The NewsSales of e-cigarettes rose by nearly 47 percent from January 2020, just before the pandemic hit the United States, to December 2022, according to an analysis released on Thursday by the Centers for Disease Control and Prevention.The increase over that period occurred while teenagers and young adults reported in surveys that they had recently tried e-cigarettes at much higher rates than older adults did.According to the C.D.C., about 4.5 percent of all adults said they used e-cigarettes. But the rates went up as the age dropped. About 14 percent of high school students and 11 percent of young adults reported using the devices within the last 30 days of the survey, the C.D.C. data showed.Sales were still growing through May of last year, but then dropped by 12 percent through December. Researchers attributed the decline to several possible factors, including state or local bans on flavored products; government enforcement; and the introduction of devices that offered thousands of “puffs” in a single device.Overall, four-week sales of e-cigarettes climbed to 25.9 million units late last year, from 15.5 million units in early 2020.A health warning accompanies the display of Vuse e-cigarettes.Michael M. Santiago/Getty ImagesWhy It Matters: Effects of vaping are still unknownThe Food and Drug Administration has embraced the use of e-cigarettes, regulating their sale on the market as an aid for adult smokers to make the transition to a less harmful product.But tobacco opponents and public health experts warn that the popular devices have lured teenagers and young people — who would be unlikely to smoke traditional cigarettes — into an addictive habit amid growing concerns about vaping nicotine.The C.D.C.’s analysis reinforces data indicating that fruit and candy flavors have surged in popularity. The vaping devices often contain high levels of nicotine and are sold in appealing colors and flavors, like strawberry ice cream and mango ice.The American Heart Association has called for more action to reduce youth vaping and issued a scientific statement last year saying that e-cigarettes appeared to lead to increased risk of heart and lung disease. The American Lung Association has also aired concerns, saying it was “very troubled by the evolving evidence about the impact of e-cigarettes on the lungs” and citing the known and unknown toxic effects of chemicals used in vapes.Background: Youth vaping was on the riseThe C.D.C. study does not include sales from vaping and tobacco shops or internet sales, so the findings are limited.Still, trends have shifted in the last few years. Vaping of e-cigarettes among minors has declined from a record high in 2019, when nearly 28 percent of high school students reported vaping within the last 30 days. At the time, products that were sleek and produced by Juul Labs were the most popular, and the company was largely blamed for the soaring rate of teenage vaping. Juul has since resolved myriad lawsuits brought by many states and individuals, resulting in settlements adding up to nearly $3 billion.The F.D.A. has rejected applications for millions of products to get on the market, approving only about two dozen tobacco-flavored vaping devices. Yet the agency has struggled with enforcement; flavored vapes have flooded gas stations, convenience stores and vape shops nationwide.The agency prevailed in court in recent weeks against the makers of Hyde vapes, which were a favorite among high school students in a recent youth tobacco survey. The latest report from the C.D.C. shows Elf Bar Vapes rising in popularity. The F.D.A. has issued an import alert for them to be seized at the border and on Thursday announced enforcement against nearly 200 retailers selling those vapes and Esco Bar products.What’s Next: Regulation and enforcementThe F.D.A. has said it will issue final decisions by the end of this year on the remaining applications for selling vaping products to address the top sellers by Vuse, Juul and others.Tobacco control advocates are pressuring the F.D.A. to step up its enforcement of unauthorized e-cigarettes and to also move forward with a proposed ban on menthol cigarettes.Many interested parties are also watching the effects of a statewide flavor ban unfolding in California — one similar to those in six other states and more than 300 jurisdictions. Since Dec. 21, when the ban took effect, vape product sales fell 35 percent through late March, according to data from the C.D.C. Foundation.

An F.D.A. advisory panel told manufacturers to aim the latest coronavirus vaccine for the fall at the dominant SARS-CoV-2 variant.The NewsVaccine makers should target the XBB variant of the coronavirus in a shot to be available in the fall, moving away from the existing formula that protected against the Omicron variant and an early form of the virus, an advisory panel to the Food and Drug Administration agreed on Thursday.The 21-member panel unanimously recommended that manufacturers should aim at the most dominant variant of the coronavirus this summer. If the F.D.A. agrees, the advice would start the manufacturing of millions of shots.Agency officials had earlier said they hoped to move toward an annual vaccine against the coronavirus. But the discussion on Thursday did not involve any timetables as to how often adults should receive new shots, or which populations should be offered the latest vaccine, though the initial advice last fall was for those age 12 and older to get the shot.Jim Wilson/The New York TimesWhy It Matters: Some people remain at risk.Pfizer, Moderna and Novavax have made it clear that they need time to make tens of millions of doses of the shots that would be available in the fall.“I think that’s what today’s discussion is about — how to best to come up with what goes into people’s arms to offer the best protection during a period when we think we’ll have waning immunity,” said Dr. Peter Marks, the F.D.A.’s vaccine chief. He added that the winter may also bring “further evolution of the virus.”Since the beginning of the pandemic, 6.2 million hospitalizations and 1.1 million deaths have been attributed to the virus in the United States, according to data presented by Natalie Thornburg, a vaccine expert at the Centers for Disease Control and Prevention.She said the picture had improved this year, but those who remain vulnerable include the unvaccinated, people who are immunocompromised and those who have diabetes or chronic kidney, lung, cardiovascular or neurologic diseases. People 65 and older are also at risk, and that rises with age.Background: Changes are afoot in who gets the shots and when.The bivalent shots offered last fall included protection against the Omicron variant and an early Covid variant. About 20 percent of adults, or about 53 million, in the United States got the booster shot, with the rates higher among older adults.Moving ahead with a shot targeted at only an XBB variant means that newborns and people with compromised immune systems may not have immunity against the earliest coronavirus variants. That should not be a problem, according to a briefing given by a World Health Organization official, who said those variants were no longer in circulation.What’s Next: A vaccine may be offered alongside flu and R.S.V. jabs.The F.D.A. is expected to make a more official recommendation to vaccine makers soon. The manufacturers will be expected to study the new formulas and submit data to the agency. If approvals are granted, the C.D.C. will advise health providers on which age groups should get the jab.An F.D.A. spokesman said it expected that an updated vaccine would be available by late September, assuming the data support safe and effective vaccines.It remains unclear whether or when the vaccine makers or the F.D.A. will examine the potential effects of administering multiple vaccines in the fall, including those for the flu and respiratory syncytial virus, or R.S.V., which are expected to be available for pregnant people and older adults. Agency advisers have also endorsed the use of an R.S.V. antibody shot to protect infants.

