The Food and Drug Administration granted full approval on Monday to Moderna’s coronavirus vaccine, the second-most widely used in the United States and the second to receive full regulatory approval.
The vaccine, which can be administered to adults and has been shown to be highly effective at preventing virus infections and severe cases of Covid-19, has been in use for more than a year under an emergency-use authorization. That rigorous standard lets federal regulators allow use of the shot in a public health emergency before they complete a longer and more detailed review. The vaccine received emergency-use authorization in December 2020.
The full approval of Moderna’s vaccine, which was widely expected, came roughly five months after the company said it had finalized its application for regulators, and after Pfizer and its partner BioNTech, the makers of a similar vaccine, won federal approval in August for use in people 16 and older. That approval set off a cascade of vaccination mandates from institutions that had eagerly awaited the more exhaustive review.
The Pfizer-BioNTech vaccine is cleared for use in people 5 and older, and could be authorized for even younger children in the next few months.
More than 204 million doses of the Moderna vaccine have been administered in the United States so far, and nearly 75 million people across the nation have been fully vaccinated with it, according to the Centers for Disease Control and Prevention.
“While hundreds of millions of doses of Moderna Covid-19 vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, F.D.A. approval of this vaccine may instill additional confidence in making the decision to get vaccinated,” Dr. Janet Woodcock, the acting F.D.A. commissioner, said in a statement on Monday.
The C.D.C. panel of vaccine experts is set to meet on Feb. 4 to review and vote on whether to endorse the approval, as it did with the Pfizer-BioNTech decision in August.
More than 38 million extra shots of the vaccine have also been administered, according to the C.D.C. Fully vaccinated adults became eligible for Moderna booster shots in the fall. The C.D.C. now considers three doses of the vaccine, with a third dose given five months after the second, to be an “up to date” regimen for most adults. Some people with weakened immune systems recently became eligible for fourth doses.
The new approval also allows Moderna to market its vaccine under the name Spikevax, and gives more latitude to physicians to prescribe use of the shot. Controls on how the vaccine is administered were tighter under emergency use authorization.
Dr. Peter Marks, who oversees the agency’s vaccines office, said in a statement that the review involved an independent verification of Moderna’s analysis of its vaccine’s effectiveness; a separate F.D.A. analysis of the data; and a “detailed assessment” of the manufacturing procedures for the vaccine.
Like the Pfizer-BioNTech vaccine, the Moderna shot has been tied to serious but rare heart-related side effects — myocarditis, or inflammation of the heart muscle, and pericarditis, or inflammation of the lining around the heart. Those conditions can also arise from Covid-19, and are typically mild. The side effects have been shown to be especially prevalent in young men.
Concerns over those side effects led federal regulators to continue reviewing Moderna’s application for use of the vaccine in adolescents. Moderna is also studying use of its vaccine in children.
The F.D.A. said on Monday that it had conducted a “rigorous evaluation” of the side effects and determined that there was increased risk within a week after a second dose, particularly in men aged 18 to 24. Available short-term follow-up data suggested that symptoms had resolved in most people, the agency said. Regulators conducted a benefit-risk analysis that showed the benefits of the vaccine still outweighed the risks for all adults.
Regulators significantly sped up the amount of time they typically take to fully approve a vaccine, shaving months off a process that experts have said is enormously complex and time-consuming, requiring large teams of F.D.A. reviewers.
Before it approved the Pfizer-BioNTech vaccine, the F.D.A. came under intense pressure from some public health experts, who accused the agency of an overly plodding review that compromised momentum in the national vaccination campaign. Public polling at the time showed that some Americans would be likelier to get the shot if it were fully approved.
The pharmaceutical company Novavax said on Monday that it had submitted an application to the Food and Drug Administration seeking authorization for its long-delayed protein-based coronavirus vaccine.
It is not clear what, if any, role Novavax’s vaccine will play in the United States if it wins clearance. The federal government ordered 110 million doses of the shot in two deals reached with the company in 2020, but the United States is now flush with other vaccines and does not need more supplies.
Stan Erck, Novavax’s chief executive, said in a statement that the company was working closely with the United States government “to develop a plan which includes doses, manufacturing, timing, and ongoing clinical trial research for boosters and pediatrics to support their pandemic response.”
