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F.D.A. Panel Endorses J.&J. Covid-19 Vaccine Boosters
A Food and Drug Administration advisory panel recommended authorizing booster shots of Johnson & Johnson’s one-dose coronavirus vaccine for people 18 years or older, at least two months after the first dose.
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“Today, we are seeking authorization for use of Janssen’s Ad26 Covid vaccine as a homologous booster in those individuals who were previously vaccinated with the single dose.” “Do available data support the safety and effectiveness of Janssen’s Covid-19 vaccine for use under EUA as a booster dose in individuals 18 years of age and older, at least two months after a single dose primary vaccination?” “We do have 19 out of 19 unanimous yes votes for this question. Thank you.”
The Food and Drug Administration’s vaccine advisory panel unanimously voted on Friday to recommend authorizing booster shots of Johnson & Johnson’s one-dose coronavirus vaccine for adults, at least two months after the first dose.
The vote paves the way for F.D.A. officials to give the booster shots a green light, which would be followed by review at the Centers for Disease Control and Prevention. The F.D.A. typically follow the panel’s advice but is not bound by it.
The panel of advisers was not asked to make a recommendation on whether Johnson & Johnson recipients should also be allowed to get a booster shot of one of the two other competing vaccines in use in the United States, though the members discussed a study showing the mix-and-match approach gives patients a stronger immune response.
Many panel members said that a second dose of the Johnson & Johnson vaccine was important because the first dose did not provide strong enough protection. Unlike the other vaccines available in the United States, Johnson & Johnson chose to seek authorization for a single dose — a decision that some committee members said was a mistake in hindsight.
“I think this frankly was always a two-dose vaccine,” said Dr. Paul Offit, an infectious disease expert at the Children’s Hospital of Philadelphia.
Representatives from the drug maker made their case to the panel in the morning, arguing that a second dose increased antibodies if given either two months or six months after the first shot. They also maintained that the single dose remained durable.
Federal vaccine experts repeatedly pointed out shortcomings in the company’s data. They warned the two-month trial had followed up with study volunteers for a only short period of time after their second shots. They also raised questions about a key test the company used to measure the antibodies produced by a booster, saying it had a low sensitivity. That concern was raised by panel members as well.
The regulators said they did not see any evidence of serious safety concerns in the booster studies. But they noted they did not have enough time to independently review much of the data that Johnson & Johnson provided, including in its large, two-dose trial that the company maintains makes a clear case for boosters.
One panel member, Dr. Archana Chatterjee, an infectious disease expert at Rosalind Franklin University, asked the F.D.A. why it convened the panel if its own experts had not had time to verify the company’s data.
Dr. Peter Marks, the agency’s top vaccine regulator, responded that it could have taken a month to verify all the data from the company’s largest-scale, two-dose trial and several weeks to review the smaller studies.
Some federal officials expressed skepticism about the claims the company made regarding the efficacy of one dose, and worried that those who received it are not as protected as Moderna or Pfizer-BioNTech recipients.
In the end, the panel voted to recommend authorizing the boosters, with some members saying the move would effectively bring the effectiveness of J.&J.’s vaccine up to the level of the two-dose vaccines made by Moderna and Pfizer-BioNTech.
Dr. Chatterjee said that her concerns about waning immunity and the shot’s efficacy against hospitalization led her to be supportive of offering boosters.
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An independent panel of experts advising the Food and Drug Administration voted on Thursday to recommend a booster shot for many recipients of the Moderna coronavirus vaccine, and on Friday to recommend authorizing booster shots of Johnson & Johnson’s one-dose coronavirus vaccine for people 18 years or older, at least two months after the first dose.
So what happens now? There are further steps at the F.D.A., then steps at the Centers for Disease Control and Prevention, and the process ends with the states. Here’s how it breaks down.
The F.D.A.
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The F.D.A., a federal agency of the Department of Health and Human Services that controls and supervises medications and other elements related to public health, takes up the advisory panel’s recommendation, which includes the question of who should be eligible. The advisory panel’s votes are not binding, but the F.D.A. typically follows them.
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The F.D.A.’s top official — its acting commissioner, Dr. Janet Woodcock — issues the agency’s final determination on whether to authorize the boosters and for whom. Such decisions are typically issued within a few days of advisory committee meetings.
The C.D.C.
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An advisory panel to the Centers for Disease Control and Prevention, the United States’ public health agency, reviews the F.D.A.’s decision. On Thursday and Friday of next week, that panel is scheduled to meet and vote on its recommendations regarding boosters.
