The U.K.’s monumental approval for Pfizer and BioNTech’s COVID-19 vaccine turned heads worldwide, but one of the leading voices in the U.S. pandemic response argues the country’s regulators acted too quickly.
“If you go quickly and you do it superficially, people are not going to want to get vaccinated,” NIAID director Anthony Fauci told Fox News. "We have the gold standard of a regulatory approach with the FDA.”
The U.K.'s Medicines and Healthcare Products Regulatory Authority (MHRA) "did not do it as carefully," he added.
By rebuking the U.K.’s review process, Fauci offered a defense to the FDA amid pressure on the agency from the Trump administration. Earlier this week, White House chief of staff Mark Meadows summoned FDA Commissioner Stephen Hahn for a meeting on why the vaccine hadn’t been approved.
After the meeting, Hahn himself defended the agency’s review process in a Wall Street Journal interview. The FDA has 150 people working in various teams around the clock on the application, he said, and it's getting ready for a public meeting next week at which independent experts will closely pore over the data.
FDA officials are expected to make a decision in the days following the Dec. 10 meeting. It’s a process that would “typically take us months,” Hahn told the newspaper, but could be complete in under a month after Pfizer’s Nov. 20 filing.
Pfizer CEO Albert Bourla has said the company aims to ship doses “within hours” of approvals, and last month wondered whether a “race to regulate” would ensue as countries vie to get their hands on the first coronavirus vaccine doses.
While Fauci may take issue with the U.K.’s process, scientists at Pfizer and BioNTech praised the country’s drug regulator following the rolling review. In a media briefing this week, Pfizer executive Ralf Rene Reinert said the regulator quickly responded to new data throughout the process, sometimes in around 10 minutes, according to the WSJ. BioNTech’s chief business and commercial officer Sean Marett added that the regulator “asked the same level of detail of questions as any agency.”
Other countries have been in touch to inquire about the U.K.’s process, Reinert also said during the briefing.
Pfizer and BioNTech plan to make around 800,000 doses available in Britain next week, The Guardian reported. The U.K. has ordered 40 million doses from the partners, or enough to vaccinate 20 million people.
In the U.S., officials have said vaccinations could start this month after Pfizer’s Dec. 10 FDA meeting and Moderna’s meeting the following week. Operation Warp Speed head Moncef Slaoui said on CNN the U.S. could reach herd immunity through vaccination by May.
Meanwhile, as the U.S. government continues prepping to change administrations, Fauci said he plans to have a "substantive" conversation with the incoming Biden team, CBS News reports.
https://www.fiercepharma.com/pharma/anthony-fauci-takes-issue-u-k-review-pfizer-biontech-covid-shot
