A key FDA committee voted to update the current vaccination strategy against COVID-19, signaling a shift in how the U.S. will handle the virus going into the fourth year of the pandemic.
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FDA panel proposes ‘harmonizing’ doses, boosters
The vaccine advisory panel for the Food and Drug Administration (FDA) on Thursday voted to recommend matching the composition of primary COVID-19 vaccines doses and booster doses, which would make all vaccines administered consist of the updated bivalent dose.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) was asked on Thursday to consider making all COVID-19 immunizations match in composition, which in this specific case would mean phasing out the original coronavirus vaccine and only administering the bivalent shot.
All 21 voting VRBPAC members present at the meeting voted in favor of making this recommendation. While the FDA is not required to abide by the committee’s recommendations, the agency usually follows the panel’s vote.
- The bivalent mRNA shot contains components of both the original ancestral strain of SARS-CoV-2 as well as the BA.4 and BA.5 omicron subvariants. The booster was authorized for use in September.
- Under the current FDA authorization, the bivalent boosters are available to people as young as six months. The shot can be administered at least two months following a primary series vaccination or a previous monovalent booster shot.
Archana Chatterjee, VRBPAC member and dean of the Chicago Medical School, endorsed the recommendation as a way of reducing confusion people may have regarding different vaccine formulations that are currently available.
- “Speaking with colleagues, friends, family — questions I’m answering from the community. There’s so much confusion about these different formulations that I think anything we can do to ease up on that confusion and simplify things is going to be a good thing,” Chatterjee said. “Having vaccines is not sufficient. We need to have them be used.”
Watchdog knocks NIH oversight of research funds
A federal watchdog agency for the Department of Health and Human Services (HHS) says in a report released this week that the National Institutes of Health (NIH) failed to carry out sufficient oversight into research conducted using millions in federal funds, including research carried out at the Wuhan Institute of Virology, which has been aggressively scrutinized amid the coronavirus pandemic.
The Office of Inspector General (OIG) for HHS focused on the awards that were distributed through the EcoHealth Alliance, a nonprofit, nongovernmental organization dedicated to protecting wildlife and public health from emerging diseases.
The OIG looked into three NIH grants awarded to EcoHealth totaling about $8 million, which in turn were awarded to several recipients, including the Wuhan Institute of Virology.
- According to the OIG, monitoring of research was done by reviewing lab reports, performing audits and corresponding directly with the award recipients. However, it was found that EcoHealth failed to submit timely progress reports to the NIH, which in turn did not follow up with the nonprofit in a “timely” manner.
- “EcoHealth’s failure to submit a progress report in a timely manner and NIH’s failure to follow up on a missing progress report limited NIH’s ability to effectively monitor its grant award to EcoHealth and evaluate whether the special terms and conditions were met,” the OIG report read.
Top FDA safety official resigns
A top Food and Drug Administration (FDA) safety official submitted his resignation this week, citing progress on tackling the U.S. infant formula shortage while also expressing frustrations with the structure of the agency.
Frank Yiannas, the FDA’s deputy commissioner for food policy and response, joined the agency in 2018 after having previously worked for several decades in food safety for Walmart and the Walt Disney World Co. His last day with the agency is set for Feb. 24.
Delayed decision: In his resignation letter to FDA Commissioner Robert Califf, Yiannas noted he had considered leaving in February 2022 due to his concerns over the “decentralized structure of the foods program” that he and Califf found themselves working with.
Yiannas, however, said he decided to postpone his exit in light of the infant formula incidents — the presence of bacteria in powdered formula that led to at least two deaths — and subsequent shortages that were reported to the FDA around that same time.
- The FDA official wrote in his letter to Califf that improvements that have been made since the crises first started have encouraged him to leave the agency.
- “With the Abbott facility now reopened, infant formula availability more prevalent, and — very importantly — the necessary monitoring, data systems, and insights now in place through the 21 Forward platform to help address the current and any future infant formula supply chain challenges, I believe the time is right for me to leave and vacate this position,” Yiannas wrote.
FDA: NEW REGULATIONS ARE NEEDED TO MANAGE CBD RISKS
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 those products.
Janet Woodcock, the principal deputy commissioner of the FDA, said in a release that the agency conducted a review and determined that a new “regulatory pathway” is needed to balance the public’s desire to use CBD with the necessary oversight. She said the FDA is prepared to work with Congress to enact the regulations.
Potential issues: The agency said CBD use has raised some safety concerns especially for long-term users, and studies have shown that it can lead to liver damage, interactions with certain medicines and harm to the male reproductive system. Exposure to CBD can be especially “concerning” to children and those who are pregnant.
Woodcock said the existing regulations for food and dietary supplements only provide “limited tools” for managing the risks of CBD use. She said the working group she chairs has examined studies related to a CBD-based drug and published scientific literature and studies but has not found sufficient evidence to determine how much CBD can be consumed without harm being caused to a person.
SEN. ANGUS KING TESTS POSITIVE FOR COVID-19
Independent Sen. Angus King (Maine) on Thursday announced he’s tested positive for COVID-19 and will isolate during his sickness.
“An hour ago, I tested positive for COVID on a routine test on my way to the airport home to Maine. I’ve been vaccinated and boosted, so I feel alright – just sorry to not make it home this weekend,” King said on Twitter.
Repeat: This COVID-19 case is the second King has reported since the start of the pandemic, after testing positive in August 2021. At the time, he and fellow Sen. Roger Wicker (R-Miss.) were the second and third breakthrough cases — in which a fully vaccinated person catches the virus — announced in the Senate.
The senator said he’ll be isolating under the guidance of Congress’s Office of the Attending Physician.
WHAT WE'RE READING
- Drug company middlemen likely to be a focus in 118th Congress (Roll Call)
- How do heavy metals like lead get in baby food? (The New York Times)
- HHS’ Becerra on enrolling in Medicare, annual Covid vaccines, and seniors’ mental health (Stat)
STATE BY STATE
- More Californians are dying at home. Another covid ‘new normal’? (Kaiser Health News)
- Autism diagnoses rose sharply in NJ suburbs, went undercounted: Rutgers (Gothamist)
- Texas to increase salaries, starting pay at state hospitals, living centers (KVUE)
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