FDA Approves and Authorizes Updated COVID-19 Vaccines

COVID-19 shot

(Adobe Stock FILE #: 327257834 by Leigh Prather)

The FDA has granted emergency use approval for the updated COVID-19 vaccines on Monday, September 11, 2023. These vaccines are designed to match the current variants of the virus closely. While they do not prevent infection, they offer improved protection against severe illness, hospitalization, and death.

According to the FDA's news release, these monovalent vaccines are those by ModernTX, Inc, and Pfizer, Inc, for the 2023-2024 fall-winter season. This covers Comirnaty, Spikevax, Moderna, and Pfizer-BioNTech COVID-19 Vaccines.

People aged 5 and older, regardless of their prior vaccination status, can receive a single dose of the updated COVID-19 vaccines if at least 2 months have passed since their last COVID-19 vaccine dose.

For individuals aged 6 months to 4 years who have previously received a COVID-19 vaccine, eligibility includes 1 or 2 doses of any updated COVID-19 vaccine, depending on the timing of their prior COVID-19 vaccination.

Unvaccinated individuals aged 6 months to 4 years can receive either 3 doses of the authorized updated Pfizer-BioNTech COVID-19 vaccine or 2 doses of the approved updated Moderna COVID-19 vaccine.

Both vaccine producers have verified the efficacy of their vaccines against the prevalent EG.5 strain in the United States. The enhanced vaccines have been tailored to combat various sublineages associated with Omicron XBB, effectively addressing most COVID-19 cases worldwide.

Infection Control Today^® spoke with Deborah Birx, MD, about the upcoming COVID-19 season and who should get the vaccine. Birx is a world-renowned medical expert and leader whose long career has focused on clinical and basic immunology, infectious disease, pandemic preparedness, vaccine research, and global health.

“Who should get immunized? People who are at risk for severe disease, hospitalization, and death," Birx said. "Going forward, we need to communicate that the protection against infection is so short-lived with our current COVID-19 vaccines that it is an individual decision to understand whether [or not] they are susceptible [to] the severe disease, that sometimes even just weeks or a few months’ protection against infection is relevant in their lives. Is that a risk-benefit ratio that they're willing to take? Because I think it's naive for us ever to say that vaccines have no side effects. We are still mapping the side effects of this [technology]. Messenger RNA vaccine is extraordinarily safe. But that doesn't answer the question, 'Will I personally benefit?' And I think what has not been effectively communicated about the COVID-19 vaccine is precisely what groups could benefit.”

On Tuesday, September 12, 2023, after receiving the FDA's approval, the CDC’s Advisory Committee on Immunization Practices will assess the “clinical recommendations” of the updated vaccines. Once the CDC director approves their recommendations, these vaccines can be administered, potentially making them available within days at select locations. However, the press release states, “Manufacturers have publicly announced that the updated vaccines would be ready this fall, and the FDA anticipates that the updated vaccines will be available in the near future.”

For those without insurance or with insufficient coverage, it is possible to obtain the latest COVID-19 vaccine at no cost through the CDC's Bridge Access Program. This program, which allows for the procurement and distribution of vaccines, is a temporary government initiative. It is essential to keep in mind that this program is set to conclude in December 2024.

Other health officials strongly urge people to get vaccinated against COVID-19, given the recent rise in hospitalizations and concerns about the impact of COVID-19, influenza, and respiratory syncytial virus during the upcoming fall and winter season.