Novavax’s vaccine uses a more conventional approach than the vaccines that were more swiftly developed and authorized. That could make it appealing to people who are hesitant to be inoculated with vaccines like those from Pfizer-BioNTech and Moderna that use the newer messenger RNA technology. Novavax’s product uses tiny particles studded with viral proteins, mixed with an immune-boosting compound known as an adjuvant. The vaccine is given as two shots, spaced three weeks apart.
Novavax’s vaccine was found to be protective against illness caused by earlier versions of the virus. The company has said its vaccine can generate an immune response against the Omicron variant, though it remains to be seen how strong the protection will be.
In the early months of the pandemic, Novavax’s vaccine was one of six selected for financing under Operation Warp Speed, the Trump administration’s effort to accelerate vaccine development. But Novavax, a Maryland company that has that has never brought a product to market, lagged behind other vaccine developers. It struggled to build up its manufacturing capacity and to demonstrate the purity of its vaccines to regulators.
Novavax’s Operation Warp Speed contract originally promised the company $1.6 billion in support for research and manufacturing in exchange for 100 million doses for the United States. As of Novavax’s most recent regulatory filing in November, the contract ceiling had been revised up to $1.8 billion, and the company reported that it had already received about $900 million.
The Serum Institute of India, the world’s largest vaccine producer, has a license to make its own version of Novavax’s vaccine and recently began exporting doses to Indonesia and the Netherlands.
Novavax’s vaccine won its first authorization in November, in Indonesia, and it has since received authorization from other regulatory bodies, including the World Health Organization and the European Commission.
The Omicron wave is receding in states where the extremely contagious variant arrived later, and some governors are saying it’s time for pandemic-fatigued Americans to try to restore a sense of normalcy.
The United States remains in a precarious position, with hospitals overstretched and daily deaths above 2,500 and rising. While case counts are declining nationally and in some states — including Arizona, Utah, Colorado, North Dakota, Louisiana and Mississippi — where Omicron swept through more recently, they remain far higher than in any other period of the pandemic. And the spread of an Omicron subvariant that appears to be even more contagious has some experts warning that it could take longer than expected for the wave to wane.
The daily average of U.S. cases remains around 519,000 — more than double the worst statistics from last winter. Hospitalizations, which lag cases, seem to have topped out nationally, though they remain higher than last winter’s peak. Deaths, which lag more, are also at record levels in some states.
In a few states, like Washington and Montana, cases are still rising. And on Monday, Gov. Brad Little of Idaho activated the National Guard in his state to help keep hospitals functioning when many medical workers are out sick.
Despite all of this, some state leaders said that while new variants and, inevitably, another surge remained a threat, Omicron had brought the country closer to the endemic stage of the virus.
“We’re not going to manage this to zero,” Gov. Philip D. Murphy of New Jersey, a Democrat, said on NBC News’s “Meet the Press” on Sunday. “We have to learn how to live with this.”
Mr. Murphy was one of several governors who met with Mr. Biden at the White House on Monday. In wide-ranging remarks, Mr. Biden emphasized efforts to limit the pandemic’s impact on education.
“We’re going to try like the devil to keep schools open,” he said, because studies have shown “that losing a semester can put a kid back a year and a half.”
And in a news conference on Monday, the White House press secretary, Jen Psaki, suggested that the country had “the tools to get to a point where it does not disrupt our daily lives.”
Public health experts say the next phase will depend on what variants emerge and whether a sluggish vaccination campaign picks up speed. Herd immunity to the coronavirus, experts say, is unlikely to be achieved.
The spread of an Omicron subvariant known as BA.2 is yet another reminder of the unpredictable path the pandemic could take.
So far, BA.2 doesn’t appear to cause more severe disease, and vaccines are just as effective against it as they are against other forms of Omicron. But it does show signs of spreading more readily.
“This may mean higher peak infections in places that have yet to peak, and a slowdown in the downward trends in places that have already experienced peak Omicron,” Thomas Peacock, a virologist at Imperial College London, told The Times’s Carl Zimmer.
