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In a new analysis, the Food and Drug Administration questioned the strength of evidence Johnson Johnson provided in its application for booster shots. A key test used by the company was likely not sensitive enough, the agency suggested, adding that it didn’t have enough time to independently review much of the raw data from the trials.
The document, released in advance of a Friday meeting of the agency’s vaccine advisers, could have significant influence on whether the 15 million Americans who have received the one-dose vaccine will be allowed to get a second shot, or if they will instead be urged to get a different brand of vaccine for added protection.
The agency’s analysis follows a report released on Tuesday, in which Johnson Johnson argued in favor of a booster, presenting data from a number of trials.
“A booster dose is recommended at 6 months or later, based on the strength of the immune responses,” the company wrote.
But on Wednesday, the F.D.A. said that the test used by the company to measure the immune response of a six-month-boost — known as a psVNA assay — is not sensitive enough for the task. The agency also questioned whether the increase in immune response was as big as the data suggested.
“It is likely that the results seen are due to the low sensitivity of the psVNA assay used,” the F.D.A. stated in its report.
The F.D.A. saw a potential improvement in protection from a J. J. booster given two months after the first shot, based on a large trial sponsored by the company.
“Although not independently confirmed by F.D.A. from datasets, summaries of the data suggest there may be a benefit in a second dose administered approximately 2 months after the primary dose,” the agency said in its report.
The fact that the F.D.A. had not independently confirmed key data was a departure from past briefing documents for other vaccines. The F.D.A. said that it didn’t have time to vet much of Johnson Johnson’s material before the meeting later in the week.
The agency scheduled the meeting of its outside advisers before the company had even submitted its application for a booster dose — an unusual move, some public health experts said.
“Except where noted, datasets were not submitted in sufficient time for FDA to conduct an independent review to verify the Sponsor’s analyses,” the F.D.A. said in its report.
A spokesman for Johnson Johnson did not immediately respond to a request for comment.
The F.D.A. has already authorized an additional shot of the Pfizer-BioNTech vaccine for people over 65 years of age, or with health conditions or job exposures that put them at higher risk. Moderna has also submitted an application for a booster which will be evaluated by the F.D.A.’s advisers on Thursday. It may also win authorization, despite limited evidence that the protection provided by an initial two doses of Moderna is waning.
When Johnson Johnson’s vaccine was authorized in February, it had several advantages over the other two. As a single shot, it was more convenient than the two-dose formulation from Moderna and Pfizer-BioNTech. It also didn’t have to be frozen to stay viable. But it also provided less robust protection.
A clinical trial showed that one dose of J. . J. had an efficacy rate of 66 percent against moderate to severe Covid-19 worldwide, and 74 percent in the United States. Its efficacy against either severe or critical disease was stronger, at 85 percent worldwide.
In its application for a booster, Johnson Johnson included the results of another large-scale trial that began in November, in which they gave half their volunteers a second dose two months after the first. The other half received a placebo.
In August, the company announced that in the portion of the trial that took place in the United States, the efficacy rose to 94 percent. But in its report, the F.D.A. focused on the worldwide results, in which the increase more modest, rising to 75 percent.
Against severe to critical Covid-19, two shots had an efficacy of 100 percent. But regulators warned in the analysis posted Wednesday that there was little data from that trial on the Delta variant, which now causes the vast majority of infections in the United States.
“The small number of accrued cases confirmed to be caused by the Delta variant precludes any conclusion regarding efficacy against that variant,” they wrote.
WASHINGTON — The Biden administration will lift travel restrictions at the borders with Canada and Mexico starting in November for fully vaccinated travelers, reopening the doors of the United States to tourists and separated family members who have been sealed out of the country during the pandemic.
Foreign travelers who provide proof of vaccination and are looking to visit families or friends or shop in the United States will be allowed to enter, senior administration officials said on Tuesday, weeks after the administration said it would soon lift a similar sweeping restriction on foreigners traveling to the country from overseas.
The lifting of the bans will effectively mark the reopening of the United States to travelers and tourism, signaling a new phase in the recovery from the pandemic after the country closed its borders for nearly 19 months.
