Vaccines must be held to standard

Dear Dr. Roach: I read recently that a coronavirus vaccine is scheduled for release in late October or early November in the very early stages of clinical trials. Although the manufacturer has offered assurances that the vaccine is safe, this seems awfully early.

I am 77 years old and reasonably healthy, but my age puts me in the higher risk category for contracting COVID-19. Would you recommend I get this vaccine as soon as it becomes available? — P.L.

I understand the desire for a vaccine quickly. An effective vaccine could dramatically change the course of the pandemic, saving lives and allowing people to return to work sooner.

However, treatments that prevent disease must be held to the highest standards of safety. I recall the 1976 swine flu vaccine, which was associated with Guillain-Barre syndrome, although there remains controversy still about whether the swine flu vaccine really caused it or if it was a statistical fluke. I still have patients who refuse the flu vaccine due to that single event and the perception that it was a rushed and inadequate vaccine.

For me to recommend a vaccine, it must have undergone extensive evaluation, showing that its benefit far outweighs its risk. This requires a large number of volunteers and a significant follow-up period to identify any potential adverse effects. I have consistently advised taking the currently recommended vaccines because of that thorough evaluation prior to approval and because of continued monitoring after release.

I am unaware of any vaccine that has the kind of record that would allow me to take or recommend it outside a clinical trial. While it is possible that such evidence will become available in the future, as of this writing I cannot recommend a coronavirus vaccine.