Covid Updates: F.D.A. Authorizes Moderna and J.&J. Boosters and Mix-and-Match Strategy

October 21, 2021 in Regional

New York City will require municipal workers to be vaccinated, a shift that covers more than 300,000 employees, and which removes an option to take regular tests instead.

WASHINGTON — The Food and Drug Administration on Wednesday authorized booster shots for tens of millions of recipients of Moderna’s two-dose coronavirus vaccine and the roughly 15 million who got Johnson & Johnson’s single-dose shot, significantly expanding the nation’s campaign to bolster protection for vulnerable people.

The agency also updated its authorizations for all three vaccines — Moderna, Johnson & Johnson and Pfizer-BioNTech — to allow medical providers to boost people with a different Covid-19 vaccine than the one they initially received, a strategy known as “mix and match.”

That update may dampen interest in Johnson & Johnson’s vaccine, which studies have found provides less protection than the other two. Providers will have the option of offering a Moderna or Pfizer-BioNTech booster, which could trigger a more substantial jump in protective antibodies.

The regulators, who already authorized boosters for high-risk Pfizer-BioNTech recipients last month, did not recommend any one vaccine over another as a booster. They also remained silent on whether it would be preferable to stick with the same vaccine when possible.

The latest authorizations arrived in the middle of a busy stretch of regulatory decisions on vaccines. The F.D.A. is expected in the coming weeks to decide on whether Pfizer and BioNTech’s vaccine should be authorized for children ages 5 to 11. The agency’s independent vaccine committee is set to vote Tuesday to consider the matter and make a recommendation.

Regulators may also decide as early as November whether to authorize boosters for younger Americans who are not at high risk. While many vaccine experts have questioned whether younger, healthy people need booster shots, some advisory committee members last week urged the agency to move to expand eligibility.

The F.D.A.’s move to make a much larger swath of Americans eligible for additional shots on Wednesday followed unanimous votes last week from a key advisory committee to recommend the authorizations. A separate committee advising the Centers for Disease Control and Prevention is scheduled to vote Thursday on its own recommendations for Moderna and Johnson & Johnson boosters.

The C.D.C. director typically endorses that panel’s recommendations as a final step before vaccines are put into use. If the agency agrees with the F.D.A.’s decision, booster shots could be offered as soon as this weekend.

Eligible Moderna recipients could get a half-dose booster of that vaccine at least six months after their second dose. Like Pfizer recipients, the eligible would include people 65 and older, and younger adults at high risk of severe Covid-19 because of medical conditions or where they work. Johnson & Johnson recipients — all of whom are 18 and older — will be eligible for a second shot at least two months after the first.

Despite high and rising coronavirus case numbers, the British government on Wednesday rejected calls for the immediate reintroduction of some restrictions in England, while warning that they might be needed if the rollout of vaccine booster shots failed to contain the worsening situation.

Speaking at a news conference, the health secretary, Sajid Javid, said that a contingency plan for tighter rules would not be carried out “at this point” but added that he would be “staying vigilant” and warned that new cases could surge to 100,000 a day.

“We will do what it takes to make sure that this pressure does not become unsustainable, and we won’t allow the N.H.S. to become overwhelmed,” Mr. Javid said, referring to Britain’s National Health Service, which is already under pressure. “We are concerned. Everyone is right to be concerned,” he added.

Mr. Javid warned that if the situation deteriorates, he could be forced to activate a contingency plan that would reimpose some restrictions that were scrapped in England in July. Under this plan, mask-wearing rules could return, people could be urged to work from home, and those visiting nightclubs and other venues could be required to show proof of their vaccination status or of a recent negative test. If necessary, he added, “we won’t hesitate to act.”

Still hoping to avoid that step, Mr. Javid urged people to meet outdoors where possible and to wear a face covering in confined spaces. He also appealed directly to people to get boosters adding: “If you are invited for a vaccine, please take it up.”

Earlier, Kwasi Kwarteng, the business secretary, told the BBC in a televised interview that an increase in booster shots was what was “going to give us more protection,” adding that he did not want “to reverse back to a situation where we have lockdowns.”

