Moderna varies vaccine dosing with teen, kid EUAs on hold

Feb 25, 2022

Presented by the Pharmaceutical Care Management Association (PCMA)

With Katherine Ellen Foley

On Tap

— Moderna is evaluating smaller doses of its Covid-19 vaccine in children as it works with FDA to get authorization for its use beyond adults.

— Sanofi and GlaxoSmithKline plan to ask U.S. and European regulators to green-light their Covid vaccine.

— The FTC is asking for public comment on PBM business practices.

It's Friday. Welcome back to Prescription Pulse. The seven-day moving average of Covid-19 infections and deaths in the U.S. is declining, but more than 1,600 people are still dying each day, according to CDC data.

Send tips and feedback to David Lim (dlim@politico.com or @davidalim), Lauren Gardner ( lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).

A message from the Pharmaceutical Care Management Association (PCMA):

Over the past half decade, brand pharmaceutical manufacturers have undertaken a massive campaign to deflect blame for their pricing decisions. Ironically, the industry that controls the list price of prescription drugs has attempted to point the finger at those focused on reducing the cost of prescription drugs for patients and payers. We urge Congressional negotiators to continue to resist the latest attempts to shift the blame that puts profits over patients.

Coronavirus

MODERNA EXECS DIVULGE DOSING, BOOSTER STRATEGIES — Moderna is testing smaller doses of its Covid-19 vaccine in adolescents and younger kids as it awaits FDA's review of its original 100-microgram dose series for teens 12 to 17, company officials said Thursday during their fourth-quarter 2021 results call. However, it still plans to seek emergency use authorization for 100-microgram doses for teens who are immunocompromised or otherwise predisposed to severe disease outcomes from Covid. Those details are the most we've heard in several months about the vaccine manufacturer's bid to inoculate younger Americans.

Quick review: Moderna sought an EUA for 12- to 17-year-olds in June, just weeks before FDA added warnings about myocarditis to the messenger RNA shots' fact sheets amid mounting evidence of a side-effect link concentrated around males under 40. A CDC vaccine surveillance program and watchdog counterparts in other countries signaled the overall risk for the condition was higher after the Moderna primary vaccine series than for those who got Pfizer, leading some nations to restrict the age range of citizens who can receive the shots.

The company announced plans in July to expand the size of its trial for children ages 5 to 11 at FDA's urging, as cases of the inflammatory heart condition post-mRNA vaccination grew worldwide. By October, the drugmaker said it would delay seeking authorization for a 50-microgram two-dose regimen for kids 6 to 11 until FDA finishes evaluating the vaccine's myocarditis risk for teens.

Lower dose: Moderna executives said the company is now testing 50-microgram doses for the adolescent series and 25 micrograms for the pediatric series, nodding to FDA's influence. It expects data on children 6 months to 5 years old by the end of the first quarter.

Still, Moderna President Stephen Hoge pointed out that several developed countries and political bodies — like the European Union, the United Kingdom, Australia and Canada — have endorsed the company's full-dose immunization regimen for adolescents.

"We do believe that 100 micrograms provides a benefit more broadly, which is why it's been authorized globally," he said. "But we'll continue to work with the FDA and the U.S. to evaluate other potential dose-sparing strategies and submit that data as we develop it."

The future is boosters: The company expects a seasonal booster to be needed every fall to curb severe disease as Covid shifts toward endemicity, Hoge said. Moderna is developing an Omicron-specific bivalent booster based on earlier bivalent candidates that may have had the potential to provide more durable protection against variants of concern.

SANOFI, GSK TO SEEK AUTHORIZATION FOR COVID SHOT — Sanofi and GlaxoSmithKline plan to apply for authorizations from U.S. and European regulators for its Covid-19 vaccine, the companies said Wednesday. Data from their booster and Phase III efficacy trials show a positive safety profile and immune response, including when the vaccine was used as a booster for someone who'd received a primary series of another product. If green-lit, the protein-based, refrigerator-stable shot is expected to be a popular option for countries that have trouble accepting shipments of vaccines that require ultra-cold storage.

FDA AUTHORIZES CHANGE TO EVUSHELD DOSE — AstraZeneca's monoclonal antibody Evusheld should be administered at a higher initial dose than previously authorized, FDA said on Thursday. The change comes after data indicated a higher dose may be more successful at preventing infection by Omicron subvariants.

