Latest news with #RetsefLevi
Politico
27-06-2025
- Health
- Politico
Vaccine panel's new path raises concerns
Driving the Day THE VIEW FROM ATLANTA — The CDC's revamped Advisory Committee on Immunization Practices wrapped up its first meeting Thursday, recommending use of a new monoclonal antibody for respiratory syncytial virus in infants and flu shots for everyone 6 months and older beginning this fall. But public health experts and former government officials said they were troubled by the tenor of the panel's vaccine discussions, as well as its move to recommend pulling a little-used preservative from the seasonal flu shot supply. Thimerosal's fate: ACIP voted to recommend against anyone — adult, child and pregnant person — receiving a seasonal flu vaccine with the mercury-containing compound, despite scientific consensus that it's not linked to severe adverse events or conditions like autism. Before the meeting, HHS Secretary Robert F. Kennedy Jr. questioned the safety of thimerosal on X, calling it a 'treadworn lie of the vaccine industry' that the compound is safe. In 2014, he wrote a book about thimerosal, arguing that it likely causes autism and should be banned. The real-world impact in the U.S. is minimal — just 4 percent of the supply last season contained thimerosal — but public health officials warn that even small percentages of a population-wide campaign matter. The multidose vials containing thimerosal are most likely purchased by state and local health departments or other entities that hold community-wide vaccination drives, potentially threatening access in low-income or rural areas. And beyond access, the suggestion that thimerosal is worth eliminating from the domestic seasonal vaccine supply could stoke vaccine hesitancy in low-income nations reliant on those products to reach as many citizens as possible. Multidose vials are also typically used in pandemics for the same access reason, and even though pandemic influenza vaccines weren't considered, a record of ACIP discouraging use of products containing thimerosal could hamper future immunization campaigns during health emergencies. Another RSV antibody: The committee's 5-2 vote recommending Merck's clesrovimab followed a tense debate among members about its benefits for otherwise healthy babies — despite ample data showing the virus can readily land those children in the hospital. Retsef Levi, an MIT business professor who voted against recommending it, focused on a nonstatistically significant increase in deaths among infants who got the immunization and questioned whether parents of healthy children would want to use it. But Dr. Cody Meissner, a Dartmouth pediatrics professor who's previously served on the ACIP and the FDA's vaccine panel, pushed back, noting it's impossible to predict which healthy children will avoid RSV's most severe consequences. 'If I were your pediatrician, I would strongly recommend that your wife either receive the RSV vaccine or a monoclonal antibody at birth,' Meissner said to Levi. Looking ahead: Lauren and POLITICO's Sophie Gardner, who was in the room at CDC headquarters, broke down the main takeaways from this week's meeting. IT'S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. How about those Washington Wizards draft picks? Send your NBA thoughts and news tips to David Lim (dlim@ @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@ @Gardner_LM or gardnerlm.01 on Signal). Eye on the FDA FDA LAYS OUT MDUFA PROCESS — The FDA announced Thursday In the Federal Register it will start the reauthorization process for its medical device user fee program by holding a public meeting on Aug. 4. People can 'present their views' on reupping the program through which industry pays fees to the agency to speed medical device reviews. Soon after, the agency says it will continue to meet with patient and consumer advocacy groups at least once a month while it negotiates with the medical device industry — with the first meeting to start by October. The FDA requests that people interested in participating in the meetings to notify the agency within 30 days. Why it matters: The notice is the latest sign the FDA will move to reauthorize its user fee programs despite HHS Secretary Robert F. Kennedy Jr.'s distaste for what he says are programs that allow industries to have a cozy relationship with the agency that regulates drugs and medical devices. Coronavirus UPDATED LABELING — The FDA formally posted a safety communication on Wednesday noting required updates to prescribing information for Pfizer's Comirnaty and Moderna's Spikevax Covid-19 vaccines to include the estimated unadjusted incidence of myocarditis and pericarditis following administration of the 2023-2024 shot. The agency also required the vaccine makers to add the results of a study that examined cardiac MRI findings in people who had developed myocarditis —an inflammation of the heart muscle — after receiving an mRNA Covid vaccine. Industry Intel NOVO'S NEXT MOVE — Fresh off a breakup with telehealth platform Hims, Danish drugmaker Novo Nordisk said Thursday it is partnering with WeightWatchers to distribute Wegovy via online mail orders at CenterWell Pharmacy. 