But the new requirements also indicate that the United States will welcome only visitors who are vaccinated. Unvaccinated travelers will continue to be banned from crossing the borders with Mexico or Canada, officials said. Those who were never banned from traveling across the land borders, including commercial drivers and students, will also need to show proof of vaccination when crossing starting in January, giving them some time to adjust to the new rules, officials said.
The travel restrictions, imposed in March 2020, only applied to “nonessential travelers” — relatives looking to visit family members, or shoppers, whom border communities relied on for profits. Politicians representing such communities have pleaded with the Biden administration to lift the restrictions to provide a reprieve for suffering businesses.
Senator Kirsten Gillibrand, Democrat of New York, said the restrictions had cost Erie County in her state at least $660 million annually.
“This reopening will be welcome news to countless businesses, medical providers, families and loved ones that depend on travel across the northern border,” Ms. Gillibrand said.
Officials did not give an exact date for the lifting of the travel restrictions. The announcement comes more than two months after Canada reopened its borders; Mexico did not close its northern border during the pandemic.
People entering the U.S. at the borders with Mexico or Canada will be questioned by Customs and Border Protection officers about their vaccination status before being allowed to cross. The officers will have the discretion to send travelers to secondary screenings for their documents to be checked, officials said.
However, President Biden will continue to use a separate border policy, implemented early in the pandemic, to turn away migrants who are seeking protection or economic opportunity — a policy that has been criticized by a top State Department official and the administration’s own medical consultants.
The decision on the land borders was made in part to coincide with the reopening to foreign air travelers, officials said. While those traveling by air will need to show both proof of vaccination and a negative coronavirus test to enter the United States, there will be no testing requirement for those crossing the land borders.
Mexico’s foreign minister, Marcelo Ebrard, said at a news conference Wednesday that his country’s vaccine rollout played a role in the reopening.
“The vaccination averages in Mexico, especially in the northern region, but also the rest of the country, are very high or are comparable to those in the United States,” Mr. Ebrard said. “The basis of global mobility will be vaccination.”
The Centers for Disease Control and Prevention considers people fully inoculated two weeks after they receive a second dose of the Pfizer-BioNTech or Moderna vaccines, or a single dose of Johnson Johnson’s.
Those who have received vaccines listed for emergency use by the World Health Organization, such as AstraZeneca’s, would also be considered fully vaccinated — a standard that one senior official said would probably be applied to those crossing the land border. Officials added that the C.D.C. was still discussing whether foreigners crossing from Canada or Mexico with two doses from different vaccines could enter.
Many Mexicans have received vaccines that do not have W.H.O. authorization, like Sputnik V, developed in Russia, or the CanSino vaccine from China. President Andrés Manuel López Obrador said on Wednesday that he would press the W.H.O. to authorize them soon.
The decision to lift the restrictions on air travel has been celebrated by business leaders overseas and in the United States. Travel spending dropped nearly in half to about $600 billion in 2020 from a year earlier, according to the U.S. Travel Association, a trade group.
“Border communities have been hamstrung because of port closures,” Representative Veronica Escobar, a Texas Democrat who represents a border district, said in an interview. “Not only did we suffer more significant health devastation in 2020, but the economic devastation has been longer for us because of those port closures.”
Senator Patty Murray, Democrat of Washington, said the lifting of the restrictions would benefit communities she represents like Point Roberts, which are “almost entirely dependent on cross-border travel to sustain their economy.”
But she warned that after “months of economic calamity” inflicted largely by the border closure, more measures would be needed to ensure that the community could fully recover.
Nicholas Fandos, Oscar Lopez and Maria Abi-Habib contributed reporting.
The World Health Organization on Wednesday named 26 scientists to a new advisory group charged with studying the origins of the coronavirus, opening another chapter of the fraught search for how the pandemic began.
The group, chosen from more than 700 applicants, includes scientists from 26 countries, a reflection of the W.H.O.’s effort to amass widespread international support for the work.
Among them are an American researcher — Dr. Inger Damon, a veteran of the country’s Ebola response who directs work on highly lethal diseases at the Centers for Disease Control and Prevention — and a Chinese scientist. The Chinese scientist, Dr. Yungui Yang, is the deputy director at the Beijing Institute of Genomics at the Chinese Academy of Sciences, a government institution.
