Independent advisors for the Food and Drug Administration on Friday voted 9–0 in support of approving Moderna's seasonal mRNA flu vaccine, which a Trump appointee at the agency initially tried to block from even being reviewed.

In an all-day meeting, members of the FDA's advisory committee—known as VRBPAC for Vaccines and Related Biological Products Advisory Committee—pored over data and presentations on the vaccine, which is dubbed mRNA-1010 and branded as mFlusiva. The presentations included a review from FDA scientists, which was supportive of the vaccine.

Data from a Phase 3 trial including over 40,000 adults age 50 and older found the mRNA vaccine was around 27 percent more effective against seasonal flu than a standard flu shot. A smaller Phase 3 trial, involving data from nearly 3,000 people age 65 years and older, showed the shot produces stronger immune responses than a high-dose flu vaccine, which is recommended for this age group. The safety profile of the vaccine was also generally good.

Read full article

Comments

Anti-vaccine Health Secretary Robert F. Kennedy Jr. posted a long, enraged social media response to a New York Times article reporting that health department insiders think Kennedy is disengaged from the work of his sprawling agency. His response, however, seems to back the Times' claim.

The report, published Sunday, June 7, relied on accounts from a dozen people who have had direct contact with Kennedy during his time as health secretary. Collectively, the sources indicate that Kennedy has little interest in the details of the health department's work and little direct interaction with career staff. Kennedy misses critical, regularly scheduled meetings with agency leaders, is sometimes "checked out" in the meetings he attends, and has been out of the loop on key decisions, such as the firing of Tracy Beth Høeg, a political appointee elevated to top drug regulator at the Food and Drug Administration. In his stead, Kennedy often refers people to his protective, longtime assistant, Stefanie Spear, who colleagues say has slowed department operations and fueled some significant leadership departures.

On Wednesday night, Kennedy responded to the report with an 871-word diatribe on social media against the reporter, veteran journalist Sheryl Gay Stolberg, and the Times. His key argument was that much of the story could be refuted by a look at his jam-packed public calendar.

Read full article

Comments

For the first time, the American College of Obstetricians & Gynecologists (ACOG) has released its own recommendations for maternal vaccination, providing formal guidance that diverges from that of the Centers for Disease Control and Prevention amid unprecedented policy changes and meddling from anti-vaccine Health Secretary Robert F. Kennedy Jr.

ACOG President Camille Clare blamed "changing national recommendations coupled with rampant vaccine misinformation" for the confusion among patients and health care professionals about vaccines during pregnancy.

"It is incredibly important for the public to have access to reliable, evidence-based information on maternal immunizations from a trusted source. ACOG is proud to be that source," Clare said in a statement.

Read full article

Comments