Healthcare – FDA committee votes to change vaccine strategy

A key US Food and Drug Administration (FDA) committee has voted to update the current COVID-19 vaccination strategy, marking a shift in how the US deals with the virus in the fourth year of the pandemic.

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The Food and Drug Administration (FDA) committee suggests “harmonizing” doses and boosters

The Food and Drug Administration (FDA)’s Vaccine Advisory Committee voted Thursday to recommend matching the dose composition of primary COVID-19 vaccines and booster doses, which would make all administered vaccines consist of the updated bivalent dose.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday was asked to consider making all COVID-19 vaccines identical in formulation, which in this particular case means phasing out the original coronavirus vaccine and giving only the bivalent shot.

All 21 VRBPAC members who attended the meeting voted in favor of making this recommendation. While the Food and Drug Administration is not required to abide by the committee’s recommendations, the agency usually follows the committee’s vote.

  • The bivalent mRNA injection contains components of both the original progenitor strain of SARS-CoV-2 as well as the Omicron variants BA.4 and BA.5. The booster was approved for use in September.
  • Under current FDA authorization, bivalent boosters are available to people as young as six months old. The injection may be given at least two months after the initial vaccination series or a previous monovalent booster injection.

Archana Chatterjee, a VRBPAC member and dean of the Chicago Medical College, endorsed the recommendation as a way to reduce confusion people may have regarding the different vaccine formulations currently available.

  • “Talking with colleagues, friends, family — questions I answer from the community. There is so much confusion around these different formulations that I think anything we can do to mitigate that confusion and keep things simple would be a good thing,” Chatterjee said. not enough. We need to use it.”

Read more here.

Oversight agency cracks down on NIH oversight of research funds

A federal oversight agency affiliated with the Department of Health and Human Services (HHS) said in a report released this week that the National Institutes of Health (NIH) failed to adequately oversight research conducted using millions in federal funds, including research conducted at the Wuhan Institute of Virology. , which has been heavily scrutinized amid the coronavirus pandemic.

HHS’s Office of Inspector General (OIG) focused on awards handed out through the EcoHealth Alliance, a nonprofit, nongovernmental organization dedicated to protecting wildlife and public health from emerging diseases.

OIG considered three NIH grants awarded to EcoHealth totaling about $8 million, which were in turn awarded to several recipients, including the Wuhan Institute of Virology.

  • According to the Office of the Inspector General, oversight of the research was conducted by reviewing lab reports, conducting audits, and corresponding directly with award winners. However, it was found that EcoHealth failed to provide timely progress reports to the National Institutes of Health, which in turn did not follow up with the nonprofit in a “timely” manner.
  • “EcoHealth’s failure to provide a timely progress report and the failure of the NIH to follow up on a missing progress report has limited the NIH’s ability to effectively monitor its award to EcoHealth and evaluate whether special terms and conditions have been met,” the OIG report states. .

Read more here.

The Food and Drug Administration’s chief safety officer resigns

A senior FDA safety official tendered his resignation this week, citing progress in addressing an infant formula shortage in the United States while also expressing frustration with the agency’s structure.

Frank Yanas, the FDA’s deputy commissioner for food policy and response, joined the agency in 2018 after previously working for several decades in food safety for Wal-Mart and Walt Disney World, and his final day with the agency is scheduled for February 24.

Deferred decision: In his resignation letter to Robert Calif, the FDA’s commissioner, Yanas indicated that he considered leaving in February 2022 due to his concerns about the “decentralized structure of the Food Program” that he and Calef found himself working with.

However, Yanas said he decided to delay its release in light of the infant formula incidents — the presence of bacteria in the powdered formula that led to the deaths of at least two people — and subsequent shortages that were reported to the FDA around the same time.

  • The FDA official wrote in his letter to Calif that the improvements made since the beginning of the crises had encouraged him to leave the agency.
  • “With the Abbott facility now reopened, the availability of infant formula more widespread and – more importantly – the necessary monitoring, data systems and insights now in place through the 21 Forward platform to help address current and future infant formula supply chain challenges, I believe the time is right for me to step out and vacate this post,” Yanas wrote.

Read more here.

Food and Drug Administration: New regulations are needed to manage the risks of CBD

The Food and Drug Administration (FDA) on Thursday called for new regulations for the cannabidiol (CBD) market, saying the agency needs to provide additional oversight to manage the risks involved in using these products.

Janet Woodcock, principal deputy commissioner of the Food and Drug Administration, he said in a statement That the agency conducted a review and determined that a new “regulatory path” was needed to balance the public’s desire to use CBD with the necessary oversight. She said the FDA is ready to work with Congress to enact regulations.

Possible problems: The agency said CBD use has raised some safety concerns especially for long-term users, and studies have shown it can damage the liver, interact with certain medications, and harm the male reproductive system. CBD exposure can be particularly “worrying” for children and pregnant women.

Woodcock said current regulations for food and dietary supplements provide only “limited tools” to manage the risks of CBD use. She said the working group she chairs has examined studies on the CBD-based drug and published scientific literature and studies but has found insufficient evidence to determine how much CBD can be consumed without causing harm to a person.

Read more here.

o. Angus King tests positive for COVID-19

Independent Sen. Angus King (Maine) announced Thursday that he has tested positive for COVID-19 and will isolate while he is ill.

“An hour ago, I tested positive for COVID on a routine test on the way home at the airport in Maine. I’ve been vaccinated and boosted, so I feel fine — just sorry not to be home this weekend,” King. he said on Twitter.

Repeat: This COVID-19 case is the second reported by King since the start of the pandemic, after positive test in August 2021. At the time, he and fellow Sen. Roger Wicker (R-Missouri) were the second and third detected cases — in which a fully vaccinated person picks up the virus — announced in the Senate.

The senator said he would be sequestered under the supervision of the congressional office of the attending physician.

Read more here.

what we read

  • Pharmaceutical intermediaries are likely to be a focus at Congress 118 (Roll Call)
  • How do heavy metals like lead get into baby food? (New York times)
  • HHS’ Becerra on Medicare Enrollment, Annual Covid Vaccinations, and Older Mental Health (stat)

State by state

  • More Californians are dying at home. Another Covid ‘new normal’? (Kaiser Health News)
  • Autism diagnoses rose sharply in suburban New Jersey, and it didn’t count: Rutgers (Gothamist)
  • Texas will increase salaries and start paying at state hospitals and living centers (KVUE)

That’s it for today, thanks for reading. Check out The Hill’s Health care page For the latest news and coverage. see you tomorrow.

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