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Novavax could soon get its shot authorized – but who will want it?
The Trump administration invested $1.6 billion in a Maryland biotechnology company that had never before successfully launched a vaccine.
Nearly two years later, Novavax’s coronavirus shot may soon get the Food and Drug Administration’s greenlight after several setbacks, including manufacturing issues.
Yesterday, a panel of independent vaccine experts recommended the agency authorize the shot. But the FDA is unlikely to make a decision right away — like it did for the country’s other three vaccines — due to an ongoing review of the company’s manufacturing processes, our colleagues Carolyn Y. Johnson and Laurie McGinley report.
Some experts have hoped the more traditional vaccine could help win over unvaccinated holdouts who are either allergic to an ingredient in the cutting-edge mRNA shots available today or were waiting for another option. But the rollout is likely to be slow, and it’s still not clear how many doses will be available in the United States.
- The federal government is coordinating with Novavax to “receive a limited quantity of vaccine” using funds under its current agreement, a Department of Health and Human Services spokesperson told The Health 202. The administration is committed to ensuring those who want a non-mRNA option can get one, the spokesperson said, though declined to answer further questions on what limited quantity meant.
- Meanwhile, a Novavax spokesperson said the company expects the first order from the U.S. government will be for “millions of doses,” and that the exact quantity is still being finalized.
A good 🧵 on the meeting from Stat's Helen Branswell:
1. #VRBPAC is meeting today to review Novavax's submission for an EUA for its Covid vaccine. Often @matthewherper & I live blog VRBPAC meetings but not today. I'll try to live tweet.— Helen Branswell 🇺🇦 (@HelenBranswell) June 7, 2022
Gonna be an interesting day.
If you want to watch the meeting: https://t.co/DPR3XqbOrH
The new vaccine isn’t likely to have a massive impact on the country’s vaccination campaign.
The potential for a fourth vaccine in the country’s arsenal comes as three-quarters of Americans 18 and older are already fully vaccinated. Yet it deploys an older and more familiar technology.
- The Novavax shot is a protein-based vaccine — a traditional technology already used against influenza, shingles and hepatitis B. Such shots take longer to make, Carolyn and Laurie explain.
- By contrast, the messenger RNA shots from Pfizer-BioNTech and Moderna instruct the body’s cells to build proteins that teach the immune system to halt the coronavirus.
Federal officials and experts argue it’s important to have multiple vaccine options, even if it won’t convince a wide swath of vaccine holdouts to get the shot. The company plans to seek permission for the shot as a booster — which is how it will most likely be used — and for use in adolescents and children. This comes as only roughly half of those vaccinated have received a booster shot.
“Having a protein-based alternative may be more comfortable for some in terms of their acceptance of vaccine,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at yesterday’s advisory committee meeting.
How protective is the vaccine? The shot was shown to be 90 percent effective in a clinical trial, results which were announced roughly a year ago. But that came before the emergence of the omicron variant, and some of FDA’s advisers expressed disappointment that there wasn't updated data on its efficacy.
That led one adviser — Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation — to ultimately abstain from voting. He explained that he was giving the vaccine a “conditional yes,” since it had been generally shown to be safe and effective, but that “we don’t know whether that is true today,” Carolyn and Laurie write. He was the only one to abstain, and 21 voted in favor of the vaccine. There weren’t any no votes.
As for rare heart inflammation … There had been hopes that Novavax’s shot wouldn’t lead to the condition associated with mRNA vaccines. But the FDA’s analysis identified five cases, though the company’s executives pushed back against the agency’s concerns. They argued the rates of the condition were about the same in the group that received the shot and those who instead got a placebo.
Expanding Medicaid in South Dakota won't get harder
Voters resoundingly rejected a constitutional amendment that would have required certain ballot initiatives pass with 60 percent support rather than a simple majority. Such a rule would have applied to the voter referendum to extend the safety net program on the South Dakota ballot in November.
As of this morning, the South Dakota secretary of state's website had the initiative to raise the threshold losing 67 percent to 33 percent after the state’s primary election yesterday. Major groups had poured resources into the opposition, such as advocacy group the Fairness Project and Sanford Health, a major health system headquartered in South Dakota.
But the amendment also had a powerful ally. Americans for Prosperity, the main political arm of the influential Koch network, had donated hundreds of thousands of dollars in mailers and postage, digital and media ads, and canvassing efforts.
FTC to investigate PBMs amid high drug prices
The Federal Trade Commission is launching a probe into how pharmacy benefit managers (PBMs) affect the accessibility and affordability of prescription drugs for millions of Americans.
The consumer protection agency said it will order six of the nation’s largest PBMs to turn over information and records detailing their business practices.
Key context: PBMs are the middlemen that negotiate rebates and fees with drug manufacturers, create formularies and more. Critics allege that some PBMs charge health insurers more than they reimburse pharmacies for prescription drugs and pocket the difference — a dynamic that some argue prompts drugmakers to push prices even higher.
