COVID-19 Vaccine Boosters May be Recommended for Most Americans

Recommendation for a COVID-19 booster for vaccinated Americans could come by Wednesday; some experts say data are too sparse to support the move.

A booster dose of COVID-19 vaccine may be recommended for most vaccinated Americans as early as this week, according to reports in The New York Times, The Washington Post and the Associated Press (AP). The recommendation for an additional dose requires the Food and Drug Administration’s (FDA) authorization, which, according to the reports, could come by September.

If authorized, administration of the booster—a third dose of the Pfizer and Moderna mRNA vaccines –d would follow by 8 months completion of the initial 2-dose series.

According to the AP the strategy is being driven by rapid spread of the more highly transmissible SARS-CoV-2 delta variant and by preliminary data that show the vaccine’s effectiveness beings to wane after several months.

The news this morning follows FDA authorization last week of mRNA booster shots for immunocompromised individuals, eg, cancer patients and organ transplant recipients.

Pfizer and BioNTech announced on Monday, August 16, submission to the FDA of initial data to support a booster dose of the companies’ mRNA vaccine. The phase 1 data “show a favorable safety profile and robust immune responses” from a third shot, the companies said in a statement. They note that those who received the third dose had higher antibody titers against the initial SARS-CoV-2 virus and against variants including Beta and Delta levels.

“Given the high levels of immune responses observed, a booster dose given within 6 to 12 months after the primary vaccination schedule may help maintain a high level of protection against COVID-19,” the companies state. They said phase 3 results are expected shortly.

In an interview with the AP, Dr William Moss of Johns Hopkins University said that more data is needed on whether “waning antibody levels lead to hospitalizations and deaths. The antibody research alone is ‘insufficient to call for booster doses for the general population.’”

Dr. Carlos del Rio, a professor at Emory University’s medical school, also speaking to the AP said: “Our hospitals are not full of people who were vaccinated six or eight months ago. Our hospitals are full of the unvaccinated.”

More than 198 million Americans have received at least one dose of a COVID-19 vaccine, or 70% of those who are eligible, according to the Centers for Disease Control and Prevention. Just under 60% of Americans 12 and older are fully vaccinated.