Marks confident in bird flu vaccine stockpile

Apr 02, 2024

Driving The Day

Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research testifies in Congress

The FDA's Peter Marks says the U.S. stockpile of avian flu vaccines would be effective against the infection. | Susan Walsh/Getty Images

STOCKPILE ON DECK — Dr. Peter Marks, the FDA’s top vaccine regulator, said Monday he’s confident the U.S. stockpile of avian flu-specific vaccines would work well if deployed. The remarks came the same day the CDC confirmed that a Texas dairy worker fell ill with bird flu.

“We believe that, if we needed to, they would be reasonably good matches," Marks said at the World Vaccine Congress in Washington, responding to Lauren's question about whether the stockpiled vaccines would be effective against the avian flu strain.

Whether the federal government would activate new vaccine production depends on how the situation unfolds, Marks indicated.

“Just because of being on edge from Covid, there are a lot of people looking at what’s going on here, and there’s probably a pretty low threshold to pull the trigger here,” he said. “This is one case we’re a little luckier because it’s a pathogen that we know. We know what this is and what we have in the freezer, so to speak. We have a little bit of a leg up on at least getting started.”

But at the conference, Dr. Luciana Borio, a former FDA official, questioned the vaccines’ potency. The shots’ two-dose regimen, which the FDA approved in 2007, produced antibody levels expected to reduce the risk of getting avian flu by 45 percent.

“I’m not as confident as Dr. Marks,” she said after his remarks.

ICYMI: The second case of H5N1 bird flu ever recorded in the U.S. is worrying public health experts who for decades have warned the disease could pose a serious threat. The virus has also sickened cows across several states in recent weeks.

The increasing prevalence of avian influenza in cows means that human surveillance of farmworkers and dairy workers should be bolstered, according to Scott Becker, CEO of the Association of Public Health Laboratories.

“The bigger picture is that this virus is not cooling off,” said Jennifer Nuzzo, director of the Pandemic Center at the Brown University School of Public Health. “We’ve been worrying about this virus for 20 years, more than 20 years. And in the last year, it has really been remarkable in how far across the globe it has been spreading and how many species it’s been affecting.”

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Coronavirus

A man receives the coronavirus vaccine in Sudan

Access to mRNA Covid vaccines was limited in many low-income countries. | Ebrahim Hamid/AFP via Getty Images

COVID REFLECTIONS — Marks urged policymakers to consider international perceptions around vaccine candidates earlier during the next pandemic at his appearance on a World Vaccine Congress panel.

Highly effective messenger RNA vaccines by Pfizer-BioNTech and Moderna dominated the immunization programs in wealthy Western nations. But access to the shots in many low-income countries lagged, meaning those nations relied more on other vaccines that some viewed as inferior to mRNA shots.

“The different flavors of vaccines that got put out there and some of the back-and-forth did not do us all that great for vaccine hesitancy at times,” Marks said. “That’s something we need to think about as we move forward — the fact that we now have a globally connected world, where everyone knows what everyone else is getting, and so you can't have the good sauce and ‘just OK’ sauce anymore.”

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Around the Agencies

MORE TIME FOR SHORTAGE COMMENTS — HHS and the Federal Trade Commission are extending the deadline until May 30 for public comment on a joint request for information about how practices of group purchasing organizations and drug wholesalers could be contributing to generic drug shortages.

The groups want feedback on whether concentration among the groups contributes to persistent drug shortages that have plagued patients in recent years, such as generic cancer drugs. It is unclear if or when the government will take action based on the information it receives.

VAX PATCH PUSHED — The Biomedical Advanced Research and Development Authority announced it is launching a $50 million prize competition that aims to bring a new vaccine administration method to market for those scared of needles.

CMS ANNOUNCES MA RATES — Medicare Advantage payments will increase by 3.7 percent in 2025, a blow to insurers that contend the new rates are insufficient given rising medical costs, POLITICO’s Robert King reports.

Tobacco

HEALTH GROUPS PAN MENTHOL BAN DELAY — Public health groups, including the American Heart Association, slammed the Biden administration on Monday for sitting on regulations to ban menthol cigarettes and flavored cigars.

The FDA had targeted a March release of the two final rules, but the White House Office of Information and Regulatory Affairs is still reviewing them.

“The administration’s inaction is enabling the tobacco industry to continue aggressively marketing these products and attracting and addicting new users,” AHA CEO Nancy Brown said in a statement.

The tobacco industry argues the menthol ban could adversely impact policing in Black communities if it is put in place.

Industry Intel

NEW REGIMEN FOR ALZHEIMER’S DRUG — Drugmaker Eisai has submitted a supplemental biologics license application to the FDA for monthly maintenance doses of its Alzheimer’s treatment Leqembi.

Patients who have completed an initial dosing regimen — which is still being determined by regulators and the manufacturer — would get a monthly dose intravenously to sustain clearance of amyloid-beta plaques believed to contribute to the disease’s progression.

Eisai, which markets Leqembi in the U.S. with Biogen, has also requested “fast-track” designation from the FDA for a form of the weekly maintenance therapy administered under the skin, for which it expects a response within two months.

WHAT WE'RE READING

Some experts think the CDC’s guidance for administering a maternal vaccine and an infant monoclonal antibody targeting respiratory syncytial virus is too strict, leaving babies vulnerable to a virus that many parents are eager to access, The Atlantic writes.

Neurologists and patients fear that the method a U.K. agency uses to evaluate the cost-effectiveness of a treatment for a rare genetic form of ALS could stymie access in the country, STAT reports.

The FDA warns clinicians that a certain heart pump poses a risk of puncturing a wall of the organ — but hasn’t pulled it from the market, The New York Times reports.

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