U.S. Health and Human Services Secretary Robert Kennedy continued his last-minute musical chairs ahead of the Dec. 4-5 meeting of the Advisory Committee for Immunization Practices (ACIP) when he named Kirk Milhoan as the new chair of the panel that advises the CDC on vaccine schedules.
Both the FDA and the CDC’s Advisory Committee for Immunization Practices are on the threshold of revising how vaccines are approved and used in the U.S., but whether that opens to a precipice or a new era of stronger evidence and safer use is in the telling of the beholder.
Changes to a U.S. CDC website regarding autism and vaccines has sparked a backlash from numerous scientific and other groups, placing HHS Secretary Robert F. Kennedy Jr. (RFK) in the spotlight once again for appearing to break promises made earlier this year to secure his nomination.
Bavarian Nordic A/S will continue operating as an independent public company after an offer to be acquired by two private equity firms failed to win sufficient shareholder approval.
Moderna Inc. stopped its efforts to develop mRNA-1647 as a vaccine for preventing congenital cytomegalovirus infection, the most common infectious cause of birth defects in the U.S. The pivotal and placebo-controlled phase III CMVictory study of mRNA-1647 missed the primary efficacy endpoint, which was preventing the infection in seronegative females ages 16 to 40.
An uncommon route to the public markets – direct listing – paid off for Turn Therapeutics Inc., with shares (NASDAQ:TTRX) closing Oct. 9 at $9.20, up $2.20, or 31%, having risen as high as $26.50 in its second day of trading. The firm is advancing late-stage clinical programs in eczema and onychomycosis. Also in the works are global health initiatives in thermostable vaccine delivery designed to serve underserved areas.
Even though the U.S. CDC is operating on a skeleton crew due to the partial government shutdown, it is updating its immunization schedules to adopt the COVID-19 and chickenpox vaccine recommendations the Advisory Committee on Immunization Practices (ACIP) made at its September meeting.
While the discussions and votes at the past two meetings of the U.S. CDC Advisory Committee for Immunization Practices (ACIP) have generated a lot of controversy and resulted in some states and medical groups issuing their own vaccine schedules, the truth is that the newly reconstituted committee’s recommendations to date are still in line with, or more generous in some instances than, global norms.
The second day’s meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) took up guidelines related to COVID-19 vaccines, of which an outspoken skeptic is Health and Human Services Secretary Robert Kennedy – who in June fired all 17 members of ACIP and replaced them with names more to his liking.
Despite some expectations that the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) would dramatically change the childhood vaccine schedule for hepatitis B, the committee is poised to vote Sept. 19 on a much smaller change that would move the current birth dose to 1 month for infants born to mothers who test negative for hepatitis B.
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