C.D.C. Panel Is Meeting on J.&J. Vaccine Pause
The U.S. is likely to permit the Johnson & Johnson shot if the panel says the benefits outweigh any blood clot risk. Here’s the latest on Covid-19.,
The Centers for Disease Control and Prevention’s independent vaccine advisory panel is meeting Friday to review the latest findings about a potential rare side effect that led to a pause in the use of the Johnson & Johnson Covid-19 vaccine.
If the panel, the Advisory Committee on Immunization Practices, decides that the vaccine’s benefits outweigh the potential risk, then the government is likely to end the pause.
The meeting comes 10 days after the U.S. government recommended that inoculations with the Johnson & Johnson Covid-19 vaccine be halted while researchers investigated six reports of unusual blood clots out of 6.8 million people who had received it.
Top federal health officials are leaning toward lifting their recommended pause on the use of the vaccine after finding only a limited number of additional cases of a rare blood clotting disorder among recipients, and the Food and Drug Administration is considered likely to attach a warning to the vaccine’s label to inform health practitioners — and the public — about the exceedingly uncommon, but dangerous possible side effect.
The officials said in interviews with The New York Times that they had found a few additional cases of the rare blood clots, but would not specify how many. They said that the overall rate did not appear to have changed significantly since last week.
The committee could recommend that Johnson & Johnson add a formal warning label about the side effect, as the company has done in the European Union. Roughly 10 million doses or more of the vaccine, produced at the company’s factory in the Netherlands, are sitting on shelves across the United States and could be deployed immediately.
The meeting comes as the federal government is also investigating problems at a Baltimore factory that was slated to help satisfy the country’s demand. Emergent BioSolutions, the plant’s operator, has produced tens of millions of doses of Johnson & Johnson’s vaccine, but they cannot be distributed until regulators certify the plant.
After Emergent had to discard up to 15 million possibly contaminated doses of the vaccine last month, federal regulators conducted an inspection that found a series of problems, including the risk that other batches could have been contaminated.
Last week’s pause followed reports of six women who experienced a rare type of blood clot in the brain within three weeks of getting the Johnson & Johnson vaccine. The clots were accompanied by an unusual drop in platelets, components of the blood that normally help heal wounds.
On Thursday, the Oregon health authorities reported that a death was being investigated for a possible connection to the Johnson & Johnson vaccine. The woman who died was in her 50s and had symptoms consistent with the blood clotting cases identified in eight other Johnson & Johnson recipients in the U.S. Dr. Shimi Sharief, the state health authority’s senior health adviser, emphasized that it was not known whether the woman’s death was related to the vaccine.
The C.D.C. committee met the day after the initial pause, and a representative from Johnson & Johnson provided details on the six cases, along with two others. Rather than voting, the panel decided to hold a second meeting the following week, giving them time to better assess the data.
European regulators, who have also been scrutinizing the shots, said on Tuesday that they would allow these vaccinations to resume with the addition of a formal warning label.
The Times’s Emily Schmall reports from New Delhi on the desperate situation in India. The following is an excerpt from her article.
NEW DELHI — A catastrophic second wave of the coronavirus is battering India, which is reporting the world’s highest number of new infections as hospitals and patients beg for fast-diminishing oxygen supplies and other emergency aid.
Canada has joined Britain, Hong Kong, Singapore and New Zealand in barring travelers coming from India. And the U.S. State Department advised people against going to India after the Centers for Disease Control raised the risk level to its highest measure.
Even as cases have climbed, Prime Minister Narendra Modi’s governing Bharatiya Janata Party and other parties have continued to hold mass rallies with thousands of people unmasked. The government has also allowed an enormous Hindu festival to draw millions of pilgrims despite signs that it has become a superspreader event.
The catastrophe in India is playing out vividly on social media, with Twitter feeds and WhatsApp groups broadcasting hospitals’ pleas for oxygen and medicines, and families’ desperate searches for beds in overwhelmed Covid-19 wards. With many hospitals short of ventilators, television reports have shown patients lying inside ambulances parked outside emergency rooms, struggling to breathe.
Some county health departments that a month ago couldn’t keep up with vaccine demand have now started closing some of their mass vaccination sites for lack of customers, and some counties are declining vaccine shipments.
