The handwritten doctor’s order was just eight words long, but it solved a problem for Dundee Manor, a nursing home in rural South Carolina struggling to handle a new resident with severe dementia.
David Blakeney, 63, was restless and agitated. The home’s doctor wanted him on an antipsychotic medication called Haldol, a powerful sedative.
“Add Dx of schizophrenia for use of Haldol,” read the doctor’s order, using the medical shorthand for “diagnosis.”
But there was no evidence that Mr. Blakeney actually had schizophrenia.
Antipsychotic drugs — which for decades have faced criticism as “chemical straitjackets” — are dangerous for older people with dementia, nearly doubling their chance of death from heart problems, infections, falls and other ailments. But understaffed nursing homes have often used the sedatives so they don’t have to hire more staff to handle residents.
one in 150 people.
Schizophrenia, which often causes delusions, hallucinations and dampened emotions, is almost always diagnosed before the age of 40.
“People don’t just wake up with schizophrenia when they are elderly,” said Dr. Michael Wasserman, a geriatrician and former nursing home executive who has become a critic of the industry. “It’s used to skirt the rules.”
refuge of last resort for people with the disorder, after large psychiatric hospitals closed decades ago.
But unfounded diagnoses are also driving the increase. In May, a report by a federal oversight agency said nearly one-third of long-term nursing home residents with schizophrenia diagnoses in 2018 had no Medicare record of being treated for the condition.
hide serious problems — like inadequate staffing and haphazard care — from government audits and inspectors.
One result of the inaccurate diagnoses is that the government is understating how many of the country’s 1.1 million nursing home residents are on antipsychotic medications.
According to Medicare’s web page that tracks the effort to reduce the use of antipsychotics, fewer than 15 percent of nursing home residents are on such medications. But that figure excludes patients with schizophrenia diagnoses.
To determine the full number of residents being drugged nationally and at specific homes, The Times obtained unfiltered data that was posted on another, little-known Medicare web page, as well as facility-by-facility data that a patient advocacy group got from Medicare via an open records request and shared with The Times.
The figures showed that at least 21 percent of nursing home residents — about 225,000 people — are on antipsychotics.
The Centers for Medicare and Medicaid Services, which oversees nursing homes, is “concerned about this practice as a way to circumvent the protections these regulations afford,” said Catherine Howden, a spokeswoman for the agency, which is known as C.M.S.
“It is unacceptable for a facility to inappropriately classify a resident’s diagnosis to improve their performance measures,” she said. “We will continue to identify facilities which do so and hold them accountable.”
significant drop since 2012 in the share of residents on the drugs.
But when residents with diagnoses like schizophrenia are included, the decline is less than half what the government and industry claim. And when the pandemic hit in 2020, the trend reversed and antipsychotic drug use increased.
A Doubled Risk of Death
For decades, nursing homes have been using drugs to control dementia patients. For nearly as long, there have been calls for reform.
In 1987, President Ronald Reagan signed a law banning the use of drugs that serve the interest of the nursing home or its staff, not the patient.
But the practice persisted. In the early 2000s, studies found that antipsychotic drugs like Seroquel, Zyprexa and Abilify made older people drowsy and more likely to fall. The drugs were also linked to heart problems in people with dementia. More than a dozen clinical trials concluded that the drugs nearly doubled the risk of death for older dementia patients.
11 percent from less than 7 percent, records show.
The diagnoses rose even as nursing homes reported a decline in behaviors associated with the disorder. The number of residents experiencing delusions, for example, fell to 4 percent from 6 percent.
A Substitute for Staff
Caring for dementia patients is time- and labor-intensive. Workers need to be trained to handle challenging behaviors like wandering and aggression. But many nursing homes are chronically understaffed and do not pay enough to retain employees, especially the nursing assistants who provide the bulk of residents’ daily care.
Studies have found that the worse a home’s staffing situation, the greater its use of antipsychotic drugs. That suggests that some homes are using the powerful drugs to subdue patients and avoid having to hire extra staff. (Homes with staffing shortages are also the most likely to understate the number of residents on antipsychotics, according to the Times’s analysis of Medicare data.)
more than 200,000 since early last year and is at its lowest level since 1994.
As staffing dropped, the use of antipsychotics rose.
Even some of the country’s leading experts on elder care have been taken aback by the frequency of false diagnoses and the overuse of antipsychotics.
Barbara Coulter Edwards, a senior Medicaid official in the Obama administration, said she had discovered that her father was given an incorrect diagnosis of psychosis in the nursing home where he lived even though he had dementia.
“I just was shocked,” Ms. Edwards said. “And the first thing that flashed through my head was this covers a lot of ills for this nursing home if they want to give him drugs.”
Homes that violate the rules face few consequences.
In 2019 and 2021, Medicare said it planned to conduct targeted inspections to examine the issue of false schizophrenia diagnoses, but those plans were repeatedly put on hold because of the pandemic.
In an analysis of government inspection reports, The Times found about 5,600 instances of inspectors citing nursing homes for misusing antipsychotic medications. Nursing home officials told inspectors that they were dispensing the powerful drugs to frail patients for reasons that ranged from “health maintenance” to efforts to deal with residents who were “whining” or “asking for help.”
a state inspector cited Hialeah Shores for giving a false schizophrenia diagnosis to a woman. She was so heavily dosed with antipsychotics that the inspector was unable to rouse her on three consecutive days.