An F.D.A. advisory panel told manufacturers to aim the latest coronavirus vaccine for the fall at the dominant SARS-CoV-2 variant.The NewsVaccine makers should target the XBB variant of the coronavirus in a shot to be available in the fall, moving away from the existing formula that protected against the Omicron variant and an early form of the virus, an advisory panel to the Food and Drug Administration agreed on Thursday.The 21-member panel unanimously recommended that manufacturers should aim at the most dominant variant of the coronavirus this summer. If the F.D.A. agrees, the advice would start the manufacturing of millions of shots.Agency officials had earlier said they hoped to move toward an annual vaccine against the coronavirus. But the discussion on Thursday did not involve any timetables as to how often adults should receive new shots, or which populations should be offered the latest vaccine, though the initial advice last fall was for those age 12 and older to get the shot.Jim Wilson/The New York TimesWhy It Matters: Some people remain at risk.Pfizer, Moderna and Novavax have made it clear that they need time to make tens of millions of doses of the shots that would be available in the fall.“I think that’s what today’s discussion is about — how to best to come up with what goes into people’s arms to offer the best protection during a period when we think we’ll have waning immunity,” said Dr. Peter Marks, the F.D.A.’s vaccine chief. He added that the winter may also bring “further evolution of the virus.”Since the beginning of the pandemic, 6.2 million hospitalizations and 1.1 million deaths have been attributed to the virus in the United States, according to data presented by Natalie Thornburg, a vaccine expert at the Centers for Disease Control and Prevention.She said the picture had improved this year, but those who remain vulnerable include the unvaccinated, people who are immunocompromised and those who have diabetes or chronic kidney, lung, cardiovascular or neurologic diseases. People 65 and older are also at risk, and that rises with age.Background: Changes are afoot in who gets the shots and when.The bivalent shots offered last fall included protection against the Omicron variant and an early Covid variant. About 20 percent of adults, or about 53 million, in the United States got the booster shot, with the rates higher among older adults.Moving ahead with a shot targeted at only an XBB variant means that newborns and people with compromised immune systems may not have immunity against the earliest coronavirus variants. That should not be a problem, according to a briefing given by a World Health Organization official, who said those variants were no longer in circulation.What’s Next: A vaccine may be offered alongside flu and R.S.V. jabs.The F.D.A. is expected to make a more official recommendation to vaccine makers soon. The manufacturers will be expected to study the new formulas and submit data to the agency. If approvals are granted, the C.D.C. will advise health providers on which age groups should get the jab.An F.D.A. spokesman said it expected that an updated vaccine would be available by late September, assuming the data support safe and effective vaccines.It remains unclear whether or when the vaccine makers or the F.D.A. will examine the potential effects of administering multiple vaccines in the fall, including those for the flu and respiratory syncytial virus, or R.S.V., which are expected to be available for pregnant people and older adults. Agency advisers have also endorsed the use of an R.S.V. antibody shot to protect infants.

The NewsA Food and Drug Administration advisory panel recommended approval of a monoclonal antibody shot aimed at preventing a potentially lethal pathogen, respiratory syncytial virus, or R.S.V., in infants and vulnerable toddlers.The treatment, called Beyfortus by its developers Sanofi and AstraZeneca, would be the second such therapy that the F.D.A. has allowed to be given to very young children to prevent R.S.V., which is a leading killer of infants and toddlers globally. A similar treatment approved more than 20 years ago is given in multiple doses and is only approved for high-risk infants.The 21-member panel voted unanimously in favor of giving the treatment to infants born during or entering their first R.S.V. season. The advisers voted 19-2 for giving the shot to children up to 24 months of age who remain vulnerable to severe disease.Up to 80,000 children younger than 5 are hospitalized annually in the United States with respiratory syncytial virus and up to 300 die. Marijan Murat/dpa, via ReutersWhy It Matters: R.S.V. is a global killer of infants.Though many people experience this common virus as a routine cold, it can be serious in young infants and older adults. According to the Centers for Disease Control and Prevention, up to 80,000 children younger than 5 are hospitalized with the virus each year and up to 300 die. R.S.V. played a role in filling children’s hospitals during this winter’s “tripledemic,” which also included the flu and Covid-19.For adults 65 and older, as many as 160,000 hospitalizations are attributed to R.S.V., and about 10,000 deaths. Vaccines for older adults have also recently been approved.Background: The shot’s safety will be monitored.More than 3,200 infants were given the antibody shot during studies provided to the F.D.A. by the drugmakers, including one that found that after six months, efficacy against very severe R.S.V. that required medical attention was 79 percent.A separate agency panel has recommended approval of a maternal R.S.V. vaccine that is also under review. Some of the advisers raised concerns about data for that vaccine, and for another like it that suggested a small increase in preterm births.If the antibody therapy is approved, the F.D.A. said it would continue to monitor the treatment for safety using several data sources. AstraZeneca said it would also conduct periodic safety reviews using worldwide data.What’s Next: The C.D.C. will review shots for mothers and babies.If the agency approves the new shot, it will likely become available in the fall — around the same time that the Pfizer R.S.V. vaccine given during pregnancy called Abrysvo goes on the market.The C.D.C. is expected to advise health providers on the use of the new treatments later this month. Families and their doctors could then choose a course of treatment that would take into account the timing of a birth and the winter R.S.V. season, among other factors.The F.D.A. said there was no study of the risks or benefits of women taking the maternal R.S.V. vaccine and giving the antibody shots to their infants.