Now that more than half of adults in the United States have received at least one Covid-19 vaccine dose and the country has surpassed 200 million administered doses, demand for shots appears to be slowing in many areas.
White House and health officials are comparing the next phase of the vaccination campaign to a get-out-the-vote effort.
While every person 16 and older in the country became eligible for a coronavirus vaccination on Monday, dropping demand has pushed Mercer County, Ohio — where 27 percent of adults have at least one dose — to announce the closing of its mass vaccination site on May 7.
“It wasn’t fair to ask our volunteers to keep showing up there when they weren’t being fully utilized — they like to keep busy,” Jason Menchhofer, county health administrator, said in an interview on Thursday about the site on the local fairgrounds.
In the first few months of the year, the site in the county of 41,000, which borders Indiana, would fill up its 400 appointments in an hour or two, he said. “We could even reach down into those who were not age-eligible to get it to come in at the end of the day to come out quickly and get it into someone’s arm,” he said.
But demand has fallen precipitously in the last several weeks, and last week the county ended up wasting two doses, which was a first. “We no longer have a reserve of people who want to be vaccinated to reach into to show up and take those doses,” he added.
The largest vaccination site in Las Vegas, the Cashman Center, will close on May 5 as the list of open appointments grow and the lines to be inoculated have dwindled. The tens of thousands of open appointments at sites across the nation are forcing officials to pivot their outreach strategies and zero in on smaller events.
Palm Beach County in Florida said on Tuesday that it would shut its three mass vaccination sites, which are operating at about half capacity, by the end of May. Of 16,000 appointment slots available this week, only 6,000 were filled, according to health officials. Instead, three mobile units will each aim to give 500 doses a day.
In Galveston County, Texas, a mass drive-through clinic at a county park won’t operate after May 1. The park has been administering 5,000 doses per day, including on Thursday. But demand for appointments has dampened in the last three weeks, according to the county’s chief public health officer. He also asked the state to pause vaccine shipments.
“We’re concerned that some of it may expire before we use it, if we keep getting it,” said Dr. Philip Keiser. “We are trying to figure out how to balance out supply and demand, yet also have enough on hand so that when school kids are able to get back, we can do them.”
There will be much more targeted outreach, down to the Census tract level, Dr. Keiser said, and there might be 100 or 200 injections per day rather than thousands.
“We got about 50 percent of our people vaccinated,” he said, “and we recognize that next 25 percent is going to be a lot harder than the first.”
For weeks, Illinois has been beset by a stubbornly high daily load of reported coronavirus cases, leading to climbing hospitalizations and deaths. But new data is signaling that the virus might be on the verge of retreat.
Illinois is reporting an average of about 2,900 new cases a day, down nearly 13 percent from a week ago. Central Illinois, which saw major growth in cases earlier this month, is now improving, according to a New York Times database — especially in Peoria, one of the metropolitan areas where the virus had been spreading the fastest.
“It is great we have seen some abatement in local hot spots,” said Dr. Emily Landon, the chief epidemiologist at the University of Chicago, who has been advising Gov. J.B. Pritzker on the state’s pandemic response. Dr. Landon cautioned that there were other pockets of the state, though, especially those with low vaccine rates, that remain ripe for “a fiery outbreak.”
“I wouldn’t say everybody is out of the woods,” she added.
Illinois’s latest surge in cases followed the rising trends in other Midwest states like Michigan and Minnesota beginning in late February and March. The situation grew particularly worrisome in Michigan, which continues to lead the nation in cases per 100,000 per people, but has seen a 15 percent decline over the past two weeks.
The case counts surged at a time when variants were starting to spread widely, and states have been racing to vaccinate as many people as possible, in part to head off the variants. About a quarter of Illinois’s population is now fully vaccinated, and 43 percent of residents have received as least one shot. Officials said the recent surge may be burning itself out in part because of the growing number of people who are protected.
“We have seen a beginning, of maybe a lessening of the rise of cases,” Governor Pritzker said last week. “I don’t want to predict anything, because this virus is unpredictable. But I think at least in the short term, that seems to be good news.”
In Central Illinois, Peoria County reported new-case declines of about 23 percent from two weeks ago. Local officials said that when vaccinations first became widely available, people started taking fewer precautions, even though highly contagious variants were spreading.
“It led to the perfect storm,” said Monica Hendrickson, public health administrator for the Peoria City/County Health Department.