The government argues that hospital admissions have remained low because of high rates of vaccination. But vaccines are waning in effectiveness at preventing infection, and Britain, which rolled out vaccines early, is now reporting one of the highest rates of new cases in the world. Vaccines still offer robust protection against hospitalizations and deaths.

There have been over 40,000 new cases for seven consecutive days — reaching 49,139 on Wednesday — and 869 patients were admitted to hospitals on Oct. 16. While the death toll is still low compared with last winter’s level, the daily death toll rose to 223 on Tuesday, the highest number since March, before falling back to 179 on Wednesday.

Analysts believe cases in Britain are rising because large numbers of children are unvaccinated and schools do not require face coverings. Among adults, mask wearing is less prevalent than in some other parts of Europe, where they are often required indoors and where cases per capita are much lower.

Health professionals have recommended the reintroduction of some of the measures — such as mandatory mask wearing in some locations — that were swept away in July, when England lifted almost all of its legal restrictions on what the tabloid media called “freedom day.”

The National Health Service Confederation, which represents organizations that provide health services, asked the government on Monday to immediately introduce mandatory face coverings in crowded and enclosed spaces.

“Without pre-emptive action, we risk stumbling into a winter crisis,” said Matthew Taylor, the confederation’s chief executive.

In recent months, Prime Minister Boris Johnson’s strategy has been to focus on rolling out boosters to the most vulnerable people and to vaccinate children ages 12 to 15. But critics say that plan has faltered.

The government has said that it is monitoring the rise in cases and that the current rates are not yet sufficient to justify a switch in strategy to help contain the spread of the virus in England. The government’s main concern has been preventing Britain’s stretched health service from being overwhelmed, and so far, vaccinations have kept the level of hospitalizations manageable, officials have said.

In September, the government in England put on hold proposals to require those entering nightclubs and attending large events like soccer games to show proof of vaccination or of a recent negative test. Scotland and Wales, however, are requiring it.

New York City took one of its most aggressive steps yet to increase vaccination rates in a city that was once the epicenter of the pandemic, requiring almost every member of the nation’s largest municipal work force to get vaccinated by the end of the month or lose their paychecks.

The new mandate by Mayor Bill de Blasio, following similar requirements for teachers and health care workers that led to a surge in vaccinations, is intended to persuade thousands of city workers who have resisted getting the shot to do so before the winter.

At least 46,000 police officers, firefighters and other city workers have not yet received the vaccine, and the mandate could lead to staffing shortages at a time when the city is still recovering from the pandemic, when shootings rose.

“We need to save lives, and we do it with vaccinations,” Mr. de Blasio, a Democrat with less than three months left in office, said at a news conference. “My goal is to end the Covid era once and for all. It can be done, but only if we keep pressing on.”

New York is one of the first major American cities to require vaccination for its entire municipal work force without a testing option. San Francisco set a similar vaccine mandate for its 35,000 city workers, which goes into effect Nov. 1, and Los Angeles and Chicago have been pushing public workers to get vaccinated. Among the states, Washington and Massachusetts are requiring state employees to be fully vaccinated.

Starting on Nov. 1, New York City workers must have received at least one dose of a coronavirus vaccine and can no longer submit to regular testing as an alternative. The mandate applies to roughly 160,000 city employees. The city has more than 300,000 workers, but nearly half were already required to be vaccinated.

Those who get their first doses at city-run vaccination sites between now and Oct. 29 will receive an extra $500 in their paychecks.

The announcement on Wednesday that New York City’s municipal employees would be required to get vaccinated against the coronavirus was met with a variety of reactions from the unions that represent those workers, from grudging acceptance to pledges to fight it.

But there is one thing most of the unions agree on: that the mandate could lead some employees to quit or move up their retirement dates, which could put a strain on some city agencies. Virtually all city workers are required to have gotten at least one dose by Nov. 1.

The mandate affects roughly 160,000 employees, who were already required to either show proof of vaccination or submit to weekly testing. The rule announced by Mayor Bill de Blasio on Wednesday removes the testing option.