There was no evidence that the woman had been experiencing the delusions common in people with schizophrenia, the inspector found. Instead, staff at the nursing home said she had been “resistive and noncooperative with care.”
Dr. Jonathan Evans, a medical director for nursing homes in Virginia who reviewed the inspector’s findings for The Times, described the woman’s fear and resistance as “classic dementia behavior.”
“This wasn’t five-star care,” said Dr. Evans, who previously was president of a group that represents medical staff in nursing homes. He said he was alarmed that the inspector had decided the violation caused only “minimal harm or potential for harm” to the patient, despite her heavy sedation. As a result, he said, “there’s nothing about this that would deter this facility from doing this again.”
Representatives of Hialeah Shores declined to comment.
Seven of the 52 homes on the inspector general’s list were owned by a large Texas company, Daybreak Venture. At four of those homes, the official rate of antipsychotic drug use for long-term residents was zero, while the actual rate was much higher, according to the Times analysis comparing official C.M.S. figures with unpublished data obtained by the California advocacy group.
make people drowsy and increases the risk of falls. Peer-reviewed studies have shown that it does not help with dementia, and the government has not approved it for that use.
But prescriptions of Depakote and similar anti-seizure drugs have accelerated since the government started publicly reporting nursing homes’ use of antipsychotics.
Between 2015 and 2018, the most recent data available, the use of anti-seizure drugs rose 15 percent in nursing home residents with dementia, according to an analysis of Medicare insurance claims that researchers at the University of Michigan prepared for The Times.
in a “sprinkle” form that makes it easy to slip into food undetected.
“It’s a drug that’s tailor-made to chemically restrain residents without anybody knowing,” he said.
In the early 2000s, Depakote’s manufacturer, Abbott Laboratories, began falsely pitching the drug to nursing homes as a way to sidestep the 1987 law prohibiting facilities from using drugs as “chemical restraints,” according to a federal whistle-blower lawsuit filed by a former Abbott saleswoman.
According to the lawsuit, Abbott’s representatives told pharmacists and nurses that Depakote would “fly under the radar screen” of federal regulations.
Abbott settled the lawsuit in 2012, agreeing to pay the government $1.5 billion to resolve allegations that it had improperly marketed the drugs, including to nursing homes.
Nursing homes are required to report to federal regulators how many of their patients take a wide variety of psychotropic drugs — not just antipsychotics but also anti-anxiety medications, antidepressants and sleeping pills. But homes do not have to report Depakote or similar drugs to the federal government.
“It is like an arrow pointing to that class of medications, like ‘Use us, use us!’” Dr. Maust said. “No one is keeping track of this.”
published a brochure titled “Nursing Homes: Times have changed.”
“Nursing homes have replaced restraints and antipsychotic medications with robust activity programs, religious services, social workers and resident councils so that residents can be mentally, physically and socially engaged,” the colorful two-page leaflet boasted.
Last year, though, the industry teamed up with drug companies and others to push Congress and federal regulators to broaden the list of conditions under which antipsychotics don’t need to be publicly disclosed.
“There is specific and compelling evidence that psychotropics are underutilized in treating dementia and it is time for C.M.S. to re-evaluate its regulations,” wrote Jim Scott, the chairman of the Alliance for Aging Research, which is coordinating the campaign.
The lobbying was financed by drug companies including Avanir Pharmaceuticals and Acadia Pharmaceuticals. Both have tried — and so far failed — to get their drugs approved for treating patients with dementia. (In 2019, Avanir agreed to pay $108 million to settle charges that it had inappropriately marketed its drug for use in dementia patients in nursing homes.)
‘Hold His Haldol’
Ms. Blakeney said that only after hiring a lawyer to sue Dundee Manor for her husband’s death did she learn he had been on Haldol and other powerful drugs. (Dundee Manor has denied Ms. Blakeney’s claims in court filings.)
During her visits, though, Ms. Blakeney noticed that many residents were sleeping most of the time. A pair of women, in particular, always caught her attention. “There were two of them, laying in the same room, like they were dead,” she said.
In his first few months at Dundee Manor, Mr. Blakeney was in and out of the hospital, for bedsores, pneumonia and dehydration. During one hospital visit in December, a doctor noted that Mr. Blakeney was unable to communicate and could no longer walk.
“Hold the patient’s Ambien, trazodone and Zyprexa because of his mental status changes,” the doctor wrote. “Hold his Haldol.”
Mr. Blakeney continued to be prescribed the drugs after he returned to Dundee Manor. By April 2017, the bedsore on his right heel — a result, in part, of his rarely getting out of bed or his wheelchair — required the foot to be amputated.
In June, after weeks of fruitless searching for another nursing home, Ms. Blakeney found one and transferred him there. Later that month, he died.
“I tried to get him out — I tried and tried and tried,” his wife said. “But when I did get him out, it was too late.”
BERLIN — As concerns grow over the highly contagious Delta variant of the coronavirus, Germany on Monday became the biggest Western country yet to announce that it will offer vaccine booster shots to a wide range of people considered potentially vulnerable, adding to growing momentum in rich nations to give additional shots to fully vaccinated people.
