Biden Delays Ban on Menthol Cigarettes

The proposal had been years in the making, in an effort to curb death rates of Black smokers targeted by Big Tobacco. In an election year, the president’s weak support among Black voters may have influenced the postponement.The Biden administration said on Friday that it was delaying a decision on whether to ban menthol cigarettes as federal officials take more time to consider the move.The White House has faced considerable opposition from the big tobacco companies that could lose billions of dollars from the move. But the proposal has also posed risks for President Biden in an election year because of his weakening support among Black voters, some of whom view it as heavy-handed.“This rule has garnered historic attention, and the public comment period has yielded an immense amount of feedback, including from various elements of the civil rights and criminal justice movement,” Xavier Becerra, the health and human services secretary, said in a statement.“It’s clear that there are still more conversations to have, and that will take significantly more time.”The delay runs counter to a major push by federal regulators, who saw a ban was a way to save lives and lower lung cancer deaths. The idea had united an array of public health groups, including leading lung, heart, cancer and pediatricians associations.They cite years of data suggesting that menthol cigarettes, long marketed to African-American smokers, make it more palatable to start smoking and more difficult to stop.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Federal Scientists Recommend Easing Restrictions on Marijuana

In newly disclosed documents, federal researchers find that cannabis may have medical uses and is less likely to cause harm than drugs like heroin.Marijuana is neither as risky nor as prone to abuse as other tightly controlled substances and has potential medical benefits, and therefore should be removed from the nation’s most restrictive category of drugs, federal scientists have concluded.The recommendations are contained in a 250-page scientific review provided to Matthew Zorn, a Texas lawyer who sued Health and Human Services officials for its release and published it online on Friday night. An H.H.S. official confirmed the authenticity of the document.The records shed light for the first time on the thinking of federal health officials who are pondering a momentous change. The agencies involved have not publicly commented on the their debates over what amounts to a decriminalization of marijuana at the federal level.Since 1970, marijuana has been considered a so-called Schedule I drug, a category that also includes heroin. Schedule I drugs have no medical use and a high potential for abuse, and they carry severe criminal penalties under federal trafficking laws.The documents show that scientists at the Food and Drug Administration and the National Institute on Drug Abuse have recommended that the Drug Enforcement Administration make marijuana a Schedule III drug, alongside the likes of ketamine and testosterone, which are available by prescription.The review by federal scientists found that even though marijuana is the most frequently abused illicit drug, “it does not produce serious outcomes compared to drugs in Schedules I or II.”We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? 

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F.D.A. Approves New Covid Shots