Harry Nespoli, the president of the Uniformed Sanitationmen’s Association, which represents sanitation workers, said the weekly testing requirement had been working well, and that he believed there was no reason to do away with it.

“I don’t understand why now all of the sudden the city wants to mandate these people,” he said. He said that sanitation workers were unlikely to pass on the virus to members of the public while picking up garbage or clearing streets of snow.

“We don’t come in contact with the public, we don’t hug the public,” said Mr. Nespoli, who is vaccinated and contracted Covid-19 early in the pandemic. “We start at 5 o’clock in the morning. No one’s there, and we do what we have to do and we come in.”

Mr. Nespoli said he believed that the sudden imposition of a mandate was disrespectful. He noted that his members had turned up for work throughout the pandemic, while many other New Yorkers had been able to work from home. “Now you’re going to turn around and say ‘Get the shot or lose your job.’ That’s not right. That’s totally wrong.”

The union representing rank-and-file police officers in New York City, the Police Benevolent Association, pledged to fight the mandate. “Now that the city has moved to unilaterally impose a mandate, we will proceed with legal action to protect our members’ rights,” the union’s president, Patrick J. Lynch, said in a statement.

But others were less enthusiastic about a legal fight.

Gregory Floyd, president of Teamsters Local 237, which represents more than 18,000 municipal workers in New York City, said that he believed Mr. de Blasio had the authority to impose a vaccine mandate and that challenging it with a lawsuit would be fruitless.

“I understand why he’s doing it,” he said. “I can’t say it’s wrong, because we have a pandemic.”

Mr. Floyd’s union represents about 7,400 employees of the New York City Housing Authority, which manages the city’s public housing, and has one of the lowest employee vaccination rates of any municipal agency, at 59 percent.

Mr. Floyd said he anticipated that many unvaccinated employees would get the shot in the days ahead, noting that the $500 incentive the city is offering to those who get their shots at city-run sites would help. “I think with the $500, and needing employment, they will have a conversation with their physician and get vaccinated.”

Still, he predicted that some of Nycha’s workforce “will probably walk away from the job.” He said that rampant misinformation about the vaccine had left many of his members fearful. “They don’t know what the vaccine is going to do to them — they’re afraid of it,” he said.

Other union leaders also thought the mandate would lead some workers to retire early or find other jobs. Mr. Nespoli said he feared the mandate could leave the Department of Sanitation short-staffed when the first snowstorm hit this winter.

The mandate applies to workers at dozens of city agencies, about 46,000 of whom have not received a vaccine dose yet, city officials said. It requires most unvaccinated city workers to have gotten a first dose by Nov. 1.

Henry Garrido, executive director of the city’s largest public union, District Council 37, urged City Hall to slow down. “The proposed mandate must be collectively bargained and we expect City Hall to slow down and sit down with us,” he said in a statement.

Eric Adams, the Democratic mayoral nominee, said he supported the mandate, but that more work was necessary to get the unions on board.

“It is essential we get all of our public employees vaccinated — especially those who interact directly with the public — and I support a mandate,” Mr. Adams said on Wednesday. “But we must also work with our unions to make sure there is buy-in from our workers to ensure compliance.”

Hours before a congressional panel was to announce on national television its recommendation that President Jair Bolsonaro be charged with homicide and genocide for his mishandling of the pandemic, a few senators had second thoughts.

Even though they believed Mr. Bolsonaro was effectively responsible for hundreds of thousands of the 600,000 Covid deaths in Brazil, these senators feared that position might not hold up legally, four panel members said.

Suddenly the highly anticipated report — which still recommended other serious criminal charges against Mr. Bolsonaro — had lost the support of the majority of the panel’s 11 voting members.

The panel, which had riveted the country with its six-month investigation, had a late-night meeting at one senator’s apartment, where, over duck and rice, they debated whether pursuing the more severe charges could jeopardize the prospects of Mr. Bolsonaro’s facing legal consequences.

The report’s author, Senator Renan Calheiros, eventually realized that he would have to walk back the charges to ensure the report would pass the committee and get to the attorney general, who could prosecute of the president. In the end, the main charge against Mr. Bolsonaro was “crimes against humanity.”