'We will continue to pursue and build on agreements with companies that share our values and refine initiatives that help improve access to our FDA-approved medicines for patients,' Dave Moore, executive vice president of U.S. operations for Novo, said in a press release. In Congress THUNE: NO PARLIAMENTARIAN OVERRIDE — Senate Majority Leader John Thune said Thursday the Senate would not move to overrule its parliamentarian after she advised that including key provisions in the GOP's domestic-policy megabill would expose it to a fatal Democratic filibuster, POLITICO's Jordain Carney and Benjamin Guggenheim report. After the decisions — including provisions that would crack down on provider taxes states used to fund their Medicaid programs as well as measures meant to exclude undocumented residents from public benefits — were publicized Thursday, multiple conservative Republicans called on the Senate to sideline Parliamentarian Elizabeth MacDonough. But when asked by POLITICO about overruling her, Thune said, 'No, that would not be a good option for getting a bill done.' Republicans are expected to try to rewrite the provisions in hopes of winning MacDonough's blessing. The FDA announced import alerts on certain Olympus medical devices, including specific models of ureterorenoscopes, bronchoscopes, laparoscopes and automated endoscope reprocessors, tied to concerns over quality system regulation violations. The FDA's Center for Drug Evaluation and Research released its annual drug trials snapshots summary report. The center approved 50 novel drugs in 2024. The FDA published guidance outlining how medical device manufacturers can submit cybersecurity information as part of premarket applications. It also published draft guidance on unique device identifier requirements for combination products. Eli Lilly is scheduled to meet with the White House Office of Information and Regulatory Affairs on Monday to discuss the Health Resources and Services Administration's 340B rebate guidance. WHAT WE'RE READING Eric Green, who led the National Human Genome Research Institute before being forced out of the NIH, still does not know who pushed him out, STAT's Anil Oza reports. The Supreme Court cleared the way for states to exclude Planned Parenthood from their Medicaid programs, Lauren and POLITICO's Alice Miranda Ollstein and Josh Gerstein write.
Gulf Insider
27-06-2025
- Health
- Gulf Insider
More Fetal Losses Than Expected After Pfizer COVID-19 Vaccination In Israel: Study
A higher-than-expected number of miscarriages and other forms of fetal loss were associated with COVID-19 vaccinations in Israel, a new study has revealed. Researchers found 13 fetal losses—four more than the nine expected—for every 100 pregnant women who received a COVID-19 vaccine during weeks eight to 13 in pregnancy, according to the study, which was published as a preprint on the medRxiv server. Most people in Israel, including pregnant women, received the Pfizer-BioNTech COVID-19 vaccine. Pfizer did not respond by publication time to a request for comment. The team behind the study includes Retsef Levi, a Massachusetts Institute of Technology researcher who was recently named to the committee that advises the Centers for Disease Control and Prevention on vaccines, and Dr. Tracy Hoeg, who works for the Food and Drug Administration. The researchers analyzed electronic health records from Maccabi Healthcare Services, one of four organizations that provide health care to Israelis. They looked at 226,395 pregnancies that occurred between March 1, 2016, and Feb. 28, 2022. The primary analysis looked at fetal loss for pregnant women after dose one or dose three of a COVID-19 vaccine, with fetal loss including miscarriage, abortion, and stillbirth. The researchers came up with an expected number of fetal losses based on a model that drew from data before the COVID-19 pandemic, then compared the expected number of fetal losses with those that occurred from week eight of pregnancy onward. They identified 13,214 fetal losses after the COVID-19 pandemic started, compared with 12,846 fetal losses in the reference period, finding that women who received a COVID-19 vaccine during weeks eight to 13 in pregnancy experienced a higher-than-expected number of fetal losses. 'If you believe this result … every 100 women that you would vaccinate during weeks eight to 13, you are going to see close to four additional fetal losses,' Levi told The Epoch Times. The researchers cautioned that more information is required to say for sure that the vaccines cause fetal losses. They also noted that when they carried out the same analysis for pregnant women who received a COVID-19 vaccine during weeks 14 to 27, the number of fetal losses was lower than expected. An additional analysis of pregnant women who received an influenza vaccine from March 1, 2018, to Feb. 28, 2019, also found a lower-than-expected number of fetal losses. The researchers said those results could stem from what is known as healthy vaccine bias—the data could be skewed because people who receive vaccines are typically healthier than those who do not. Maccabi Healthcare Services did not return an inquiry by publication time. Dr. Yaakov Segal, head of obstetrics and gynecology medicine at the organization, is one of the paper's co-authors. Israel's Ministry of Health and the American College of Obstetricians and Gynecologists, which encourages pregnant women to receive a COVID-19 vaccine in any trimester, did not respond to requests for comment by publication time. 'Generally, medical advice to pregnant women follows the precautionary principle and is based on sound and careful research,' Josh Guetzkow, researcher with Hebrew University of Jerusalem and another study co-author, told The Epoch Times via email. 'Our study shows just how irresponsible it was for our health authorities to abandon these core principles.' COVID-19 vaccination was recommended for pregnant women in Israel and the United States early in the COVID-19 pandemic, even though the clinical trials for the vaccines excluded pregnant women. Moderna's clinical trial for pregnant women was ultimately terminated, while Pfizer ended its trial early after enrolling just 175 women. The latter found slightly lower COVID-19 incidence among the vaccinated when compared with those who received a placebo. Some observational studies have determined that pregnant women benefit from COVID-19 vaccination. The Centers for Disease Control and Prevention recently narrowed its COVID-19 vaccine recommendations and no longer advises COVID-19 vaccination during pregnancy. The new paper was published as a preprint, without peer review. Levi said the paper had been rejected by two journals, and the authors decided that the implications were too important to continue to not release it to the public. Guetzkow said the researchers are going to keep trying to get the paper published by a journal.