A committee of experts voted in favor of a new shot administered to pregnant women, one in a series of new ways to arm the very young against a life-threatening virus.An advisory panel to the Food and Drug Administration voted on Thursday in favor of approving a vaccine by Pfizer to prevent the severe respiratory virus that is a potentially deadly threat to infants.The vaccine would be the first to protect babies from respiratory syncytial virus, or R.S.V., which is the reason many infants are admitted to children’s hospitals each year and kills several hundred under 5 each year.Fourteen agency advisers unanimously agreed that the vaccine was effective, and the F.D.A. typically follows the recommendations of its advisory panels.Ten of the 14 agreed that the vaccine was safe, with some airing concerns about elevated rates — not all statistically significant — of preterm births among mothers who got the vaccine compared to those who received a placebo.The vote follows the F.D.A.’s earlier decision to approve the first R.S.V. vaccine for older adults in the United States. Several other options are still being evaluated.The Pfizer vaccine for pregnant women, called Abrysvo, is being reviewed ahead of another option submitted to the F.D.A. that would be given to infants — a monoclonal antibody shot meant to provide five months of protection.R.S.V. is a common ailment that is most severe in young infants and older adults. According to the Centers for Disease Control and Prevention, up to 80,000 children younger than 5 are hospitalized with the virus each year and up to 300 die. (As many as 160,000 adults 65 and older are hospitalized each year with the virus, and about 10,000 die.)The youngest infants face the greatest risk. Data presented at the meeting showed that infants 6 months or younger were twice as likely to be hospitalized compared with older babies or children. Efforts to test a vaccine in infants began in the 1960s but were abandoned when the vaccine caused more severe cases, said Dr. Bill Gruber, the head of clinical vaccine research and development at Pfizer.The prospect of having a large number of babies immunized in the fall, before the winter when R.S.V. rates are typically highest, would be “huge,” said Dr. Jonathan Miller, a pediatrician who sees children in the clinic and hospital for Nemours Children’s Health, Delaware Valley.“I’m thrilled about the prospect of this, as well as about the prospect of other R.S.V. vaccines in the pipeline,” said Dr. Miller, who is not an adviser to the agency. “This looks as if it will be the first one coming our way, and it’s a long time coming.”The vaccine under review Thursday was tested in about 7,300 women after the 24th week of pregnancy. About half received a placebo, and half were given the vaccine as a shot. For the first 90 days after birth, six infants in the vaccination group had a serious case of R.S.V., compared with 33 in the placebo group, translating to an efficacy of nearly 82 percent.The study, published in The New England Journal of Medicine, showed that for six months after birth, the vaccine was 69 percent effective. In the treatment group, 19 babies fell seriously ill compared to 62 in the placebo group.The main safety concern during the hearing was whether the vaccine was linked to preterm birth, a safety signal that led GSK to halt its trial of a similar R.S.V. vaccine that was being tested in pregnant patients, according to Dr. Hal Barron, a former company executive. The F.D.A. approved that vaccine, called Arexvy, for older adults earlier this month. (Like GSK, Pfizer tested the same vaccine formula in older adults and infants.)“We quickly halted the trial based on it confirming that the signal was real,” Dr. Barron said in a March 2022 presentation to investors, “but we are still puzzled as to exactly why this occurred.”The label for the GSK vaccine says that in tests of pregnant women, 6.8 percent receiving the treatment had preterm births, compared to 5 percent in the placebo group.In the Pfizer study, premature delivery was reported in 5.6 percent of the pregnancies in the treatment group, compared with 4.7 percent in the placebo group. Officials at the F.D.A. reported that the difference was not statistically significant.Pfizer said if the drug were approved, the company would conduct a post-approval study of real-world use of the vaccine, monitoring health records for the incidence of preterm birth and other possible problems. Agency advisers, though, expressed skepticism about a plan to use data generated from health care billing records to monitor vaccine safety. Several noted that such data could make it hard to link a parent who got the vaccine to the child.“I do feel like we should be setting the bar higher for review,” said one adviser, Dr. Amanda Cohn, the director of the division of birth defects and infant disorders at the C.D.C., adding that more data might help clarify questions about the effects on preterm birth.Dr. Hana El Sahly, the advisory committee chairwoman and professor of virology at Baylor College of Medicine, said the number of preterm births among those given the vaccine in a prior Pfizer study, in the main study under review and in the GSK study of a similar product were concerning, particularly given that the United States is not in the midst of an R.S.V. outbreak. She said the pattern should have been examined more carefully.“That was a big missed opportunity and I feel it’s unfair that we kicked the can down the road to the larger public,” said Dr. El Sahly, who voted “no” to the question about whether the safety data was adequate.There is another remedy under regulatory consideration, a monoclonal antibody shot developed by Sanofi and AstraZeneca, called nirsevimab. It is meant to be given at the hospital to babies who are born during the winter or in the fall, Jonathan Heinrichs, a Sanofi executive said in an interview.The medication is under F.D.A. review and was found in one study of nearly 2,500 infants to reduce cases of severe R.S.V. by 75 percent.

A worrisome scarcity of cancer drugs has heightened concerns about the troubled generic drug industry. Congress and the White House are seeking ways to address widespread supply problems.Thousands of patients are facing delays in getting treatments for cancer and other life-threatening diseases, with drug shortages in the United States approaching record levels.Hospitals are scouring shelves for supplies of a drug that reverses lead poisoning and for a sterile fluid needed to stop the heart for bypass surgery. Some antibiotics are still scarce following the winter flu season when doctors and patients frantically chased medicines for ailments like strep throat. Even children’s Tylenol was hard to find.Hundreds of drugs are on the list of medications in short supply in the United States, as officials grapple with an opaque and sometimes interrupted supply chain, quality and financial issues that are leading to manufacturing shutdowns.The shortages are so acute that they are commanding the attention of the White House and Congress, which are examining the underlying causes of the faltering generic drug market, which accounts for about 90 percent of domestic prescriptions.The Biden administration has assembled a team to find long-term solutions for shoring up the pharmaceutical supply chain, at a time when the United States remains heavily reliant on medicines and drug ingredients from India and China. And in recent weeks, generic drug makers, supply-chain experts and patient advocates have appeared before lawmakers to discuss the problems.The scarcity of generic forms of chemotherapy to treat lung, breast, bladder and ovarian cancers has only heightened concerns.“This is, in my opinion, a public health emergency,” said Dr. Amanda Fader, a professor at the Johns Hopkins School of Medicine and a president-elect of the Society of Gynecologic Oncology, “because of the breadth of the individuals it affects and the number of chemotherapy agents that are in shortage right now.”The American Cancer Society last week warned that delays caused by the shortages could result in worse outcomes for patients.“If these drugs are not available, people are going to get inferior care,” Dr. William Dahut, the society’s chief medical officer, said. “That’s the bottom line. These aren’t third- or fourth-line drugs where there are multiple other agents around. These are used up front for people you are trying to cure.”Ryan Dwars beat pancreatic cancer in 2021, but late last year a scan showed cancerous spots on his liver. Mr. Dwars, 39 and a father of two young girls, had hoped to receive his final four doses of chemotherapy in April.Then his doctor delivered stunning news: He didn’t make the cut of those given priority for the treatment.