Luciana Borio and Scott Gottlieb's "Why Does the U.S. Have So Few Confirmed Coronavirus Cases?" (op-ed, Feb. 21) is far too optimistic about the prospect of a vaccine to prevent infections by the Wuhan coronavirus (officially SARS-CoV-2) in the near future. The authors write, "Once a plausible vaccine candidate is identified, the early phases of safety testing could take several weeks. But the vaccine could be ready for broader distribution soon after that as safety and efficacy tests continue." History argues otherwise.
The FDA prematurely approved a vaccine for swine flu virus almost a half-century ago, and regulators have both a long memory and an intense desire to stay out of trouble. Of the 45 million people vaccinated against the swine flu in 1976, 450 developed a serious adverse reaction. What made the situation even more unfortunate (for regulators) is that the predicted epidemic never materialized, so the vaccine wasn't needed.
Since then, the regulatory bar has been very high for approval of vaccines that would be administered to vast numbers of healthy people. For example, before approval, the first rotavirus vaccine (RotaTeq) was tested on 72,000 healthy infants, and the first human papillomavirus vaccine (Gardasil) on more than 24,000 people. Just planning and getting clinical trials of that magnitude under way would be a monumental undertaking.
Drugs to treat infected patients could likely be available relatively soon, but we should not pin our hopes on a vaccine for the foreseeable future.
Henry I. Miller, M.S., M.D.
Redwood City, Calif.