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We hope you had a restful Memorial Day weekend. Today, we recap last week’s big vaccine news, what RFK Jr. said on Capitol Hill, and the release of the MAHA report. (776 words, 3 minutes, 52 seconds) |
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FDA framework changes standard for approval, use for COVID vaccines
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The Food and Drug Administration (FDA) announced plans to require placebo studies to test updated COVID-19 vaccines for people who are under 65 and not immunocompromised.
The rule: Updated COVID vaccines could be approved for those who are over 65 or immunocompromised based on lab tests, as before. But vaccines would not be recommended for others without trials that give some participants placebos. Proof of effectiveness would be lower numbers of COVID infections.
Why it matters: Experts say it’s unethical to give trial participants a placebo and expose them to infection when COVID-19 vaccines are already proven safe and effective. Changes to match the current variant can be tested in the lab.
What’s ahead: FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that vaccines being formulated for release this fall target the JN.1 variant—the same variant targeted last year.
The big question: Whether VRBPAC’s recommendation to use existing, approved vaccine formulas would mean current vaccines are still approved for all ages and conditions. The FDA and CDC consider VRBPAC’s recommendations when setting vaccine policy.
What they’re saying: “For many diseases, scientists already know how to measure if the vaccine is giving the immune system the information it needs to fight the disease, and there is no need to use a placebo injection,” said Northwestern University’s Prof. Seema Shah. “If we have vaccines or treatments that work, it’s wrong to give some research participants nothing.” |
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Lawmakers question Kennedy on vaccines, biosecurity, and NIH cuts |
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During congressional hearings on the Health and Human Services (HHS) budget, lawmakers asked HHS Secretary Robert F. Kennedy, Jr. about staff reductions, vaccines, biosecurity, and federal research funds.
The hearings: Kennedy testified at a May 20 hearing of the Senate Appropriations LHHS subcommittee and two May 14 hearings before the House Appropriations LHHS subcommittee and the Senate Health Education, Labor and Pensions (HELP) Committee.
On staffing: Kennedy testified HHS downsizing was needed to counter “bureaucratic bloat” from the Biden Administration and limit the federal deficit. Food and Drug Administration (FDA) Commissioner Marty Makary, M.D. also testified in the Senate, Thursday, about the 2026 FDA budget, saying any staff reductions would not impede timely operation.
On measles: “I don’t think people should be taking medical advice from me,” Kennedy responded when asked about rhetoric that undermines vaccine confidence amid measles outbreaks.
On placebo tests for vaccines: “The only vaccine that has been tested in a full-blown placebo trial against an inert placebo was the COVID vaccine,” he told the HELP Committee.
“For the record, that’s not true,” said HELP Chair Bill Cassidy, M.D. (R-LA). “The rotavirus, measles, and HPV vaccines have been (placebo tested), and some vaccines are tested against previous versions.”
On NSCEB and biosecurity: Asked about the congressional National Security Commission on Emerging Biotechnology (NSCEB) report, which finds China may soon create a security threat by surpassing U.S. biotech leadership, Kennedy urged bringing drug production back to the U.S.
For example: “I’ve met repeatedly with Eli Lilly, which is now building nine facilities, nine factories, in this country, including for essential medicines,” Kennedy told the House. He repeated praise of Eli Lilly in the HELP hearing.
On NIH cuts: Sen. Cassidy warned NIH budget reductions would impair crucial research on neurodegenerative diseases, hinder the development of new scientists, and undermine U.S. competitiveness with China. Many lawmakers agreed, including Sen. Susan Collins (R-ME), Rep. Rosa DeLauro (D-CT), and Sen. Shelley Moore Capito (R-WV). Read more in Bio.News. |
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What Else to Read This Week |
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MAHA report urges more government research into the “childhood chronic diseases crisis.” The “MAHA Report: Make Our Children Healthy Again,” released May 22, cites factors including poor diet, environmental chemicals, chronic stress and lack of physical activity, and “overmedicalization of our kids.” ICH asks BIO-led group to investigate guidelines on comparability of changes in producing cell and gene therapies (CGTs). The International Council for Harmonisation (ICH) announced the approval of a proposal from the ICH Cell and Gene Therapy Discussion Group (CGTDG), which was formed and is led by BIO, to move forward on harmonizing approvals for changes in CGT manufacturing. The group will investigate and recommend guidelines for “Comparability of Advanced Therapy Medicinal Products (ATMPs) Subject to Changes in Their Manufacturing Process.” ATMPs include CGTs. ICH works to harmonize regulatory agencies worldwide in order to enable global recognition of approvals by national regulators.
USTR seeks comments on “Foreign Nations Freeloading on American-Financed Innovation.” To help implement the Most Favored Nation Executive Order, USTR has issued a call for comments “regarding any act, policy, or practice that may be unreasonable or discriminatory and that has the effect of forcing American patients to pay for a disproportionate amount of global pharmaceutical research and development, including by suppressing the price of pharmaceutical products below fair market value in foreign countries.” Comments are due by June 27. Read more here.
FDA plans listening tour, asks biotech CEOs to share their thoughts. The Food and Drug Administration (FDA) announced it will visit major innovation hubs across the country, in a “listening tour,” to meet directly with pharmaceutical and biotech CEOs and learn how FDA can “better support innovation and patient access to safe and effective therapies.” FDA Commissioner Marty A. Makary, M.D. and top FDA officials will join. Registration is necessary to participate in the visits. Read more here.
The Bayh-Dole Coalition will hold its American Innovator Award and “Faces of American Innovation” Capitol Hill Briefing on June 4-5. The event will celebrate the 45th anniversary of the Bayh-Dole Act and recognize “five trailblazers whose visionary work in bringing early scientific breakthroughs to the marketplace has made a lasting impact around the world, and even beyond.” The Bayh-Dole Coalition’s third annual “Faces of American Innovation” report highlights these trailblazers.
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