CDC won’t publish report showing COVID-19 vaccine effectiveness; former pharmacy president sentenced in $33M compounded drug kickback scheme; mRNA bird flu vaccine hits late-stage testing – Morning Medical Update

CDC won’t publish report showing COVID-19 vaccine effectiveness

HHS cited concerns about the study’s methodology; the report found vaccines cut ED visits and hospitalizations by approximately half this past winter.

A report showing the effectiveness of COVID-19 vaccines has been blocked from publication in the CDC's Morbidity and Mortality Weekly Report (MMWR). "The manuscript was not accepted for publication" due to concerns about the "methodological approach estimating vaccine effectiveness," said HHS spokesman Andrew Nixon.

The MMWR is one of the CDC's primary vehicles for publishing public health findings and is closely watched by physicians, researchers and state health officials. The decision comes under the leadership of HHS Secretary Robert F. Kennedy Jr., whose vaccine advisory panel last September scrapped a broad recommendation for COVID shots — a move since temporarily blocked by a federal court. Had it been published, the report would have shown that the vaccines reduced emergency department (ED) visits and hospitalizations among healthy adults by approximately ‌half this ⁠past winter, as reported by Reuters.

Former pharmacy president sentenced in $33M compounded drug kickback scheme

Adam Brosius was ordered to pay $33 million in restitution and forfeit $27 million.

A former New Jersey pharmacy president has been sentenced to 24 months in prison for his role in a $33 million health care fraud and kickback scheme involving medically unnecessary compounded medications including scar creams, pain creams, migraine medication and vitamins. Adam Brosius, 61, of Delray Beach, Florida, served as director of business development and later president of Main Avenue Pharmacy, a mail-order pharmacy in Clifton, New Jersey, which from 2014 through 2016 distributed pre-printed prescription pads featuring high-reimbursement compounded drug formulas to marketers nationwide.

Those marketers passed the pads to telemedicine companies and physicians under financial arrangements, and Main Avenue paid kickbacks based on prescription volume and reimbursement amounts after billing Medicare, TRICARE and commercial insurers.

The pharmacy collected approximately $33 million in reimbursements for compounded medications, more than $5.8 million of which came from TRICARE. In addition to his prison term, Brosius was ordered to pay $33 million in restitution and forfeit $27 million.

Moderna launches late-stage bird flu vaccine trial in U.S. and UK

The mRNA-1018 vaccine is the first pandemic bird flu shot made with mRNA technology to reach late-stage trials.

Moderna has begun a late-stage trial of its experimental bird flu vaccine, mRNA-1018, enrolling approximately 4,000 healthy adults in the United States and United Kingdom — the first time an mRNA-based pandemic bird flu vaccine has reached this stage of testing. The trial is backed by a $54 million investment from the Coalition for Epidemic Preparedness Innovations (CEPI), which stepped in after HHS Kennedy canceled more than $700 million in U.S. government contracts with Moderna for bird flu vaccine development last May.

If approved and a flu pandemic is declared, Moderna said it would reserve 20% of its manufacturing capacity for supply to low- and middle-income countries at affordable prices. The company said any regulatory filing for mRNA-1018 would also be supported by data from its seasonal flu vaccine candidate, mRNA-1010, currently under review in the U.S., European Union, Canada and Australia.