Decision expected soon on Moderna, J&J boosters

FDA and CDC advisory committees also are expected to consider administration of the Pfizer COVID-19 vaccine to children 5 through 11 in the coming weeks.

Individuals who received the Moderna or Johnson & Johnson COVID-19 vaccine could soon have more guidance on if they’ll be eligible for booster shots.

Following meetings of the U.S. Food and Drug Administration’s advisory committee, Kentucky Public Health Commissioner Dr. Steven Stack said during the governor’s COVID-19 briefing Monday that available data supports the safety and effectiveness for the Moderna booster at least six months after completion of the initial series in the following populations:

  • Ages 65 and older
  • Ages 18 to 64 at high-risk for severe COVID-19
  • Ages 18 to 64 with heightened job and institutional COVID-19 exposure risk

It was a recommendation made Thursday by the FDA’s Vaccines and Related Biological Products Advisory Committee that mirrored earlier guidance issued regarding Pfizer booster shots.

Committee recommends boosters for all J&J recipients

For people who received the one-shot Johnson & Johnson dose — which has been shown to be the least effective of all three vaccines — the committee recomended boosters after two months for everyone who’d received it.

“If you have received J&J, and once the CDC makes its review and the FDA and CDC make their outlines, next week it is anticipated that you are likely to have access to a booster,” Stack said. “If you received J&J, I would encourage you to go out and get a booster.”

The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to meet Wednesday and Thursday to make recommendations regarding boosters for recipients of both vaccines. A final recommendation from both the FDA and the CDC is expected this week.

In September, the agencies approved Pfizer vaccine boosters at least six months after primary vaccination for:

  • People 65 years and older
  • Residents in long term care settings
  • Individuals aged 50 to 64 with certain underlying health conditions
  • Individuals aged 18 to 49 who are high risk for severe COVID-19 due to certain underlying health conditions
  • Individuals aged 18-64 who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional settings

Following the guidance, Gov. Andy Beshear recommended that Kentuckians who received the Pfizer vaccine get a booster if they at high-risk of severe COVID-19 or work in high-risk settings.

A vaccine for young children

A request to amend the emergency use authorization for administration of Pfizer’s COVID-19 vaccine to children 5 through 11 will be considered on Oct. 26 by the FDA’s advisory committee and on Nov. 2-3 by the CDC’s ACIP. The panels are considering doses of 10 microgram for children — significantly smaller doses than the 30 microgram given to people 12 and older.

Stack said the state Department of Public Health is working with pharmacies and pediatric providers to ensure they are ready to vaccinate children in this age group quickly if it is approved. Kentucky’s population of those ages 5 to 11 is estimated at 388,896.

Testing underway for oral antiviral treatment

Stack also provided updates about the antiviral drug being tested by Merck. Molnupiravir is an oral antiviral that could be used to treat COVID-19 patients soon after they test positive and start displaying symptoms of the virus.

“The preliminary data that Merck provided showed, in a sample size of a little over 700 people, about a 50% reduction in those who had mild to moderate COVID from progressing to severe COVID,” Stack said. “This was an early finding in the research, but it was so compelling and statistically reliable that they decided to go forward and ask the FDA to review it for approval. That meeting will happen on Nov. 30, and the treatment could potentially be available after that. This is not a replacement for vaccination.”

If approved, availability will be limited starting in December, according to Stack.

Decision expected soon on Moderna, J&J boosters

Julia Hunter

Julia Hunter is the engagement editor for Hoptown Chronicle. Reach her at julia@hoptownchronicle.org.

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