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The C.D.C. takes up that panel’s recommendations, and the agency’s director, Dr. Rochelle P. Walensky, issues the agency’s guidance on whether boosters should be used and who should be eligible. That guidance is deeply influential for states, doctors, pharmacies and other health care institutions and the general public. As with the process at the F.D.A., the panel’s recommendations are not binding, but the C.D.C. usually follows them.
However, there was a rare exception last month: When a C.D.C. advisory panel rejected the F.D.A.’s recommendation that frontline workers be included among those eligible for the Pfizer-BioNTech booster, Dr. Walensky overrode her own agency’s advisers and sided with the F.D.A.
The states
State health departments generally follow the recommendations of the C.D.C. In the case of the Pfizer-BioNTech booster, the shots began being administered widely immediately after Dr. Walensky announced the C.D.C.’s guidance to allow them for people over 65, patients in nursing homes and other institutional settings, those with underlying medical conditions, and frontline workers.
The Food and Drug Administration’s panel of expert advisers voted on Friday to recommend authorizing booster shots of Johnson & Johnson’s one-dose vaccine for people 18 and older, at least two months after the first dose. The committee also voted on Thursday to recommend booster shots for many recipients of the Moderna coronavirus vaccine.
While the panel’s recommendations are not binding, they are very likely to influence the F.D.A.’s decision — typically issued within a few days after the advisory committee weighs in. If the agency says yes to the boosters, the process moves to the Centers for Disease Control and Prevention.
Who are the experts on the F.D.A.’s Vaccines and Related Biological Products Advisory Committee?
The committee now has 19 voting members who are scientific authorities from a range of fields, including immunology, vaccine safety and virology. Many are medical practitioners.
Dr. Arnold Monto, the acting chair of the committee, is a professor of epidemiology at the University of Michigan School of Public Health.
Here are the other voting members:
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Dr. Archana Chatterjee, a pediatric infectious diseases specialist, is the dean of the Chicago Medical School and vice president for medical affairs at Rosalind Franklin University of Medicine and Science.
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Capt. Amanda Cohn is a doctor and senior official overseeing vaccine policy at the C.D.C.’s National Center for Immunization and Respiratory Diseases.
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Dr. Oveta Fuller is a trained pathologist and an associate professor of microbiology and immunology at University of Michigan Medical School.
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Dr. Hayley Gans is a professor of pediatrics infectious diseases at Stanford University Medical Center.
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Dr. James Hildreth is a professor of medicine and the president and chief executive officer of Meharry Medical College.
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Dr. Randy Hawkins is a practicing physician who specializes in internal medicine and sits on the committee as a consumer representative.
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Dr. Michael Kurilla is a senior official with expertise in infectious diseases and vaccine development at the National Institutes of Health.
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Dr. Jeanette Lee is a professor of biostatistics at the University of Arkansas For Medical Sciences in Little Rock, Ark., and an expert on clinical trials.
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Dr. Ofer Levy is the director of the Precision Vaccines Program at Boston Children’s Hospital, and a professor of pediatrics at Harvard Medical School.
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Dr. H. Cody Meissner is professor of pediatric infectious disease at the Tufts University School of Medicine and Tufts Children’s Hospital in Boston.
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Dr. Patrick Moore is a professor of microbiology and molecular genetics at the University of Pittsburgh.
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Dr. Michael Nelson is a professor of medicine at the University of Virginia in Charlottesville. He is also president of the American Board of Allergy and Immunology.
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Dr. Paul Offit is a professor of pediatrics at Children’s Hospital of Philadelphia and the University of Pennsylvania School of Medicine.
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Dr. Steven Pergam is an expert on infectious diseases at the Fred Hutchinson Cancer Research Center in Seattle and an associate professor at the University of Washington.
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Dr. Stanley Perlman is professor of microbiology and immunology at the University of Iowa, and a pediatric infectious diseases specialist with expertise in coronaviruses.
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Dr. Eric Rubin is the editor in chief of the New England Journal of Medicine and an expert on infectious diseases at the Harvard T.H. Chan School of Public Health.
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Dr. Mark Sawyer is a professor of pediatrics and a pediatric infectious disease specialist at the University of California, San Diego, and Rady Children’s Hospital in San Diego.
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Dr. Melinda Wharton is the associate director for vaccine policy at the C.D.C.’s National Center for Immunization and Respiratory Diseases.
A clash between Mayor Lori Lightfoot of Chicago and the head of the city’s largest police union over coronavirus vaccinations intensified on Friday as the city filed a complaint against the union, arguing that it was threatening an illegal strike.