With this new group, the W.H.O. is trying to revive its study of the pandemic’s origins. That work that had become bogged down in a political rivalry between China and the United States, and concerns about scientists’ conflicts of interest, since the W.H.O. sent a previous team to China in early 2021.
The result of that visit was a joint report by the W.H.O.-chosen team and China that said a leak of the coronavirus from a lab, while possible, was “extremely unlikely,” a conclusion that the W.H.O.’s director general, Tedros Adhanom Ghebreyesus, later called premature.
Six members of that since-disbanded W.H.O. team have joined the new advisory group. The committee also includes the head of a Swiss biosafety center, an indication of W.H.O.’s efforts to ensure that a laboratory leak be considered alongside scenarios in which the virus spilled over naturally from animals to humans.
“A lab accident cannot be ruled out until there is sufficient evidence to do so and those results are openly shared,” Dr. Tedros and two top W.H.O. officials wrote in an editorial in Science outlining the advisory group’s mandate.
After a two-week public comment period that is customary before W.H.O. advisory groups are set up, the committee will begin to meet.
W.H.O. officials said the group would assess recent studies, including those describing bats harboring close relatives of the virus behind Covid-19, and advise the organization on what future studies were needed — potentially including field research in China.
China has reacted angrily to the idea that the virus may have emerged from a lab and, analysts have said, is almost certain to resist outside requests to visit research centers, bat caves or wildlife farms within its borders.
Unlike the last W.H.O. team, which was assembled specifically for the visit to China, the new committee will also have a mandate to weigh in on the emergence of any new pathogens beyond the coronavirus, giving it a permanence that the W.H.O. hopes will help insulate it from political squabbling.
At a news briefing on Wednesday, Dr. Michael Ryan, the executive director of the W.H.O. Health Emergencies Program, said it was impossible to ignore obstacles like “national pride” standing in the way of hunting down the origins of the coronavirus. But he said the new advisory group was an effort to return to the scientific issues at the core of that effort.
“This is our best chance,” he said. “And it may be our last chance to understand the origins of this virus in a collegiate and collective and mutually responsible way.”
Intensive care units are nearing capacity and health care workers are in short supply in Minnesota, as coronavirus cases, hospitalizations and deaths all reach levels not seen since vaccines became widely available.
All of the state’s counties are at high risk for community transmission, according to the Centers for Disease Control and Prevention. New daily cases have risen by 29 percent in the last two weeks and hospitalizations by 17 percent, according to a New York Times database.
About this data Source: U.S. Department of Health and Human Services. The seven-day average is the average of a day and the previous six days of data. Currently hospitalized is the most recent number of patients with Covid-19 reported by hospitals in the state for the four days prior. Dips and spikes could be due to inconsistent reporting by hospitals. Hospitalization numbers early in the pandemic are undercounts due to incomplete reporting by hospitals to the federal government.
The state’s daily case average is at its highest level for 2021 and reached 2,932 on Monday, a dramatic increase since the summer, when it bottomed out at an average of 81 daily cases.
While a monthslong increase driven by the Delta virus variant is waning in much of the country, Minnesota is just one of several Upper Midwestern and Mountain West states where the virus is surging. Cases are up and hospitals have been overwhelmed in North Dakota, Wyoming, Montana and Idaho, all of which have low vaccination rates. Some areas have had to ration care and send patients to distant hospitals for treatment.
The Minnesota Department of Health said the state’s surge is overwhelming hospitals, with rural and metropolitan areas equally stretched.
“Even before Covid cases started to rise in this latest surge, our hospitals were very full with patients needing care for other critical conditions,” Jan Malcolm, the state’s health commissioner, said in a news conference last week.
According to a state health department database, 96 percent of I.C.U. beds in Minnesota are in use along with 93 percent of non-intensive care beds. Although beds are almost at capacity, the state is equipped with respirators to combat the surge, Ms. Malcolm said. The bigger issue now is a shortage of medical personnel, she said.
“What’s important to understand is that this isn’t so much about the physical asset of a hospital bed or a ventilator, and those were big focuses earlier in the pandemic, but now this is really an issue of health care worker capacity,” Ms. Malcolm said. “There are actually fewer health care workers on the job today than there were last year due to the extreme stress and burnout that they have faced for over 18 months now.”
