News : Feds plan for smoother access to RSV infant shot

Wednesday, May 29, 2024

Feds plan for smoother access to RSV infant shot

May 29, 2024

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By David Lim and Lauren Gardner

With Megan R. Wilson and Kyle Duggan

Driving The Day

This illustration provided by AstraZeneca depicts packaging for their medication Beyfortus.

Federal health officials are working to ensure that an adequate supply of the RSV vaccine for infants, Beyfortus, will be on hand for the upcoming respiratory illness season. | AstraZeneca via AP Photo

PREPPING FOR RSV — Top Biden administration health officials, including CDC Director Mandy Cohen, don’t want parents to run into roadblocks this coming respiratory illness season when they seek an immunization for babies that protects against respiratory syncytial virus.

The government has repeatedly met with vaccine makers AstraZeneca and Sanofi in recent months to ensure there is enough supply early in the season after unanticipated demand caused widespread shortages last year, POLITICO’s Chelsea Cirruzzo and David report.

“We all know that last year there was a supply-demand mismatch,” said Dr. Demetre Daskalakis, director of the CDC’s National Center for Immunization and Respiratory Diseases. He said the CDC is working with CMS to ensure that providers receive reimbursement when they administer shots, and the agencies are making efforts to get private insurance plans to cover the shots.

Last year, enough doses were available to immunize nearly 40 percent of U.S. infants, and manufacturers plan to more than double the number of available U.S. doses this upcoming season, according to Ayanna Santos, head of the RSV franchise in Sanofi’s U.S. vaccines unit.

RSV sends 58,000 to 80,000 children under age 5 to the hospital each year, and severe cases can be fatal. AstraZeneca’s monoclonal antibody shot Beyfortus cuts by about 90 percent the risk of RSV-associated hospitalization for infants in their first respiratory virus season — but shortages of the drug last year left many families without the immunization.

Expansion efforts: Sanofi, which leads the therapy’s marketing, said that efforts to expand manufacturing are progressing as planned.

“Based on this, and assuming regulatory validations are delivered in due time by regulatory agencies, Sanofi and AstraZeneca are confident to meet global commitments and build inventory that can be used in future RSV seasons,” Santos said in an email. “In addition, the companies are producing Beyfortus well in advance of the RSV season, with the vast majority of doses planned to be available by October.”

CDC Director Mandy Cohen and agency officials recently visited a Thermo Fisher Scientific manufacturing plant in Greenville, North Carolina, that handles what is known as fill and finish for Beyfortus.

What’s next: There still could be surprises. A manufacturing insider familiar with AstraZeneca’s production efforts granted anonymity to speak candidly about the upcoming season said that while manufacturing capacity is stronger, the shot is complicated to make.

“If there were any hiccups along the way, that would potentially cause a disruption,” the person said, adding that pivoting to produce more in the moment is not a surefire solution.

IT’S WEDNESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Summer is approaching, and it’s a great time to grab a source coffee or lunch.

Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

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In Congress

Elizabeth Warren speaks with reporters at the U.S. Capitol.

Sen. Elizabeth Warren and other lawmakers are asking the FDA to require hearing aid manufacturers to disclose whether their products contain proprietary software. | Francis Chung/POLITICO

HEARING AIDS BACK IN THE HOT SEAT — A bipartisan group of lawmakers wants the FDA to force hearing aid companies to disclose whether their devices contain software that compels consumers to return it to the manufacturer or network-affiliated clinics or doctors for repairs, replacements or adjustments.

The push is notable because it comes in light of the FDA finalizing regulations that allowed over-the-counter hearing aids to be marketed in the U.S., meaning consumers can sidestep an audiologist visit.

“When a consumer buys a locked hearing aid from a company that goes out of business, they are left unable to repair it should it break or even need routine repairs,” Sens. Elizabeth Warren (D-Mass.) and Marsha Blackburn (R-Tenn.) and 13 other lawmakers wrote to FDA Commissioner Robert Califf. “Additionally, when a consumer moves or is traveling far from where they originally purchased the hearing aid, they may effectively become unable to have the device serviced at all.”

The lawmakers want the FDA to issue a rule that would require hearing aid labels to contain a disclaimer if the devices are locked.

Research Corner

EAT THOSE PEANUTS EARLY — Regularly feeding infants peanuts until they are 5 years old reduces the rate of peanut allergies in adolescence by 71 percent, according to a new study by the NIH’s National Institute of Allergy and Infectious Diseases.

“If widely implemented, this safe, simple strategy could prevent tens of thousands of cases of peanut allergy among the 3.6 million children born in the United States each year,” NIAID Director Jeanne Marrazzo said in a press release.

Drug Pricing

FIRST IN RxP: PCMA PRIMES YEAR-END DEBATE — The Pharmaceutical Care Management Association, the industry group for pharmacy benefit managers, is launching a six-figure summer ad blitz as they look to stave off legislation attacking their members’ business models, Megan reports.

The campaign, “How PBMs Work,” aims to counter drugmakers’ attacks on PBMs, blaming them for driving up the cost of medicines. The videos — short vignettes and longer-form testimonials — feature business owners touting the benefits of the PBMs they contract with for pharmacy benefits.

“The campaign will tell the employer’s side of the pharmacy benefit story, including why the vast majority of employers voluntarily choose to hire PBMs to help design their prescription drug benefit to best meet the unique needs of their organization and employees,” said PCMA CEO JC Scott.

PCMA is making an “initial six-figure” investment in advertising inside the Beltway in June and July, but a spokesperson for the group said that “the campaign will become a tentpole of PCMA’s long-term [advocacy] strategy going forward.”

Pharma Worldwide

CANADA EYES PHARMACARE PROGRAM — Canada’s Liberal government aims to pass so-called pharmacare legislation before Parliament breaks for the summer late next month, Kyle reports.

The legislation would establish universal coverage of a range of contraceptives and certain diabetes drugs — it wouldn’t include Ozempic — in the country, which has public health care available through the provinces and territories that don’t yet include prescription drug coverage. A mix of private and public payers covers Canadians’ medications.

Should the legislation pass, the federal government will have to negotiate funding agreements for those drugs with the provincial and territorial governments — some of which have indicated they’re not interested in participating.

Passing pharmacare is a priority for the Justin Trudeau-led Liberals, who have an agreement with the left-leaning New Democratic Party to pursue the legislation to maintain their hold on power.

WHAT WE'RE READING

Johnson & Johnson struck a deal to buy an experimental skin disease drug for $1.25 billion, BioPharma Dive’s Ben Fidler reports.

Document Drawer

The FDA issued a priority review voucher to Pfizer for its Covid-19 antiviral Paxlovid. The company can use the voucher to expedite the review of a future drug or sell it to another drugmaker.

The FDA is co-sponsoring a public workshop on using patient-generated health data in the development of medical devices on June 26-27.

Former NIAID Director Anthony Fauci will testify before the House Select Subcommittee on the Coronavirus Pandemic on June 3.

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