The agency said it will look at the “complicated and opaque methods” to determine pharmacy reimbursement, efforts to steer patients to PBM-owned pharmacies and their specialty drug policies.
Officials from CVS and Prime Therapeutics said they intended to cooperate, Reuters reports. Meanwhile, the major PBM trade group — the Pharmaceutical Care Management Association — defended the industry, expressing confidence that any examination of the middlemen will show that they are decreasing drug costs for consumers.
Alvaro Bedoya, FTC commissioner:
2/ Instead, they're told that the medicine can only be dispensed by the PBM’s mail order specialty pharmacy. The family was to go home and wait *two weeks* to receive the medicine for their child in the mail.— Alvaro Bedoya (@BedoyaFTC) June 7, 2022
Sen. Chuck Grassley (R-Iowa):
Glad FTC followed my request & will probe Rx middlemen aka PBMs We need more transparency/accountability in Rx pricing 2 lower prices u pay @ pharmacy counter Need 2 also pass my bipartisan Rx pricing bills Wyden-Grassley/Rx Pricing 4 the People Act /PBM Transparency Act— ChuckGrassley (@ChuckGrassley) June 7, 2022
On the Hill
Senate advances toxic burn pits legislation
The Senate voted to advance legislation that would expand health care and disability benefits to millions of veterans exposed to toxic burn pits during their time in the military.
The bill cleared a Senate procedural hurdle in a 86 to12 yesterday, setting up full passage in the coming days. All 12 lawmakers who voted against the bill were Republicans.
The bill would almost certainly be signed into law by President Biden, who has wondered publicly if burn pits contributed to the brain cancer that killed his son, Iraq War veteran Beau Biden, and has vowed to help other veterans exposed to the toxins.
Sen. Marco Rubio (R-Fla.):
Right now veterans exposed to toxic “burn pits” have to fight with the @DeptVetAffairs to get medical care but the Senate will soon pass our bill to get them the help they have earned and deserve pic.twitter.com/2bxdhpVvr0— Marco Rubio (@marcorubio) June 7, 2022
Hopes for quick gun deal fade as Senate negotiators plead for patience
Senators buckled down Tuesday for days of additional negotiations on a response to recent high-profile mass shootings, and pleaded for patience as they expressed optimism that a long-elusive deal to address gun violence might be possible, The Post’s Mike DeBonis reports.
The calls for more time come as a small bipartisan group of senators negotiate a legislative package that could include the first new significant federal gun restrictions in decades, along with provisions for school security and mental health. But a top Republican said the lawmakers would not be ready for a vote this week.
Among the possibilities: Several modest restrictions are under discussion, including a system to potentially screen gun buyers under 21 for juvenile offenses and mental health episodes.
Republicans said this week there is a growing consensus on finding a way to search sealed juvenile justice and mental health records for gun buyers under 18. Such a measure, though, would take time and prolong the waiting process for those buyers — something gun rights groups, like the National Rifle Association, fiercely oppose.
Reproductive Freedom Taskforce launches ahead of Supreme Court decision
The Committee to Protect Health Care, an advocacy coalition of health-care professionals, this morning launched a new Reproductive Freedom Taskforce to protect and expand abortion access.
The coalition of health-care providers, attorneys and elected officials will tell the public about what it believes are the consequences of limiting access to the procedure and work to elect abortion rights candidates at all levels of the government.
The launch of the task force comes before the Supreme Court is set to issue a ruling in a Mississippi abortion case that may overturn Roe v. Wade’s decades-old protections. More than 2,500 health-care professionals also released an open letter urging the Supreme Court's justices to uphold the right to an abortion.
Our colleagues dove into the politics behind how we talk about abortion and what it could mean for reproductive health care.
CDC clarifies masking advice for monkeypox
The Centers for Disease Control and Prevention recommended travelers wishing to protect themselves against monkeypox wear masks last week. But by late Monday night, that recommendation was gone, the New York Times reports.
The CDC said it removed the advice because it caused confusion, but still advises household contacts and health-care workers to consider masking in countries where monkeypox is spreading. According to preliminary data, the latest outbreak of monkeypox in the U.S. has been primarily spread by men who have sex with men.
Most information about the monkeypox has been gleaned from studies on smallpox, its viral cousin. While smallpox is usually transmitted by large droplets expelled by infected individuals, experts say it can occasionally be spread via small particles in the air.
Health officials have yet to explicitly address whether airborne transmission is possible or the use of masks. In interviews with the NYT, they emphasized the role of large respiratory droplets expelled from infected patients, saying monkeypox requires “really close sustained contact.”
Don’t say I didn’t warn you pic.twitter.com/YrTEwLbTka— Dr. Glaucomflecken (@DGlaucomflecken) May 21, 2022
Thanks for reading! See y'all tomorrow.