Dr. Kevin Croston, chief executive officer at North Memorial Health, one of Minnesota’s largest medical systems, said “every element of our health system is incredibly stressed.”
Both hospitals run by North Memorial — North Memorial in Robbinsdale and Maple Grove Hospital — are almost running at capacity and are experiencing staffing shortages that have reached a “critical level.”
“Staff vacancies are increasing while our customer patient volumes remain high,” Mr. Croston said. “We have rapidly escalated measures to attract and retain talent in health care and that’s adding more expense to an already stressed financial picture for all these health care systems.”
He also noted that all patients hospitalized with Covid were unvaccinated.
In Minnesota, 59 percent of the state’s population is fully vaccinated compared to 56 percent of the population nationally.
“With the amount of virus that’s out there and the amount of the population that is not protected by the vaccine, there’s unfortunately plenty of room for the virus to still do its harm,” Ms. Malcolm said.
Chinese authorities are rolling out third shots of coronavirus vaccines for high-risk groups in at least 10 regions, according to state media, as the country races to meet its goal of fully vaccinating 80 percent of its population by the end of the year.
After a series of outbreaks of the Delta variant, Wang Huaqing, chief expert for China’s immunization program at the Chinese Center for Disease Control, recommended last month that additional shots be administered to people in frontline professions, including medical workers; people with weaker immune systems; those age 60 or older; and travelers going to countries deemed at high risk.
Chinese health officials have said that further studies were still needed to determine whether the rest of the population would benefit from getting an additional shot.
By Sunday, more than 40,000 people in Hubei, the province encompassing Wuhan where the virus first emerged, had received booster shots, according to state media reports. In the northeastern province of Heilongjiang, which had a flare-up of the Delta variant last month, local health officials said that people who got the booster shot would see their government-issued health codes upgraded to reflect their strengthened immune status.
Last month, China announced that it had fully inoculated 1 billion people, or about 71 percent of its population of 1.4 billion. The country has administered 2.21 billion doses, more than twice that of India, which is ranked second for shots given, according to Our World in Data, which tracks vaccination figures.
Despite its high vaccination rate, China has shown no signs of abandoning its “zero Covid” strategy, and has instead continued to employ a mix of stringent border controls, mass testing and snap lockdowns to tame outbreaks.
On Monday, a panel of experts advising the World Health Organization recommended that an additional dose be administered to people over 60 who were inoculated with vaccines made by the Chinese companies Sinopharm and Sinovac. The panel cited evidence from studies in Latin America that immune protection from the Chinese vaccines wanes significantly over time. While the experts also recommended additional doses of the seven W.H.O.-authorized vaccines for people with weaker immune systems, the Chinese-made shots were the only ones that were singled out for expanded use for older people in the general population.
In a nod to concerns that poorer countries are struggling to offer first doses to their populations while some wealthier countries administer boosters, the W.H.O. panel recommended that health authorities using the Sinovac and Sinopharm vaccines aim to fully inoculate older populations before administering third doses.
Authorities in Turkey have already been allowing people inoculated with Sinovac’s vaccine to get an additional shot of the Pfizer vaccine to help facilitate travel to countries where the Chinese vaccines have not been approved.
More than 1 billion Chinese-made doses have been administered in over 90 countries outside China, though outbreaks in several countries over the summer have raised questions about the efficacy of the shots at preventing the spread of the virus, especially new variants.
The concerns have not slowed China’s efforts to engage in vaccine diplomacy. Last month, the Pan American Health Organization struck a deal with Sinovac to buy millions of Covid-19 vaccines for countries in Latin America and the Caribbean where access to vaccines has been highly uneven.
The Anchorage Assembly approved a mask mandate on Tuesday after two weeks of heated public discussion amid a Covid outbreak that has forced doctors to ration life-saving care in Alaska’s largest city.
The vote was 9-1, concluding a tense, often chaotic debate that included doctors being heckled by members of the public, an armed man being arrested, and protesters sparking outrage by turning up to meetings wearing Stars of David — an attempt to liken mask requirements to the persecution of Jews in the Holocaust.
“The time to act is now,” Meg Zaletel, an assembly member, said on Tuesday night while pressing for a vote. One person in the crowd shouted objections, leading security officers to intervene.
