STICKER SHOCK — The CDC recommended late Thursday that children up to 8 months old receive a newly approved respiratory syncytial virus antibody ahead of their first RSV season, Katherine reports.
The agency also endorsed a second shot for toddlers up to 19 months old at risk of severe disease. The recommendation follows a meeting of the agency’s vaccine advisers, who unanimously voted in favor of the shot earlier in the day. It is the first time all infants can have protection against the virus.
“Essentially every child will get RSV by the time they’re 2 years of age,” Dr. Steve Furr, the American Academy of Family Physicians’ president-elect, told Prescription Pulse. “This is a chance to prevent disease.”
But advisers balked at the price: Beyfortus, a product from Sanofi and AstraZeneca, is estimated to cost $495 a vial for infants and $990 for those older than 8 months. For the Vaccines for Children program, a federal program that provides free immunizations by clinicians who provide care for low-income children, a single vial would cost $395.
Sanofi said consumers could receive Beyfortus at no cost thanks to insurance and the Vaccines for Children program. But advisers fear that providers may punt the responsibility of administering the shot because of the high price.
“I am worried about equity,” said Dr. Katherine Poehling, a committee member and professor of pediatrics at Wake Forest School of Medicine. She pointed out that a hospital’s cost differential for children born in June vs. October would be almost $500.
It’s not clear where the shot will most often be administered. Infants born shortly before or during the RSV season — which in the continental U.S. typically runs from October through March — should receive the vaccine in their first week of life, Dr. Jefferson Jones, a CDC official, said in a presentation during the meeting.
This means they’d likely get the shot during their hospital stay. Those born outside of the RSV season would get their shot during a well-child pediatrician’s visit.
Eye on the FDA: The FDA is poised to decide on Pfizer’s RSV vaccine for pregnant people, who pass immunity on to their newborns. The CDC’s advisory committee must reconvene to recommend which option would provide optimal protection.
IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We welcome Beyoncé to the DMV for the weekend.
Send news, tips and BeyHive content to Katherine Ellen Foley ([email protected] or @katherineefoley), Lauren Gardner ([email protected] or @Gardner_LM or @gardnerlm19) and David Lim ([email protected] or @davidalim or @david.a.lim).
TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with David, who gives an update on the rise in Covid-related hospitalizations and explains why the White House is confident that treatments and vaccines can manage a potential fall outbreak.
FIRST IN RXP: VACCINE INJURY BILLS INTRODUCED — Rep. Lloyd Doggett (D-Texas) is expected to unveil two bipartisan bills today to revamp the Vaccine Injury Compensation Program, including shifting Covid-19 vaccines under the program’s purview.
One measure, which mirrors legislation Doggett championed last Congress and is co-sponsored by Rep. Lloyd Smucker (R-Pa.), would expedite the amount of time the HHS secretary has to add a vaccine to the program’s injury table to six months from two years while ensuring the table covers shots routinely recommended by the CDC for adults. The bill would also require a minimum of 10 special masters to be appointed to the court that hears vaccine injury claims, up from the current maximum of eight.
The bill would transfer pending Covid-related claims from the Countermeasures Injury Compensation Program, designed for treatments created or used during public health emergencies, to the VICP. Such a move would trump the Biden administration’s May decision to leave Covid-related injury claims under the countermeasures program through the end of 2024. Both programs have struggled to meet their mandates in recent years, and advocates fear the VICP, absent congressional reform, could collapse once Covid vaccines fall under it.
“I believe that those who suffer rare injuries associated with vaccines, including those to fight Covid-19, should receive prompt, reasonable compensation for medical bills and other losses,” Doggett said in a statement shared first with POLITICO. “By assuring a prompt and fair response to any related injury, we build confidence in vaccines and reduce hesitancy.”
The second bill, co-sponsored by Rep. Mike Kelly (R-Pa.), would impose the 75-cent excise tax that funds the VICP on any new shots added to the injury table, eliminating the need for Congress to act separately.
PFIZER, MODERNA SEE EARNINGS DECREASE — The country’s top Covid vaccine makers reported lower quarterly revenues this week as they grapple with decreased demand for the shots compared with 2022.
Moderna posted a 94 percent drop in Covid vaccine sales — the company’s only commercially available product — in the second quarter of 2023 and downgraded its 2023 Covid sales expectations to a $6 billion to $8 billion range, reflecting the uncertainty of future U.S. vaccination rates.
Pfizer announced second-quarter revenues from its Covid-19 vaccine dropped 83 percent compared with the same quarter last year, and sales of antiviral Paxlovid fell 98 percent over the same period.
Moderna CEO Stéphane Bancel pointed to the company’s pipeline of products, such as flu and RSV vaccines and a melanoma therapy, that could win approval within the next three years that he said positions Moderna to grow sales.
Meanwhile, Pfizer also said that bringing a combination flu/Covid vaccine to market in the future could help grow revenue.
FDA, DEA ADDRESS STIMULANT SHORTAGE — The FDA and the Drug Enforcement Administration called on drugmakers this week to increase production of prescription stimulants used to treat conditions like ADHD, which have been in short supply in recent months.
The agencies’ joint letter also urged providers and professional groups to expedite “efforts to support appropriate diagnosis and treatment of ADHD,” develop alternative treatments and avoid medication misuse.
AGENCY WARNS ‘NATURAL BIRTH CONTROL’ MAKER — The FDA has warned a company selling what it claims is a “natural birth control cream” that its product is an unapproved new drug. The late July warning letter to Wise Women’s Choice notes that the agency previously issued a warning to another company selling a similarly named product purporting to be a contraceptive.
Lauren Love, CEO of Wise Women’s Choice, told Prescription Pulse her website states that the product cannot be shipped to the U.S. and that the company is based in Central America. “This product is not a new drug, as it is not a drug,” she said in an email. “It is not intended to prevent, treat, or cure any disease or ailment whatsoever, as pregnancy is a blessed state.”
“The FDA will continue to be vigilant and continue efforts to stop those selling fraudulent and otherwise unlawfully marketed products,” an agency spokesperson said.
CBC MEMBERS CALL FOR MENTHOL BAN — Thirty-two members of the Congressional Black Caucus urged the FDA in a letter this week to finalize its proposed menthol ban given the disproportionate negative impacts the flavored cigarettes have had on Black Americans’ health.
The lawmakers emphasized that the rule, due to be finalized this month, can’t be enforced against individual consumers, addressing concerns raised about the potential for increased policing in Black communities if and when the prohibition becomes effective.
Health insurers increasingly refuse to cover off-label use of weight-loss drugs, STAT’s Elaine Chen reports.
A White House task force on drug shortages met last week with hospitals, pharmacies, drugmakers and others, STAT’s John Wilkerson reports.
The White House Office of Information and Regulatory Affairs is reviewing a guidance document outlining enhanced drug distribution security requirements.
CMS published its fiscal 2024 hospital inpatient prospective payment system final rule.
The FDA published guidance outlining how authorized trading partners can request a waiver from certain Drug Supply Chain Security Act requirements.