CDC and FDA strengthening efforts for fall vaccine campaign as US stands in ‘most powerful position yet’

Federal health authorities are unveiling their strategies for tackling this year’s respiratory viral season, fueled by the confidence they have in the new preventive medications the U.S. has acquired for the upcoming fall and winter. During a press call, a Centers for Disease Control and Prevention (CDC) official expressed optimism, stating, “We are better equipped than ever before to combat COVID-19 and the other viruses that are responsible for the majority of hospitalizations in the fall and winter, namely the flu, COVID, and RSV.”

The officials highlighted the high rate of COVID-19 immunity, which stands at 97% among individuals aged 16 and older in the U.S. They emphasized, however, that immunity is not an absolute guarantee of protection and highlighted the availability of new vaccines and antibodies.

Reaffirming their previous statements, authorities confirmed that updated COVID-19 vaccines from Pfizer, Moderna, and Novavax are scheduled to launch in mid-September. These will be fully licensed vaccines for individuals aged 12 and above, while emergency use authorization will cover children aged 11 and younger. Novavax’s protein-based vaccine will also be available under emergency use authorization, with the difference in licensing related to the timelines of the license applications.

Regarding the dominant EG.5 omicron subvariant, officials assured that the vaccines provide robust protection, but it is too early to determine their effectiveness against the recently discovered BA.2.86 strain. An FDA official stated that the updated shots have shown a clear reduction in hospitalization and death, indicating a favorable benefit-risk profile.

While no official recommendation has been given, officials suggested the possibility of seniors or immunocompromised individuals needing a second COVID-19 vaccine dose during this year’s campaign. They believe that receiving an additional shot a few months after the first might be reasonable.

Excitingly, this year will also witness the availability of preventive medicines for respiratory syncytial virus (RSV). Two RSV vaccines have been approved for adults over 60, a preventive monoclonal antibody has been approved for infants and toddlers, and the FDA has recently approved a vaccine for pregnant mothers to pass on immunity to their newborns. The RSV monoclonal antibody, Beyfortus, has been included in the federal Vaccines for Children program, ensuring free access to uninsured, Medicaid-eligible, American Indian or Alaska Native, and underinsured children.

However, it is crucial that these medicines are administered rather than being left unused in storage in order to be effective. Vaccine companies, such as Pfizer, have expressed uncertainty about the popularity of their COVID-19 vaccines during this year’s campaign.

When asked about vaccine uptake, a CDC official emphasized its importance, saying, “It is one of our top priorities, and we are making every effort to encourage it.” While the final uptake rate remains uncertain, the goal is to achieve the highest possible number of vaccinations.

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