The order requires everyone to wear a mask or face covering in public indoor spaces, with limited exemptions for younger children and for religious or medical reasons.
Alaska has recorded the highest coronavirus case numbers per person in the United States in recent weeks. Although new infections have fallen from a late September high, the surge has overwhelmed hospitals, especially in Anchorage, where many of the state’s patients come for critical needs.
About this data Source: State and local health agencies. Daily cases are the number of new cases reported each day. The seven-day average is the average of a day and the previous six days of data.
Heart surgeries have been canceled to preserve space in hospitals. One facility rationed oxygen. And doctors have been forced to implement “crisis standards of care,” prioritizing some critical patients over others because of the lack of resources.
One patient who needed emergency surgery was not attended to; a second was taken off of dialysis because another needed it. In both cases, the patients who received substandard care died.
Gov. Mike Dunleavy has resisted a statewide mask mandate, but assembly members in Anchorage — home to about 40 percent of the state’s population — moved forward. Doctors had gone to the assembly meetings in recent weeks to detail the crisis they have been facing, but they faced blowback from community members. One man followed doctors out of a meeting, calling them liars.
Anchorage Mayor Dave Bronson, who has opposed a mask requirement, vowed to veto the mandate, although it appears the assembly has the votes to override it.
About 51 percent of Alaska’s population is fully vaccinated, according to a New York Times database, lower than the national figure of 57 percent.
American Airlines and Southwest Airlines, citing federal requirements, said on Tuesday that they would not comply with an order from the governor of Texas barring private employers from mandating coronavirus vaccines in the state.
Gov. Greg Abbott, a strong opponent of vaccine mandates, issued the order on Monday, saying inoculation against the coronavirus should “always be voluntary for Texans.”
“We believe the federal vaccine mandate supersedes any conflicting state laws, and this does not change anything for American,” said a spokeswoman for the airline, which is based in Fort Worth. Southwest, which is based in Dallas, said it would “remain compliant” with the federal mandate.
About this data Source: State and local health agencies. Daily cases are the number of new cases reported each day. The seven-day average is the average of a day and the previous six days of data.
The Greater Houston Partnership, a business group that counts Exxon Mobil, Chevron and JPMorgan Chase as members, also came out on Tuesday against Mr. Abbott’s order, saying it “does not support Texas businesses’ ability and duty to create a safe workplace.”
President Biden announced last month that federal contractors and their employees would need to be vaccinated, with limited exceptions. Like other major employers, American and Southwest cited that requirement and their status as contractors in announcing that employees must be vaccinated.
Mr. Biden also announced that workers at companies with more than 100 employees would have to be vaccinated or tested regularly, but those requirements are dependent on new rules that the Occupational Safety and Health Administration has not issued yet. That requirement will cover tens of millions of workers, the administration said. Health care workers at institutions that receive funding from Medicaid and Medicare are also required to be vaccinated.
Jen Psaki, the White House press secretary, accused Mr. Abbott on Tuesday of putting “politics ahead of public health” and said federal laws superseded state and local ones.
The administration will continue to pursue the expansive mandates it announced last month, she said, adding that business leaders who had already introduced mandates had reported positive results.
“Beyond the legal aspect, which is unquestionable in our view, the question for any business leader is: What do you want to do to save more lives in your companies?” Ms. Psaki said.
A spokeswoman for Mr. Abbott said that the Biden administration had “left employers with the unfair choice of either violating federal regulations or losing their valued employees” and that the governor’s order was “enforceable by state and local law enforcement.”
Late Tuesday, a federal judge in Texas issued a temporary restraining order telling United Airlines not to place on unpaid leave any employee who had been granted a vaccine exemption. The court’s order said it was not ruling on any merits of the case, but was allowing for more time to consider a preliminary injunction. The order is in place until Oct. 26.
In Florida, another state with a governor who has battled vaccine mandates, the Department of Health issued a notice of violation to Leon County, which encompasses Tallahassee, for violating a ban on “vaccine passports” in the state.
The department said in a release on Tuesday that it was fining the county nearly $3.6 million for requiring 700 government employees to provide their vaccine status and firing 14 who refused to comply. Gov. Ron DeSantis said he wanted to “preserve the ability of Floridians to make their own decisions regarding what shots to take.”
