New FDA Guidelines: As COVID Continues to Evolve, So Should You

Two weeks ago, the Food and Drug Administration issued new rules for COVID vaccines, eliminating the earliest versions and recommending a second bivalent shot for people older than 65 and those with a weakened immune system or underlying medical condition such as diabetes.

That raises two questions: Should I get the shot? And, how can I tell if it’s working?

The original bivalent vaccine was designed to protect against COVID’s Omicron variant, the virus running rampant a year ago. But Omicron has now given way to new variants, so some–including some primary care physicians–wonder whether it’s worth a second shot. The facts in favor of being stuck twice are (1) the original protection seems to last only six months, and (2) Omicron’s still around, which means you can’t know for sure whether the person sitting next to your on the bus or subway or restaurant is hosting it.

So, the new rules are that adults age 65 and up may receive one additional dose at least four months following their initial bivalent dose. For those who are immunocompromised, the waiting period is a scant two months. Unvaccinated children and adults are also eligible; how many doses varies with age.

The second question is more complicated. Some people respond to vaccines, including those for COVID-19 and its variants, with a panoply of unpleasant experiences such as fever, chills, and days of fatigue. Others sail through with mild injection site pain and maybe a headache. Clearly something was going on in the first bodies; the second, not so much, leaving the second group to worry that they were not protected.

Rest easy, says Megan Coffee, co-author of Vaccines for Dummies. “Some folks may feel side effects after the vaccine and other folks do not. Everyone is different.” Researchers at Johns Hopkins in Baltimore agree. They measured antibody response in 954 medical worker volunteers, all of whom had received either the Pfizer or Moderna vaccine, and some of whom had previously run a round with a SARS-CoV-2 infection. The results? A mere 5 percent of the people in the study reported side effects after their first inoculation; 43 percent after the second one. The people most likely to experience problems were women, people younger than 60, and those who’s had COVID previously. But either way, 953 out of 954 volunteers showed respectable levels of antibodies two weeks after the shot. As for the one guy who ruined an almost perfect record, he was taking immunosuppressant meds.

And that, said Amanda Debes, a molecular epidemiologist at the Johns Hopkins Bloomberg School of Public Health, shows that the vaccine works “even if a person doesn’t experience symptoms after vaccination or if they had a prior infection by the virus. This should help reduce anxieties that the vaccines will be less effective in either situation.”

But as you might suspect, after nearly four years of viral mutations, that’s not the end of the COVID story. About six weeks from now, when May slides into June, a group of FDA folks and friends will meet to identify the next round of COVID variants likely waiting to make an appearance. Once they nail down the specific strains, Moderna and Pfizer are expected to update the formulae for this Fall’s vaccines.

And do the same next year.

And the year after that.

Just like the flu.