Dr. Anthony S. Fauci, the chief Covid adviser to President Biden, recently offered words of cautious optimism, saying he believed outbreaks could become much more manageable in the coming months — to a point where “they’re there, but they don’t disrupt society.”
As Omicron declines, Gov. Asa Hutchinson of Arkansas, a Republican, said the United States should remain vigilant but move toward treating the virus as endemic. He acknowledged that more variants were inevitable and called on the federal government to help states increase testing capacity and access to treatments.
“That’s where the federal government needs to step up,” he said on “Meet the Press” on Sunday. “Let’s take advantage of this going down to be prepared for what’s around the corner.”
Roni Caryn Rabin, Carl Zimmer and Maggie Astor contributed reporting.
— Ron DePasquale
Downing Street suffers from a culture of “excessive” workplace drinking that led to social gatherings during pandemic lockdowns, according to a highly anticipated report from a British government investigation released on Monday.
The document described leadership failures in the office of Prime Minister Boris Johnson, though it did not directly implicate Mr. Johnson in wrongdoing, leaving that judgment to a separate police investigation. That may give him some political breathing room, but it is unlikely to dispel the cloud of what has become a career-threatening scandal.
The report, by a senior civil servant, Sue Gray, was scrubbed of its most potentially damaging findings at the request of London’s Metropolitan Police, which launched their own investigation of the lockdown breaches last week. So abridged was the document released on Monday that the Cabinet Office characterized it as an “update” of Ms. Gray’s investigation rather than as a report.
Still, even in its redacted form, the report painted a troubling portrait of a work culture at Downing Street, where staff members held alcohol-fueled gatherings with colleagues during a period when the government was urging the public to avoid socializing, even with close friends and relatives. Accusations of double standards have engulfed Mr. Johnson’s government and threatened his grip on power.
“At least some of the gatherings in question represent a serious failure to observe not just the high standards expected of those working at the heart of government, but also of the standards expected of the entire British population at the time,” Ms. Gray said in one of her general findings.
“There were failures of leadership and judgment by different parts of No. 10 and the Cabinet Office at different times,” she continued. “Some of the events should not have been allowed to take place. Other events should not have been allowed to develop as they did.”
Ms. Gray took particular aim at the regular drinking at these events. “The excessive consumption of alcohol is not appropriate in a professional workplace at any time,” she wrote, adding that government agencies needed “a clear and robust policy in place covering the consumption of alcohol in the workplace.”
The prime minister had shored up his position somewhat in recent days, and the findings released on Monday did not immediately appear to pose a fresh threat to him. But at a minimum, they raised hard questions about the operation Mr. Johnson and his senior aides have put together at Downing Street.
Mr. Johnson, who addressed Parliament about the report on Monday, has been scrambling to avoid a vote of no-confidence in his leadership by Conservative lawmakers. Such a vote would be called if 54 members submit confidential letters demanding it. That threshold has not yet been met, and it was unlikely that the details released Monday would lead to a flood of new dissidents.
Indeed, Downing Street moved swiftly to change the subject. Mr. Johnson was scheduled to have a call with President Vladimir V. Putin of Russia on Monday to discuss the mounting tensions in Ukraine, although that did not take place amid the parliamentary questions over the report. He was expected to visit the Ukrainian capital, Kyiv, on Tuesday.
Britain has been staking out a more assertive policy on Ukraine in recent weeks. But Mr. Johnson has been forced to cede much of the spotlight to his foreign secretary, Liz Truss, and defense secretary, Ben Wallace, while he grappled with the mutiny inside his Conservative Party over the party scandal.
Later in the week, the government will release a report on its “leveling up” program, the blueprint to bolster economically blighted parts of the country’s north, which is the centerpiece of its legislative agenda.
Mr. Johnson hopes to mollify Conservative lawmakers, many of whom were swept into Parliament in 2019 on the strength of Mr. Johnson’s “Get Brexit done” campaign slogan but who have grown disillusioned with him, particularly in the wake of disclosures about pandemic socializing at Downing Street.
Frontline health workers in England may no longer be required to get vaccinated, Britain’s health secretary said on Monday. He recommended a review of a mandate that employers and trade unions have warned would lead to crippling staff shortages.
