Policy & Regulation News

CDC Recommends Updated COVID-19 Boosters This Fall/Winter

The updated boosters, which include a monovalent compound that is effective against XBB.1.5, were approved on Monday.

The updated boosters, which include a monovalent compound that is effective against XBB.1.5, were approved on Monday.

Source: Getty Images

By Veronica Salib

- Yesterday, the United States Center for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) met to discuss updated COVID-19 booster recommendations for the 2023–2024 viral season. A release statement notes that the CDC recommends an updated booster dose for everyone over six months who has not been vaccinated in the last two months.

“We have more tools than ever to prevent the worst outcomes from COVID-19,” said Director Mandy Cohen, MD, MPH, in the CDC statement. “CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.”

This advisory comes one day after the Food and Drug Administration (FDA) made a regulatory decision to approve the updated boosters. According to the FDA press release, the regulatory changes include the following:

  • The FDA granted Pfizer Inc. approval for Comiranity, an updated version of the Pfizer–BioNTech mRNA COVID-19 vaccine, for patients 12 and older who have completed their primary vaccination series.
  • ModernaTX was given approval for Spikeax, a 2023–2024 updated version of the Moderna mRNA COVID-19 vaccines, as a single dose for all patients over 12.
  • Emergency use authorizations (EUAs) were updated for the Moderna COVID-19 vaccine, allowing a single dose for patients 6 months to 5 years old.
  • Emergency use authorizations (EUAs) were also updated for the Pfizer–BioNTech COVID-19 vaccine, allowing a single dose for patients between 6 months and 11 years old.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research (CBER), in the FDA release. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

The FDA emphasizes that these vaccines are safe and effective for the indicated age ranges, with benefit–risk assessments favoring vaccination. The administration notes that vaccine side effects may be similar to those of the original vaccination series.

In response to the CDC guidance, the Department of Health and Human Services (HHS) released a statement from Secretary Xavier Becerra saying, “Following the Biden–Harris Administration’s launch of the largest adult vaccination program in our nation’s history, COVID-19 vaccines saved millions of lives, kept countless people out of the hospital, and provided peace of mind for the country. As fall and winter approach, I encourage everyone six months and older to get an updated COVID-19 vaccine to protect themselves and their loved ones.”

The vaccines are expected to become available later this week. Public health experts and providers urge patients to get their updated COVID-19 booster if they are eligible. If they qualify, patients should also consider other vaccinations for common viral infections such as influenza and respiratory syncytial virus (RSV).