F.D.A. Panel Recommends Johnson & Johnson Boosters

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 people 18 years or older, at least two months after the first dose.

Before the vote, a top federal health official, Dr. Peter Marks, said that the agency may consider regulatory action that would allow Johnson & Johnson recipients to receive a booster shot of Moderna or Pfizer-BioNTech’s vaccines. But Dr. Marks, who oversees the F.D.A.’s vaccine division, gave no timetable for any decision, saying only that authorization of the use of a different vaccine as a booster for Johnson & Johnson recipients was “possible.”

Representatives from Johnson & Johnson presented their case Friday morning during a meeting of the advisory panel, arguing that a second dose given either two months or six months after the first shot increased antibody levels, part of the immune response to vaccines. They also said that the single dose of the vaccine remained durable. The F.D.A. typically follows the panel’s advice.

Federal regulators also presented on the company’s data, repeatedly pointing out its shortcomings. They warned that the two-month booster trial only followed up with study volunteers for a short period of time after their second shot. They also noted that a key test used by the company to measure the antibodies produced by a booster had a low sensitivity, calling the results into question — a concern raised by members of the panel on Friday. (Watch the meeting here.)

Dr. Archana Chatterjee, an infectious disease expert at Rosalind Franklin University, asked the F.D.A. why the agency convened the panel if regulators had not had time to verify critical the company’s data. Dr. Marks, the agency’s top vaccine regulator who has argued for a “harmonized” approach to booster policy, said 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.

“I think there was a thought that there was some solution needed potentially for boosting,” he said.

The regulators did not see any evidence of serious safety concerns in the booster trial, but they noted they were not afforded enough time to independently review much of the data that Johnson & Johnson provided in its application for authorization.

Some federal officials appeared skeptical of the claims the company made about the efficacy of one dose, and expressed worry that those who received it are not as protected as Moderna or Pfizer-BioNTech recipients.

“It was used as an outreach vaccine,” Dr. Marks said. “Many of the people who got that may not have been part of a health maintenance organization or an organized health care system.”

Dr. Amanda Cohn, a C.D.C. official, said that “the effectiveness or protection with a single dose of the J.&J. vaccine is not equivalent” to two doses of the Pfizer-BioNTech or Moderna vaccines, “and certainly not in the group who have now been authorized to receive a booster dose of an mRNA vaccine.”

Some committee members argued that the vaccine should have been used in a two-dose regimen from the start.

Panel members repeatedly conveyed concern about the size of the study Johnson & Johnson used to ask for authorization of a six-month interval. “I’m not sure why you’re asking for an indication that would apply to millions of patients with a data set that includes 17 patients,” said Dr. Eric Rubin, an adjunct professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health.

After voting on a Johnson & Johnson booster, the panel will hear from a scientist who helped lead a study that found Johnson & Johnson vaccine recipients may benefit more from a booster of the Moderna or Pfizer-BioNTech vaccine.

Preliminary data from the study — testing a strategy known as “mix and match” — showed that those who got a Johnson & Johnson shot followed by a Moderna booster saw their antibody levels rise 76-fold within 15 days, whereas those who received another dose of Johnson & Johnson saw only a fourfold rise in the same period. A Pfizer-BioNTech booster raised antibody levels in Johnson & Johnson recipients 35-fold.

The trial only looked at antibody levels, which on their own are an insufficient measure of how well different combinations of vaccines would protect people.

In Friday’s morning session, Dr. Johan Van Hoof, a Johnson & Johnson executive, referred to that limited data, saying that a booster was preferable. “These findings are important,” he said of the mix and match study, “but only a piece of the puzzle, and they don’t give the complete picture.”

Even so, some experts said the evidence was still pointing to switching vaccine platforms.

“At the end of the day, folks having the Johnson & Johnson should probably get an mRNA booster,” said Scott Hensley, an immunologist at the University of Pennsylvania.

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.

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 is meeting on Friday to consider booster shots for recipients of the Johnson & Johnson vaccine.

So what happens after the panel votes? 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.

• 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.

• 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.

• 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.

• 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.

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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.

It can be hard to keep track of developments on coronavirus vaccine boosters without a scorecard.

The Food and Drug Administration’s panel of expert advisers voted on Thursday to recommend booster shots for many recipients of the Moderna coronavirus vaccine, and is meeting on Friday to consider boosters for recipients of Johnson & Johnson’s vaccine.

