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

Although most Americans have eschewed seasonal COVID-19 vaccines, the updated shots continue to show significant protection against cardiovascular disease, especially for those over age 75 and those with underlying medical conditions. That's according to a new study that pulled data from more than 1 million patients in a US Department of Veterans Affairs (VA) health system.

The finding builds on previous data showing that the vaccines significantly lower the risk of COVID-19-associated cardiovascular risks, particularly heart attacks and strokes. But it wasn't a given that the benefit would hold up over time—as the virus evolved, the vaccines were updated, population-level immunity increased from previous infection and vaccination, and risk of severe outcomes fell.

The new study, published in JAMA Internal Medicine, found that the 2024–2025 COVID-19 vaccine continued to protect against COVID-19-associated "major adverse cardiovascular events" (MACE), which include cardiovascular death, heart attack, stroke, and hospitalization for heart failure.

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