“The light at the end of the tunnel was within sight,” Mr. Dwars, a special education teacher in Iowa City, said. “It made it even worse to be so close — and now this.”Laura Bray, who founded a nonprofit called Angels for Change, works as a liaison among patients, health systems and drug companies to “micro-source,” as she calls it, hard-to-find medications.Dr. Robert Califf, the F.D.A. commissioner, said the agency had prevented a number of drug shortages. “Our employees can only plug a certain number of holes in a system which has got real problems,” he said.Julia Nikhinson/Reuters“Will we have the resolve and sense of urgency to fix this?’’ asked Ms. Bray, an adjunct business professor who has been providing information to the White House and Congress. “It’s possible. It can be done. It happens in other supply chains. But we have to focus on it and we have to think about ending it — instead of mitigating it. I think the jury’s out on that.”For Mr. Dwars, Ms. Bray contacted a maker of cisplatin, the chemo drug he needed and arranged for a supply to be sent within days and for others at his hospital. Some in states around the country have not been as fortunate, encountering frightening gaps between treatments.The White House team working on the broader issue of longstanding drug supply breakdowns includes national security, economic and health officials, according to James McKinney, a spokesman for the Food and Drug Administration. Bloomberg reported earlier on the White House involvement.Officials have been debating possible measures like tax incentives for generic drugmakers and greater transparency around generic drug quality. The current incentives favor drugmakers with the lowest prices, which includes those that might cut corners — leading to disruptive plant shutdowns if the F.D.A. demands a fix. (Some shortages, like those of weight-loss drugs, are the result of sky-high demand, while others have been attributed to overprescribing, including for antibiotics, or a lack of investment in potential alternatives.)The F.D.A., which employs a team of about 10 people who do the day-to-day work of mitigating and reporting drug shortages, has said it is seeking authority from Congress to get additional information about the drug manufacturing and supply chain.But the agency has also expressed its concerns to the White House about severe financial strain in the generic drug industry — an economic problem that F.D.A. officials say they are not suited to address.Dr. Robert Califf, the F.D.A. commissioner, highlighted the agency’s views during recent appearances before Congress, saying officials can only plug so many holes.“We have got to fix the core economics if we’re going to get this situation fixed,” Dr. Califf told a House panel on May 11.David Gaugh, the interim chief executive of the Association for Accessible Medicines, which represents generic drugmakers, recalled warning F.D.A. officials in an April meeting that the recent bankruptcy and shutdown of Akorn Pharmaceuticals would likely be followed by others.“Shortages are on the rise. We’ve all seen that,” Mr. Gaugh said in an interview. “And it is likely going to get worse, not better, very soon.”Mr. Gaugh cited data underscoring pressure facing the generic industry. Although the number of generic drugmakers has increased, a review by IQVIA, a health care analytics company, showed that the market has consolidated such that three buyers account for about 90 percent of generic drug purchases. The intermediaries are combined major drug distributors and retail chains, like Red Oak Sourcing, which includes CVS Health and Cardinal Health and ClarusONE, which includes Walmart and McKesson. Walgreens also has distribution agreements with AmerisourceBergen. The companies did not reply to requests for comment.The competition for the contracts with those intermediaries pits U.S. manufacturers against those in India, where labor costs are far lower. When a generic drug company can’t get a contract for a medication, it tends to stop making it and might see already-slim profits shrink.“The opportunity to get it wrong is much narrower if you’re a generic manufacturer,” Mr. Gaugh said.Hospital pharmacists and supply-chain experts were stunned in February by the abrupt shutdown of Akorn, whose products were then recalled since there was no staff remaining to address potential quality concerns.That added “insult to injury,” said Eric Tichy, a supply chain division chair at the Mayo Clinic and the board chairman of the End Drug Shortages Alliance.Akorn made roughly 100 medications, including cylinders of albuterol that children’s hospitals had relied on to ease their breathing difficulties. And it was the only company that made an antidote to lead poisoning, Dr. Tichy said.“Health is so foundational to our country functioning well,” Dr. Tichy said. “And then we have a domestic manufacturer that just goes under and there’s not a lot of action.”A respiratory therapist held a nebulizer with albuterol, one of the drugs manufactured by the shuttered pharmaceutical company Akorn, at a hospital in New Orleans.Erin Schaff/The New York TimesFour Senate bills with bipartisan sponsorship could help get generic drugs to market more quickly by addressing tactics or loopholes that cause delays. During a House hearing on the shortages Thursday, Anthony Sardella, a business research adviser at Washington University in St. Louis, said generic drug prices had fallen by about 50 percent since 2016.“But there is a high cost to low prices,” Mr. Sardella said, noting that they may lead to cost cutting that can result in quality problems.A recent case in point was Intas Pharmaceuticals, a company in India that makes three key chemotherapy drugs that are difficult to find: methotrexate, carboplatin and cisplatin, the drug Mr. Dwars needed. Intas temporarily suspended manufacturing of the drugs after the F.D.A. found serious quality-control violations.During an unannounced visit to the Intas plant, F.D.A. inspectors discovered a “truck full of” hundreds of plastic bags filled with torn and shredded documents, according to a report issued in December. One quality-control worker poured acid on torn records and stuffed them in a garbage bag, the report said.F.D.A. inspectors pieced papers together and found quality control records for products bound for the United States, the report said. The agency cited a raft of other problems as well.To ease the supply disruption, the U.S. distributor for Intas, Accord Pharmaceuticals, said a handful of lots were tested by a third party, certified and released to the U.S. market. The treatments arranged by Ms. Bray that reached patients in Iowa were among them.The companies were working with the F.D.A. to restart manufacturing for U.S. customers, a statement from Accord said, adding that it found the shredding to be an “isolated incident.”The Society of Gynecologic Oncology sent out a nationwide survey in recent weeks. In response, doctors in 35 states said they had little to no supply of key chemotherapy drugs, even at large cancer centers and teaching hospitals.Dr. Patrick Timmins, a partner of Women’s Cancer Care Associates in Albany, N.Y., said his practice ran out of some chemotherapy drugs on May 9, but still has 25 patients who need them.“Our patients are in a war, and what we’re doing is we’re taking their weapons away,” Dr. Timmins said. “It’s completely ridiculous that we can’t figure out a way, at least in the short run, to get our patients treated, and in the long run to solve these recurring problems.”When Ms. Bray met with White House staff members in late April, she said that she recommended creating an exchange, to get drugs where they were needed most, and increasing the production of small-batch medicines, often referred to as compounding.Dr. Kevin Schulman, a professor at Stanford Medicine who has studied the generic drug industry, said he had urged the White House team to examine how much power the intermediary companies have in contracting with generic drug makers. He said they demand rock-bottom prices, but unlike a customer-facing company like Apple that contracts with suppliers worldwide, the drug intermediaries face no accountability when shortages arise.Dr. Schulman said he had recommended expanded government contracting with the nonprofit Civica, which sells generic drugs at slightly inflated prices, which can help generic makers run a stable business.“The intermediaries are driving people out of the market,” Dr. Schulman said. “I think it’s a market problem and we need market-level solutions.”

