Necessary or not, Covid vaccine booster shots may hit the market.
 | By Alexandra Sifferlin Senior Staff Editor, Opinion |
The Covid-19 vaccines used in the United States work very well. And yet Pfizer, one of the drugmakers of the mRNA vaccines, recently announced that vaccinated people may eventually need booster shots. |
Health regulators have pushed back, arguing that it's not yet clear that boosters are needed. But as Elisabeth Rosenthal writes in an essay this week, "if recent history is predictive, booster shots will be here before long." |
That's because, as she argues, the Food and Drug Administration won't have much reason to prohibit them from the market. The boosters appear to increase antibodies against Covid-19, and are likely to be quite safe. But, Rosenthal asks, are they really necessary? |
The U.S. drug authorization system isn't adequately set up to address that question, she says. The F.D.A. has a process for determining whether drugs are safe and effective, but drugs of arguably questionable value are still authorized. |
What if the process were refined so that drugmakers also had to prove their product is significantly more effective than products already on the market? Or demonstrate cost effectiveness? |
One expert Rosenthal spoke to suggests that the United States should adopt a two-part system similar to other countries. Once a drug is determined to be safe and effective, an independent body would assess how it fits in with other treatments already available and whether its price tag makes sense. |
Because pharmaceutical manufacturing is such big business, Rosenthal argues that the F.D.A. needs to clarify what kind of effectiveness the agency demands from drug companies. And determining that bar perhaps shouldn't be up to the agency alone. |
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