FDA authorizes Novavax Covid vaccine, adding a more traditional shot to the mix

The FDA approved another Covid-19 vaccine for adults yesterday, a more traditional one developed by Novavax that the agency’s advisers hope might win over skeptics who have stayed away from mRNA vaccines. The vaccine still needs a recommendation from the CDC’s director, which will likely follow a meeting of its own expert committee.

The Pfizer and Moderna vaccines use messenger RNA to lead cells to create a protein on the virus’ surface that the immune system can recognize. The Novavax vaccine instead produces this protein in vats of insect cells and delivers it to patients with a chemical adjuvant that spurs the immune system to recognize it. “Anything we can do to make people more comfortable to accept these potentially lifesaving products is something we are compelled to do,” FDA’s Peter Marks said in June. STAT’s Matthew Herper has more.

Relaxed rules for methadone work, study suggests

Some good things have come out of the pandemic. One is the move to telehealth when appropriate and another, a new study in JAMA Psychiatry tells us, may be the change in rules around methadone access. Dating to the nation’s near lockdown in March 2020, federal rules allowed methadone clinics to let patients with opioid addiction who were stable take their medicine at home rather than under supervision in methadone clinics. Methadone is also an opioid, but when taken correctly in the proper doses, it can eliminate drug cravings without causing a high, helping people resume healthy lives.

The relaxed rules worked, researchers conclude: Fatal overdoses from January 2019 to August 2021 did not include more deaths involving methadone. The Associated Press has more here.

Senators call out FDA for not banning some synthetic e-cigarettes

Late last week STAT’s Nicholas Florko told us the FDA had seemingly failed to move against certain illegal vaping companies despite a congressional directive to pull their products off the market. Citing Nick’s story, Sens. Dick Durbin (D-Ill.) and Susan Collins (R-Maine) said in a letter yesterday the FDA “appears to be on the brink of failing yet again at protecting our nation’s children.”

Synthetic tobacco products, often sold in fruity flavors popular with teens, have escaped regulation because they use lab-made nicotine, rather than nicotine extracted from tobacco leaf. But Congress closed that loophole in March, setting deadlines after which FDA was supposed to act. The law states that every product not authorized by yesterday is considered illegal. An FDA spokesperson told STAT Friday the FDA has yet to take action against any synthetic product. Read more.

Closer look: How a hospital worked to meet its patients’ needs outside the clinic

(Creative commons)

When we talk about social determinants of health — such as income, housing, education, food — we might not think of electronic health records. But if social factors dictate up to 80% of a person’s health, it’s time they’re connected, a growing movement says. In 2016, Manisha Parulekar, director of geriatrics at New Jersey’s Hackensack Meridian Health, joined an effort to simplify screening for social needs and make it a regular part of medical care. As of July, Hackensack had used such information to refer patients to community health resources more than a million times.

“Some people had gone from going from the emergency department almost 13 times, to not visiting the emergency department at all in the six months since they were enrolled in our program,” Parulekar told STAT’s Katie Palmer. Read more on the human and technical challenges.

American men are sicker and die sooner than peers in other high-income countries

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A damning new report on the U.S. health care system says that men in the U.S. are more likely to have serious medical conditions, die from avoidable causes, and feel the system does not meet their needs than men in 10 other high-income countries. Personal income matters: U.S. men of average or below-average means were less likely to receive preventive care, more likely to have difficulty affording their care, and more likely to have physical and mental health conditions. Men in the U.S. are significantly more likely to skip or delay needed care because of cost.

The Commonwealth Fund analysis found one bright spot: U.S. men had the lowest rate of prostate cancer deaths. If you’re wondering about women, a previous Commonwealth Fund study also found poor health care access and outcomes for U.S. women of reproductive age.

Drop in violent crime coincided with dip in deaths from heart disease

Gun violence has been unrelenting across the U.S. during the pandemic, so it’s hard to recall a time when it was receding. A new study in the Journal of the American Heart Association looks back to such a stretch, from 2000 to 2014 in Chicago, when violent crimes fell — and so did deaths from heart disease. Bigger drops came in neighborhoods that saw deeper declines in crime rates, a correlation the study authors say makes violent crime an important social determinant of health.

Over the study’s 15 years — using the latest available data — violent crime in Chicago decreased by 16% overall, and cardiovascular disease mortality fell by 13%. In neighborhoods where violent crime dropped an average of 59%, heart disease mortality dropped 15%. In areas where violent crime dipped 10%, cardiovascular mortality still declined by 11%.

What to read around the web today

Federal officials warn pharmacists about denying abortion medication, Washington Post
Nearly 200,000 disabled Texans are waiting for the state’s help — some for longer than a decade, Houston Chronicle
A treatment for a deadly condition in newborns fails to improve outcomes, study finds, STAT
Unseating big pharma: the radical plan for vaccine equity, Nature
Opinion: Empower primary care with adequate payments and technology, STAT