The shots would be the first vaccines available against a respiratory virus that kills thousands and leads to many more hospitalizations each year.The NewsThe Food and Drug Administration on Wednesday approved GSK’s vaccine for the respiratory syncytial virus, or R.S.V., for adults who are 60 and older, the company said. The vaccine, to be sold as Arexvy, appears to be the first in the world approved for sale to protect older adults.An transmission electron microscopic image of R.S.V.Centers for Disease Control and PreventionWhy It Matters: R.S.V. can be lethalThe F.D.A. estimates that R.S.V. is associated with 6,000 to 10,000 deaths each year in adults 65 and older and at least 60,000 hospitalizations in that age group. It is a leading killer of children worldwide.This winter, R.S.V. contributed to the “tripledemic” also involving flu and Covid cases that swamped children’s hospitals and some I.C.U. wards.Background: Benefits and risks of the shotsOn March 1, an F.D.A. advisory panel reviewed data from trials for two vaccines aimed at older adults, one from GSK and one from Pfizer. The panel recommended that the agency approve both.The GSK vaccine was nearly 83 percent effective in preventing lower respiratory tract illness in adults 60 and older in a study of about 25,000 patients, according to data published in The New England Journal of Medicine. The virus can lead to pneumonia, which is far more worrisome for older adults and especially for those with underlying medical conditions like heart and lung disease or diabetes.Pfizer’s R.S.V. vaccine for older adults is also expected to receive F.D.A. approval this month. In a large study of that shot, it was found to be nearly 67 percent effective in preventing R.S.V.-related illness.The Pfizer and GSK vaccines were even more effective in treating older and sicker patients.The advisers did learn of some rare side effects from the vaccine trials. In the days after the shots were given, two recipients of the Pfizer vaccine and one recipient of the GSK shot developed cases of Guillain-Barré, a condition where the immune system attacks the nervous system (but not the spine or brain), according to data given to the F.D.A. panel.Moderna is also developing a vaccine for R.S.V. in older adults and said it expected authorization in the first half of this year. The company said a trial of 37,000 older adults showed 82 percent efficacy of the shot. The study was completed with “no safety concerns identified,” a Moderna news release said, though the company added that safety analyses were continuing.AstraZeneca and Sanofi are also seeking F.D.A. approval of a monoclonal antibody treatment meant to protect infants and toddlers up to 2 years old from R.S.V. infections. The companies reported findings from a major study indicating that the therapy reduced confirmedillnesses by 75 percent after one shot, according to AstraZeneca.Pfizer is seeking a separate approval for an R.S.V. vaccine given in the later stages of pregnancy to protect young infants.What’s Next: When will the vaccines be available?The Centers for Disease Control and Prevention is expected to follow the F.D.A.’s approval with a recommendation for use of the R.S.V. vaccines for older adults, possibly in June. The vaccine is expected to be available in the fall at local pharmacies, clinics and other health care settings.GSK executives have said that supplies of the vaccine, which is manufactured mainly at a plant in Belgium, should be readily available once it’s approved for use. For Medicare patients with Part D drug coverage, the vaccine will be available with no out-of-pocket expense, Alison Hunt, a GSK spokeswoman, said. But the company has not released a price, although insurers typically cover vaccines.The company told investors this year that it hoped to gain approval from the European Union for its R.S.V. vaccine, and later in China. Last week, the European Medicines Agency did recommend approval of GSK’s vaccine for adults 60 and older.

The Academies accepted millions of dollars from members of the Sackler family — including some who led Purdue Pharma, makers of OxyContin — even while advising federal officials on opioid policy.More than 75 members of the National Academies of Sciences, Engineering and Medicine demanded on Thursday that the organization explain why it has for years failed to return or repurpose millions of dollars donated by the Sackler family, including some who led Purdue Pharma.The company’s drug, OxyContin, helped set in motion a prescription opioid crisis that has claimed hundreds of thousands of lives. The New York Times reported this month that even as the Academies advised the government on opioid policy, the organization accepted $19 million from the Sackler family and appointed influential members to its committees who had financial ties to Purdue Pharma.One report issued by the Academies claimed that 100 million, or 40 percent of Americans, were in chronic pain. The figure, later found to be inflated, was cited by drugmakers to convince doctors to write large numbers of opioid prescriptions.In a letter delivered to Marcia McNutt, president of the National Academies of Sciences, scientists and economists called on the organization to clarify how research committee members who ran nonprofits heavily funded by Purdue were chosen to provide guidance to federal authorities on opioid policy: “How did the system fail in the past?” the letter asked.“The academy was looking like it had been morally asleep for the last 30 years,” Robert Putnam, an author of the letter and Harvard public policy professor, said in an interview.“We of course take the concerns of National Academy of Sciences members seriously, and their concerns were in part what prompted very serious conversations here about returning or repurposing the funds, to which the N.A.S. remains committed,” the organization said in a statement on Friday.The National Academies was chartered in 1863 by Abraham Lincoln to advise the nation on scientific and medical questions. The institution elects new members each year — elite scientists and physicians — and delivers influential advice to the White House, Congress and federal agencies.Though about 70 percent of the National Academies budget comes from federal funds, it also raises private donations from individuals, nonprofits and companies, including Chevron, Google, Merck and Medtronic.“If they begin to see the problem — that is, this huge influx of private money, and private money often comes with implicit strings — they will see it’s a threat to the core principles of the Academies,” Dr. Putnam said of the National Academies’ current leadership.Signatories of the letter include eight Nobel Prize winners. Two authors are National Academies of Sciences members who in 2017 urged top officials to distance the organization from the Sacklers.Robert M. Hauser, a prominent social scientist, wrote in an October 2017 email to two top Academies officials: “I have been thinking about the willingness of the N.A.S. to accept support from the Sackler family and to produce events and awards — lectures, forums, colloquia, prizes — however meritorious, in their name.”He and another Academies member had concluded “that the N.A.S. should disassociate itself from the Sacklers.” The other member was Angus Deaton, a Nobel Laureate and co-author of a book about surging deaths tied to substance use and suicide among members of the white working class.Dr. Deaton said in an interview that he and Dr. Hauser had asked for a call with top officials about the Sacklers’ involvement.