The move by Germany came even as a top European Union official criticized the bloc as falling far short of its promises to donate vaccine doses to Africa and Latin America. And with a limited global vaccine supply, health experts say the top priorities should be distributing doses to poor countries that lag far behind in inoculations, and persuading vaccine-resistant people in wealthy countries to get their first shots.
There is also still no consensus among scientists on the need for booster shots, but as fears rise of more pandemic waves and more costly lockdowns, a growing number of countries are preparing to give their people booster doses — or have already started.
Starting in September, Germany, Europe’s largest economy, wants to administer a booster of the Pfizer-BioNTech or Moderna vaccine to older people, residents of care homes, and people with compromised immune systems — and also to anyone who was already fully vaccinated with the two-dose AstraZeneca or single-dose Johnson & Johnson shots, which clinical trials have shown are not as highly protective.
an early leader in vaccination, began administering boosters to people 60 and older last week. A month ago, Russia made additional shots available to anyone six months after inoculation, and on Sunday, Hungary began offering them four months post-vaccination.
France is offering them only to those with weak immune systems, and plans to give them this fall to those who were the first to be vaccinated early this year — mostly people over 75 and those with serious health problems.
government advisers recommended in late June that everyone over 50 should be eligible but said the priority should be getting the shots to people over 70, health workers, nursing home residents, and younger adults with immune problems or other serious vulnerabilities.
increasingly think that vulnerable populations may need additional shots even as research continues into how long the vaccines remain effective. Some people have already obtained boosters simply by not revealing previous vaccination.
But as governments, terrified of another surge in the virus, increasingly lean toward boosters, the need for them remains unclear.
Studies have indicated that immunity resulting from the Pfizer-BioNTech and Moderna vaccines is long-lasting, and researchers are still working to interpret recent Israeli data suggesting a decline in efficacy of the Pfizer-BioNTech vaccine months after inoculation.
although the vaccine remains powerfully effective against severe disease and death.
Experts were divided on the utility of booster shots so soon after vaccination began. Experience with other diseases indicates that older people and those with weak immune systems might benefit, but there is little hard evidence with the coronavirus.
“The problem here is, we’re just sort of going on immunological priors, rather than really great data to justify things one way or the other,” said Deepta Bhattacharya, an immunologist at the University of Arizona. “I totally understand the decision, but I think we have to acknowledge that there’s a wide range of uncertainty on what it’s going to do.”
Booster doses may help some people with weak immune systems, but others may show little improvement even after a third dose, and still others may not need a booster at all, scientists say.
While dozens of mostly wealthy countries, including the United States and most of Europe, have administered more than 100 doses per 100 people, many other nations remain below five per 100 — primarily in Africa, where cases have soared as the Delta variant spreads.
Understand the State of Vaccine Mandates in the U.S.
Doctors Without Borders said recently that it would be “unconscionable” to give booster doses in richer nations before people in poorer ones get their first doses.
“Wealthy governments shouldn’t be prioritizing giving third doses when much of the developing world hasn’t even yet had the chance to get their first Covid-19 shots,” Kate Elder, the senior vaccines policy adviser at Doctors Without Borders’ Access Campaign, said in a statement.
a so-called vector vaccine, like AstraZeneca or Johnson & Johnson.
It is the latest sign that governments are encouraging their citizens to mix and match vaccines in the hope of provoking a more protective immune response against Covid-19. Early results from a British vaccine study showed that volunteers produced high levels of antibodies and immune cells after getting one dose each of the Pfizer-BioNTech and AstraZeneca-Oxford shots.
The new German guidelines announced Monday also went a step further in encouraging parents to vaccinate children between 12 and 17, announcing that doctors and vaccination centers across the country would make the jab available to them before the start of the new school year.
Health ministers stopped short of making a formal recommendation for vaccinating children, but the move made plain their impatience with Germany’s Standing Committee on Vaccinations, which has so far refrained from guiding parents one way or the other, pending more data becoming available.
Vaccinating children “is one building block to allow a safe start into the new school year after the summer vacation,” Mr. Holetschek said.
Apoorva Mandavilli contributed reporting from New York, Benjamin Mueller from London, Aurelien Breeden from Paris, Gaia Pianigiani from Rome, Monika Pronczuk from Brussels, Raphael Minder from Madrid and Thomas Erdbrink from Amsterdam.
LONDON — A new and potentially more contagious variant of the coronavirus has begun to outpace other versions of the virus in Britain, putting pressure on the government to shorten people’s wait for second doses of vaccines and illustrating the risks of a faltering global immunization drive.
The new variant, which has become dominant in India since first being detected there in December, may be responsible in part for a grievous wave of infections across Southeast Asia, including Nepal, where people have been dying in hospital corridors and courtyards. But efforts to understand the variant picked up once it began spreading in Britain, one of at least 49 countries where it is present. Scientists there are sequencing half of all coronavirus cases amid a push to complete the reopening of its economy.
The preliminary results out of Britain, drawn from only a few thousand cases of the variant, contained both good and bad news, scientists said.