City employees in Chicago are required to report their vaccination status by the end of Friday, but John Catanzara, the president of the Fraternal Order of Police in Chicago, has urged police officers to ignore the order and risk discipline or loss of pay. Employees who are not vaccinated will be subject to twice-weekly testing, but vaccinations are not required.
Mr. Catanzara released a video on Tuesday predicting that Chicago police officers would not report to work because of the policy. He said that if a large number of police officers refuse to submit to testing or reporting their vaccination status to the city, “it’s safe to say the city of Chicago will have a police force at 50 percent or less for this weekend coming up.”
“Whatever happens because of the manpower issue, that falls at the mayor’s doorstep,” he added.
He escalated the dispute on Thursday, releasing another video that urged officers not to comply with any direct orders from their supervisors to provide their vaccination status in an online portal.
But, on Friday, the police union said in a statement: “President John Catanzara has never engaged in, supported, or encouraged a work stoppage.” The police union also announced that it had filed its own legal request for the courts to hear the case.
Ms. Lightfoot, who has often faced resistance from Mr. Catanzara since taking office in 2019, said in a statement on Friday that his actions threatened public safety.
“As Chicago’s mayor, I cannot and will not stand idly by while the rhetoric of conspiracy theorists threatens the health and safety of Chicago’s residents and first responders,” Ms. Lightfoot said in a statement. “President Catanzara has time and again deliberately misled our police officers by lying about the requirements of the policy and falsely claiming that there will be no repercussions if officers are insubordinate and refuse to follow a city and department directive or order.”
On Friday evening, a judge in Cook County ordered Mr. Catanzara to refrain from making additional statements on social media encouraging police officers to refuse to enter their vaccination status in the city portal.
A strike from the police union is illegal under both state law and the union’s contract with the city, Ms. Lightfoot said.
Chicago is following other cities throughout the United States in requiring city employees to be vaccinated or submit to frequent coronavirus testing. Last week, Ms. Lightfoot softened the original policy requiring vaccination, saying that public workers could opt out of the city’s mandate until the end of the year by getting tested regularly.
City officials have said that employees who fail to report their vaccination status by the Friday deadline will be placed on unpaid leave.
Law enforcement officers have died of Covid-19 in large numbers throughout the pandemic, making the virus by far the most common cause of duty-related deaths in 2020 and 2021, according to the Officer Down Memorial Page, a website that catalogs the deaths of law enforcement officers.
Police officers in many departments have been slow to get vaccinated, and several other cities have issued vaccine or testing mandates. In San Jose, Calif., city leaders decided just as a vaccine mandate was taking effect to allow unvaccinated officers to remain employed through the end of the year, with incremental discipline and testing requirements.
International travelers fully vaccinated against the coronavirus who have been barred from entering the United States during the pandemic will be able to enter the country on Nov. 8, according to a White House official, marking an end to restrictions that had walled off tourists and relatives seeking to visit their families.
The specific date for when the Biden administration would lift travel restrictions for those traveling by air or hoping to cross the land border was previously unclear. The administration last month said it would be implementing a new system in which fully vaccinated foreigners who show proof of a negative coronavirus test would be able to fly to the United States in early November.
Earlier this week, administration officials said those hoping to enter from Mexico or Canada who are fully vaccinated would be able to cross at the same time. But thousands around the world eager to organize their travel plans were still left wondering what specific date they would be able to enter.
The Centers for Disease Control and Prevention considers people fully inoculated two weeks after receiving the second dose of the Pfizer or Moderna vaccine, or two weeks after receiving the single dose of the Johnson & Johnson vaccine.
Those who have received vaccines listed for emergency use by the World Health Organization, such as the AstraZeneca vaccine, would also be considered fully vaccinated, according to the C.D.C.
The new travel system also comes with stringent requirements.
Unvaccinated foreigners will be broadly barred from entering the United States, although the White House official said there will be limited exemptions, including for young children.
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. Those crossing land borders will not need to show a coronavirus test.
Foreigners hoping to fly to the United States will need to show proof of vaccination before boarding and a negative coronavirus test within three days of entering.
Unvaccinated Americans traveling from overseas will need to test negative for the coronavirus one day before returning home and show proof that they have bought a test to take after arriving in the United States.
The U.S. Travel Association, an industry group, applauded the moves.
“The date is critically important for planning — for airlines, for travel-supported businesses, and for millions of travelers worldwide who will now advance plans to visit the United States once again,” Roger Dow, the group’s president, said in a statement. “Reopening to international visitors will provide a jolt to the economy and accelerate the return of travel-related jobs that were lost due to travel restrictions.”
A spokeswoman for Airlines for America, another industry group, noted that even before the announcement of the date, airlines had seen an uptick in ticket sales to the United States from abroad.
