Top government health officials immediately and emphatically announced that the booster isn’t needed right now — and held firm to that position even after Pfizer’s top scientist made his case and shared preliminary data with them last week. This has led to confusion. Should the nearly 60 percent of adult Americans who have been fully vaccinated seek out a booster or not? Is the protection that has allowed them to see loved ones and go out to dinner fading? Ultimately, the question of whether a booster is needed is unlikely to determine the F.D.A.’s decision. If recent history is predictive, booster shots will be here before long. That’s thanks to the outdated, 60-year-old basic standard that the F.D.A. uses to authorise medicines for sale: Is a new drug “safe and effective”?
The F.D.A., using that standard, will very likely have to authorise Pfizer’s booster for emergency use, as it did the company’s prior COVID-19 shot. The booster is likely to be safe — hundreds of millions have taken the earlier shots — and Pfizer reported that it dramatically increases a vaccinated person’s antibodies against SARS-CoV-2. From that perspective, it may also be considered very effective. But does that kind of efficacy matter? Is a higher level of antibodies needed to protect vaccinated Americans? Though antibody levels may wane some over time, the current vaccines deliver perfectly good immunity so far.
What if a booster is safe and effective in one sense but simply not needed — at least for now? Reliance on the simple “safe and effective” standard — which certainly sounds reasonable — is a relic of a time when there were far fewer and simpler medicines available to treat diseases and before pharmaceutical manufacturing became one of the world’s biggest businesses.
The F.D.A.’s 1938 landmark legislation focused primarily on safety after more than 100 Americans died from a raspberry-flavored liquid form of an early antibiotic because one of its ingredients was used as antifreeze. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act set out more specific requirements for drug approval: Companies must scientifically prove a drug’s effectiveness through “adequate and well-controlled studies.”
In today’s pharmaceutical universe, a simple “safe and effective” determination is not always an adequate bar, and it can be manipulated to sell drugs of questionable value. There’s also big money involved: Pfizer is already projecting $26 billion in COVID-19 revenue this year.
The US’ continued use of this standard to let drugs into the market has led to the approval of expensive, not necessarily very effective drugs. In 2014, for example, the F.D.A. approved a toenail fungus drug that can cost up to $1,500 a month and that studies showed cured fewer than 10 percent of patients after a year of treatment. That’s more effective than doing nothing but less effective and more costly than a number of other treatments for this bothersome malady.
It has also led to a plethora of high-priced drugs to treat diseases like cancers, multiple sclerosis and Type 2 diabetes that are all more effective than a placebo but have often not been tested very much against one another to determine which are most effective. In today’s complex world, clarification is needed to determine just what kind of effectiveness the F.D.A. should demand. And should that be the job of the F.D.A. alone? Until the US refines the F.D.A.’s “safe and effective” standard or adds a second layer of vetting, when new products hit the market and manufacturers promote them, Americans will be left to decipher whose version of effective and necessary matters to them.
Dr. Rosenthal is the editor in chief of Kaiser Health News
The New York Times