“We wanted more than anything to warn them that there was a lot of trouble ahead down this route, and that tens of thousands of people were dying and the Sacklers were giving them money,” Dr. Deaton recalled in an interview.The organization accepted $19 million from the Sackler family and appointed influential members to its committees who had financial ties to Purdue Pharma.Eric Baradat/Agence France-Presse — Getty ImagesDr. Hauser, who worked at the National Academies from 2010 to 2016, referenced an in-depth New Yorker article about the Sackler family’s “ruthless” marketing of OxyContin in the email, which was sent to Bruce Darling, then the executive officer, and James Hinchman, then the chief operating officer.“Sooner or later I thought this was going to blow up in their faces,” Dr. Hauser said in an interview. “And it would really besmirch the reputation of the Academies, which I felt strongly about defending.”Four minutes after Dr. Hauser’s initial request was emailed, he received a reply from Mr. Darling: “We had a conversation at the N.A.S. Council this past summer on the very issue that you raise, and we made a decision that I would be pleased to discuss with you.”Mr. Darling and Mr. Hinchman did not respond to messages requesting comment.Dr. Hauser recalled that Mr. Darling summarized the Sacklers’ donations as something that had been discussed and required no new action. Dr. Deaton and Dr. Hauser felt their concerns had been dismissed.Two National Academies reports on opioids have faced criticism from experts. One published in 2011 included two panelists with significant financial ties to Purdue and concluded that 100 million Americans were in chronic pain, a number that proved to be greatly inflated. (The Centers for Disease Control and Prevention later estimated that roughly 52 million adults suffered from chronic pain, and more than 17 million U.S. adults experience high-impact or more severe chronic pain.)Still, the report armed drug companies with a talking point that proved influential with Food and Drug Administration officials who oversaw opioid approvals. It was also cited by Purdue Pharma attorneys in their response to a Senate inquiry.Another Academies committee on opioid policy was singled out by Senator Ron Wyden, Democrat of Oregon, because of some members’ links to Purdue. That panel, formed in 2016, went forward with a study after four members were replaced.Articles in The Progressive and in The BMJ, or the British Medical Journal, have also noted the Sacklers’ ties to the Academies and identified additional committee members with links to Purdue.The letter on Friday asked for “clear answers” to what procedures are in place to “ensure that advisory committee members are properly vetted,” among other questions.The Academies told The Times that beginning in 2019 Sackler family donations were no longer used for science-related events, research and awards, the purposes for which they were intended. The funds “were never used to support any advisory activities on the use of opioids,” Megan Lowry, a spokeswoman, said.The donations amounted to roughly $19 million and, as invested funds in the institution’s endowment, were worth about $31 million in late 2021, the most recent accounting available. Universities that accepted Sackler funds, including Tufts and Brown, have reallocated some of the money to addiction prevention and treatment efforts.Members of the Sackler family who were active in running Purdue Pharma began donating in 2008 to the National Academies of Sciences. The money was used to sponsor forums and studies.In 2015, family members donated $10 million to launch the Raymond and Beverly Sackler Prize in Convergence Research, according to reports by the organization’s treasurer. Dr. and Ms. Sackler died in 2017 and 2019. An attorney for the family said those donations had “nothing at all to do with pain, medications or anything related to the company.”Dame Jillian Sackler, whose husband, Arthur, died years before OxyContin arrived on the market, began giving to the Academies in 2000, and donated $5 million by 2017, Academies reports show.A day after The Times’s report ran, the National Academies issued a statement saying it had explored returning or repurposing the funds. “Doing so in an ethical and transparent manner will be the most important consideration,” the organization said.A perceived lack of urgency in the statement helped prompt the new letter from Academies members. “It’s another brushoff the way we read it,” Dr. Hauser said.He added: “We wrote our letter to tell them, ‘You guys have to be serious, prompt and sufficient about this.’”

Even as the nation’s drug crisis mounted, the National Academies of Sciences, Engineering and Medicine continued to accept funds from some members of the Sackler family, including those involved with Purdue Pharma.For the past decade, the White House and Congress have relied on the National Academies of Sciences, Engineering and Medicine, a renowned advisory group, to help shape the federal response to the opioid crisis, whether by convening expert panels or delivering policy recommendations and reports.Yet officials with the National Academies have kept quiet about one thing: their decision to accept roughly $19 million in donations from members of the Sackler family, the owners of Purdue Pharma, the maker of the drug OxyContin that is notorious for fueling the opioid epidemic.The opioid crisis has led to hundreds of thousands of overdose deaths, spawned lawsuits and forced other institutions to publicly distance themselves from Sackler money or to acknowledge potential conflicts of interest from ties to Purdue Pharma. The National Academies has largely avoided such scrutiny as it continues to advise the government on painkillers.“I didn’t know they were taking private money,” Michael Von Korff, a prominent pain care researcher, said. “It sounds like insanity to take money from principals of drug companies and then do reports related to opioids. I am really shocked.”Unlike the World Health Organization, which was accused of being manipulated by Purdue and later retracted two opioid policy reports, the National Academies has not conducted a public review to determine if the Sackler donations influenced its policymaking, despite issuing two major reports that influenced national opioid policy.One of those reports, released in 2011 and now largely discredited, claimed that 100 million Americans suffered from chronic pain — an estimate that proved to be highly inflated. Still, it gave drugmakers another talking point for aggressive sales campaigns, primed doctors to prescribe opioids at an accelerating rate and influenced the Food and Drug Administration to approve at least one highly potent opioid.Another problem arose in 2016, months after the National Academies received a $10 million Sackler family donation. The F.D.A. had tapped the institution to form a committee to issue new recommendations on opioids. But one senator took exception to some of the members selected by the Academies, complaining they had “substantial ties” to opioid makers, including Purdue. Before work began, four people were removed from the panel.The headquarters of Purdue Pharma in Stamford, Conn., in 2018.George Etheredge for The New York TimesThe National Academies is a nongovernmental institution, chartered by Abraham Lincoln in 1863, to serve as an independent adviser to the nation on science and medicine. Members of the Academies are elected each year — a career-capping honor for scientists and doctors.In recent years, though, the advisory group has come under criticism for lapses over disclosing conflicts of interest in reports on biotechnology, genetically modified food and pharmaceutical pricing. Lisa Bero, chief scientist at the University