Hospitalizations and Covid deaths remain high in Illinois, putting mounting pressure on the health care system. Hospitalizations are up by about 29 percent over the past two weeks, and deaths have risen by 15 percent during that period, according to Times data.
Dr. Michael Cruz, chief operating officer at OSF HealthCare, said on Thursday that about a half-dozen of the hospital system’s medical centers in Illinois are at more than 90 percent of capacity. He said it was too early to say whether the recent decline in new case reports was a “true inflection point.”
“The virus does what the virus does,” Dr. Cruz said. “Let it hang around long enough, it will start mutating.”
SAN JUAN, P.R. — Throughout the pandemic, Dr. Victor Ramos, a pediatrician, had not seen more than two Covid-19 patients hospitalized at the same time at San Jorge Children & Women’s Hospital in San Juan, the Puerto Rican capital, where he works nights. When he left after one of his shifts a few days ago, the hospital’s pediatric patient count had grown to 10.
“We had never seen that,” he said.
Puerto Rico has experienced its worst coronavirus outbreak of the pandemic over the past five weeks, with an explosive growth in cases exceeding records that had been set in December. Only this week did the numbers stop rising, giving the territory its first respite since the surge began in mid-March.
Behind the rise, experts say, was a confluence of factors, including the arrival of variants that probably made the virus more contagious right when people weary of staying home and hopeful about vaccines began to let their guard down, returning to work in person and shopping and dining indoors. Tourists poured in for Spring Break season. People gathered to celebrate Holy Week, a time when many are off work.
“The government relaxed restrictions around January and February — it opened the economy completely,” said Mayor Luis Javier Hernandez Ortiz of Villalba, a town in south-central Puerto Rico. “This gave the virus opportunities to spread that it didn’t have a year ago.”
In early April, the island went from averaging about 200 new cases a day to about 800, according to a New York Times database. In the week leading up to April 13, more than 7,100 cases were identified, a record. A two-week period this month saw cases grow by 151 percent.
AstraZeneca, which shipped millions of doses of its coronavirus vaccine to Mexico and Canada last month at the direction of the Biden administration, said on Thursday that the doses had been made at a Baltimore plant where production was halted because of serious manufacturing flaws.
AstraZeneca’s vaccine, made until recently by Emergent BioSolutions in Baltimore, is not approved for use in the United States, and tens of millions of doses have been sitting idly at manufacturing plants. But the White House said last month that the federal government, which committed last year to buying 300 million doses from the company, intended to “loan” 2.5 million doses to Mexico and 1.5 million doses to Canada.
Whether regulators from those countries inspected the Emergent plant before accepting the AstraZeneca doses, and whether American officials warned them of the ongoing issues at the site, is unclear.
The New York Times reported this month that from early October to January, Emergent discarded five lots of AstraZeneca vaccine — each the equivalent of two million to three million doses — because of contamination or suspected contamination, according to internal logs, a government official and a former company supervisor.
Officials from the Biden administration declined to comment. The Canadian government has said that the AstraZeneca doses were received and distributed, and that it reserved several thousand for quality testing. The status of the doses sent to Mexico is unclear.
In a statement on Thursday, AstraZeneca said that the doses delivered to Mexico and Canada “met the stringent requirements we are required to follow,” and that “required safety tests and quality control measures” were conducted at each step of the production process and before the batches were released.
Last month, The Times reported that an ingredient mix-up at the Emergent Baltimore plant had ruined up to 15 million doses of a coronavirus vaccine developed by Johnson & Johnson. Workers at the plant had conflated ingredients from the two vaccines.
Federal officials ordered major changes to the plant after those revelations.
The Biden administration ordered Emergent to stop making the AstraZeneca vaccine, and put Johnson & Johnson in charge of running the Baltimore plant. A report by Food and Drug Administration inspectors, made public on Wednesday, concluded that Emergent may have contaminated additional doses. It also spotlighted numerous other problems with training and cleanliness at the plant.
The disclosure that the vaccine doses sent to Mexico and Canada came from the Emergent plant raises questions about the Biden administration’s role in arranging for the shipments. Reporting in The Times has shown that federal health officials — and the F.D.A. — were aware of problems at the Emergent plant long before the recent disclosures.
