The United Kingdom on Monday became the first country to approve a vaccine that targets new variants of the coronavirus—the second time that Britain has authorized a U.S.-made COVID vaccine before the United States.
The vaccine in question, manufactured by Moderna, targets both the original virus and the Omicron variant. It is "a sharpened tool in our armory to help protect us against this disease," June Raine, the head of Britain's Medicines and Healthcare Products Regulatory Agency, said in a statement.
It is also a key part of the Biden administration’s plan to roll out updated boosters in September. But the Food and Drug Administration has yet to approve the new shot, even as health officials warn that the United States could see as many as 100 million coronavirus cases this fall.
It’s not the first time British regulators have beaten the FDA to the punch. On December 2, 2020, the United Kingdom became the first country to authorize the original Pfizer vaccine, a head start that helped it vaccinate its population much faster than the United States. The United Kingdom also began planning its initial booster campaign in June 2021, just as the Delta variant was taking off. FDA officials, on the other hand, were insisting as late as September 2021 that boosters were unnecessary.
The contrast highlights the paradox of the U.S. pandemic response: From mRNA vaccines to antivirals, the United States has produced nearly every tool in the world’s pharmaceutical arsenal against COVID-19 but has often been slow to take full advantage of these tools, hamstrung by the bureaucratic caution that defines U.S. regulatory culture.
In early 2021, for example, the FDA insisted that doses of the coronavirus vaccine be given three weeks apart, in keeping with the terms of its emergency use authorization. That by-the-book approach strained scarce supplies and prolonged the wait for first doses, which provided significant protection on their own. By contrast, U.K. regulators delayed the second shot in order to get first doses to as many people as possible.
Political forces have exacerbated the FDA’s foot-dragging. The first version of the coronavirus vaccine was on track for approval in October 2020 until the FDA pumped the brakes, telling Pfizer and Moderna it wanted more safety data before signing off on the shots. Scientists and FDA officials were concerned that releasing the shots before the November election—as President Donald Trump had promised to do—would undermine trust in the vaccine.
The FDA didn’t approve Pfizer’s vaccine until December 11, 2020. The delay, the economist Garrett Jones estimated, may have cost more than 100,000 lives.
Published under: Coronavirus , FDA , United Kingdom , Vaccines