FDA Panel Gives Thumbs Up to Omicron-Containing COVID Boosters
An FDA advisory committee voted 19-2 on Tuesday to recommend use of an Omicron-specific component in a future COVID-19 vaccine booster. “We really do need vaccines that provide broader protection against variants that have not yet emerged,” said Melinda Wharton, MD, MPH, associate director of vaccine policy at the CDC, at a remote meeting of […]
ACIP Backs Moderna’s COVID Shot for Kids 6-17 Years
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously on Thursday to recommend that children ages 6-17 years receive Moderna’s COVID-19 vaccine. With a 15-0 vote, ACIP endorsed a two-dose primary series of the mRNA vaccine for kids ages 6-11 years (50 mcg per dose) and adolescents ages 12-17 (100 mcg per dose). The […]
CDC’s Advisers Endorse COVID Vaccines in Youngest Kids
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously on Saturday to recommend that children 6 months and older receive COVID-19 vaccines. As proposed by CDC staff, and now approved by CDC Director Rochelle Walensky, MD, MPH, the recommendations call for a two-dose series of Moderna’s product for children ages 6 months to 5 […]
Is Monkeypox a Global Health Emergency? – MedicineNet Health News
Latest Infectious Disease News WEDNESDAY, June 15, 2022 An emergency committee of independent experts will meet next week to determine whether the growing monkeypox outbreak that’s spread to dozens of countries should be declared an international health emergency, the World Health Organization announced Tuesday. That’s the highest level of alert for viral outbreaks and doing […]
COVID Toddler Vax Clears Major Hurdle
An advisory committee recommended that the FDA give emergency use authorization (EUA) to both Moderna and Pfizer/BioNTech’s mRNA COVID-19 vaccines for infants, toddlers, and preschool kids. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21-0 in favor of expanded access to each vaccine, in another unanimous decision that the benefits of the vaccines […]
FDA Panel Unanimously Backs Moderna’s COVID Vax for Kids and Teens
A committee of independent vaccine experts recommended that the FDA grant an emergency use authorization (EUA) for the two-dose Moderna COVID-19 vaccine for kids ages 6 to 17 years. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 22-0, agreeing unanimously that the benefits of vaccination outweigh the risks in two age groups: kids […]
Beta-Thalassemia Gene Tx Gets Ringing Endorsement From FDA Advisers
An FDA advisory committee on Friday unanimously recommended betibeglogene autotemcel (beti-cel) for approval in patients with transfusion-dependent beta-thalassemia, a chronic inherited blood disorder. With a 13-0 vote, FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee said the benefits of the one-time, first-in-class lentiviral vector (LVV) gene therapy outweigh any of the risks associated with the […]
ALS Drug Needs More Evidence, FDA Advisors Say
In a close call, an FDA advisory committee said data from a single trial for AMX0035, an investigational agent being studied to treat amyotrophic lateral sclerosis (ALS), did not support a conclusion that the drug was effective. The 6-4 vote of the Peripheral and Central Nervous System Drugs Advisory Committee was based on findings from […]
Opinion | Can Primary Care Physicians Address the Behavioral Health Crisis?
In a recent Senate Finance Committee hearing, U.S. Surgeon General Vivek Murthy, MD, MBA, said, “We are on the verge of beating back one public health crisis in COVID-19, only to see another grow in its place … We have the opportunity and the responsibility to make change happen now.” Murthy was referring to what […]
Abortion Stays in Spotlight at SCOTUS Nominee’s Senate Hearing
WASHINGTON — During the third day of her Senate Judiciary Committee nomination hearing, Republican senators continued peppering President Biden’s Supreme Court nominee Ketanji Brown Jackson Wednesday with questions about her views on abortion. “Can an unborn child feel pain at 20 weeks?” asked Sen. Lindsey Graham (R-S.C.). “I don’t know,” replied Jackson, who, if confirmed, […]