of Colorado Center for Bioethics and Humanities, said the group’s longtime failure to disclose financial ties between committee members and industry placed the Academies in the “dark ages” of research integrity.Accepting millions of dollars from the Sackler family while advising the federal government on pain policy “would be considered a conflict of interest under almost any conflict-of-interest policy I’ve ever seen,” Dr. Bero said.Lawmakers and others have issued investigations into the business practices of members of the Sackler family and lavish spending by Purdue that amplified the voices of doctors and medical organizations wanting more opioid prescriptions despite soaring overdose deaths.Yet aside from an article in a medical journal in 2019, the National Academies has not drawn public attention. After internal meetings, it quietly removed the Sackler name from the conferences and awards the family once helped sponsor.Megan Lowry, a spokeswoman for the National Academies, said in a statement that the Sackler donations “were never used to support any advisory activities on the use of opioids or on efforts to counter the opioid crisis.” Ms. Lowry added that the organization had been prevented from returning the Sackler money because of legal restrictions and “donor unwillingness to accept returned funds.” The Academies declined to make senior officials available for interviews.The Sackler donations emerged as an internal issue for the advisory group in 2019, when members of the governing council were briefed about the money. Sylvester Gates, known as Jim, a prominent Brown University physicist on the council, said members were “outraged” and wanted to ensure the funds did not influence the work of the Academies. But returning the money, Dr. Gates said, “was more complicated than the string theory I studied.”The Lincoln SocietyRaymond and Beverly Sackler in 2004. The family branch’s donations to the National Academies began in 2008.Taco van der Eb/Hollandse Hoogte, via Redux PicturesThe National Academies receives 70 percent of its budget from federal funding, with the remainder from its endowment and private donors, including corporations that sell fossil fuels, chemicals and myriad prescription drugs. Members of the Sackler family who were among the most heavily involved in running Purdue Pharma made their first donations to the National Academies in 2008, when Dr. Raymond Sackler, and his wife, Beverly Sackler, and the couple’s foundation, started contributing, according to Academy treasurer reports. Dr. and Ms. Sackler died in 2017 and 2019, respectively.Daniel S. Connolly, a lawyer for the Raymond and Beverly Sackler branch of the family, said the couple gave $13.1 million, which differs slightly from the $14 million listed in the National Academies treasurer reports. The donations were intended to support the National Academy of Sciences “in ways that are clearly described publicly as having nothing at all to do with pain, medications or anything related to the company,” Mr. Connolly said.The reports from the National Academies treasurer describe science-related events, prizes and studies supported by Raymond and Beverly Sackler. Donations from Dame Jillian Sackler, whose husband, Arthur, died years before OxyContin arrived on the market, began in 2000 in amounts that by 2017 reached $5 million, reports show. Those donations funded a series of scientific meetings, the treasurer reports say. The gifts qualified the Sackler donors for the institution’s Lincoln Society, consisting of top givers who enhance the Academies’ “impact as advisers to the nation,” according to the 2021 treasurer report. The Academies invested the funds, which grew to more than $31 million by the end of 2021, the most recent accounting available.A Flawed ReportA worker removed the Sackler name from the Tufts Medical Center campus in Boston in 2019.Cody O’Loughlin for The New York TimesAs the Sackler donations grew, a Purdue Pharma lobbyist was trying to make inroads with the Academies, according to records released in lawsuits against opioid makers. The Pain Care Forum, a group co-founded by Burt Rosen, the Purdue lobbyist, pushed for legislation introduced in 2007 and 2009 that included calling for a National Academies report to “increase the recognition of pain as a significant public health problem.”Soon after the measure passed in a 2010 law, Mr. Rosen convened the Pain Care Forum at a 10 p.m. gathering to focus on “meetings with the Institute of Medicine,” the former name for the National Academy of Medicine, and for “membership on I.O.M. Committee.”At the same time, the National Academies was forming the committee that would produce its 2011 opioids report, which included the estimate that about 100 million or 42 percent of American adults were in pain, a figure that other researchers later found to be significantly inflated. The report described chronic pain that limited function and cost the nation billions of dollars in lost salary and wages. Later estimates from the Centers for Disease Control and Prevention defined chronic pain by different categories of severity, saying the condition affects 7 percent to 21 percent of Americans.The report did not disclose any conflicts of interest for committee members nor did it disclose the Sackler funds. A spokeswoman for the National Academies said it did not release members’ conflict statements.But among the panelists chosen, Dr. Richard Payne was president of the American Pain Society, a physicians group, in 2003 and 2004, which at the time drew more than $900,000 from Purdue. Dr. Payne died in 2019.Another panelist, Myra Christopher, was swapping emails in 2007 with Purdue staff about “talking points” to respond to a news broadcast critical of opioids, records released in a Senate Finance Committee investigation in 2020 show.At the time that the 2011 report was written, Ms. Christopher was president of the Center for Practical Bioethics, a nonprofit based in Kansas City, Mo. Purdue gave $934,770 to the organization that year. Asked about the funding, John Carney, a former chief executive at the center, sent an opinion article that stated the group’s donors did not dictate any of its work. Ms. Christopher declined to comment.The 2011 report, which allowed pharmaceutical companies to argue that doctors should prescribe more opioids, came out even as the White House announced a very different message — that the nation was facing an opioid addiction crisis.Soon after the National Academies report was issued, Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, emailed the institution and asked whether it would disclose that Ms. Christopher’s organization had received funds from Purdue.