"Patients who have already received the previously authorized dose (150 mg of tixagevimab and 150 mg of cilgavimab) should receive an additional dose of 150 mg of tixagevimab and 150 mg of cilgavimab as soon as possible to raise their monoclonal antibody levels to those expected for patients receiving the higher dose," FDA said in its announcement of the emergency use authorization revision.

FDA said that since it's not known what Covid-19 variant will be dominant in the U.S. in the coming months, new recommendations for repeated dosing cannot be provided yet.

A message from the Pharmaceutical Care Management Association (PCMA):

Eye on FDA

FOR THE FIRST TIME, PILLS ACCOUNT FOR MOST U.S. ABORTIONS — Abortion pills, which FDA decided in December can be prescribed via telemedicine and dispensed at local pharmacies or through the mail, are the most popular method for ending a pregnancy in the U.S. for the first time since their approval, POLITICO's Alice Miranda Ollstein reports. The pills' rise in popularity comes amid a national battle over access to the pill. A federal push to make the drugs more accessible is running into a wall of red states restricting or banning their use.

FDA EXPANDS APPROVAL FOR DIABETES DRUG TO TREAT HEART FAILURE — FDA expanded the use of Eli Lilly and Boehringer Ingelheim's type 2 diabetes drug Jardiance to treat heart failure regardless of ejection fraction, a measure of how well the left ventricle pumps blood. FDA first approved Jardiance in 2014, later expanding approval to include the reduced risk of cardiovascular death in people with diabetes and certain kinds of heart failure. It made the latest expanded approval, announced Thursday, via priority review after Jardiance reduced the number of patients hospitalized for heart failure in a two-year trial of nearly 6,000 participants.

FDA PLANS TO PROPOSE RULE ON DISTRIBUTION OF CERTAIN COMPOUND DRUGS — FDA announced Wednesday it would begin the rule-making process regarding the transport of compounded drugs across state lines in some circumstances. In 2020, FDA created a memorandum of understanding that states could ratify to address interstate distribution of compound drugs, but several pharmacies sued the agency over what they believed would be harmful to small businesses and patients. In 2021, the U.S. District Court for the District of Columbia sided with the pharmacies; the current memorandum of understanding is void.

FDA GREENLIGHTS FIRST CONDOM INDICATED FOR ANAL SEX — FDA on Wednesday granted a De Novo authorization to the first condom specifically indicated for anal intercourse — which carries "the greatest sexual exposure risk of HIV transmission" for those not using protection, according to the agency. In a clinical study, the One Male Condom, had a total failure rate of 0.68 percent for anal intercourse and 1.89 percent for vaginal intercourse.

"This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations," said Courtney Lias, director of FDA's Office of GastroRenal, ObGyn, General Hospital, and Urology Devices.

Around the Agencies

FTC SEEKS COMMENT ON PBM PRACTICES — The Federal Trade Commission issued a request for information Thursday on how the business practices of pharmacy benefit managers affect patients, doctors, employers, pharmacies and other businesses in the prescription drug space. The comment call, open through April 25, comes a week after the independent agency deadlocked on whether to begin a study of the biggest PBMs, the findings of which could have formed the basis of a future investigation.

Pharma Worldwide

CANADA APPROVES COVID-19 VACCINE WITH TIES TO BIG TOBACCO — Health Canada approved Medicago and GlaxoSmithKline's Covid-19 vaccine on Thursday, making it the first plant-based Covid-19 shot for adults. In late-stage trials, the two-dose vaccine prevented 71 percent of Covid cases with every variant except Omicron, which wasn't circulating at the time of the studies Philip Morris Investments B.V., a subsidiary of tobacco giant Philip Morris International, owns approximately a third of Medicago and partially funded the vaccine's development.

Pharma Moves

House Ways and Means Committee lawyer Orriel Richardson is joining Morgan Health, JPMorgan's health care arm. Richardson was previously a Democratic counsel for the panel's health subcommittee.

BD announced Wednesday Shana Neal will be its chief people officer effective April 4.

Rebecca Salay will be House Appropriations Chair Rosa DeLauro's new chief of staff once Liz Albertine departs.

Quick Hits

ResMed CEO Mick Farrell said the company cannot keep up with demand for respiratory care products due to Philips' recall of sleep apnea and ventilator devices as well as supply chain shortages of electronic components and semiconductors, MedTech Dive's Elise Reuter reports.

Document Drawer

FDA will hold a virtual public meeting on March 22 at 9:30 a.m. to discuss a program for enhanced review transparency and communication under the Biosimilar User Fee Act.

A message from the Pharmaceutical Care Management Association (PCMA):