The variant, known by evolutionary biologists as B.1.617.2, is “highly likely” to be more transmissible than the variant behind Britain’s devastating wintertime surge, government scientists have said. That earlier variant, known as B.1.1.7, was itself considerably more contagious than the one that first emerged last year in Wuhan, China.
Public Health England report published this weekend provided signs that government scientists said were consistent with a more transmissible virus: The variant first seen in India was roughly 50 percent more likely than B.1.1.7 to be transmitted to the close contacts of an infected person. Government scientists said last week that it could be anywhere from a few percentage points to 50 percent more contagious than B.1.1.7.
Helpfully for Britain and other wealthy nations, the latest worrisome variant has emerged at a less dire moment of the pandemic. More than four out of every five people in England above the age of 65 — among the groups most vulnerable to the virus — have been given both doses of a coronavirus vaccine, driving down hospitalizations and deaths.
And a new study by Public Health England offered reassuring signs that fully vaccinated people were about as well protected from the variant first detected in India as they were from other forms of the coronavirus.
The Pfizer-BioNTech vaccine offered 88 percent protection against the variant first sampled in India, only a slight drop from the 93 percent protection given against the variant from Britain, Public Health England said. The AstraZeneca-Oxford vaccine was 60 percent effective against the variant from India, compared to 66 percent effective against the one first seen in Britain.
Other studies in England have shown little to no difference between the effectiveness of the Pfizer and AstraZeneca vaccines.
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In Britain, part of its rapid growth may have to do with the particular places it was first introduced. Bolton, in northwest England, where the new variant is most advanced, is a highly deprived area with tightly packed housing that could be hastening its spread, scientists said.
“We do not know if the increase in transmissibility is the result of specific mixing patterns, or super-spreading events,” a group of researchers led by Robert Challen of the University of Exeter reported on May 11, in a study that was among those presented to an influential government advisory group.
That government advisory body said several days later that it had “high confidence” that the variant first seen in India was indeed more contagious, warning that a “substantial resurgence of hospitalizations” was possible. It said that the variant was gaining a foothold in diverse parts of Britain where “contact patterns or behaviors” alone could not explain its spread.
It is not clear if the variant from India is any deadlier than B.1.1.7.
With cases of B.1.1.7 falling, the variant first seen in India now accounts for roughly half of the sequenced coronavirus cases being monitored by Public Health England. The agency’s scientists have said it was likely to replace B.1.1.7 as England’s dominant virus within a month, a startling turnabout so soon after B.1.1.7 swept much of the world.
“For countries that are starting to struggle with B.1.1.7, they now know they have an even faster one close by,” said Devi Sridhar, a professor of global public health at the University of Edinburgh in Scotland.
experimenting with ways to encourage sick people to isolate.
Some scientists have urged the government to go further by dramatically closing the gap between doses of the Pfizer or Moderna vaccine, for instance, and rerouting those shots to cities hardest hit by the variant from India. Because the AstraZeneca vaccine appears most protective with a 12-week dosing interval, those scientists said, using it meant leaving people only partially vaccinated for a period of time.
At the very least, Professor Sridhar said, people needed to be reminded to remain cautious until they were fully vaccinated.
Prime Minister Boris Johnson’s plan to scrap almost all remaining lockdown restrictions on June 21 rests in large part, scientists said, on how many second doses Britain can administer in the coming weeks.
For many poorer nations, starved for vaccines, there is little choice but to leave long delays between first and second doses. Some of them are uncertain about when shipments of second doses will arrive. Large portions of those countries remain entirely unprotected.
If the variant from India spreads as quickly in other countries as it has in Britain, the burden on unvaccinated nations may grow.
“It’s a warning,” Professor Sridhar said. “What we’re seeing in India is being repeated in Nepal, it’s being repeated in other countries. You need to get ahead of it.”
Sanofi, the French pharmaceutical company, said on Monday that it would move the experimental Covid-19 vaccine it is developing with GlaxoSmithKline into a late-stage trial after the shot produced strong immune responses in volunteers in a mid-stage study.
The findings are encouraging news for a vaccine that has fallen behind in development and has so far disappointed those expecting that it would be crucial in combating the pandemic. If the vaccine can become available in the last three months of this year, as its developers hope, it could still play a central role as a booster shot as well as an initial inoculation in the developing world, where the pace of vaccination is lagging.
The vaccine hit a major setback in December, when its developers announced that it did not appear to work well in older adults and that they would have to delay plans to test it in a Phase 3 trial, the crucial test that will assess the vaccine’s effectiveness.
But the companies modified the vaccine and in February began testing it in a Phase 2 study that included more than 700 volunteers in the United States and Honduras between 18 and 95 years old. Sanofi said the vaccine did not raise any safety concerns and produced a strong immune response across age groups, a finding suggesting it has been successfully tweaked.
Sanofi announced the findings in a statement and said it plans to soon publish the results in a medical journal.
Sanofi and GSK are much more experienced in vaccine development than a number of their rivals that have already won authorization. The two companies used a more established approach than those deployed in other, more swiftly developed Covid vaccines. Their shot is based on viral proteins produced with engineered viruses that grow inside insect cells. GSK is supplying the Sanofi vaccine with an adjuvant, an ingredient used in many vaccines meant to boost the immune response.