The F.D.A. has not cleared the Emergent plant to release any doses in the United States and has not indicated when, or whether, it will do so. If a drug or biologic made in the United States is shipped to another country, it is up to that country’s regulators to certify whether it is safe.
In its statement on Thursday, which was issued first to CBS News, AstraZeneca said, “The quality information from the manufacturing plants involved was properly submitted to the relevant regulatory agencies in each country to support authorization and approval of shipments from this supply chain.”
TOKYO — Japan on Friday declared states of emergency in Tokyo, Osaka and surrounding areas in an effort to stem a widening coronavirus outbreak three months before the country plans to host the Summer Olympics.
The measures will take effect on Sunday, Prime Minister Yoshihide Suga said, calling them “a short and concentrated measure” to slow the virus’s spread during the Golden Week holiday, traditionally one of the year’s busiest travel periods.
In addition to Tokyo and Osaka, the states of emergency cover the neighboring prefectures Kyoto and Hyogo and will be in place until May 11. Together, the four prefectures are home to roughly a quarter of Japan’s 126 million people.
Japan has managed the pandemic better than many other large economies, but a stubborn fourth wave, propelled by more infectious variants of the virus, has produced the most daily cases since January. Officials began imposing looser restrictions in early April over parts of 10 prefectures, but those steps have failed to corral the outbreak.
Over all, the country has recorded slightly more than half a million infections and about 10,000 deaths from the virus.
The new restrictions are intended to be tougher and shorter than two states of emergency Japan imposed over parts of the country at the start of the pandemic last year and in January, although they fall shy of the total lockdowns seen in other countries. The measures give the prefectures the authority to ask businesses to close or restrict hours, and to fine those that do not comply.
Large department stores, shopping malls, amusement parks and movie theaters will be asked to close, and all establishments will be banned from serving alcohol. Schools can remain open, and shops that sell food and other essential items will be spared. But restaurants and karaoke parlors will be asked to shorten their hours, and residents will be told not to drink alcohol in public venues.
Organizers of sporting events, including professional baseball games and soccer matches, will be asked not to allow spectators — although officials have said that the emergency measures will not affect the Tokyo Olympics, whose opening ceremony is scheduled for July 23.
Polls indicate that the Japanese public is increasingly frustrated with Mr. Suga, who took office in September, over his handling of the pandemic and his government’s insistence on going ahead with the Olympics, which were rescheduled from last year. Organizers have said the event will take place without spectators from abroad, and have barred crowds from parts of the ceremonial torch relay. Still, in surveys, more than 70 percent of Japanese say the games should be postponed again or canceled.
Eiji Fukui said he had managed to keep his Tokyo restaurant operating during previous states of emergency by reducing hours and offering takeout items. But this time he plans to close the restaurant completely, even though the rules allow him to stay open until 8 p.m. if he does not serve alcohol.
“It’s almost a tacit message not to operate during this period,” said Mr. Fukui, 39. “I don’t want to be bothered with operating without alcohol, so I will close this time since I received zero reservations anyway.”
Rail-thin teenagers holding placards at traffic stops with fome — the word for hunger — in large print. Children begging for food outside supermarkets. Families huddling in flimsy encampments on sidewalks, asking for baby formula, crackers, anything.
The scenes of hunger in Brazil are stark evidence that President Jair Bolsonaro’s bet that he could protect the country’s economy by resisting public health policies intended to curb the virus has failed. From the start of the pandemic, he scorned the guidance of health experts, arguing that the economic damage wrought by lockdowns would be a bigger threat to the economy than the coronavirus itself.
That trade-off led to one of the world’s highest death tolls, but it has not kept the country afloat.
About 19 million people have gone hungry over the past year, and about 117 million people — more than half the country — faced food insecurity, with uncertain access to enough nutrition, in 2020, according to estimates. One expert says: “The way the government has handled the virus has deepened poverty and inequality. Hunger is a serious and intractable problem in Brazil.”
Plans to play some European soccer championship matches this summer in Dublin and in Bilbao, Spain, have been abandoned after the local authorities were unable to guarantee that a sufficient number of fans could attend because of coronavirus restrictions.
Munich’s role in the tournament, Euro 2020, was also in doubt, but its place was confirmed during an emergency meeting of members of the executive committee for UEFA, soccer’s governing body in Europe. The tournament, which was postponed last year because of the pandemic, is soccer’s No. 2 most-watched competition, after the World Cup. This summer it is being played on a continentwide basis, in 11 cities, for the first time.
