A key FDA committee has voted to review the current vaccine strategy against COVID-19, marking a change in how the US will deal with the virus as it enters its fourth year.
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FDA panel suggests ‘synchronizing’ doses, boosters
The Food and Drug Administration’s (FDA) vaccine advisory panel on Thursday voted to recommend matching the composition of the primary vaccine for COVID-19 and booster doses, which would make all vaccines offered include the updated bivalent dose.
The Vaccines and Related Products Advisory Committee (VRBPAC) was asked on Thursday to consider making all COVID-19 vaccines the same, which would mean scrapping the first coronavirus vaccine and giving it a bad shot.
All twenty-one VRBPAC members present at the meeting voted to make this recommendation. Although the FDA is not required to comply with the committee’s recommendations, the agency usually follows the panel’s vote.
- The bivalent mRNA fragment contains components of both the original SARS-CoV-2 progenitor strain and the BA.4 and BA.5 omicron subvariants. The booster is approved for use in September.
- Under current FDA approval, bivalent boosters are available for people as young as six months. The shot can be given at least two months following the main series vaccination or the previous monovalent booster shot.
Archana Chatterjee, VRBPAC member and dean of the Chicago Medical School, endorsed the recommendation as a way to reduce confusion people may have about the various vaccines currently available.
- “I talk to colleagues, friends, family — questions I answer in the community. There is so much confusion about these different episodes that I think anything we can do to help clear that confusion and make things easier will be a good thing,” said Chatterjee. “Having vaccines is not enough. We need them to be used.”
Read more here.
Watchdog slams NIH for oversight of research funds
The 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) has failed to conduct adequate research using millions of federal funds, including research conducted. at the Wuhan Institute of Virology, which is under heavy scrutiny during the coronavirus pandemic.
The Office of Inspector General (OIG) of HHS focused on awards distributed through the EcoHealth Alliance, a non-profit, non-governmental organization dedicated to protecting wildlife and public health from emerging diseases.
The OIG looked into three NIH grants awarded to EcoHealth totaling approximately $8 million, which were awarded to several recipients, including the Wuhan Institute of Virology.
- According to the OIG, research monitoring is done by reviewing lab reports, conducting audits and corresponding directly with award recipients. However, it was found that EcoHealth failed to submit timely progress reports to the NIH, which also did not follow up with the nonprofit in a “timely” manner.
- “EcoHealth’s failure to submit a timely progress report and NIH’s failure to follow up on the missing progress report limited NIH’s ability to effectively monitor its grant award to EcoHealth and assess whether specific terms and conditions were met,” the OIG report read. .
Read more here.
FDA’s top safety official resigns
The Food and Drug Administration’s (FDA) chief safety officer submitted a letter of resignation this week, citing progress in addressing infant formula shortages in the US while expressing frustration with the agency’s structure.
Frank Yiannas, the FDA’s deputy commissioner for food policy and response, joined the agency in 2018 after working for several decades in food safety for Walmart and Walt Disney World Co. His last day with the organization is scheduled for Feb. 24.
Delayed decision: In his resignation letter to FDA Commissioner Robert Califf, Yiannas noted that he had considered leaving in February 2022 because of his concerns about the “distributed structure of the food system” that he and Califf found themselves working with.
Yiannas, however, said he decided to postpone his exit because of the infant formula incidents — the presence of bacteria in powdered formula that led to at least two deaths — and the subsequent shortages that were reported to the FDA at the same time.
- The FDA official wrote in his letter to Califf that the progress made since the unrest began encouraged him to leave the agency.
- “With the Abbott facility reopened, the availability of infant formula has increased dramatically, and – most importantly – the necessary monitoring, data systems, and insights are now available through the 21 Forward platform to help address current and any future challenges to the infant formula supply chain, I believe it is time for me to leave this position,” Yiannas wrote.
Read more here.
FDA: NEW REGULATIONS NEEDED TO CONTROL CBD RISKS
The Food and Drug Administration (FDA) on Thursday requested new regulations for the cannabidiol (CBD) market, saying that the agency needs to provide more precautions to manage the risks involved in using those products.
Janet Woodcock, the FDA’s deputy commissioner, said in a statement that the agency had conducted a review and determined that a new “regulatory approach” was needed to balance the public’s desire to use CBD with the necessary oversight. He said the FDA is willing to work with Congress to develop regulations.
Possible problems: The agency said the use of CBD has raised some safety concerns especially for long-term users, and studies have shown it can lead to liver damage, interactions with certain medications and harm to the male reproductive system. Exposure to CBD can “affect” especially children and those who are pregnant.
Woodcock said existing food and supplement laws provide only “limited tools” to manage the risks of CBD use. He said that the working group he leads has examined the studies related to CBD medicine and published books and scientific studies but did not find enough evidence to determine how much CBD can be consumed without harm to a person.
Read more here.
SEN. ANGUS KING IS TESTING FOR COVID-19
Sen. Independent Rep. Angus King (Maine) announced Thursday that he has tested positive for COVID-19 and will self-isolate during his illness.
“An hour ago, I tested positive for COVID in a routine test when I went to the airport to go to Maine. “I’ve been immunized and boosted, so I’m fine – sorry I’m not coming home this weekend,” King said on Twitter.
Repeat: This case of COVID-19 is the second King reported since the beginning of the epidemic, after he was diagnosed with it in August 2021. At that time, he and his colleague Sen. Roger Wicker (R-Miss.) were the second and third cases of success – in which a fully vaccinated person catches the virus – announced in the Senate.
The senator said he will remain in isolation under the guidance of the Congressional Office of the Attending Physician.
Read more here.
WHAT WE STUDY
- Drug dealers likely to be targeted in 118th Congress (Roll Call)
- How do heavy metals like lead get into children’s food? (The New York Times)
- HHS’ Becerra on Medicare enrollment, annual Covid vaccines, and seniors’ mental health (Stat)
STATE BY NATION
- Most Californians die at home. Another covid ‘new normal’? (Kaiser Health News)
- Autism diagnoses spike in NJ suburbs, undercounted: Rutgers (Gothamist)
- Texas to raise wages, start paying public hospitals, residential facilities (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.