The agency has already authorized booster shots of the other vaccine in use in the United States, from Pfizer-BioNTech, for certain groups who got that vaccine initially. Third doses of the Pfizer-BioNTech and Moderna vaccines also have been authorized for some people with weaker immune systems, who may not have gotten full protection from the original two doses.

All three vaccines initially provide very strong protection against infection, serious illness and death from Covid-19. The impetus for boosters comes from studies suggesting that while that protection remains strong against serious illness and death, it may decline somewhat over time and could allow more breakthrough infections, especially of the highly contagious Delta variant. The decline tends to be most pronounced in older people and those with certain underlying medical conditions.

Here is a rundown of the booster-shot situation for the three vaccines available in the United States.

Pfizer-BioNTech

What you would get: A third full dose, at least six months after your second.

Where it stands in the U.S.: Available now for many people. The F.D.A. has authorized third shots for people over 65, people with certain medical conditions and some others who are at high risk because of where they work or live. (Some immunocompromised people can get a third shot a month after their second.) The agency has put off a decision on whether to authorize boosters for other people.

Where it stands elsewhere: Israel and some other countries are administering Pfizer-BioNTech booster shots widely.

What the science says: The Pfizer-BioNTech vaccine was the first to win full approval in the United States (for those 16 and older), the first to be authorized for some children (those 12 to 15) and the first to be authorized for boosters; the available data on its safety and effectiveness is especially robust. Some studies suggest that the vaccine may decline in effectiveness over time a bit more than the Moderna vaccine.

Moderna

What you would get: A half-dose, at least six months after your second full dose.

Where it stands in the U.S.: An F.D.A. advisory panel voted on Thursday to recommend Moderna boosters for the same population groups who are now eligible for a Pfizer booster. The panel’s vote is nonbinding, but its recommendations are generally followed by the F.D.A. (Some immunocompromised people can receive a full third dose a month after their second.)

Where it stands elsewhere: Some countries are already offering Moderna booster shots or planning to do so soon.

What the science says: Some studies suggest that the Moderna vaccine’s effectiveness declines less than the other two vaccines available in the United States do. That may mean there is less need for Moderna recipients to get boosters. Taking that into account, an F.D.A. staff report took a neutral stance on Moderna’s booster-shot application.

Johnson & Johnson

What you would get: A second dose, probably six months after the initial dose.

Where it stands in the U.S.: Awaiting authorization. The F.D.A. advisory panel is meeting on Friday to decide on a recommendation. An F.D.A. staff report found significant shortcomings in the data that the company submitted with its application, but it was not clear whether that would delay a decision.

Where it stands elsewhere: No country has yet recommended administering second doses of the Johnson & Johnson vaccine.

What the science says: The Johnson & Johnson vaccine gives strong initial protection after one dose, though not as strong as the Pfizer or Moderna two-dose vaccines, so there has long been interest in boosters for Johnson & Johnson recipients.

A committee of scientific advisers to the Food and Drug Administration is meeting on Thursday and Friday to examine the available data on using additional doses of the Moderna and Johnson & Johnson vaccines to boost immunity.

The committee voted unanimously on Thursday to endorse a half-dose of Moderna’s vaccine for people 65 and older and younger adults at high risk of infection because of their medical conditions or jobs. The panel is expected to vote on boosters for recipients of Johnson & Johnson’s vaccine on Friday.

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:

• 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.

• 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.

• Dr. Oveta Fuller is a trained pathologist and an associate professor of microbiology and immunology at University of Michigan Medical School.

• Dr. Hayley Gans is a professor of pediatrics infectious diseases at Stanford University Medical Center.

• Dr. James Hildreth is a professor of medicine and the president and chief executive officer of Meharry Medical College.

• Dr. Randy Hawkins is a practicing physician who specializes in internal medicine and sits on the committee as a consumer representative.

• Dr. Michael Kurilla is a senior official with expertise in infectious diseases and vaccine development at the National Institutes of Health.

• 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.

• 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.

• Dr. H. Cody Meissner is professor of pediatric infectious disease at the Tufts University School of Medicine and Tufts Children’s Hospital in Boston.

• Dr. Patrick Moore is a professor of microbiology and molecular genetics at the University of Pittsburgh.

• 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.