The last-minute shift reflects the polarized and complicated political landscape under Mr. Bolsonaro, whose popularity has plummeted since he took office in 2019 but who still retains enormous power.

The campaign to vaccinate young children in the United States against the coronavirus will not look like it did for adults. There will be no mass inoculation sites. Pediatricians will be enlisted to help work with parents. Even the vials — and the needles to administer doses — will be smaller.

Biden administration officials, anticipating that regulators will make the vaccines available to 5- to 11-year-olds in the coming weeks, laid out plans on Wednesday to ensure that some 25,000 pediatric or primary care offices, thousands of pharmacies, and hundreds of school and rural health clinics will be ready to administer shots if the vaccine receives federal authorization.

The campaign aims to fulfill the unique needs of 28 million people in the United States, largely still in elementary school, while absorbing the lessons from the rollout of vaccines to other age groups. The 5-to-11 range has far more members than the teenage cohort already approved to receive the vaccine.

“Kids have different needs than adults, and our operational planning is geared to meet those specific needs, including by offering vaccinations in settings that parents and kids are familiar with and trust,” President Biden’s coronavirus response coordinator, Jeffrey D. Zients, told reporters. “So we are going to be ready, pending the F.D.A. and C.D.C. decision that will be based on science.”

The White House announcement came as regulators greatly expanded the number of Americans eligible for booster shots. The Food and Drug Administration authorized boosters on Wednesday for tens of millions of recipients of Moderna’s two-dose coronavirus vaccine and the roughly 15 million who got Johnson & Johnson’s single-dose shot. The agency also updated its authorizations for all three types — Moderna, Johnson & Johnson and Pfizer-BioNTech — to allow medical providers to give people a different vaccine as a booster shot, a strategy known as “mix and match.”

Still, with the school year well underway and the holiday travel season approaching, much of the country has been waiting to see when younger children can receive their first dose.

This month, Pfizer and BioNTech asked the F.D.A. to authorize emergency use of their vaccine for 5- to 11-year-olds. A meeting to discuss the authorization is set for Tuesday, and an F.D.A. ruling could come in the days after, possibly clearing a path for the Centers for Disease Control and Prevention to make recommendations on a pediatric dose in early November.

Regulators have delayed a decision to authorize Moderna’s vaccine for adolescents over concerns about cases of rare heart problems. Both Pfizer-BioNTech and Moderna have expanded the scope of their trials for children ages 5 to 11 as a precautionary measure to detect any rare side effects.

In laying out a plan for distribution before regulators have given their sign-off, the White House is exposing itself to criticism that it is acting before the scientists. Administration officials say they want to make sure that any barriers to access are removed if children are approved to receive the vaccine. Sonya Bernstein, a senior policy adviser for the White House Covid-19 Response Team, stressed that the process was independent of the administration’s plans.

“We know that access is going to be critical here,” Ms. Bernstein said, adding that the administration had in recent weeks explored ways to provide a “kid-friendly experience that makes sure that we’re getting shots in arms with trusted providers in ways that makes parents feel comfortable.”

Other experts said on Wednesday that it made sense for officials to plan ahead.

With the death toll from the coronavirus continuing to soar, President Vladimir V. Putin of Russia announced new restrictions on Wednesday, declaring that a seven-day period starting Oct. 30 would be a non-working week in the country.

The measure is intended to combat the rapid spread of the virus in Russia, where known deaths from Covid-19 have recently climbed above 1,000 a day.

The Kremlin has hesitated to impose unpopular restrictions because of economic fears and widespread public nonchalance about the pandemic.

The “non-working week” is a new and vaguely defined concept created after the onset of the pandemic. It is not a full lockdown; instead, nonessential workers are encouraged to stay home, while their employers are encouraged to pay them at least the minimum wage to do so.

The chosen week appears to be a compromise: four of the days are already public holidays in Russia.

The last time the Kremlin announced a similar non-working week was in May, a time when there were also several public holidays.

