U.S. Health Officials: COVID-19 Booster Shots Likely to Begin Rollout for Everyone in September

A third COVID-19 shot for everyone who has been fully vaccinated with the two-shot vaccines from Pfizer-BioNTech or Moderna will begin to become available Sept. 20 because data finds that protection — at least against mild-to-moderate illness — wanes over time, according to a joint statement by U.S. health officials.

The officials emphasize that the currently authorized vaccines are “remarkably effective in reducing risk of severe disease, hospitalization, and death, even against the widely circulating Delta variant.”  Nonetheless, the vaccines’ effectiveness decreases over time. They said the booster shots will be offered beginning the week of Sept. 20.

At that time, those who were fully vaccinated earliest in the initial vaccination rollout, including many healthcare providers, nursing home residents, and other seniors, will likely be eligible for a booster, the health officials said. The booster rollout still needs a final authorization from the Food and Drug Administration (FDA), and a formal recommendation from the Centers for Disease Control and Prevention (CDC).

“The available data make very clear that protection against (COVID-19) infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease,” according to the statement signed by CDC Director Rochelle Walensky, M.D.; Janet Woodcock, M.D., acting commissioner of the FDA; White House chief medical advisor Anthony Fauci, M.D., and other U.S. health leaders.

The booster shots are recommended for everyone starting at about eight months after getting the second dose of the Pfizer or Moderna vaccines. The FDA is expected to approve Pfizer’s booster shot by next month. Authorization of the Moderna booster shot will likely follow. The CDC is also expected to officially recommend the boosters following the FDA’s clearance.

“Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout,” the U.S. health officials said.

Last week, the U.S. Food and Drug Administration (FDA) authorized such “booster shots” for those with compromised immune systems, such as organ transplant recipients and some cancer patients.

The booster shot recommendation stems from the dominance of the highly contagious Delta variant, combined with data showing that initial immunity from the vaccines diminishes over six or more months. The three currently authorized vaccines seem to offer sufficient protection against serious illness, hospitalization and death from delta and other variants, according to studies that have reviewed the effectiveness of the vaccines after six months.

The FDA has been considering whether adults who received Johnson & Johnson’s single-dose vaccine shot will also need a booster shot. Officials are anticipating results from a clinical trial that provided participants with two Johnson & Johnson doses. “We also anticipate booster shots will likely be needed for people who received the Johnson & Johnson (J&J) vaccine,” today’s joint statement said. “Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.”

Segments of the population that are most vulnerable should be part of the first wave of booster shots, federal officials said. The first booster shots should go to nursing home residents, healthcare workers and emergency workers — these groups were the first vaccinated late last year when the vaccines were initially approved.

More than 155 million people in the U.S. have been fully vaccinated with the mRNA vaccines from Pfizer-BioNTech and Moderna.