Vaccine Syringes and Vials

CDC and FDA Preparing for Fall Vaccine Campaign

Federal health authorities are getting ready to face this year’s respiratory virus season, strengthened by the range of preventive medications available in the U.S. as we head into fall and winter.

“We are in our strongest position yet to be able to fight COVID-19 as well as the other viruses that are responsible for the majority of fall and winter hospitalizations, namely flu, COVID as well as RSV,” stated a CDC official during a press call on Thursday.

Pointing to the high rate of COVID-19 immunity — 97 percent — among U.S. individuals aged 16 and older, officials expressed confidence about the country’s readiness. Nevertheless, they highlighted that immunity does not guarantee protection and drew attention to the new vaccines and antibodies at disposal.

Officials confirmed that updated COVID-19 shots made by Pfizer, Moderna, and Novavax are set to roll out in mid-September. The Pfizer and Moderna mRNA vaccines will be fully licensed for individuals 12 years of age and older, while they will be under an emergency use authorization for children 11 and younger.

The Novavax protein-based vaccine will also be available under an emergency use authorization, with officials explaining the licensing differences primarily relate to when the license applications were submitted.

Officials cited “robust” protection provided by the vaccines against the dominant EG.5 omicron subvariant, though they noted it’s too early to determine their effectiveness against the recently detected BA.2.86 strain.

An FDA official confirmed that the updated shots showed a “clear reduction in hospitalization and death” in benefit-risk assessments.

Additionally, the vaccination program has provisioned for seniors or immunocompromised individuals potentially requiring a second COVID-19 vaccine dose a few months after the first one.

For the first time, people will also have access to preventive medicines against RSV. Two RSV vaccines have been approved for adults over the age of 60, a preventive monoclonal antibody has been approved for infants and toddlers, and a vaccine meant for pregnant mothers to pass on immunity to their newborns has recently been approved by the FDA.

However, the success of this campaign relies on these vaccines being administered rather than sitting unused. When questioned about vaccine uptake, a CDC official stated, “It’s one of our top priorities, and we’re pulling out all the stops.” They further expressed the goal for vaccine uptake to be as high as possible.