Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Fierce Healthcare, in “New-Look ACIP, Down a Member and Homing In on ‘Long-Settled Safety Topics,’ Kicks Off Controversial Vaccine Meeting,” by Fraiser Kansteiner.
Following is an excerpt:
With controversial presentation topics on the docket and the already abbreviated panel suddenly down one member, this week’s meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP) is shaping up to be a long, strange two days. …
However, while some presentations of the two-day meeting appear to be business-as-usual, others seem to regurgitate “long-settled safety topics” around the mercury-containing flu vaccine preservative thimerosal and the combination measles, mumps, rubella and varicella (MMRV) shot, Richard Hughes IV, a health lawyer at Epstein Becker Green, wrote in an emailed preview of the event.
One of the presentations (PDF) targeting thimerosal—slated for Thursday—originally cited a study of dubious provenance, with one of the study’s listed co-authors denying that the data reflect his work, according to Reuters. Since the initial release of presentation materials on Tuesday, the CDC has since uploaded a new version of the presentation that removes the study citation, the news service reports.
Meanwhile, several sections on the docket, including the deliberations around COVID-19 and respiratory syncytial virus (RSV) vaccines, “appear rushed or procedurally incomplete,” Hughes said. The issue could stem from a pause in work group meetings after Kennedy abruptly fired all 17 of ACIP’s sitting members earlier this month, he added.
Kennedy quickly slotted in eight picks of his own for the panel. However, in another unexpected turn for this week’s meeting, one of the new appointees—Michael Ross, M.D.—has withdrawn from the vaccine advisory group, The New York Times first reported Tuesday. …
Packed agenda
Over the next two days, ACIP is slated to review the safety and effectiveness of vaccines for COVID-19, RSV, influenza, chikungunya, anthrax and MMRV. The panel will only vote on recommendations for maternal and pediatric RSV vaccines and flu shots.
Given the lack of a vote on the COVID vaccine issue, recent limitations to CDC immunization policies for healthy kids and pregnant people are “unlikely to change,” said health lawyer Hughes. Although the planned presentations on COVID vaccines outline evidence of the shots’ benefits, the data are “juxtaposed with adverse events slides … which could be used to validate the recent policy change,” he explained.
Safety concerns will factor into the panel’s vote on material and pediatric RSV immunizations, too, with Hughes pointing out that presentation slides highlighting pregnancy-related safety signals could be used by the new ACIP members “as a justification for recommendation change at this meeting or in the future.”
The same issue is also at play in the reviews of chikungunya and MMRV vaccines, with the latter shot subject to scrutiny over a potential increased risk of febrile seizures following an initial dose in kids between the ages of 12 and 23 months.
Although the overall evidence being presented on MMRV vaccines “affirms a favorable safety profile,” the presentation also “elevates older studies showing a modest seizure risk in infants” who received the quadruple combination shot over a measles, mumps and rubella vaccine and a separate varicella shot, Hughes said.
Targeting thimerosal
It is Thursday’s review of influenza vaccines, however, that is likely to prove the most controversial during the two-day ACIP meeting. The agenda starts out relatively par for the course, with Sanofi planning to present immunogenicity and safety data for a recombinant flu shot in kids, followed by a separate presentation on the 2024-25 flu season and proposed recommendations.
However, the panel is then slated to review data on thimerosal—a mercury-containing preservative used in certain adult flu vaccines—which has been inaccurately linked to the development of autism spectrum disorder (ASD). The ingredient was removed from most childhood vaccines in the early 2000s and there is little evidence to suggest it poses safety concerns, Bloomberg News noted in a report last week.
To hear Hughes tell it, the thimerosal data—which are being presented by former Children’s Health Defense president Lyn Redwood—lean “heavily on outdated or misrepresented evidence … to argue that thimerosal is unsafe and ineffective.” Children’s Health Defense, whose stated mission revolves around “ending childhood health epidemics by eliminating toxic exposure,” was founded by Kennedy.
As of early Wednesday morning, the presentation material list for this week’s ACIP meeting also included a separate CDC background document that Hughes noted “directly refutes many of the claims related to thimerosal and neurodevelopmental disorders including autism.” But by about 11:00 a.m. ET on Wednesday, the document was not clickable on the CDC’s meeting materials page.
