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C.D.C. Panel to Discuss Johnson & Johnson Blood Clot Risk

C.D.C. Panel to Discuss Johnson & Johnson Blood Clot Risk

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A woman receiving the Johnson & Johnson Covid-19 vaccine in New York earlier this year.
Credit…James Estrin/The New York Times

Expert advisers to the Centers for Disease Control and Prevention will meet on Thursday to discuss what federal health officials see as a concerning increase in the rates of a rare but serious blood clotting disorder linked to Johnson & Johnson’s coronavirus vaccine.

The Advisory Committee on Immunization Practices will see new data at the meeting that shows elevated risks of the condition in men and women, according to one federal official, setting the stage for the experts to possibly recommend new restrictions on the use of the vaccine.

The F.D.A. on Tuesday said that although problems arose in men and women, the highest rate was in about 1 in 100,000 in women aged 30-49.

Among the women who were diagnosed with the syndrome, which can impair clotting and cause internal bleeding, about one in seven of them died, the F.D.A. said. The federal official who described the planning for Thursday’s meeting said that updated figures showed roughly nine deaths from the disorder.

The panel on Thursday may advise that the vaccine only be given to people who cannot access a different brand or who want it despite the risk, or restrict it to certain groups.

The Washington Post first reported the plans for Thursday’s meeting and the new federal data.

Jake Sargent, a spokesman for Johnson & Johnson, said the company shares with regulators reports of side effects in people who have received the vaccine and “strongly support raising awareness of the signs and symptoms of this rare event.”

About 16 million people in the United States have received a single shot of the Johnson & Johnson vaccine as their primary immunization, compared to 73 million fully immunized with Moderna’s vaccine and 113 million with Pfizer’s. Among the people in the United States who have received a booster shot, just 1.5 percent have gotten the one from Johnson & Johnson.

The side effect, known as thrombosis with thrombocytopenia syndrome, can impair clotting and cause internal bleeding. An increased risk for the condition has been linked to the Johnson & Johnson vaccine and the shot from AstraZeneca, which is not authorized in the United States. It has not been linked to the vaccines from Moderna or Pfizer.

On Tuesday, the Food and Drug Administration announced that it added a warning to the vaccine’s fact sheets for patients and providers, saying the shot should not be given to anyone who has had a clotting problem after a first dose. The agency said that it “continues to find” that the benefits of the vaccine outweigh its risks.

As more cases of the clotting disorder were adjudicated by federal health officials in recent months, F.D.A. and C.D.C. officials grew increasingly alarmed by the numbers presented to them by the C.D.C.’s immunization safety office, which monitors reports in the Vaccine Adverse Event Reporting System, or VAERS, a decades-old system that relies on self-reported cases from patients and health care providers.

The reports of the condition grew worrisome enough in recent weeks that federal officials determined they needed to call an emergency meeting of the C.D.C. advisers.

In April, soon after Johnson & Johnson’s vaccine started being administered in the United States, federal officials briefly recommended halting use of the shot because of concerns about the risk of blood clots. At the time, the condition had emerged in six women, all of whom developed the illness within one to three weeks of vaccination. One of the women had died. By May, 28 cases had been confirmed.

The updated F.D.A. fact sheet for providers says that “currently available evidence supports a causal relationship” between the condition and Johnson & Johnson’s vaccine.

The new data come during a surge in virus cases driven by the Delta coronavirus variant and Omicron, the version of the virus that has already become dominant in some countries and is spreading fast in the United States.

Several laboratory experiments suggest that a single dose of Johnson & Johnson’s shot may offer little defense against infection with Omicron. The company said late last month that it is testing blood samples from clinical trial participants who have received its shot as a booster to see how their vaccine-induced antibodies fare against Omicron.

The shot has largely fallen out of favor in the United States, despite early hopes that its one-and-done format would be easy to deploy in more isolated communities, and among people skittish about receiving two doses.

Federal health officials in October authorized booster shots for people who had received a single shot of Johnson & Johnson vaccine at least two months earlier. They allowed for a “mix and match” approach, allowing people to get a second shot of a Pfizer or Moderna vaccine. Among people in the United States who originally received a single Johnson & Johnson shot and then got a second shot, fewer than 28 percent have gotten Johnson & Johnson as their booster.

Christina Jewett contributed reporting.

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Credit…Sarah Meyssonnier/Reuters

The French government on Thursday banned nonessential travel to and from Britain and tightened testing requirements as a record-breaking surge of Omicron cases across the English Channel raised worries that France would soon face a similar tsunami of new infections.