Sanofi and GSK’s vaccine was one of six selected for funding from Operation Warp Speed, the Trump administration’s effort to accelerate vaccine development. Last summer, the federal government agreed to give the companies $2.1 billion to develop and manufacture the vaccine, in exchange for 100 million doses once the shot was ready.
Sanofi also has supply deals with the European Union and Canada. It has also agreed to supply 200 million doses to Covax, the program to deliver vaccines to middle- and lower-income countries that has been struggling with a shortfall in expected doses. Sanofi has also announced plans to help manufacture the authorized vaccines made by Pfizer-BioNTech, Moderna and Johnson & Johnson.
Sanofi said its Phase 3 trial of its vaccine will begin in the coming weeks and enroll more than 35,000 adult volunteers around the world. It will test two formulations of the vaccine, one aimed at preventing the original strain of the virus and the other aimed at the B.1.351 variant first seen in South Africa that some vaccines appear to be less effective against.
Su-Peing Ng, Sanofi’s global head of medical for vaccines, told journalists on Monday that the company expects it to be “operationally quite challenging” to enroll unvaccinated participants in the Phase 3 trial as vaccination coverage increases in many nations. Still, she said, vaccine doses are still scarce in many parts of the world, pointing to Latin America and Asia as places where the company may look to enroll volunteers.
The company said that soon after starting the Phase 3 trial it plans to assess whether its vaccine can boost immune responses in people who had been vaccinated months before with authorized vaccines. Those booster studies are expected to enroll volunteers in well-vaccinated parts of the world, including the United States and Europe.
Sanofi and GSK said last year they were preparing to be able to make 1 billion doses annually. Thomas Triomphe, Sanofi’s global head of vaccines, said on Monday that the company’s production this year, if its vaccine is shown to work, would depend on the world’s needs.
The vaccine, he said, has “potential to be a booster of choice for many nations and many different platforms.”
Advice from federal health officials that fully vaccinated people could drop their masks in most settings came as a surprise to Americans, from state officials to scientific experts. Even the White House got less than a day’s notice from the Centers for Disease Control and Prevention, the press secretary, Jen Psaki, said at a news briefing on Friday.
“The C.D.C., the doctors and medical experts there, are the ones who determined what this guidance would be based on their own data, and what the timeline would be,” Ms. Psaki said. “That was not a decision directed by or made by the White House.”
For months, federal officials have vigorously warned that wearing masks and social distancing were necessary to contain the pandemic. So what changed?
Introducing the new recommendations on Thursday, Dr. Rochelle P. Walensky, the C.D.C. director, cited two recent scientific findings as significant factors: Few vaccinated people become infected with the virus, and transmission seems rarer still; and the vaccines appear to be effective against all known variants of the coronavirus.
There is no doubt at this point that the vaccines are powerful. On Friday, the C.D.C. released results from another large study showing that the vaccines made by Pfizer-BioNTech and Moderna are 94 percent effective in preventing symptomatic illness in those who were fully vaccinated, and 82 percent effective even in those only partly vaccinated.
“The science is quite clear on this,” said Zoë McLaren, a health policy expert at the University of Maryland, Baltimore County. Mounting evidence indicates that people who are vaccinated are highly unlikely to catch or transmit the virus, she noted.
The risk “is definitely not zero, but it’s clear that it’s very low,” she said.
One of the lingering concerns among scientists had been that even a vaccinated person might carry the virus — perhaps briefly, without symptoms — and spread it to others. But C.D.C. research, including the new study, has consistently found few infections among those who received the Pfizer-BioNTech and Moderna vaccines.
“This study, added to the many studies that preceded it, was pivotal to C.D.C. changing its recommendations for those who are fully vaccinated against Covid-19,” Dr. Walensky said in a statement on Friday.
Other recent studies confirm that people who are infected after vaccination carry too little virus to infect others, said Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai.
“It’s really hard to even sequence the virus sometimes because there’s very little virus, and it’s there for a short period of time,” he said.
Still, most of the data has been gathered on the Pfizer-BioNTech and Moderna vaccines, Dr. Krammer cautioned. Because Johnson & Johnson’s vaccine was authorized later, there are fewer studies assessing its effectiveness.
In clinical trials, the Johnson & Johnson vaccine had 72 percent efficacy — lower than the figure for the Pfizer and Moderna vaccines. And effectiveness was measured in terms of moderate and severe disease, rather than mild disease.
“It’s a very good vaccine, and I’m sure it will save many, many, many lives,” Dr. Krammer said. “But we need more data on how well the J.&J. vaccine prevents infection, and how well it prevents transmission.”
Variants of the virus have been a particular worry for scientists. While Dr. Walensky cited evidence showing that the mRNA vaccines like those from Pfizer and Moderna are effective against the variants circulating in the United States, there is little data about variants and the Johnson & Johnson vaccine. And new variants are emerging constantly.
“I’m not at all saying that this is now a big problem,” Dr. Krammer said. But before lifting the masking requirements, “I might have waited a little bit longer to look at the numbers.”
In a statement on Friday, a C.D.C. spokesman said, “All of the authorized vaccines provide strong protection against serious illness, hospitalization, and death, and we are accumulating data that our authorized vaccines are effective against the variants that are circulating in this country.”
