fully assessed the vaccine.
Its approval followed "the most rigorous scientific assessment of every piece of data" to meet safety, effectiveness, and quality standards, MHRA CEO June Raine said at a press conference on December 2.
"The safety of the public will always come first," she said.
She added that the MHRA's standards were equivalent to all international ones.
Peter Openshaw, a professor of experimental medicine at Imperial College London, told the BBC that there had been "no shortcut" in the regulatory processes.
The MHRA reviewed data from the laboratory preclinical 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, and got a critical assessment from the government's independent advisory body, the Commission on Human Medicines, too.
Now that the vaccine has been approved, the MHRA will continue monitoring its safety to ensure the benefits in protecting people outweigh any side effects or potential risks.
The National Institute for Biological Standards and Control, which is a branch of the MHRA, will also continue the independent batch testing it started in November. This ensures that every batch of the vaccine meets of safety and quality standards.
But EU lawmakers spoke out against the approval, calling it "hasty" and "problematic."
"The idea is not to be first but to have a safe and effective vaccine," Germany's Health Minister Jens Spahn said.
Dr. Anthony Fauci, the top infectious-disease expert in the US, also criticized the decision. UK regulators hadn't scrutinized the Pfizer trial data as "carefully" as the FDA, he said, and the quick approval could reduce public confidence in the shot. But later that day he apologized for his comments, saying he has "great faith in both the scientific community and regulatory community in the UK."
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, the UK still has to follow European Union 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 the MHRA.
But as COVID-19 cases in the UK continued to climb, the government activated emergency powers which allows it to bypass EU regulation during a crisis. The MHRA launched an accelerated review independent from the EMA.
The format of this was a "rolling review," where data is reviewed as it becomes available from ongoing studies, rather than waiting for it to be submitted as a full package. This has been "key" to the vaccine's speedy approval, MHRA CEO June Raine said.
The EMA said its longer approval procedure was "the most effective regulatory mechanism," as it was based on more evidence than the emergency procedure chosen by Britain.
The EMA has said it hopes to authorize at least one vaccine by the end of the year. Pfizer said it had asked the EU to approve its vaccine, and the EMA said its scientific committee would decide whether Pfizer's vaccine was 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 CEO Albert Bourla praised the UK's approval.
"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 said.