“No, sorry, can’t do that,” Clyde Behney, an official with the Academies replied in an email in August 2011 reviewed by The New York Times. “Keep in mind that the report is done and released, so the future is more important than the past.”Mr. Behney declined to comment. In a statement, the National Academies said it published an article in JAMA to explain how the committee arrived at the estimate that 100 million Americans were in pain. And the article, by Dr. Victor Dzau, president of the National Academy of Medicine, said that “conflict of interest is not an issue for the authors of the report,” who he said were carefully vetted. The JAMA article made no mention of Sackler family donations.Dr. Dzau later wrote a letter to JAMA clarifying that he should have disclosed — in that article and others — conflicts of his own, including funds he received from Medtronic, which made a device to infuse pain medication.The outsize pain figure was invoked routinely over the years — including in 2012 by Purdue’s own lawyers, who described the figure as evidence of pain that was “untreated or under-treated” in response to a Senate inquiry. Federal officials also highlighted the statistic. In 2014, Dr. Margaret Hamburg, the F.D.A. commissioner at the time, cited the figure of 100 million people “living with severe chronic pain” to explain why the agency approved a controversial and potent opioid called Zohydro.Another Panel QuestionedDr. Robert Califf, the F.D.A. commissioner, in April convened a meeting of experts to review study methods for evaluating long-term use of opioids.Anna Rose Layden for The New York TimesBy 2016, a new set of National Academies committee members would face scrutiny.Opioid overdose deaths were soaring that year and would soon overtake car crashes as the leading cause of death in the United States. Dr. Robert Califf, then the acting commissioner of the F.D.A., was under pressure from Congress to do something.He turned to the National Academies. Citing the 100 million people in pain, Dr. Califf and other top F.D.A. officials wrote in an article in The New England Journal of Medicine that the institution “brings an unbiased and highly respected perspective on these issues that can help us revise our framework.” (Dr. Califf was elected to be a member of the Academies later that year.)Soon after, names were floated to sit on the committee, leading Senator Ron Wyden, a Democrat of Oregon, to raise concerns about “potential conflicts of interest and bias” in a letter to Dr. Dzau, the National Academy of Medicine president. One person’s work, funded by Purdue, used the term “pseudoaddiction” to downplay the lure of opioids, the senator noted.The National Academies then replaced four panelists. The committee’s final report was widely respected and remains a key document for the F.D.A., which said it had consulted a variety of sources to address the drug crisis. Dr. Califf continues to rely on the report, which called for a “fundamental shift” in the nation’s approach to prescribing opioids.Shannon Hatch, an agency spokeswoman, said that the F.D.A. was not aware that the Sackler family donated to the Academies and that the 2017 report speaks for itself.Two members of the panel — Richard Bonnie, chairman of the committee and director of the University of Virginia Institute of Law, Psychiatry and Public Policy, and Dr. Aaron Kesselheim, a Harvard Medical School professor — said they were not aware of the Sackler family donations until asked about it by The Times. “I certainly didn’t feel any influence or pressure or expectations of what we would say from anyone at the National Academies,” Dr. Kesselheim said.Two years after that report was released, The BMJ examined the potential conflicts of Dr. Dzau and of members of yet another Academies committee convened to examine opioid-prescribing guidelines.Since then, the Justice Department announced an $8 billion civil and criminal settlement with Purdue Pharma and a civil settlement with members of the Sackler family. Those Sackler family members agreed to pay $225 million to resolve civil claims, and said they acted “ethically and lawfully.” Members of the family have not faced criminal charges.A bankruptcy plan to reorganize Purdue and resolve thousands of opioid cases was challenged over the Sacklers’ proposed conditions and is under appellate review.Purdue Pharma was asked by The Times to respond to a list of questions about its contacts with the Academies. But Michele Sharp, a Purdue spokeswoman, did not respond directly to any of those issues. Instead, she said the company was focused on its bankruptcy and settlement proceedings. “The settlement would deliver over $10 billion of value for opioid crisis abatement, overdose rescue medicines, and victim compensation,” she said.Institutions that more publicly examined their use of Sackler donations include Tufts University, which released a review of possible conflicts of interest related to pain research education funded by Purdue Pharma. Concerns noted in the report included a senior Purdue executive’s delivering lectures to students each semester.The World Health Organization in 2019 retracted two guidance documents on opioid policy after lawmakers aired concerns about ties to opioid makers, including a Purdue subsidiary, among report authors and funders.Going forward, experts in nonprofit law said the National Academies was in the unusual position of having millions of dollars with no plans for their use.Some universities, including Brown and Tufts, have dedicated their respective funds from the Sacklers to address the prevention or treatment of addiction.Given the devastation of the opioid crisis, Michael West, senior vice president of the New York Council of Nonprofits, said that it would be worth the effort for the Academies to follow their lead.“This would be a way,” he said, “of trying to make it right.”Alain Delaquérière

The NewsThe Food and Drug Administration on Tuesday authorized an additional round of bivalent booster shots for adults who are 65 and over as well as people with compromised immune systems. The effort is to ensure ongoing protection against Covid, which is still claiming more than 1,300 lives each week.The bivalent shots target Omicron variants of the coronavirus. The agency said people who are 65 and older who have not had a bivalent booster shot in at least four months may get another one. For those who are immunocompromised, additional doses of the bivalent vaccine can be given two months after the last shot. Those who are unvaccinated can get a single dose of the bivalent booster, the agency said.“Covid-19 continues to be a very real risk for many people,” Dr. Peter Marks, the F.D.A. vaccine chief, said. “The available data continue to demonstrate that vaccines prevent the most serious outcomes of Covid-19, which are severe illness, hospitalization and death.”The Food and Drug Administration on Tuesday approved an additional round of bivalent booster shots to ensure ongoing protection against Covid. Rosem Morton for The New York TimesWhy It MattersAlthough levels of the virus are dipping as the summer months approach, it is still being linked to 1,300 deaths each week, according to data from the Centers for Disease Control and Prevention.C.D.C. data also show that only 43 percent of people over 65 have received an Omicron booster shot, and just 20 percent of those 18 and older.BackgroundThe spring booster approval was for the same formula that was released to protect people from the Omicron variant of the virus. An updated vaccine is expected later this year. (The agency on Tuesday also rescinded authorization for the original monovalent vaccines that Americans received in the first mass-vaccination campaign.)The decision to offer the booster to the most vulnerable this spring is sound for two reasons, said Dr. Daniel Griffin, an infectious disease specialist at Columbia University.“One is the traditional reason — it protects people from severe disease,” he said. “But there is what I call the superpower where for a matter of three or four months, you get an extra benefit of reducing your risk of even getting infected.”What’s NextThe C.D.C. typically endorses updated vaccine schedules after F.D.A. authorizations.The F.D.A. said it intended to make decisions about the recommended vaccine schedule for people younger than 65 after a June advisory meeting. The agency said its advisers would make their recommendations based on whatever strain of the virus is circulating at that time.The F.D.A. said it expected to make updated formulations of the vaccines for this fall “once the specific strains are selected for the Covid-19 vaccines.”