“Week by week, we are carefully moving our Covid response from one of rules and restrictions back to one of personal responsibility,” the health secretary, Sajid Javid, told Parliament on Monday. “We’re able to do this because of the defenses that we’ve built throughout this pandemic in vaccines and antivirals, in testing and surveillance.”
Originally, the mandate said National Health Service workers in England had to be fully vaccinated by April 1, meaning that they would have needed to receive their first dose of a two-dose vaccine no later than Thursday in order to be eligible for their second dose before the deadline.
Mr. Javid noted that the Omicron variant that is now dominant tends to cause severe illness less often than Delta, which was the dominant version when the mandate was announced in November. He said the mandate was the right policy during the Delta wave, but that Omicron may call for a different approach.
“Given that Delta has been replaced, it’s only right that our policy on vaccination as a condition of deployment is reviewed,” he said. “While vaccination remains our very best line of defense against Covid-19, I believe that it is no longer proportionate to require vaccination as a condition of deployment through statute,” he added.
Nineteen out of 20 of the service’s workers have “done their professional duty” and gotten vaccinated, Mr. Javid said to Parliament. He had reported last week that about 77,000 N.H.S. workers remained unvaccinated against the virus.
Employers and union heads have warned for a long time that the April 1 deadline would prompt health workers who were hesitant about vaccination to quit their jobs, making severe staffing shortages worse.
A report released by the parliamentary health committee earlier this month detailed an array of issues straining the health care system, including record waiting lists, caseloads and staff vacancies. The report called on the government to immediately devote more resources to recruiting and training health workers to plug the gaps.
The Royal College of Nursing and the Royal College of Midwives urged the government earlier this month to delay the vaccination deadline for frontline workers, saying that the effects on health care from sidelining unvaccinated workers could be “catastrophic.”
“To dismiss valued nursing staff during this crisis would be an act of self-sabotage,” Pat Cullen, the general secretary and chief executive of the R.C.N., said in a statement. “We’re calling on the government to recognize this risk and delay a move which, by its own calculations, looks set to backfire.”
Their fears are not unfounded. The effects of the vaccine requirement have already been felt by the social care sector, where workers have been required to be vaccinated since November. Care providers say the rule has worsened staff shortages that the sector already faced throughout the pandemic.
As daily reports of new coronavirus cases have declined, England has departed from its “war footing” and begun treating the virus as endemic. Most remaining pandemic restrictions were lifted last week. Starting Feb. 11, fully vaccinated travelers will no longer be required to take coronavirus tests before entering the country.
“Covid-19 is here to stay,” Mr. Javid said on Monday. “While some countries remain stuck on a zero Covid strategy and others think about how they will safely open up, here we are showing the way forward and showing the world what successfully living with Covid looks like.”
Maggie Astor contributed reporting.
The Austrian government ended its lockdown for unvaccinated people on Monday, even as it experiences a record number of daily coronavirus cases and prepares to approve a vaccine mandate for adults later this week.
Karl Nehammer, the Austrian Chancellor, announced last week that the restrictions would end because the strain on hospitals from cases of the Omicron variant was less severe.
Starting Monday, unvaccinated Austrians will no longer be confined to their homes. But they still cannot enter nonessential shops, restaurants and cultural institutions for another two weeks.
The rule, which was introduced in mid-November, was one of the first lockdown restrictions in Europe that targeted people who were neither vaccinated nor had recovered from Covid. But as cases continued to rise, the government announced a broader 20-day lockdown for the entire population a week later. A general vaccine mandate was also announced at that time.
The upper house of Austria’s Parliament is expected to pass a bill later this week that will make vaccinations mandatory for almost everyone aged 18 and over. Starting March 15, officials will be authorized to do routine checks of vaccination status.
People who fail to produce proof of vaccination could face fines as high as 3,600 euros, or about $4,000.
Austria’s vaccination rate is currently 73 percent. Last week Austrian authorities registered a record 38,423 new daily cases.
Prime Minister Justin Trudeau of Canada has tested positive for the coronavirus after an exposure last week. He said on Twitter that he was not feeling ill.
He said later in an online news conference that two of his three children had also tested positive.
Mr. Trudeau has been isolating since last Thursday, when he learned that he had been exposed. He revealed his own positive test result in a statement posted to social media on Monday morning, and added that he would “continue to work remotely this week while following public health guidelines.”