A nationwide rollout of the vaccines by Pfizer and Moderna should begin later this week, after the C.D.C. considers guidelines to prepare Americans for this season when infections usually tick upward.The Food and Drug Administration approved a new round of Covid boosters on Monday, that will arrive alongside the seasonal flu vaccine and shots to protect infants and older adults from R.S.V., a potentially lethal respiratory virus.The Centers for Disease Control and Prevention is expected to follow up on Tuesday with an advisory meeting to discuss who should get the new shots, by Pfizer-BioNTech and Moderna. After a final decision by the C.D.C.’s director, millions of doses will be shipped to pharmacies, clinics and health systems nationwide within days.As Covid cases creep up, the trifecta of prevention measures could portend the first winter of the decade without a crush of patients overwhelming some hospitals. But a healthy winter is far from a lock: In the last year, the updated Covid vaccine made it into the arms of only 20 percent of adults in the United States.Some experts view that statistic with little alarm because the number of Covid deaths slowed considerably over the last year, thanks to an increasingly immune population and higher vaccine rates among older Americans. Others see this year as an opportunity to protect more vulnerable people from severe illness or death.“Vaccination remains critical to public health and continued protection against serious consequences of Covid-19, including hospitalization and death,” said Dr. Peter Marks, the F.D.A’s top vaccine expert.The F.D.A. granted full approval for the new formulas for people who are 12 and older and authorized them to protect infants six months and older through age 11. The Pfizer shot was authorized in the European Union for ages 6 months and older on Aug. 31.Covid vaccines are just rolling out in the United Kingdom this week, with the first doses going to the highest risk people in care homes, ages 65 and over as well as health and social care staff members.Federal officials have been retreating from labeling the new formulation as boosters to previous shots, preferring to recast them as an annual immunization effort akin to the flu vaccine. That shift may reflect concern over the fatigue that some Americans have expressed about yet another round of shots against the virus.The vaccine campaign will also be the first since the end of the public health emergency, which expired in May. In previous years, the U.S. government bought hundreds of millions of vaccine doses and distributed them for free. This year, private insurance and government payers like Medicare that cover the vast majority of Americans are expected to provide the vaccines to people for free.But the question remains whether the private market of hospitals, clinics and pharmacies will be able to calibrate their vaccine orders to stock a realistic supply. Experts are uncertain how much demand there will be for the latest shots.“There could be a period in here where things are a little bit chaotic, and that’s never a good situation,” said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials, a public health group.Packing the Moderna vaccine at a distribution center in Mississippi in 2020. This year, vaccine makers are expected to donate doses for the uninsured.Paul Sancya/Agence France-Presse — Getty ImagesAlso of concern in the handoff to the private market: the nation’s 23 million adults with no health insurance. The Biden administration has made plans to cover costs and offer the Covid vaccine through local clinics and major pharmacies, but some experts are worried about whether people who lack insurance will be aware of the new shots — or where to get them.“They don’t have an insurer sending them leaflets — they may not have a usual source of care,” said Anthony Wright, executive director of Health Access, a California advocacy group. “And so the trusted messenger of their health plan, their doctor, their clinic, is not there saying, ‘It’s no cost. It’s really easy.’”Vaccine manufacturers are expected to donate doses for the uninsured. Kelly Cunningham, a spokeswoman for Moderna, said the company had no cap on the number.The latest shots are becoming available as Covid hospitalizations and deaths are rising slightly, albeit not to the levels of past years. In the week ending Aug. 26, there were 17,400 people admitted to the hospital — more than about 6,000 at a low point this summer. Deaths were also up to about 600 a week last month, though far lower than the weekly average of 14,000 deaths of 2021.Once the C.D.C. signs off, the Biden administration plans to urge the public to get their Covid and flu shots at the same time, a practice that has been studied and considered by some experts to be safe. It’s a messaging effort they expect to share with major vaccine makers, which will be marketing the Covid doses commercially for the first time.Walgreens and CVS said they both already have the updated flu and R.S.V. shots available in stores. Dr. Kevin Ban, Walgreens’ chief medical officer, said the chain would have the new Covid shots on hand “as soon as possible.” A CVS spokesperson said doses could be arriving later this week. Representatives of both chains said the Covid shot would be available at no cost to all who are eligible under the C.D.C. guidelines expected Tuesday.Targeted populations most certainly will include people 65 and older as well as those who are immunocompromised or have serious underlying medical conditions that leave them more susceptible to severe illness from the virus.Nursing homes, which inoculated nearly all of their residents in the first waves of the pandemic, have fallen behind on booster rates: Recent Medicare data show that about 62 percent of residents are up-to-date on their shots even though older adults are among the most vulnerable to severe disease and death from the virus.The new Covid vaccines target the XBB.1.5 variant, which was dominant when vaccine makers began to formulate and test a new version. They are monovalent because, unlike the earlier boosters, they do not include protection against the original virus that caused widespread infections in China more than three years ago. Though the virus has had a rotating cast of variants, experts say the new Covid jab should fortify protections against severe infection.Recent fears that one newer, highly mutated variant would escape the vaccine proved unfounded by reputable independent labs, said Fikadu Tafesse, an associate professor of molecular microbiology and immunology at Oregon Health & Science University. The C.D.C. also reviewed studies on the matter and confirmed Friday that the vaccine was holding strong.“We were really getting ready for no response at all, but the data is very, very promising,” Dr. Tafesse said.A production line of Pfizer’s Covid vaccine in Michigan. As with previous shots, the latest vaccine won’t eliminate the chances of getting the disease, but is expected to reduce the chances of severe illness, hospitalization or death.Pfizer, via Associated PressAs with earlier shots, the updated ones are not expected to eliminate the chances of contracting a mild case of Covid. Instead, they are expected to reduce the chances of severe illness, hospitalization or death. As the first vaccine’s potency waned with newer Omicron variants, a bivalent booster was approved in August 2022 that targeted the initial virus and BA.5, which was dominant at the time. That shot led to fewer people with Covid being hospitalized, dropping over several months to 25 percent from 60 percent.Pfizer and Moderna reported that their vaccines had a potent response to the newest circulating variants, though only Moderna posted its initial data on Thursday.But researchers continue to discuss how well it will stand up to new variants. The F.D.A. has mainly reviewed results submitted by the companies of animal or smaller human studies of immune response.Jerica Pitts, a spokeswoman for Pfizer, said the data submitted by the company to the F.D.A. in June involved tests in animals. Trials following people who received the shot are continuing, she said.Moderna submitted data to the F.D.A. on the immune response of 100 people to the new shots, which the company said in June “robustly elicit neutralizing antibodies” against XBB variants.Federal officials would also need to consider whether to recommend the shot to healthy young Americans, said Dr. Walid Gellad, a drug safety expert at the University of Pittsburgh.Young males have experienced higher rates of myocarditis, or inflammation of the heart muscle, after getting vaccinated, although many recovered after a few months.“The benefits are just getting lower and lower for young healthy people who’ve had Covid before,” he said. “You have to think about how any risk can change that balance.”Regulators are also considering whether to authorize a booster dose from Novavax, which employs a different but widely used technology for its coronavirus vaccine. Dr. Daniel Griffin, an infectious disease physician at Columbia University in New York, said getting the Covid shot would help stop the virus’s spread to the most vulnerable, including older adults, pregnant people and those with compromised immune systems.And while many might be weary of the social-protection argument, he said they could lessen their own odds of a more serious outcome.“So a younger individual may say, ‘I’m not going to get a booster for the public health,’” Dr. Griffin said, “‘but I am going to get a booster because if I can reduce my chance of getting Covid, I can reduce my chance of long Covid.’”Carl Zimmer and Apoorva Mandavilli contributed to this report.

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