Fully immunized people are unlikely to get seriously ill, even if they are infected with the coronavirus. The risk of infection is greater for the people around them — unvaccinated children and adults, or vaccinated people who remain unprotected because of a medical condition or treatment.
C.D.C. officials said they weighed those factors and were confident in their assessment of the science. And the new advice has other salutary effects, rewarding fully immunized people by giving them permission to end their social isolation — and perhaps incentivizing others to opt for vaccination.
The new advice “signals that we really are on the final stretch here, and I think that’s a very good thing for people,” said Dr. Joshua Sharfstein, the vice dean for public health practice and community engagement at Johns Hopkins University Bloomberg School of Health.
“It’s unlikely that we’re going to have another huge surge in cases,” he added. “But will the final stretch last for weeks or months is still a question.”
The difficulty with the new recommendations, he and other experts said, is not so much the science underpinning them as their implementation.
Leaders at the state, city and county levels still have the authority to require masks even for vaccinated people, as the C.D.C. was quick to acknowledge on Thursday. After the agency’s announcement, some states instantly lifted mask mandates, while others said they would need more time to weigh the evidence.
But in states without mask mandates, the onus of checking vaccination status will fall on shopkeepers, restaurant workers, school officials and workplace managers.
“Without a means to verify vaccination, we will have to rely on an honor system,” said Caitlin Rivers, an epidemiologist at Johns Hopkins University.
The number of cases in the country is the lowest it has been since September, and many experts support lifting mask mandates in much of the country. But doing so will be riskier in places like Michigan, where there are more cases, and for people who are unprotected, including children under 12 and people with a weak immune systems, Dr. Rivers said.
“People who are unvaccinated should continue to wear masks in public indoors and avoid crowds,” she said.
In Nacogdoches, Texas, Dr. Ahammed Hashim fretted that only 36 percent of the population was immunized and the pace seemed to have stalled. And yet only one or two people in 10 in the local shops wore masks.
“I think the C.D.C. might send a wrong message saying that everything’s OK,” said Dr. Hashim, a pulmonologist. “It would feel much better if we had a 60 or 70 percent vaccination.”
The C.D.C.’s guidance is intended for fully vaccinated individuals, and should only be interpreted as such, Dr. Sharfstein cautioned. Nationwide, only 36 percent of the population is fully vaccinated.
“What we’re just seeing is a little bit of the distance between advice that is entirely appropriate for people who are vaccinated, and the reality that there are places that still are seeing viral transmission and a lot of people who aren’t vaccinated,” he said.
Individuals may make choices based on their perception of their own risks, but state and local leaders must decide what’s best for the community based on the rate of infections. “Those are two different things,” Dr. Sharfstein said. “And when they get conflated, that’s when people may make bad judgments about policy.”
The new guidelines should serve as a reminder to health officials to step up their outreach and investment to ensure that everyone has access to vaccines, Dr. McLaren said. Parents of children under 12 should continue to urge them to wear masks indoors.
The C.D.C.’s new policy shifts the onus onto the immunocompromised as well, to protect themselves from unmasked and unvaccinated people.
“When we make policy, we need to balance the needs and desires of everyone,” Dr. McLaren said. “We could keep masking forever, but there are benefits to getting back to a life that looks more normal.”
Health officials should emphasize that the situation may yet change, and official recommendations with it, she added: “We really need to practice being good at responding to changing situations.”
The federal government on Wednesday took a final step toward making the Pfizer-BioNTech coronavirus vaccine available to adolescents in the United States, removing an obstacle to school reopenings and cheering millions of families weary of pandemic restrictions.
An advisory committee to the Centers for Disease Control and Prevention votedto recommend the vaccine for use in children ages 12 to 15. The C.D.C. director, Dr. Rochelle Walensky, is expected to review the recommendations and approve them later on Wednesday.
“Approving Covid-19 vaccines for children 12 to 15 years of age is an important step in removing barriers for vaccinating children of all ages,” said Dr. Yvonne Maldonado, who represents the American Academy of Pediatrics on the federal Advisory Committee on Immunization Practices.
Many parents are eagerly anticipating the availability of vaccines for children, at least in part to speed their return to schools. Roughly one-third of eighth graders, usually 13 or 14 years old, are still learning fully remotely.
at least as effective in 12- to 15-year-olds as it has been in older teenagers and adults. Apart from a slight increase in the frequency of fevers, the shots also seemed to have comparable, mostly negligible side effects.
The company plans to continue monitoring trial participants for two years after the second dose to assess the vaccine’s long-term safety and efficacy.
The Food and Drug Administration reviewed the clinical data and on Monday authorized the Pfizer vaccine for use in these children, capping weeks of anticipation from parents and children about a swifter return to normalcy.
“While it’s true that children are generally spared from severe disease, the fact that they’ve been unable to be vaccinated has caused major disruptions in their lives that have real developmental consequences,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. “Vaccination of this age cohort will allow these children to more fully return to their normal lives.”
about 20,000 pharmacies nationwide are expected to offer the vaccine for free to these children.
survey by the Kaiser Family Foundation.