This morning, I tested positive for COVID-19. I’m feeling fine – and I’ll continue to work remotely this week while following public health guidelines. Everyone, please get vaccinated and get boosted.
— Justin Trudeau (@JustinTrudeau) January 31, 2022
Several Canadian news outlets reported that Mr. Trudeau and his family were relocated out of their official residence in Ottawa, the capital, by the Royal Canadian Mounted Police over the weekend as thousands of protesters converged on the city.
The police force declined to comment on those reports, citing security concerns.
Loosely organized trucker convoys traveled across the country to Ottawa to protest vaccine mandates, attracting supporters and millions of dollars in donations along the way. They gathered in front of Canada’s Parliament building on Saturday, clogging downtown streets, with cars and pickup trucks outnumbering the heavy trucks that initially made up the convoys.
Some protesters carried Canadian flags held upside down, traditionally a signal of dire distress or danger. At least one flag had swastikas drawn on it.
“Hate can never be the answer,” Mr. Trudeau said in the virtual news conference. “Over the past few days, Canadians were shocked and frankly, disgusted, by the behavior displayed by some people protesting in our nation’s capital.”
Some protesters were still in the area on Monday, and the Ottawa police said they expected “major traffic, noise and safety issues.”
Mr. Trudeau, who is fully vaccinated and received a booster dose at the beginning of January, planned to participate in his scheduled events remotely on Monday, including a question period in the House of Commons.
It is not the first time Mr. Trudeau has had to conduct his duties from home. His wife, Sophie Grégoire Trudeau, came down with flulike symptoms in March 2020 and later tested positive for the coronavirus. As his wife isolated in one part of their home, Mr. Trudeau became the full-time caretaker to his three children, cleaning up and doing laundry, though cooked meals were dropped off.
Public health guidelines have changed recently in several provinces, including Ontario, where Ottawa is located. Ontario now requires vaccinated people who test positive for the virus to isolate for at least five days after the onset of symptoms, a household contact or a positive test; earlier in the pandemic, the minimum was about 14 days.
Close to 78 percent of Canadians are fully vaccinated, according to federal public health data, and 88 percent of people who are 5 and older have received at least one dose of vaccine.
Ian Austen contributed reporting from Ottawa.
The Omicron variant has dampened the plans of tens of millions of people across several Asian countries to travel during the Lunar New Year, as officials battle the pandemic for a third year.
Observed this year on Feb. 1, Lunar New Year falls just as many countries are seeing surges in coronavirus cases. Omicron is becoming the dominant variant in countries like South Korea, which expects up to 90 percent of its cases to be Omicron-related by the end of February.
Before the pandemic, as many as three billion trips were made over the holiday in China — often described as the world’s largest annual migration. People visit their hometowns or go on vacation.
Once again this year, there will be far fewer trips, with travel regulations and pressure from governments restricting the exodus.
“Large gatherings will have to wait a little longer, as the Omicron variant has forced us to maintain strict measures,” said Singapore’s prime minister, Lee Hsien Loong, in a statement about the holidays. “We must continue to exercise social responsibility and take precautions.”
Singapore has reported a 457 percent increase in daily cases over the past two weeks, according to Our World in Data. The city state’s Ministry of Health said it expects “cases to double every two or three days.” In December, Singapore and Malaysia temporarily halted ticket sales for airplanes and buses in response to the rise of Omicron, even for those who were fully vaccinated.
Chinese citizens are under strict government surveillance, with a color code system restricting their movements and making travel difficult. The country’s “zero Covid” approach has led to lockdowns across various cities.
In January, Beijing officials reported the city’s first Omicron case and called for an immediate lockdown in one neighborhood. With the Olympics just around the corner, China has decided not to sell tickets to most domestic or international spectators.
On Sunday, Beijing reported its highest case count in 18 months, just days before the Games.
South Korea has not placed a travel ban on its citizens, but it has repeatedly urged them to refrain as much as possible from visiting relatives and going on vacation.
Although the country has fully vaccinated 85 percent of its population, according to Our World in Data, it reached a record case count of 17,532 over the long Lunar New Year weekend, which started on Saturday and will last through Wednesday.