Jean Castex, France’s prime minister, said in a statement that “faced with the extremely rapid spread of the Omicron variant in the United Kingdom,” the government had decided to act. He urged people planning to travel to Britain to postpone their trips.

British authorities reported 78,610 new coronavirus cases on Wednesday, the highest number of infections in a single day since the start of the pandemic. England’s chief medical officer warned that further records would likely be broken in the coming days, with cases of the Omicron variant doubling less than every two days in parts of the country.

Mr. Castex said that starting Saturday, travel to or from Britain would be allowed for only “urgent” reasons — like a family medical emergency or a legal summons — regardless of the traveler’s vaccination status. The new restrictions effectively bar French and British tourists during the busy holiday season.

Nonessential business trips are also banned under the new restrictions, Mr. Castex said, but he added that the new rules would not apply to French citizens living in Britain who wish to return to France.

Those who do leave Britain for France will face stricter testing requirements, even if they are vaccinated. All travelers will have to present a negative Covid test taken within 24 hours of departure, down from 48 hours. (The 24-hour rule already existed for unvaccinated travelers.)

All travelers arriving from Britain will also have to register online and isolate for up to 10 days. However, they can take a test 48 hours after arrival, and if that comes back negative, they can end their isolation period.

France is already facing a surge in cases attributed to the Delta variant, pressuring a hospital system that is short-staffed and under strain after nearly two years of battling the virus. Nearly 3,000 Covid-19 patients are in intensive care, the highest level since June, and the authorities expect that number to rise to 4,000 by the end of the year.

Gabriel Attal, a French government spokesman, told the BFMTV news channel on Thursday that the goal of the new travel restrictions was to “slow down and reduce as much as possible the arrival of cases of the Omicron variant on our soil.”

Mr. Attal said that 240 cases of the variant had already been detected in France, but he added that “there are probably more.” The government is convening a special cabinet meeting on Friday over the virus, and could announce more new measures in the coming days.

France recently closed nightclubs for four weeks and tightened some restrictions in schools. But President Emmanuel Macron, who is widely expected to run for re-election in April, has ruled out any additional lockdowns, curfews or closures, arguing that heightened vigilance around social distancing, coupled with a swift booster shot campaign, would be enough to keep the surges in check.

In a televised interview on Wednesday evening, Mr. Macron said it was likely that additional Covid-19 booster shots would be necessary in the future.

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Credit…Glyn Kirk/Agence France-Presse — Getty Images

LONDON — Prime Minister Boris Johnson asked Britons on Wednesday to think twice about holiday socializing as the Omicron variant rampages through the country. A day later, Queen Elizabeth II canceled her annual pre-Christmas lunch for the royal family, according to people with connections to Buckingham Palace.

The queen’s decision to call off the lunch for the second year in a row comes as Britain reported a record 78,610 new infections from the virus on Wednesday. Palace officials said it was a precautionary measure to avoid putting family members at risk by bringing a large group together at Windsor Castle.

The pre-Christmas meal is a longstanding tradition for the House of Windsor, assembling children, grandchildren, cousins and other members of the extended family before the queen leaves for Sandringham, her country estate in Norfolk, where she celebrates the holiday with her immediate family.

Elizabeth, 95, has largely receded from public view since October, when she abruptly canceled a trip to Northern Ireland after what palace officials characterized as exhaustion. She has continued to conduct video calls and taped a speech to welcome delegates to the United Nations’ climate conference in Scotland.

The queen sequestered herself inside Windsor Castle with her husband, Prince Philip, for the first year of the pandemic. When Philip died in April, coronavirus restrictions forced the queen to grieve alone in a choir stall at St. George’s Chapel in Windsor, kept apart from other members of her family.

But the queen ventured back onto the public stage after that, welcoming leaders to the Group of 7 summit in Cornwall and playing host to President Biden and his wife, Jill, at Windsor Castle in June. She was a spry presence at those events, though palace officials said she overdid it and became fatigued.

The royal family’s holiday celebrations were already going to be missing key members: Prince Harry and his wife, Meghan, as well as their children, Archie and Lilibet, are not expected to travel from their home in Montecito, Calif., to Britain for Christmas.

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Credit…Narendra Shrestha/EPA, via Shutterstock

KATHMANDU, Nepal — As coronavirus vaccines were rolled out last spring across the world, Nepal struggled to find doses because they were being hoarded by richer countries.