• Dr. Paul Offit is a professor of pediatrics at Children’s Hospital of Philadelphia and the University of Pennsylvania School of Medicine.

• 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.

• Dr. Stanley Perlman is professor of microbiology and immunology at the University of Iowa, and a pediatric infectious diseases specialist with expertise in coronaviruses.

• 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.

• 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.

• Dr. Melinda Wharton is the associate director for vaccine policy at the C.D.C.’s National Center for Immunization and Respiratory Diseases.

Italy set a new bar on Friday for major Western democracies seeking to move beyond the pandemic by putting in place a sweeping law that requires the nation’s entire work force — public and private — to have government-issued health passes.

The measure requires workers to show proof of vaccination, a negative rapid swab test or recent recovery from Covid-19 before returning to offices, schools, hospitals or other work places.

Under the new rules, those who do not have a Green Pass, as Italy’s health pass is called, must take unpaid leave. Employers will be responsible for verifying the certificates, for the most part a cellphone app. Workers risk fines of up to 1,500 euros ($1,760) for not complying.

The law goes further than those in other European countries or the United States in pushing vaccination mandates, which have become central — and hotly contested — parts of government strategies to curb the spread of the coronavirus.

With the step, Italy — the first democracy to have quarantined towns and applied national lockdowns — is again first across a new threshold, making clear that it is willing to use the enormous leverage of the state to try to curb the pandemic and get its economy moving.

President Biden has appealed to private companies to mandate coronavirus vaccinations for employees, asking them to take initiative as an effort that he announced in September to require 80 million U.S. workers to get the shot undergoes a lengthy rule-making process.

China, where more than one billion people are now fully vaccinated, has no qualms about pushing a more forceful stance on vaccines. In August, the authorities in at least 12 Chinese cities warned residents that unvaccinated people could be punished if they are found to be responsible for spreading outbreaks.

Democratically elected governments, however, must balance public health needs with civil liberty concerns and political realities. For many Western governments, that has resulted in refraining from national mandates while seeking other ways to encourage, coax and even mildly coerce people to get vaccinated.

In Italy, where more than 80 percent of people over age 12 are now fully vaccinated against Covid, the sweeping national mandate has stirred protests among hard-core holdouts.

By late afternoon, protests had sprouted up in Italy’s major cities and ports. But unlike a major demonstration of 10,000 vaccine skeptics that was hijacked by right-wing extremists last weekend, they had so far attracted a fraction of the numbers that opponents to the health pass had hoped for. More than anything, they seemed to underscore that the Green Pass was now a fact of Italian life.

The measure has also faced no serious legal challenge, and Prime Minister Mario Draghi and his government say they are confident that the courts will not delay or reverse the law.

Italy has now taken the boldest position in Europe. In France, President Emmanuel Macron has tried to make life uncomfortable for unvaccinated people, requiring a health pass to enter restaurants and for long-distance train travel, for instance, but has mandated vaccines only for some essential workers.

Italy earlier put in place tough requirements for health workers and teachers, significantly increasing vaccination rates in those categories. But to reach the most reluctant unvaccinated workers — an estimated 3.5 million people — the government has now taken one of the Western world’s hardest lines.

Government officials say that the measure is already working, and that more than 500,000 previously reluctant people — much higher than expected — have gotten inoculated since the government announced its plan last month.

An estimated 43,000 people in Britain were mistakenly informed that they had tested negative for the coronavirus after previously testing positive, the U.K. Health Security Agency said in a statement on Friday.

The agency, which was formed two weeks ago, suspended operations at a private laboratory in Wolverhampton, in the West Midlands of England, after an investigation by the N.H.S. Test and Trace program, which is designed to track down anyone who has been exposed to the coronavirus.

The investigation revealed that about 43,000 people — most of whom were based in 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.

The mistake was described as an “isolated incident attributed to one laboratory,” in a statement released by the agency on Friday.

Dr. Will Welfare, a director at the agency, said in the statement that officials were working alongside Test and Trace and the private company, Immensa Health Clinic, to determine the “laboratory technical issues” which had led to the false results.

“There is no evidence of any faults” with lateral flow devices or P.C.R. test kits, Dr. Welfare said, adding, “the public should remain confident in using them and in other laboratory services currently provided.”

Officials with the Test and Trace program have said that they will contact those affected and that they will request that they take another test. The existing samples are now being redirected to other laboratories for retesting.

