Coronavirus

The U.K. Approves COVID-19 Vaccine While the U.S. FDA Dawdles

It's not like we're in the middle of a pandemic or anything, right?

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PfizerVaxLutsenkoDreamstime | Oleksandr Lutsenko | Dreamstime.com
(Oleksandr Lutsenko | Dreamstime.com)

The Pfizer/BioNTech COVID-19 vaccine was approved today by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the United Kingdom. The Telegraph reports U.K. Health Secretary Matt Hancock's observation that the vaccine's approval is a "day to remember in a year to forget" and he further described the vaccine as a "victory for science." Vaccinations in Britain will likely begin next week.

Meanwhile the U.S. Food and Drug Administration (FDA) continues to dawdle while the COVID-19 pandemic accelerates. The agency's Vaccines and Related Biological Products Advisory Committee (VRBPAC) won't get around to considering the Pfizer/BioNTech request for emergency use authorization for their vaccine until Dec. 10.

What happens next if the VRBPAC reviews the data and finds that the vaccine is safe and effective? Last Wednesday, Peter Marks, the in-house official who heads up the FDA's Center for Biologics Evaluation and Research suggested that issuing emergency authorization "could be from days to weeks. It's possible it could be within days, but our goal is to make sure it's certainly within a few weeks."

How is it that the U.K.'s regulatory authorities were able to move so quickly? They reviewed the safety and efficacy results from the clinical trial as they came in on a rolling basis. However, the FDA has not taken the data for the new vaccines on a rolling basis. Pfizer/BioNTech submitted their final data for FDA review on Nov. 20.

It is probably the case that the VRBPAC meeting was scheduled for Dec. 10 because it seemed unlikely that the companies could accumulate enough data before then to submit an application for emergency use authorization. However, due to the accelerating pace of the pandemic, the data came in much faster.

So why the hell didn't the FDA reschedule the vaccine evaluation committee's meeting for at least this week, given that the data necessary for evaluation was submitted nearly two weeks ago? It's not like there's a pandemic or anything going on.

While we wait for agency action, the companies are evidently ready to ship out the vaccine the day after they receive FDA approval.