Elasomeran

Covid-19 shot makers have not been working closely with the CDC’s vaccine advisors and aren’t expected to make substantive presentations to the panel when it convenes later this week, multiple sources familiar with the planning told Endpoints News . The CDC’s Advisory Committee on Immunization Practices is scheduled to meet starting Thursday to discuss and vote on recommendations for hepatitis B, MMRV and Covid-19 vaccines. Sources told Endpoints that an agenda item for Friday, listed as “COVID-19 Vaccine Manufacturer updates,” will be an opportunity for the companies to respond to earlier presentations made during the meeting. Companies have historically been allotted time during ACIP meetings to give detailed presentations on updated vaccine data. Moderna, Pfizer and Novavax will each have a couple of minutes to present or make remarks, the sources said. Two sources said the remarks need to first be reviewed by ACIP and HHS for “transparency.” Sources also said the companies have not been asked to produce data for ACIP’s new Covid-19 vaccine working group ahead of the meeting. There was a call between Pfizer and the working group last week, one source told Endpoints, although the contents of that call were not disclosed. Working groups deliberate and propose recommendations to the full ACIP committee. The shift reflects how the committee, rebuilt under HHS Secretary Robert F. Kennedy Jr., is siloing itself from key stakeholders involved in vaccine development and public health. An HHS spokesperson and Retsef Levi, chairman of the working group, did not immediately respond to requests for comment. Levi, an operations management professor at MIT, and fellow Covid-19 working group member Robert Malone have expressed skepticism about the value of the Covid-19 vaccines, especially the mRNA shots developed by Pfizer and Moderna. After being named to ACIP in June, Levi said in an interview with independent journalist Maryanne Demasi that he wasn’t convinced the mRNA vaccines were safe to give to anybody, despite the FDA’s approval for broad swaths of the population. The companies’ scheduled time to respond will follow presentations on Covid-19 epidemiology and vaccine data from the CDC. The panel has also scheduled “Additional COVID-19 vaccine safety presentations,” but the presenters have not yet been announced. Other key stakeholders have already been sidelined by the rebuilt ACIP, after Kennedy fired all 17 members in June and replaced them with seven new members. The committee began excluding non-voting liaisons from working group meetings more than a month ago. Liaisons include representatives from key clinician groups as well as organizations that represent pharmacies, insurers and drugmakers. And a new “terms of reference sheet” for the Covid-19 vaccine working group, updated last month, calls for limiting the role of in-house experts. The document said that CDC staffers would not be members of the Covid-19 working group and that presentations made by CDC employees would be “transparent” in order to “minimize the risk of, or the appearance of, undue influence that would compromise the independence of the” working group. HHS announced five new ACIP members on Monday, some of whom have expressed skepticism about the safety of the Covid-19 vaccines. The full advisory panel is slated to dedicate all of Friday to discussing Covid-19 vaccines and voting on new immunization recommendations for them. On Thursday, ACIP members will review and vote on new recommendations for the MMRV and hepatitis B vaccines.

HHS Secretary Robert F. Kennedy Jr. has appointed five new members to the Advisory Committee on Immunization Practices ahead of a critical meeting slated for later this week. The new panelists have varied infectious disease experience, similar to the members chosen by Kennedy in June. They include Hillary Blackburn, Evelyn Griffin, Kirk Milhoan, Raymond Pollak and Catherine Stein. Milhoan is a senior fellow with the Independent Medical Alliance, a coalition that includes many Covid-19 vaccine skeptics and promoters of unproven remedies like ivermectin. One study co-written by people affiliated with the alliance, formerly known as the Front Line Covid-19 Critical Care Alliance, was corrected after “several authors failed to disclose all relevant conflicts of interest.” Milhoan was not an author on that study. Blackburn is a pharmacist and director of medication access and affordability at the hospital network Ascension. Griffin is an OB/GYN at Baton Rouge General Hospital. She previously worked as an OB/GYN at Ochsner Health, but a company spokesperson said she was no longer employed there as of January 2022. Stein is an infectious disease professor at Case Western Reserve University. Pollak is a transplant specialist from Illinois. The new additions to the group come as ACIP is prepared to meet for a second time since Kennedy ousted all 17 existing members and began replacing them, often with ideological allies who do not have extensive infectious disease experience. Only one member, Cody Meissner, had previously served on ACIP. The panel will meet on Thursday and Friday, and is set to review data and vote on recommendations for hepatitis B, MMRV and Covid-19 vaccines. Some of the new members have been especially critical of the Covid-19 vaccines and the mRNA technology that underpins Pfizer and Moderna’s products, alleging that the spike protein produced by the vaccine is harmful and dangerous. A newly-established ACIP Covid-19 working group is chaired by Retsef Levi , an operations management professor at MIT who has questioned whether the mRNA vaccines are safe to give to anyone.