“The full reopening of international travel is also critical to reviving economies around the globe, reinvigorating communities and supporting millions of jobs in the U.S. and abroad,” Katherine Estep, the spokeswoman, said in a statement.
ROME — Italy on Friday set a new bar for major Western democracies seeking to move beyond the pandemic by enacting a sweeping law that requires the nation’s entire work force — public and private — to have government-issued health passes, essentially forcing Italians to choose between getting a pass and earning a living.
With the step, Italy, the first democracy to quarantine towns and apply national lockdowns, is again first across a new threshold, making clear that it is willing to use the full leverage of the state to try to curb the pandemic and get the economy moving.
Italy’s measures, which require proof of vaccination, a negative rapid swab test or recent recovery from Covid-19 to go to the workplace, now stand as some of the toughest among Western democracies, which have struggled to balance public health needs with civil liberty concerns.
For many Western governments, like those of the United States and France, that has resulted in refraining from national mandates while seeking other ways to encourage, coax and even mildly coerce people to get vaccinated.
Under Italy’s new rules, those who do not have a Green Pass, as the health certificate is called, must take unpaid leave. Employers are responsible for verifying the certificates, which are for the most part shown on a cellphone app, though hard copies are also acceptable. Workers risk fines of up to 1,500 euros — or about $1,750 — for not complying.
Not everyone has been accepting of the requirements. Last weekend, a demonstration of 10,000 Green Pass opponents — a mix of vaccine skeptics, conspiracy theorists, anti-establishment types and workers livid about having to pay for frequent swabs — was hijacked by right-wing extremists and turned violent, prompting Italy to once again reckon with its fascist legacy.
But on Friday, the rollout went more or less smoothly, with only scattered protests, as the majority of citizens accepted the new pass as a fact of Italian life and a tolerable sacrifice, like wearing masks indoors, to help the country get out of the pandemic and return to normalcy.
Global Roundup
South Korea said on Friday that it was a week ahead of schedule for fully vaccinating 70 percent of its population against Covid and that it would ease social-distancing rules starting next week.
“If vaccinations continue without any setbacks and cases remain controlled in the next two weeks, a full-fledged transition to the new strategy will be possible from November,” said Lee Gi-il, a senior official in the health ministry.
In an effort to encourage more people to get vaccinated, President Moon Jae-in and the first lady, Kim Jung-sook, each received a booster shot of the Pfizer-BioNTech vaccine in public on Friday.
South Korea never went into a full lockdown but has imposed stringent social-distancing rules, including a mask mandate, even outdoors. The country reached record numbers of new infections a few weeks ago after a major holiday, but daily coronavirus case numbers dropped to a seven-day average of 1,386 in the past week, according to figures from Johns Hopkins University.
The number of reported deaths has remained very low, at 0.02 per 100,000 people in the past week, according to the data. Nearly 63 percent of the country had been fully vaccinated as of Thursday, the health authorities said.
The rules are being relaxed as the pace of vaccinations outperforms earlier expectations, health officials said. Officials said they would likely reach the 70 percent target by the end of next week — about a week sooner than expected.
For the two-week period starting on Monday, the government will allow gatherings of up to four people who are not fully vaccinated, expanding the limit by two, and will permit reading rooms, performance halls and movie theaters to stay open until midnight, two hours longer than before.
People who are fully vaccinated will also be allowed to watch sports events in person again and to attend larger weddings, officials said.
Curbs on social gatherings, however, will remain tougher in and around Seoul, where cases have been more frequent.
In other Covid-related news around the world:
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An estimated 43,000 people in Britain were mistakenly informed that they had tested negative for the coronavirus after previously testing positive, the officials said in a statement on Friday. The government suspended operations at a private laboratory after an investigation revealed that thousands of people — most of them from southwestern England — had received false negatives on P.C.R. tests from Sept. 8 to Oct. 12, after previously testing positive on lateral flow devices.
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New South Wales will become the first state in Australia to allow fully vaccinated residents to return to the country without quarantining, starting next month, the authorities announced on Friday. Tens of thousands of Australians have been stranded abroad because of caps on the numbers of weekly returnees, and people entering the country must quarantine for 14 days in a hotel at their own expense. New South Wales is the country’s most populous state, encompassing Sydney.
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The authorities in pandemic-stricken Thailand, seeing to revive the country’s tourism, have reopened a cave where a dozen young soccer players and their coach were trapped for 18 days in 2018, becoming the focus of a tense rescue effort that captivated the world. The cave complex had been closed to tourists in April to prevent the spread of the coronavirus.
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