The race for combo Covid-flu shots

Aug 20, 2024

Driving the Day

Vaccine

Several drugmakers are working to develop a combination flu and Covid vaccine that will pass muster with the FDA. | Siphiwe Sibeko/Pool via AP

WHERE’S THE ONE-TWO PUNCH? With respiratory virus season approaching — and the FDA green light for updated Covid-19 shots expected soon — your morning hosts decided it’s time for a checkup into the status of combination Covid and flu vaccines.

Pfizer and BioNTech reported Friday that their candidate combo shot failed to meet its immune-response goals against the influenza B strain, despite the vaccine meeting or exceeding its endpoints for Covid and flu A.

“The companies are evaluating adjustments to the combination vaccine candidate aimed at improving immune responses against influenza B and will discuss next steps with health authorities,” they said in a statement.

That means Moderna could be better positioned to get a combination mRNA vaccine to market. The company said earlier this summer that its Phase III trial met its primary endpoints and provoked higher immune responses against both viruses than licensed vaccines in people 50 and older.

Moderna “is engaging with regulators on next steps,” it said in an Aug. 1 release about its second-quarter earnings.

Caution note: A research note by Leerink Partners, a health care investment bank, questioned whether the weak flu B results for Pfizer and BioNTech’s vaccines could signal challenges for mRNA-based combination vaccines, meaning Sanofi and Novavax have an opening for a peptide-based combination vaccine in development.

Novavax plans to launch its Phase III trial for both its combination shot and its flu vaccine in the fourth quarter of 2024, with data expected by the middle of next year. Company officials have previously said they’re targeting FDA approval for the combination vaccine by the beginning of the 2026-2027 flu season.

Market analysts at William Blair also noted that problems generating such responses to flu B strains aren’t new and that — while Moderna may have a leg up on its candidate now — Pfizer and BioNTech shouldn’t be counted out.

Public health benefits: Covid has yet to fall into a predictable seasonal pattern like other coronaviruses and the flu, as evidenced by summer disease spikes that have persisted since the pandemic’s onset.

Still, Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said combining Covid and flu vaccines into one product would help reach individuals who may not be keen to receive multiple jabs to ward off the infections, noting how pediatric combo shots targeting a litany of pathogens have made it easier to protect children.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. ICYMI, Lauren appeared on C-SPAN’s Washington Journal on Saturday to talk and take viewer questions about the results of the first Medicare prescription drug price negotiations.

Reach out and send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

Drug Pricing

A sign for the California delegation and the stadium scoreboard are seen at the Democratic National Convention at the United Center in Chicago

Delegates at the DNC approved the Democrat's party platform, which includes proposals to lower prescription drug costs. | Francis Chung/POLITICO

DEM PLATFORM: EXPAND NEGOTIATIONS, PRICE CAPS — Among the 92-page Democrat party platform approved by delegates Monday night are familiar prescription drug policy proposals to anyone who has tracked the Biden administration.

The 2024 platform calls to expand the cap on monthly out-of-pocket costs on insulin spending and the total cap for all drugs at $2,000 a year to Americans not on Medicare. Democrats also aim to expand the Inflation Reduction Act’s Medicare drug price negotiations to at least 50 additional drugs a year compared to the 15 additional drugs being added to the program in 2027.

Democrats also say they want to expand inflation rebates — which aim to disincentivize drugmakers from raising prices faster than inflation — from Medicare to the private insurance market as well.

Antitrust watch: The platform pledges to use antitrust laws to challenge hospital, insurance and pharmaceutical mergers “that undermine competition and increase health care prices for consumers.”

In the Courts

AMP SUES FDA OVER LDT RULE — The FDA’s final rule for laboratory-developed tests is facing another lawsuit from an industry group — this time, the Association for Molecular Pathology.

The group argues that the FDA overstepped its regulatory authority, adding that modernizing CMS’ Clinical Laboratory Improvement Amendments regulations is a more effective way to oversee lab tests.

The new lawsuit, filed Monday in the U.S. District Court for the Southern District of Texas, follows a similar lawsuit against the FDA regulation that the American Clinical Laboratory Association filed in May.

Industry Intel

DEMOCRATIZING TRIALS — Walgreens and HHS’ Biomedical Advanced Research and Development Authority launched a partnership Monday to promote decentralized clinical research in hopes of better diversifying trials.

Just 5 percent of the U.S. population participates in clinical trials, and companies are often delayed meeting their enrollment targets, Walgreens said. The FDA released guidance in June detailing how drug and device companies should approach enrolling clinical trial participants to ensure greater diversity and improve data quality.

“Our network of community pharmacies and our compliant and secure clinical trial platform enables us to pioneer a comprehensive solution to make clinical research an integral part of a patient’s healthcare journey, especially when it is most critical for the well-being of our country, during a public health emergency,” Ramita Tandon, Walgreens’ chief clinical trials officer, said in a statement.

The national pharmacy chain is already working with BARDA on a Phase IV observational study of immune responses to the Covid vaccine.

Pharma Worldwide

WILL EUROPE SHARE MPOX VACCINES? European health systems are bracing for cases of a type of mpox more dangerous than the one that spawned a 2022 outbreak as African governments struggle to access vaccines against the virus, POLITICO’s Rory O’Neill reports.

The French government says it will donate shots to the most affected African nations, while other governments say they’re monitoring their own supplies. The World Health Organization, which declared mpox a public health emergency of international concern on Aug. 14, has said a “coordinated international response” is crucial to combating the outbreak, so governments will be under pressure to send vaccines to where they’re needed most instead of stockpiling them.

Commitments so far: The European Commission has agreed to donate more than 215,000 vaccine doses, 40,000 of which are a donation from the manufacturer Bavarian Nordic. But some European governments want to ensure they have enough supplies for their own citizens.

Dutch Health Minister Fleur Agema said she would wait to ensure the Netherlands had enough doses before deciding on a donation. The Netherlands has about 100,000 shots stockpiled, while African health authorities suggest they need 10 million vaccines to control the outbreak.

Sound familiar? Vaccine nationalism persisted during the height of the Covid pandemic, with experts warning it could cause more coronavirus mutations. With mpox, hoarding doses in Europe would prevent African countries from curbing the spread within — and beyond — its borders.

WHAT WE'RE READING

Racial and economic disparities persist in access to popular weight-loss drugs, The Washington Post’s Ariana Eunjung Cha writes, reporting from Atlanta.

Brookings’ Anna Anderson-Cook and Richard Frank used publicly available data to approximate how the estimated $6 billion in savings from the Medicare drug price negotiation program are distributed across the 10 drugs.

Document Drawer

The FDA convenes its Vaccines and Related Biological Products Advisory Committee on Sept. 20 to discuss pertussis vaccine development and hear an update on the agency’s Laboratory of Mucosal Pathogens and Cellular Immunology research program.

The FDA will hold a webinar on Aug. 22 for labs on how to comply with medical device reporting requirements and other related regulations.

The FDA issued final guidance containing recommendations on how generic drug applicants or prospective applicants can request and hold product-specific guidance meetings.

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