Some of those parents may change their minds, as other children safely receive vaccines and resume in-person schooling, or rejoin team sports like football and basketball that involve close contact, the researchers suggested.
Others may wait until they must comply with school requirements. Public schools in all 50 states require certain vaccines, but officials may not be able to enforce compliance until the Pfizer-BioNTech vaccine gains the F.D.A.’s full approval.
The vaccine has emergency authorization now. Pfizer has applied to the F.D.A. for full approval, but that process is expected to take several months. Even after approval, students may still opt out by citing medical reasons or religious beliefs.
State and local leaders will need to make particular efforts to reach children in low-income families or in communities of color. Black and Hispanic adults have among the lowest rates of vaccination: As of May 3, just 25 percent of Black people and 27 percent of Hispanic people had been inoculated, compared with 39 percent of white people.
Making the vaccine accessible to these communities will require easier transportation and storage of doses. The Pfizer-BioNTech vaccine can be stored for only five days in standard refrigerators. The companies are planning to ship smaller packs for use in doctors’ offices, and are developing a formulation that can be refrigerated for up to 10 weeks.
Pfizer and BioNTech plan in September to submit requests for authorization of the vaccine in children ages 2 to 11.
HAVANA — Cuba began a mass vaccination campaign on Wednesday in the capital, Havana, where authorities aim to eventually vaccinate 1.7 million people. The campaign is using homegrown vaccines that have not yet been shown to work, an emergency step intended to blunt the rapid spread of the coronavirus.
The country’s decision to deploy unproven vaccines mirrors the early introduction of vaccines in Russia, China and India, where regulators permitted mass vaccination campaigns to begin before the completion of Phase 3 clinical trials, which assess the vaccines’ effectiveness and safety.
In Florida, news reports critical of the Cuban government accused it of jumping the gun and endangering public health. American and European health regulators do not allow vaccines to be introduced, even for emergency use, until Phase 3 clinical trials are completed.
Though Cuba’s daily coronavirus case counts remain low by Latin American standards, they have spiked alarmingly in recent months. The island, which reported 12,225 confirmed cases in all of 2020, saw 31,465 confirmed cases in April 2021 alone.
hard for Cuba to do business with foreign suppliers and complicating international humanitarian initiatives to donate syringes to the island, which needs about 20 million more to vaccinate the whole country.
Of the 90 coronavirus vaccines around the world currently in clinical trials, five were developed in Cuba, the smallest country to develop and produce its own vaccines.
“We will probably be the first country to immunize its whole population with its own vaccine,” said Dr. Eduardo Martínez, president of BioCubaFarma, the state conglomerate overseeing vaccine development and production.
NEW DELHI — Just a few months ago, the southwestern state of Goa was welcoming tourists from across the rest of India who were drawn to its picture-perfect beaches, an ideal source of relief from coronavirus rules in other regions.
Group celebrations, many without masks, were common. Life appeared to have gone back to normal.
But it did not last.
With India in the grip of a devastating coronavirus outbreak, 26 people died at the state-run Goa Medical College and Hospital on Tuesday morning, possibly because of an oxygen shortage, one official said.
“Due to interrupted supply of oxygen, we feel that between 2 a.m. and 6 a.m. many people are dying in G.M.C.,” the health minister for Goa, Vishwajit Rane, told The Times of India. He also called for a High Court inquiry to investigate the cause of the deaths.
might be “misguided.”
Goa has been reporting one of the highest infection rates in the country for at least a week.
Mr. Rane said in an interview with CNN last week, “Opening up of tourism without any restrictions in December has led to this situation.”
Goa has also created headlines for approving the use of ivermectin, an anti-parasite drug, in the treatment and prevention of Covid-19. The World Health Organization has said that there is not enough evidence to suggest that the drug reduces mortality in coronavirus patients.
On Monday, Mr. Rane announced on Twitter that the state government would make the drug available for everyone over 18 as a prophylactic.
Novavax, one of the first players in the race to vaccinate the world against Covid, delivered disheartening news on Monday, saying that its highly protective vaccine would not be authorized in the United States or Britain until at least July, and that it would not reach peak production until the end of the year.
The delays, announced during an earnings call with investors, are the latest setback for the little-known Maryland company, which was granted up to $1.6 billion from the U.S. federal government last year and whose product has shown robust results in clinical trials. Despite these wins, the company has struggled to demonstrate that it can deliver on its promise to supply the world with 2 billion doses this year. Novavax has never brought a vaccine to market in its 34-year history.
On the call, the company’s president and chief executive, Stanley C. Erck, said that the regulatory and manufacturing hurdles causing the delay have now been resolved. “Nearly all of the major challenges have been overcome, and we can clearly see the light at the end of the tunnel,” he said.
Investors did not appear to agree: By Tuesday morning, the company’s stock had fallen to $133.86, down nearly 17 percent, although it rebounded somewhat later in the day.
finalized a deal with Gavi, a public-private global vaccine partnership, to supply 1.1 billion doses of its shot to low- and middle-income countries. Novavax has struck other deals with countries like South Korea, Japan and Australia, and has set up agreements with eight production plants around the world.
