Breaking: UK first country to approve clinically-tested COVID-19 vaccine; where's the FDA?

“It’s the beginning of the end of the pandemic,” says the inventor of the Pfizer vaccine. The months-long race to find a way to immunize the world has reached its finish line, and the United Kingdom gets to break the tape. Brits will start queuing up next week for vaccinations after Pfizer got emergency-use approval from the government:

The UK has become the first country in the world to approve the Pfizer/BioNTech coronavirus vaccine, paving the way for mass vaccination.

Britain’s medicines regulator, the MHRA, says the jab, which offers up to 95% protection against Covid-19 illness, is safe to be rolled out.

The first 800,000 doses will be available in the UK from next week, Health Secretary Matt Hancock said.

Boris Johnson offered his thanks in Parliament, noting that this will finally begin the process of getting back to normal. It capped off a series of happy announcements from government officials, who both cheered the vaccine and exhorted the public to trust the science behind its development and the approval process:

Health Secretary Matt Hancock announced the approval, noting that he was “very proud that the UK is the first place in the world to have a clinically authorised vaccine.” That distinction addresses earlier efforts to rush not-fully-tested vaccine candidates into mass distribution, primarily in Russia and China. Not much has been known about the performance of those compounds yet. So far they do not appear to be on the radar screens of any Western nations, which might indicate that their effectiveness could be suspect — or just that those nations don’t plan on going through a normal trial process in the future.

That shouldn’t be a problem, given that we have two vaccines at the ready (Pfizer and Moderna), one nearly so (AstraZeneca), and another getting closer (Johnson & Johnson). With the buy-in of governments in the West, hundreds of millions and perhaps billions of doses will get produced and distributed over the next few months. The finish line isn’t as important as the race itself; everyone wins.

That doesn’t mean it’s entirely unimportant, though. Americans had assumed we’d break the tape, and one American in particular wants to know why we finished with the silver medal … or worse:

A president who preached “America First” is demanding to know why the United States could end up third, or worse, in the global vaccine race.

President Donald Trump and his deputies are privately admonishing Food and Drug Administration officials for not moving faster to authorize promising coronavirus vaccines — a push partially motivated by Trump’s desire to claim credit for record-fast vaccine development, four officials said.

HHS Secretary Alex Azar and White House Chief of Staff Mark Meadows grilled Commissioner Stephen Hahn and other top FDA officials in meetings this week on their decisions to require more rigorous review of initial data from the first vaccine candidates. In particular, they questioned why the agency won’t authorize a vaccine until after Dec. 10 at the earliest — about a month after Pfizer first reported that its shot was more than 90 percent effective, and roughly three weeks after Moderna announced similarly impressive findings. Multiple Trump appointees and even some career civil servants have argued that every day of delay could make a difference for the most vulnerable populations in a life-threatening pandemic.

Before anyone climbs all over Trump for politicizing the process — which he’s done — the UK’s approval today makes these questions pertinent. Unless someone can point to a deficiency in British scientific review, one does have to wonder why we have to wait eight more days for an FDA meeting to act on an emergency-use application. Did the FDA get the data from Pfizer eight days later? That seems unlikely, given how much incentive Pfizer had to get ahead of Moderna in its own race to produce the first approved vaccine.

It’s a question worth asking, and more to this than jingoistic pride. Critics have long complained about the FDA’s inefficiency and clumsy processes, and it looks like those might have cost us a couple of weeks of vaccinations, right as community spread is filling hospitals to the breaking point. This is more than an emergency — it’s a global disaster. Did the FDA respond to it properly, or did it stumble over its own bureaucracy in the home stretch?