An order by the governor of Texas barring nearly all Covid-19 vaccine mandates in the state appears sweeping. But legal experts say that it does not supersede President Biden’s orders requiring vaccine mandates for many kinds of employees, and that it is likely to be challenged in court, where the case law so far has been heavily in favor of the validity of vaccine requirements.
The order issued on Monday by Gov. Greg Abbott of Texas, a Republican, bars vaccine mandates by any “entity” — including private employers, who were not covered by his previous orders forbidding mandates. States like Florida have also acted to ban public agencies and private businesses from requiring vaccination, and those bans are also likely to end up in court, experts say.
“Texas has just set itself up for a grand political show, but not a potentially legally sound initiative to stop all vaccine mandates,” said James Hodge, the director of the Center for Public Health Law and Policy at Arizona State University. “It boils down to a lot more politics than law.”
Courts in the United States have a long history of upholding vaccine mandates, Mr. Hodge said, and of ruling that protecting public health takes precedence over personal choice.
“That individual right to liberty has never gone that far to actually engage in behaviors that directly impact the public’s health,” said Mr. Hodge.
The right of the government to impose vaccine mandates has been established at least since 1905, when the Supreme Court ruled that Cambridge, Mass., could require adults there to be vaccinated against smallpox. Later court cases set the legal groundwork for vaccine mandates in schools, health care and other fields, Mr. Hodge said.
The Texas order also ramps up an emerging battle between Republican governors and President Biden, who is testing the limits of presidential power by asserting executive authority to require Covid-19 vaccines for workers in the federal government and the health care industry.
The president has also moved to require that all companies with more than 100 workers maintain safe workplaces through vaccination or weekly testing, relying on the federal government’s power to regulate commerce and the Occupational Safety and Health Act of 1970.
Abbott ‘Putting Politics Ahead of Public Health,’ Psaki Says
Jen Psaki, the White House press secretary, criticized Gov. Greg Abbott of Texas for signing an executive order banning vaccine mandates, and said that it does not supersede President Biden’s orders requiring vaccinations for many kinds of employees.
Governor Abbott’s executive order banning mandates, and I would also note announcement by Governor DeSantis this morning essentially banning the implementation of mandates fit a familiar pattern that we’ve seen of putting politics ahead of public health. Over 700,000 American lives have been lost due to Covid-19, including more than 56,000 in Florida and over 68,000 in Texas. And every leader should be focused on supporting efforts to save lives and end the pandemic. Why would you be taking steps that prevent the saving of lives, that make it more difficult to save lives across the country or in any state? And I would also note that vaccine requirements have been standard in both the Lone Star State, Texas in case you’re not familiar, and the Sunshine State, Florida, in schools for decades. Whether polio, measles, mumps, rubella, the chickenpox, there are vaccine requirements that have been implemented for decades in these states. Bottom line is we’re going to continue to implement the law, which the president of the United States has the ability, the authority, the legal authority to do, and we are going to continue to work to get more people vaccinated to get out of this pandemic. The president will use every lever at his disposal to do that.
Jen Psaki, the White House press secretary, said on Tuesday that the president’s legal authority to issue mandates “overrides state law,” and that “to get out of this pandemic, the president will use every lever at his disposal.”
Republican governors like Mr. Abbot and Ron DeSantis of Florida have accused Mr. Biden of overreach. Mr. DeSantis said at a news conference on Tuesday that Florida and other states were prepared to mount a legal challenge to Mr. Biden’s mandate for private employers. But the states are likely to lose in court, experts say.
“It’s highly unlikely that you’re going to see any sort of higher-level court consistently agree that this type of intervention exceeds federal authority, when it’s been in place for 50 years,” Mr. Hodge said.
In August, a federal judge ruled against Florida’s ban on “vaccine passport” requirements. Ruling on First Amendment grounds, the judge issued a temporary injunction allowing Norwegian Cruise Line to continue requiring its embarking passengers to show proof of vaccination, despite the state ban.
Correction: Oct. 12, 2021
An earlier version of this article misstated the year that the Supreme Court ruled governments have the right to impose vaccines. It was 1905, not 1904.