CDC, FDA gearing up for fall vaccine campaign with US in 'strongest position yet'
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(The Hill) – Federal health authorities are laying out plans for taking on this year’s respiratory viral season, with officials emboldened by the new spate of preventive medications the U.S. has gathered heading into the 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,” a CDC official said in a press call on Thursday.

They cited the high rate of COVID-19 immunity — 97 percent — among U.S. individuals 16 and older for helping the country get into a stronger position. They acknowledged, however, that immunity is not a guarantee of protection and noted the new vaccines and antibodies at hand.

Officials on Thursday reaffirmed the updated COVID-19 shots made by Pfizer, Moderna and Novavax are expected to rollout in mid-September.

The new mRNA vaccines from Pfizer and Moderna will be fully licensed vaccines for individuals 12 years of age and older, though they will be under an emergency use authorization for children 11 and younger.

Novavax’s protein-based vaccine will also be made available under an emergency use authorization, with officials saying these differences in licensing mainly have to do with when the license applications were submitted.

Officials stated the protection the vaccines provide against the now dominant EG.5 omicron subvariant is “robust” while adding it’s still too early to know their effectiveness against the recently detected BA.2.86 strain.

An FDA official stated the benefit-risk assessments of the updated shots demonstrated a “clear reduction in hospitalization and death.”

While there is no official recommendation as of yet, officials said the potential for seniors or immunocompromised people needing a second COVID-19 vaccine dose this time around has been built into the vaccination program, with one official saying an additional shot may be “reasonable” a few months after the first.

This year will also mark the first time people will have access to preventive medicines against RSV. Two RSV vaccines have been approved for adults over the age of 60, one preventive monoclonal antibody has been approved for infants and toddler and a vaccine administered to pregnant mothers so they can pass on immunity to their newborns has recently just been approved by the FDA.

The RSV monoclonal antibody Beyfortus has been added to the federal Vaccines for Children program, meaning it will be available for free to children who are uninsured, Medicaid eligible, American Indian or Alaska Native or underinsured in a plan that doesn’t cover vaccines.

Still, these medicines need to be injected into people’s arms as opposed sitting unused in storage in order to be effective. Companies including Pfizer have forecasted uncertainty over how popular their COVID-19 vaccines will be during this year’s campaign.

When pressed on getting people to take the vaccine, a CDC official said, “It’s one of our top priorities, and we’re pulling out all the stops.”

“We can’t speculate or predict where it will ultimately land, but our goal is for that number of uptake to be as high as possible,” they said.

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