For 18 days in 2018, Tham Luang Cave in northern Thailand was the scene of a tense rescue that captivated the world. Twelve young soccer players and their coach were trapped by rising floodwaters in a cavern deep inside the cave complex.

All 13 were brought safely from the cave in a giant rescue effort that involved British cave divers, Thai Navy SEALs and an elite United States Air Force team. One Thai diver died during the rescue effort.

Now, as pandemic-stricken Thailand struggles to revive its economy and lure tourists back, officials on Friday reopened the cave complex, which has been closed since April to prevent the spread of Covid-19.

Some restrictions still apply. No more than 40 visitors are allowed in the cave at a time. They can walk to a large cavern that was used as a staging area for the rescue, but the chamber where the soccer team was found, nearly two miles from the entrance, is off limits.

The reopening of the cave comes as Thailand attempts to revive its tourism industry, which accounted for as much as a fifth of the economy before Covid-19.

Thailand announced this week that vaccinated travelers from low-risk countries who tested negative would be allowed to enter without undergoing quarantine, starting Nov. 1. Thailand’s prime minister, Prayuth Chan-ocha, named five such departure points — Britain, China, Germany, Singapore and the United States — with more to be added soon.

Mr. Prayuth said that the relaxation of quarantine rules for those countries would “at least be a small starting point” in putting people back to work.

Mr. Prayuth is pushing to reopen the country to foreign tourists despite case numbers that have remained at an average of more than 10,000 new infections a day for weeks.

Thailand began allowing tourists back into the country in July through the “Phuket Sandbox,” which allows vaccinated visitors to roam freely on the resort island for 14 days before traveling to other parts of the country. That program is still in place for tourists from many countries, but the required length of stay has been reduced to seven days.

One well-known tourist who passed through was the actor Russell Crowe, who posted numerous photographs on Twitter during his 14-day stay on Phuket and from Bangkok after arriving there.

The reopening of Tham Luang Cave to tourists coincides with the theatrical release this month of “The Rescue,” a documentary about saving the boys. A feature film on the rescue, directed by Ron Howard, is also in production.

New South Wales will become the first Australian state to allow fully vaccinated residents to return to the country without quarantining, starting next month, the authorities announced on Friday.

Since the start of the pandemic, tens of thousands of Australians have been stranded abroad because of caps on the numbers of weekly returnees. Anyone entering the country must quarantine for 14 days in a hotel at their own expense.

Although the authorities in New South Wales, which includes Sydney and is Australia’s most populous state, implied that tourists and other visa holders would also be able to enter, Prime Minister Scott Morrison rejected that notion at a news conference later on Friday, saying that such a move would be a decision for the federal government.

“We are not opening up to everyone coming back to Australia at the moment,” he said. “We are only extending this to Australian residents, citizens and their immediate families.”

The federal government has not made a decision about when to allow overseas students, visa holders and other international visitors to enter the country, Mr. Morrison, the prime minister added. Other states are expected to follow New South Wales’s lead on relaxing rules for residents but have not set dates yet.

Coronavirus rules in Australia vary. Covid-free states have few internal regulations but have imposed border restrictions in an attempt to keep out the virus, while states like New South Wales and Victoria are on a path to easing rules as they emerge from outbreaks of the Delta variant. Entry to the country is closed to most overseas visitors.

Under the rule change, starting Nov. 1, New South Wales will remove restrictions for fully vaccinated residents, citizens and their immediate families. Eligible travelers will be able to enter the state without quarantining, but will need to provide a negative P.C.R. test before boarding their flights. Caps on the number of such arrivals allowed into the state will also be scrapped.

Unvaccinated travelers allowed entry will still need to quarantine for 14 days in a hotel upon arrival, and their numbers will be capped at 210 per week.

Dominic Perrottet, the premier of New South Wales, said on Friday that a move toward opening up was needed to revitalize struggling industries like tourism.

“We need to rejoin the world,” he said. “We can’t live here in ‘hermit kingdom.’”

Starting on Monday, when 80 percent of New South Wales’s population above the age of 16 is expected to be fully vaccinated, other restrictions in the state will be allowed to ease. Nightclubs will reopen, limits on the number of people permitted at weddings and funerals will be removed and customers at pubs will be able to drink standing up.