Breaking News

Advisers vote on updated Covid vaccine, FDA punts on CBD, & buying banned flavored vapes in California

January 27, 2023
Reporter, Morning Rounds Writer
Good morning. What do you get when you're the only reporter at a federal official's 65th birthday celebration at a Hispanic senior center in D.C.? An exclusive, of course, from Xavier Becerra on enrolling in Medicare, annual Covid vaccines, and seniors' mental health. Read Sarah Owermohle's story here.

vaccines

FDA advisers recommend updating Covid shots

Covid vaccines
Paul White/AP

In a unanimous vote yesterday, an FDA advisory panel endorsed a plan to move all Covid vaccines to the formulation now used in updated boosters, in hopes of creating a single annual Covid shot for most Americans. The advisers said a single vaccine would be more effective and less confusing to people who get it and the health care workers who administer it. The 21-to-0 vote directs vaccine manufacturers Pfizer/BioNTech, Moderna, and Novavax to "harmonize" the primary series of their vaccines — the first doses that people receive — with the new bivalent booster containing both the original strain of the SARS-CoV-2 virus and a new Omicron strain.

Panel members also supported the FDA's plan to move to a single annual vaccine dose matched annually to circulating strains of the SARS-CoV-2 virus,  giving two doses to older people, immunocompromised individuals, and young children. But the FDA did not ask the panel to vote on these elements. Read more here and don't miss the day's twists and turns here.


policy

FDA passes on regulating CBD, turning to Congress for help

Nearly four years ago, then-FDA Commissioner Scott Gottlieb organized a working group to examine whether a pathway could be created for supplement makers or food companies to legally sell CBD products. Yesterday the agency turned to Congress instead, asking for help finding a way to sell CBD in capsules, gummy vitamins, and foods, along with guidance on other hemp products like Delta 8 THC. 

A statement from Janet Woodcock, the FDA's principal deputy commissioner, was light on details but implied that legislation could include such restrictions as CBD serving size limits and minimum purchase ages. But it's not clear what Congress will do. Lawmakers have previously introduced legislation directing the FDA to regulate CBD, but sometimes that meant regulating the product as a dietary supplement. Meanwhile, people in the dietary supplement industry are frustrated. STAT's Nicholas Florko has more.


Health

Ban on gay men donating blood to be modified 

The FDA plans to ease a ban on gay and bisexual men donating blood, relaxing restrictions that date back to the 1980s AIDS crisis, agency sources told the Washington Post. The policy prohibiting donations from men who had sex with men will be modified to focus on sexual behaviors, regardless of gender, that pose a higher risk of contracting and transmitting HIV. Gay and bisexual men in monogamous relationships will no longer be forced to abstain from sex to donate blood under federal guidelines.

Potential donors, regardless of gender and sexual orientation, would be asked if they have had any new sexual partners in the past three months, a person familiar with the FDA proposal told the Post. They can give blood if they say no. Those who have had new sexual partners would be asked if they had engaged in anal intercourse in the past three months; those who have would be asked to wait three months to donate. 



closer look

Flavored vapes are against the law in California. It's easy to buy them despite longtime bans

A California vape store.
Nicholas Florko/STAT

Sales of flavored vapes are now illegal across California. But STAT's Nicholas Florko had no trouble buying them. Earlier this month he visited 24 shops in Oxnard, Ventura, Pasadena, El Monte, Carson, and West Hollywood, Calif. — all of which have long had local bans on flavored vapes. Seventeen shops sold them anyway. Oxnard is doing better: None of five shops Nick went to did. 

Some shops appear to be flouting the law with no repercussions, like two shops in Ventura selling vapes less than a block from City Hall. Enforcement of the new law will primarily be handled by the same local jurisdictions that failed to enforce their own policies, not the state attorney general. "If California doesn't enforce this law against the manufacturers and distributors quickly, then trying to do it store by store [will be] an enforcement nightmare," Matt Myers of the Campaign for Tobacco-Free Kids told Nick. Read more.


pharma

Biosimilar versions of Humira are coming. Here's why we should pay attention

It's a watershed moment for biosimilars, medicines intended to cost less than the biologic treatments they mimic. A parade of these alternatives to the world's best-selling medicine will start rolling out next week when the first biosimilar version of Humira becomes available. Just like the original, it will treat rheumatoid arthritis and other autoimmune disorders. But its arrival will mark the end to a patent thicket created by Humira's maker, AbbVie, to keep its hold on the billions of dollars a year the drug represents.

Historically, hopes had been high for patients and health payers like Medicare to save money by choosing identical variants of many brand-name biologic medicines that deliver the same health outcomes but at a lower cost. That hasn't happened — yet — but the needle is moving in that direction, STAT's Ed Silverman tells us. Read what's involved, from rebates to prescribing patterns to interchangeability.


health inequity

Attention on white 'deaths of despair' overshadows rising Indigenous mortality rates, report says

STAT's Usha Lee McFarling brings this report: A new perspective piece in Lancet is challenging the widespread notion that "deaths of despair" — a steep rise in midlife mortality in recent decades tied to economic hardship in the working class — are a unique phenomenon among white people. The original 2015 study that spawned the term — and many that have followed — compared white populations only to Black and Hispanic populations, leaving out Indigenous people, whose midlife mortality rose three times higher than white people in the original study period, 1999-2013. 

Because of higher death rates due to Covid, and even higher rates than white people of deaths due to alcoholic liver disease and overdose, midlife mortality rates among Indigenous people in 2020 were 102.6% higher than those in white populations. Even that stark number is likely an undercount due to misclassification of race on death certificates, the authors note. Calling out the data gap, the authors say the finding that deaths of despair are a uniquely white phenomenon "was only made possible by the erasure of data describing Native American mortality."


by the numbers

jan. 26 cases covid-chart-export - 2023-01-26T173601.459


jan. 26 deaths covid-chart-export - 2023-01-26T173625.376


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What we're reading

  • FDA pulls Evusheld authorization as coronavirus evolution quashes another therapy, STAT
  • The cause of depression is probably not what you think, Quanta
  • Long Covid: What do the latest data show? Kaiser Family Foundation
  • Why inventing a vaccine for AIDS is tougher than for Covid, NPR
  • Warren urges the FTC to scrutinize two pharma mergers over "anti-competitive" practices, STAT

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