But now, the small Himalayan nation finds itself in a peculiar situation: It suddenly has too many for its cold-storage capacity, and it has asked for shipments to be slowed down.

“Due to a lack of adequate cold-room space, we have been requesting vaccine suppliers to delay shipment for a while,” Badebabu Thapa, a government official who deals with the logistical management of Nepal’s vaccination campaign, said on Thursday. “If vaccines keep coming at the present rate, arranging warehouses for sensitive vaccines will be a herculean task.”

Health officials said they had been making frequent slowdown requests in recent weeks, after the flow of vaccines from Unicef — which has been delivering coronavirus vaccines from the global Covax pool meant for poorer nations — and other suppliers significantly increased.

This week alone, about four million doses have arrived in the capital, Kathmandu — 2.1 million doses of Johnson and Johnson from Germany, and 1.8 million doses of Covishield, which is manufactured by India’s Serum Institute. In the coming days, Nepal is expecting 2.4 million doses of Vero Cell from China, and 676,000 doses of Pfizer from the United States via Covax.

Health authorities are now seeking to delay shipments until the modest central and regional warehouses are emptied.

The country’s poor health infrastructure has struggled in the face of deadly waves of the virus, and vaccination efforts have been slowed by the country’s difficult terrain. Doses to some far-flung villages are transported using helicopters, mules and yaks. Nepal has vaccinated only about 30 percent of its population of 30 million.

Mr. Thapa said the government could not arrange enough warehouses in time for the sudden influx of supplies. What made planning particularly difficult, he said, was the unpredictable nature of the deliveries.

But he said the Health Ministry was working to build new cold-storage facilities and to expand the capacity of the existing ones.

Bhadra Sharma

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Credit…Mario Tama/Getty Images

Coronavirus deaths in the United States surpassed 800,000 on Wednesday, according to a New York Times database, as the pandemic neared the end of a second year and as known virus cases in this country rose above 50 million.

The new death toll — the highest known number of any country — comes a year after vaccines against the coronavirus began rolling out in the United States. It also comes at a tenuous moment in the pandemic: Cases are rising once again, hospitals in some parts of the country are stretched to their limits with Covid patients and the threat and uncertainties of a new variant loom.

More than 1,200 people in the United States are dying from Covid-19 each day.

The last 100,000 deaths occurred in less than 11 weeks as the pace of death has picked up, moving faster than at any time other than last winter’s surge. The current uptick is being driven by the Delta variant. It is not yet known how the Omicron variant, which continues to emerge in more states, might affect those trends in the coming weeks and months.

Naoko Muramatsu, a professor at the University of Illinois at Chicago’s School of Public Health, said that from the beginning of the pandemic in 2020, older people have suffered disproportionately.

“Early on, Covid was considered to be an older people’s problem,” she said. Nearly two years later, those difficulties have persisted, whether in the form of a high death rate or isolation, which in many cases already existed but expanded significantly as the months wore on. Older people steered clear of crowded public gatherings and younger relatives stayed away, fearful of exposing those more vulnerable to the virus.

Some 75 percent of the 800,000 Covid-19 deaths have involved people 65 or older. One in 100 older Americans has died. Countless others have found themselves isolated.

“Covid really made something visible that was already going on for older adults,” she said. “Older people were so vulnerable.”

After the first known coronavirus death in the United States in February 2020, the virus’s death toll in this country reached 100,000 people in only three months. The pace of deaths slowed throughout summer 2020, then quickened throughout the fall and winter, and then slowed again this spring and summer.

Throughout the summer, most people dying from the virus were concentrated in the South. But the most recent 100,000 deaths — beginning in early October — have spread out across the nation, in a broad belt across the middle of the country from Pennsylvania to Texas, the Mountain West and Michigan.

The benchmark of 800,000 deaths in the United States occurred despite the wide availability of vaccines for most of 2021.

Older people have been vaccinated at a much higher rate than younger age groups and yet the brutal effects of the virus on them has persisted. The share of younger people among all virus deaths in the United States increased this year, but, in the last two months, the portion of older people has risen once again, according to data from the Centers for Disease Control and Prevention.

By now, Covid-19 has become the third leading cause of death among Americans 65 and older, after heart disease and cancer. It is responsible for about 13 percent of all deaths in that age group since the beginning of 2020, more than diabetes, accidents, Alzheimer’s disease or dementia.

Julie Bosman, Amy Harmon, Albert Sun, Chloe Reynolds and Sarah Cahalan

Source: https://www.nytimes.com/live/2021/12/16/world/covid-omicron-vaccines