Wall Street Journal
27-06-2025
- Health
- Wall Street Journal
RFK Jr.'s Vaccine Panel Has a New Approach: Question Everything
ATLANTA—Retsef Levi wasn't convinced. Data for a new drug showed it can help keep babies out of the hospital with respiratory syncytial virus, or RSV. Scientists of the Centers for Disease Control and Prevention presented the evidence in a long series of slides to the federal vaccine panel recently remade by Health and Human Services Secretary Robert F. Kennedy Jr. Outside experts considered recommending the drug an obvious choice for the Levi, a new member of the panel and a Massachusetts Institute of Technology operations-management professor, said he thinks about other things when considering immunizations, including his experience as a father of six. He was one of two members to vote 'no' on a recommendation for the drug, which the five other members passed.
France 24
26-06-2025
- Health
- France 24
US panel replaced under Trump backs new shot for kids
The vote marked the first by the Advisory Committee on Immunization Practices (ACIP) since Kennedy dismissed all members of the influential group of independent experts and replaced them with his own nominees, a move that made this decision a test of the new panel's intentions. Clesrovimab was recently approved by the Food and Drug Administration as a shot for newborns and young babies experiencing their first respiratory syncytial virus (RSV) season. Marketed under the name Enflonsia by its manufacturer Merck, it was shown in clinical trials to be safe and effective at significantly reducing RSV infections and hospitalizations among infants. The ACIP panel was asked to adjudicate the next step after approval -- namely, whether it should now be recommended for infants under eight months old entering their first RSV season who are not already protected by an RSV vaccine administered to their mother during pregnancy. They voted 5-2 in favor. The two dissenters were Retsef Levi, a professor of operations management at MIT who has questioned the safety of Covid-19 vaccines, and Vicky Pebsworth, a nurse and member of the anti-vaccine National Vaccine Information Center (NVIC). "I don't feel this is ready to be administered to all healthy babies. I think we should take a more precautionary approach," said Levi, explaining his "no" vote. Pebsworth did not offer comments, but the NVIC previously opposed the earlier-approved RSV antibody, nirsevimab. Kennedy -- who spent decades spreading vaccine misinformation before becoming President Donald Trump's top health official -- abruptly fired all 17 members of the ACIP earlier this month, accusing them of conflicts of interest.
Wall Street Journal
17-06-2025
- Health
- Wall Street Journal
Defending RFK Jr.'s Adviser
In your editorial 'Meet RFK Jr.'s Vaccine Advisers' (June 13), you write of the secretary's new plans for the Advisory Committee on Immunization Practices: 'One appointee, Retsef Levi, is an MIT business school professor of operations management. What does he know about vaccines?' Allow me to rise to my colleague's defense. The members of ACIP don't develop vaccines. They are charged with assessing their safety and efficacy. That is done through statistics and data science, areas in which Mr. Levi excels. His assessments will be conducted through vaccine trials, using a statistically significant number of participants and correlating the efficacy with a host of variables such as age, comorbidity, gender and dosage. The primary tool available to the researchers is statistical modeling. Only after discovering correlations may medical researchers try to explain them, but that is a secondary part of the trials.