In January, the company estimated that it would hit its full production capacity of 150 million doses a month by the middle of this year, a prediction it later revised after facing a shortage of supplies like filters and the giant single-use bags that are used in vaccine manufacturing. On Monday, the company delayed its estimate again, saying it expected to reach production of 100 million doses a month by the end of the third quarter, and to make 150 million a month by the fourth quarter.
One of its major manufacturing partners, the Serum Institute in India, has faced its own production and geopolitical challenges. A fire at the facility earlier this year reduced its capacity, and in April, Serum’s chief executive, Adar Poonawalla, called out the United States for restricting access to raw vaccine ingredients. And though Novavax’s deal with Serum is intended to supply the rest of the world through its arrangement with Gavi, the Indian government has banned exports of vaccines from the country as it struggles with a deadly second wave of Covid-19.
which is tracking global vaccine deals. “I think particularly for countries in South and Southeast Asia, as well as countries in Africa, it is hard to overstate the impact that this is having.”
Regulatory hurdles have also set Novavax back. On Monday, company executives said that a now-resolved issue with an “assay” — a test that was needed to confirm that their product can be consistently manufactured at commercial scale across multiple production plants — was delaying regulatory approvals around the world, and that countries like Britain and the United States would not grant authorization until at least July. Company officials once said they hoped to gain authorization for their vaccine in April.
persuaded Novavax to set up a trial there last year in part by promising speed in clinical development and regulatory approval. But time is running out: About two-thirds of British adults have received a first dose of a coronavirus vaccine, most made by AstraZeneca, and every adult is expected to be offered one by the end of July.
The vaccine’s role in Britain depends in part on how quickly Novavax can start distributing its shot. A British factory making the vaccines has said that it would be ready by the summer. The country has recently turned away from the AstraZeneca shot in younger people because of the risk of very rare blood clots, leaving room for Novavax to be an alternative for people under 40.
The country is also studying the effects of administering a second dose of the Novavax vaccine in people who have already received a first dose from either Pfizer or AstraZeneca.
the company was on the verge of closing after a major trial failure for another vaccine, and it was forced to sell off its manufacturing facility to raise money.
Last year, the Trump administration placed a major bet on the tiny company as part of its Operation Warp Speed project, signing a $1.6 billion contract for delivery of 110 million doses by early this year. In April, the total amount of the deal was increased to $1.75 billion, according to Novavax’s financial filings. The company’s large trial in the United States and Mexico has still not been completed, although executives said on Monday that they expected results from that study “in a few weeks.”
Novavax officials said they now did not expect to deliver those doses until the end of this year or early 2022. A spokeswoman for Novavax said there was no penalty for later delivery in its contract with the U.S. government.
Novavax’s spotty track record does not offer confidence that it can rise to the challenge of producing billions of doses, said Les Funtleyder, a health care portfolio manager at E Squared Capital Management who invests in domestic and emerging markets. “It seems they were really unprepared for a challenge of this magnitude,” he said.
Recent news of internal turnover — such as the departure last month of Novavax’s chief financial officer, five months after taking the role, for personal reasons — does not help, Mr. Funtleyder said. “It’s a bad look,” he said.
children older than 12, in an effort to catch up to Moderna and Pfizer, which have already tested their products in that age group.
The vaccine can also be stored at normal refrigeration temperatures, without the freezing temperatures required by Pfizer and Moderna’s vaccines.
“By the end of 2021 there will still be a great need for safe and effective vaccines that can travel well,” said Ms. Taylor, of Duke University. “Novavax looks like it can fit that description.”
Dr. Saad B. Omer, the director of the Yale Institute for Global Health, noted that when concerns were raised over the Johnson & Johnson and AstraZeneca vaccines because of links to blood clots, countries with multiple vaccines available were able to switch to other options.
“It’s good to hedge our bets,” he said. “If we want to avoid, for example, body blow after body blow to low-income countries in many parts of the world that has an impact on everyone, we need to vaccinate a huge chunk of the world.”
Benjamin Mueller and Noah Weiland contributed reporting.
Vaccinating children is crucial to building up population levels of immunity and curtailing the spread of the coronavirus. Though children spread the virus less efficiently than adults do, they make up about 23 percent of the population.
Experts have said that the country is unlikely to reach the “herd immunity” threshold — the point at which virus transmission essentially stalls — but vaccinating children will be important for getting as close as possible.
Ty Dropic, 14, one of the trial participants, urged others his age to be vaccinated so they could build up widespread immunity and protect themselves. He had no side effects, leading him to suspect that he got the placebo. If that turns out to be the case, he plans to be immunized as soon as possible.
“I know it can be kind of scary, but it’s really not as bad as it seems,” he said. “If you do get Covid, it’ll be a lot worse than getting stuck with a needle for, like, two seconds.”
Ty’s three siblings, ages 8, 10 and 16, are also enrolled in vaccine trials for their age groups. Their mother, Dr. Amanda Dropic, a pediatrician in northern Kentucky, said that in her practice, most parents were eager to have their children vaccinated so they could regain some semblance of normalcy.
“The anxiety and depression that we’re seeing with kids, the social delays, has been tremendous,” she said.
Dr. Dropic said her children understood the risks and were willing to volunteer because they saw it as a civic duty. Every medicine available today came to be because “somebody was willing to go first,” she added.