Several countries that had put in place strict international travel restrictions will continue moving toward a gradual reopening of their tourism industries.
Vietnam has been slowly reopening to international visitors. Certain destination spots have already opened up, and the country will be fully accessible to travelers in April.
Indonesia lifted a ban on travelers from 14 countries in mid-January, allowing people from any country to visit if they quarantine upon arrival. “Learning from the surge of the Omicron variant cases in various countries, the government has made adequate preparations to deal with it,” President Joko Widodo said in a statement on Friday.
A high-level Hong Kong official who attended a birthday party with members of the local political elite just as the city was entering a new wave of coronavirus infections resigned on Monday, saying he did “not set the best example during the recent outbreak.”
Carrie Lam, Hong Kong’s chief executive, singled out the official, Caspar Tsui, the home affairs secretary, for the most flagrant behavior among officials who attended the party.
More than 200 people attended the Jan. 3 birthday event for Witman Hung, a local delegate to China’s National People’s Congress, including 15 senior officials and 20 members of Hong Kong’s Legislature. Hong Kong has managed to keep the coronavirus largely contained through strict quarantines and social distancing policies, but the party was held as the Omicron variant had already begun spreading through the city.
The party guests ate, drank wine and sang karaoke for hours at a tapas restaurant. Several were photographed not wearing masks. The officials’ indifference to pandemic precautions stirred anger among Hong Kong residents, who have experienced two years of restrictions.
Mrs. Lam said that Mr. Tsui stayed at the party for close to two hours, did not wear a mask when required and did not use an official contact tracing app. His conduct was especially egregious because of his role in fighting the pandemic, including attending high-level prevention planning meetings on Dec. 31 and the morning of Jan. 3., Mrs. Lam said.
“His conduct has brought the Hong Kong government into disrepute and has created a negative perception among the general public,” she said.
Mrs. Lam said that two other officials who did not have pandemic prevention roles would be given verbal warnings for other transgressions. (One attended the party for four hours and drank too much to recall whether he wore a mask, while the other went to work before submitting to a mandatory test.) Twelve other officials who attended for brief periods and followed other rules would not be punished, Mrs. Lam said.
All the guests were sent to quarantine after two people who attended were later found to be infected with the coronavirus. Many, however, had their isolation cut short after one case turned out to be a false positive.
On Thursday, Hong Kong recorded 164 new coronavirus infections, its highest single-day total. The numbers have eased somewhat in recent days, dropping to 81 new cases on Sunday.
In other global news:
The Australian curler Tahli Gill has been cleared to compete in the Winter Olympics after initially testing positive for the coronavirus upon landing in Beijing this past weekend, in a sign of hope for athletes who are flagged as positive upon arrival for the Games. Ms. Gill contracted the coronavirus several weeks ago in Canada. In statement released on Monday, the Australian Olympic Committee said that she had since returned two negative tests — on Sunday and Monday — and would be allowed to compete. “We are greatly relieved,” Ms. Gill and her teammate, Dean Hewitt, said in the joint statement. “This experience is not going to define our Olympic campaign.”
Previously undisclosed data about the financial performance of individual Broadway shows reveal that the fundamental modern economics of the industry, in which big brands dominate and adventurous new works struggle to break through, were reinforced rather than upended as the industry reopened last fall.
The numbers contradict a hypothesis that took hold while the coronavirus pandemic kept Broadway shuttered: that once theaters reopened, audiences would include more New Yorkers and fewer tourists, and the result could be a more receptive marketplace for ambitious new plays.
Instead, in the months between the reopening and the upheaval caused by Omicron, many unfamiliar plays — including a heralded wave of work by Black writers and a pair of experimental plays by white writers — struggled to sell tickets.
The information about the shows’ financial performance was collected by the Broadway League, a trade association representing producers and theater owners, and distributed to the association’s membership in mid-January. In a break with past practice, the League decided not to make show-by-show box office data public this season, saying the circumstances were so unusual that the data could not fairly be compared to that of other seasons, but The New York Times obtained the numbers.
The data runs from mid-September through Dec. 12, just before a spike in coronavirus cases among theater workers forced as many as half of all Broadway shows to cancel performances.