“the FDA’s approval is coming nearly two weeks after British regulators greenlighted the same vaccine, and almost a month since Pfizer/BioNTech submitted its final data for the agency to review.
Had the FDA acted more swiftly—say by bumping up the December 10 meeting it held to recommend approval of the Pfizer vaccine—Monday’s good news could have arrived a few weeks earlier. Meanwhile, the advisory committee tasked with evaluating another vaccine developed by Moderna is not set to meet until Thursday.
Given the slow rollout of these vaccines (slow, at least, when considered against the number of people needing to be vaccinated), it’s easy to think that the delay of a few days or weeks isn’t all that consequential.
Not so, says George Mason University economist Alex Tabarrok, who deploys some back-of-the-envelope math to argue that a few thousand people will die for every day the FDA dawdles in approving new vaccines.”
“It’s great to have highly effective vaccines, but as the researchers observe, “How well a vaccine program ‘works’ will also depend on how quickly it can be manufactured, how efficiently it can be distributed to locations in greatest need, how persuasive health messaging can be in promoting public acceptance, and how consistently the public can adhere to the many complementary prevention strategies (e.g., masks, hand-washing, distancing) to limit the spread of the virus.”
“The pursuit of a vaccine across federal health agencies has also forced tradeoffs. The Biomedical Advanced Research and Development Authority, for example, has halted a push for lung treatments to fight the coronavirus, potentially putting a treatment option on the back burner.
The danger of going all in on a vaccine may be that President Donald Trump is pinning hopes on a miracle shot while there’s considerable reason to believe that the outbreak could stretch on for years.
“There’s no guarantee that a vaccine is going to work,” said Luciana Borio, who served as the FDA’s acting top scientist and worked on White House pandemic preparedness efforts earlier in the Trump administration. “And even if it does, there’s no guarantee that it’ll be the right product for most people, or that people will want to take it, or that the virus won’t mutate.”
Vaccines are notoriously difficult to make; the vaccine for mumps, the fastest ever developed, took four years. Many take far longer, and more still fail in animal or human testing and never reach the market. Public health experts say the U.S. government is making a risky bet by focusing so much of its pandemic response on the hope that a shot will end the coronavirus’ devastating march.”