Dublin and Bilbao were set to stage three group games and one round-of-16 match. Dublin’s group-stage schedule will move to St. Petersburg, Russia, which had already been selected to host four games. London’s Wembley Stadium, where the tournament’s semifinals and final will be played, will pick up Dublin’s knockout-round game.
Seville will take on the games slated to be played in Bilbao, despite opposition from the authorities in Bilbao, who said they would seek compensation from UEFA after working on hosting the tournament for six years.
Without hospitals or medical specialists in space, NASA and other space agencies have always been concerned about astronauts falling sick during a mission. To minimize the chances of that, they typically spend the two weeks before launch in quarantine.
A Covid-19 superspreader event at the space station would disrupt operations.
The interior of the space station has a volume equivalent to a Boeing 747 jetliner, so there would be space for infected crew members to isolate themselves. But space station managers certainly would not want to worry about the virus spreading in the station’s perpetually filtered and recycled air.
During a news conference last week, Shane Kimbrough, the NASA astronaut who is the commander of Crew-2, said all four astronauts had received Covid vaccinations. “I guess it went fine,” he said. “We all have a little bit different reactions, just like most people do. So we’re no different in that regard. But we’re thankful that we have the vaccines.”
The four astronauts of the Crew-1 mission are not, because no vaccines were available when they launched last November. When they return to Earth, every human not on the planet will be vaccinated against Covid-19.
Both the Pfizer-BioNTech and Moderna vaccines will effectively prevent serious illness and death from a coronavirus variant that has kept cases in New York City stubbornly high, two independent studies suggest.
City officials had repeatedly warned that the variant may be more contagious and may dodge the immune response. But researcher say that the antibodies stimulated by Pfizer-BioNTech and Moderna vaccines are only slightly less potent at controlling the variant than the original form of the virus.
“We’re not seeing big differences,” said Michel Nussenzweig, an immunologist at Rockefeller University in New York who is a member of the team that published one of the studies on Thursday.
The results are based on laboratory experiments with blood samples from small numbers of vaccinated people and have not yet been peer-reviewed. Still, they are consistent with what is known about similar variants, several experts said, and they add to a growing body of research that suggests that the two main vaccines in the United States are protective against all of the variants identified so far.
“The take-home message is that the vaccines are going to work against the New York variant and the South African variant and the U.K. variant,” said Nathan Landau, a virologist at N.Y.U.’s Grossman School of Medicine who led the study.
With summer on the horizon, states are beginning to rethink social-distancing measures.
In Rhode Island, Gov. Dan McKee said that starting May 7, the state will stop requiring masks outside, and social gatherings can increase to 25 people indoors and 75 people outdoors. By May 28, the state will lift capacity limits on businesses and houses of worship, the bar areas of restaurants will be able to open, and dance floors can once again be filled.
“It’s a good day for everyone here in the Ocean State,” Mr. McKee said at a news conference on Thursday. “It’s a little early to put a ‘Mission Accomplished’ sign up, but we’re getting ready to order that sign.”
Mr. McKee attributed the reopening plans to the state’s vaccination rate — 48 percent of residents have received at least one shot, and 33 percent are fully vaccinated, according to a New York Times database. But masks will still be required indoors.
Rhode Island is not alone.
On Monday, Gov. Ned Lamont of Connecticut said that the state would phase out all pandemic restrictions, except the indoor mask mandate, by May 19. And in New Jersey, Gov. Phil Murphy said on Wednesday that he would announce “a pretty significant amount of guidance” for summer activities next week.
“We don’t want to lurch, in other words go forward and then have to pull something back,” Mr. Murphy said at his weekly news conference. “And we don’t want to start that now. But we also owe people our best guesses for what it’s going to look like for graduation, summer, the beaches and what not.”
As more people get vaccinated and the outdoors become more appealing with spring weather and sunshine, one question persists: Do people still need to wear masks outside? Science shows that the risk of viral transmission outside is very low. The Times’s Well columnist, Tara Parker-Pope, suggests making sure activities meet two out of the following three conditions: outdoors, distanced and masked.
Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said on Thursday that the agency was “looking at the outdoor masking question” and whether to revise current guidance.