Infectious disease

While last week’s recommended changes by CDC advisors to the MMRV vaccine schedule are unlikely to have a tangible effect on Merck’s business, the company said the removal of choice for healthcare providers is “concerning.”

BMO Capital Markets analysts said the first day of the CDC vaccine advisory committee meeting Thursday had anti-vaccine overtones as the panel, which was revamped by Health Secretary Robert F. Kennedy, Jr. in June, voted to recommend that children under four receive the measles, mumps, rubella (MMR) vaccine separately from a chickenpox vaccine. Today the advisors will vote on changing the childhood schedule for the hepatitis B and COVID-19 vaccines.

Ousted CDC Director Susan Monarez claimed in an op-ed published in The Wall Street Journal Thursday that she was fired for refusing to rubber-stamp COVID-19 recommendations to be made by an advisory panel that has expressed “antivaccine rhetoric.”

Albert Bourla heralded the president’s COVID-19 leadership and Operation Warp Speed initiative as a Nobel Prize–worthy achievement and said that Pfizer stands by the integrity of the data already shared.

In a series of memos last week, Center for Biologics Evaluation and Research Director Vinay Prasad outlined the FDA’s thinking on the recent limited approvals for updated COVID-19 vaccines.

In an opinion piece in the Wall Street Journal, Health Secretary Robert F. Kennedy Jr. said he will roll chronic disease programs into a new Administration for a Healthy America.

The MIT professor of management, who already sits on the CDC’s revamped immunization advisory committee, is a known skeptic of vaccines, particularly mRNA technology.

The company expects that the U.S. COVID-19 vaccination rate will be “maybe a couple of points lower” than the prior level of around 20% but that pricing and Comirnaty’s market share will hold steady.

The FDA greenlit multiple new drugs this month and issued some notable label expansions, including for Eli Lilly’s Kisunla. Meanwhile, the regulator turned away a cell therapy for Duchenne muscular dystrophy and a gene therapy for the rare disease Sanfilippo syndrome.

The decision follows last month’s vote of the CDC’s revamped vaccine advisory committee. Thimerosal, mostly removed from vaccines decades ago, has long been a target of anti-vaccine advocates for unfounded links to autism and adverse health outcomes.