Deputy Prime Minister Tatiana Golikova, who first proposed the measure, said she hoped some regions would introduce the non-working week earlier, starting Oct. 23.

Mr. Putin said it was possible the week would grow. “If necessary, non-working days could be extended beyond Nov. 7,” he told his cabinet in broadcast remarks.

“We only have two ways to get through this — get sick or get vaccinated,” he said in a news conference. “But it’s better to get vaccinated. Why wait for an illness or its serious consequences?”

Ms. Golikova proposed restricting access to certain institutions, including workplaces, to vaccinated, tested or recently recovered people. Moscow introduced and then withdrew a similar measure over the summer.

Mr. Putin said that workers should be paid even if they don’t work, but did not stipulate who would foot the bill. Details about implementing the decree, including who would be considered an essential worker, will be left to regional leaders.

Russian-made coronavirus vaccines, including Sputnik V and the one-dose Sputnik Light, are widely available country, but only 45 million of the country’s 146 million people have been fully vaccinated. Scholars attribute the hesitancy to low levels of trust in the authorities, who have sent conflicting messages about the pandemic since it began last year.

Sputnik V has not been approved by the World Health Organization or the European Medicines Agency, the European Union regulator.

Russian authorities have been critical of Western-made vaccines, which are not available in Russia, while promoting Sputnik. Analysts say that has also contributed to confusion and mistrust.

There is also widespread skepticism about the state’s pandemic statistics, with allegations that officials are underreporting cases and deaths.

Mayor Sergei Sobyanin of Moscow announced on Monday that people who rode the subway without wearing masks would be fined. On Tuesday, he asked Muscovites over 60, who make up 60 percent of all Covid patients in hospitals, to get vaccinated or stay at home.

On Oct. 13, Mr. Sobyanin announced he would pay the equivalent of $140 to older residents as an incentive to get the vaccine. Only one-third of people in Moscow over 65 have been vaccinated, lower than the city’s average.

Andrei Makarov, chair of the lower house of parliament’s budget committee, said Tuesday that 1,100 doctors in Russia had died from Covid during the first six months of this year, more than twice the number who died in all of 2020. Officials estimate that more than 225,300 have people died since the beginning of the pandemic, though independent experts say the government has drastically underestimated the death toll.

Bucking the trend in much of the Americas, several Caribbean countries are reporting significant surges in known coronavirus infections, World Health Organization officials warned on Wednesday.

Reports of new cases are up 40 percent over the last week in the Dominican Republic and Barbados, said Dr. Carissa F. Etienne, the director of the Pan American Health Organization, a division of the W.H.O.

“In fact,” Dr. Etienne said at a news conference, “half of Barbados’s cumulative Covid infections since the pandemic began have been reported in the last month.”

Cases are also rising in Trinidad and Tobago and some smaller island nations and territories in the region, including St. Martin, St. Kitts and Nevis, Anguilla and the Cayman Islands.

Many Caribbean countries have had difficulty moving quickly with vaccination efforts, both because of difficulty obtaining doses and because of widespread public hesitancy.

“It really troubles me that some of my Caribbean brothers and sisters have been slow to accept the Covid-19 vaccines that have been made available to them,” said Dr. Etienne, who is from Dominica.

Across Latin America and the Caribbean, 41 percent of the population has been fully vaccinated against Covid-19, according to the Pan American Health Organization.

New case reports are declining across North America, and infections and deaths are declining in most of Central America. The picture is also improving in South America, with the exception of Bolivia and Venezuela, the organization said.

Dr. Etienne said it was important for countries in the region to build up testing even as reports of new cases ebbed, so that any fresh outbreaks could be caught before they developed into widespread surges. “More and more, we’re seeing how local hot spots are driving national trends,” she said.

A good approach, she said, would be to integrate surveillance for Covid-19 with monitoring of other respiratory viruses. She said her organization was working with the Centers for Disease Control and Prevention in the United States to develop a new protocol for P.C.R. testing that would screen the same samples for both Covid-19 and influenza.

Strong surveillance networks, she said, could also help detect emerging pathogens before they spread, and serve “as the region’s backbone for pandemic preparedness.”