India Sets Global Record for Daily Infections

A man who died of Covid-19 is cremated in New Delhi on Wednesday.
Credit…Adnan Abidi/Reuters

India’s rapidly worsening coronavirus outbreak is now expanding on a scale beyond any previously measured in more than a year of the pandemic: The health ministry reported 312,731 new infections on Thursday, the most recorded in any country on a single day.

India’s total eclipsed the previous one-day high of 300,669 recorded coronavirus cases, set in the United States on Jan. 8, according to a New York Times database, though differences in testing levels from country to country, and a widespread lack of tests early in the pandemic, make comparisons difficult.

Over the past two months, the outbreak in India has exploded, with reports of superspreader gatherings, oxygen shortages and ambulances lined up outside hospitals because there were no ventilators for new patients.

As cases worldwide reach weekly records, a substantial proportion of the infections are coming from India, a sobering reminder that the pandemic is far from over, even as infections decline and vaccinations speed ahead in the United States and other wealthy parts of the world. India has surpassed 15.6 million total infections, second most after the United States.

The death toll has also begun to climb precipitously.

On Thursday, the Indian government recorded 2,104 deaths, and an average of more than 1,300 people have died of the virus every day for the past week. That is less than the tolls at the worst points of the pandemic in the United States or Brazil, but it is a steep increase from just two months ago, when fewer than 100 people in India were dying daily.

There are signs that the country’s health system, patchy even before the pandemic, is collapsing under the strain. On Tuesday, at least 22 people died in an accident in the central city of Nashik when a leak in a hospital’s main oxygen tank cut the flow of oxygen to Covid-19 patients.

The picture is staggeringly different from early February, when India was recording an average of just 11,000 cases a day, and domestic drug companies were pumping out millions of vaccine doses. More than 132 million Indians have received at least one dose, but supplies are running low and experts warn that the country is unlikely to meet its goal of inoculating 300 million people by the summer.

Critics say Prime Minister Narendra Modi, who imposed a harsh nationwide lockdown in March 2020 in the early stages of the pandemic, failed to prepare for a second wave or to warn Indians to remain vigilant against the virus, especially as more infectious variants began to spread.

Mr. Modi’s Hindu nationalist government has also allowed a massive Hindu festival to take place, drawing millions of pilgrims to the banks of the Ganges River, and his party has held packed political rallies in several states.

“India’s rapid slide into this unprecedented crisis is a direct result of complacency and lack of preparation by the government,” Ramanan Laxminarayan, the director of the Center for Disease Dynamics, Economics and Policy in Washington, wrote in The New York Times on Tuesday.

The hardest-hit region is Maharashtra, a populous western state that includes the financial hub of Mumbai. On Wednesday, the state’s top leader ordered government offices to operate at 15 percent capacity and imposed new restrictions on weddings and private transportation to slow the spread of the virus.

This week, Britain’s prime minister, Boris Johnson, and Japan’s prime minister, Yoshihide Suga, called off plans to visit India. On Thursday, the Australian prime minister, Scott Morrison, said that direct flights from India would be reduced by about 30 percent, and that Australians would be allowed to travel to India only in “very urgent circumstances.”

A pregnant woman receiving the Pfizer vaccine in Schwenksville, Pa., in February.
Credit…Hannah Beier/Reuters

In an early analysis of coronavirus vaccine safety data, researchers at the Centers for Disease Control and Prevention have found no evidence that the Pfizer-BioNTech or Moderna vaccines pose serious risks during pregnancy.

The findings are preliminary and cover just the first 11 weeks of the U.S. vaccination program. But the study, which included self-reported data on more than 35,000 people who received one of the vaccines during or shortly before pregnancy, is the largest yet on the safety of the coronavirus vaccines in pregnant people.

During the clinical trials of the vaccines, pregnant women were excluded. That left patients, doctors and experts unsure whether the shots were safe to administer during pregnancy.

“There’s a lot of anxiety about whether it’s safe and whether it would work and what to expect as far as side effects,” said Dr. Stephanie Gaw, a maternal-fetal medicine specialist at the University of California, San Francisco.

The new data, Dr. Gaw said, demonstrate that “a lot of pregnant people are getting the vaccine, there isn’t a significant increase in adverse pregnancy effects at this point, and that side effect profiles are very similar to nonpregnant people.”

“I think that’s all very reassuring,” she said, “and I think it will really help providers and public health officials more strongly recommend getting the vaccine in pregnancy.”

Covid-19 poses serious risks during pregnancy. Pregnant women who develop symptoms of the disease are more likely to become seriously ill, and more likely to die, than nonpregnant women with symptoms.

Because of those risks, the C.D.C. has recommended that coronavirus vaccines be made available to pregnant women, though it also suggests that they consult with their doctors when making a decision about vaccination.

The new study, which was published on Wednesday in The New England Journal of Medicine, is based largely on self-reported data from V-safe, the C.D.C.’s coronavirus vaccine safety monitoring system. Participants in the program use a smartphone app to complete regular surveys about their health, and any side effects they might be experiencing, after receiving a Covid-19 vaccine.

The researchers analyzed the side effects reported by V-safe participants who received either the Pfizer or Moderna vaccine between Dec. 14, 2020, and Feb. 28, 2021. They focused on 35,691 participants who said that they had been pregnant when they received the vaccine or became pregnant shortly thereafter.

After vaccination, pregnant participants reported the same general pattern of side effects that nonpregnant ones did, the researchers found: pain at the injection site, fatigue, headaches and muscle pain.

Women who were pregnant were slightly more likely to report injection site pain than women who were not, but less likely to report the other side effects. They were also slightly more likely to report nausea or vomiting after the second dose.

Pregnant V-safe participants were also given an opportunity to enroll in a special registry that tracked pregnancy and infant outcomes.

By the end of February, 827 of those enrolled in the pregnancy registry had completed their pregnancies, 86 percent of which resulted in a live birth. Rates of miscarriage, prematurity, low birth weight and birth defects were consistent with those reported in pregnant women before the pandemic, the researchers report.

“This study is of critical importance to pregnant individuals,” Dr. Michal Elovitz, a maternal-fetal medicine specialist at the University of Pennsylvania, said in an email. “It is very reassuring that there were no reported acute events in pregnant individuals” over the course of the study, she said.

But the report has several limitations and much more research is needed, experts said. Enrollment in the surveillance programs is voluntary and the data are self-reported.

In addition, because the study period encompassed just the first few months of the U.S. vaccination campaign, the vast majority of those enrolled in the pregnancy registry were health care workers. And there is not yet any data on pregnancy outcomes from people who were vaccinated during the first trimester of pregnancy.

“I think we can feel more confident about recommending the vaccine in pregnancy, and especially with pregnant people that are at risk of Covid,” Dr. Gaw said. “But we do need to wait for more data for complete pregnancy outcomes from vaccines early in pregnancy.”

Federal regulators have found many shortcomings at a plant of Emergent BioSolutions in Baltimore.
Credit…Saul Loeb/Agence France-Presse — Getty Images

Federal regulators on Wednesday issued highly critical findings from their inspection of a Baltimore plant that was forced to throw out up to 15 million doses of Johnson & Johnson’s coronavirus vaccine and ordered to temporarily stop all production.

The Food and Drug Administration cited a series of shortcomings at the massive plant, which is operated by Emergent BioSolutions. The inspection was triggered by reports that Emergent workers had contaminated a batch of Johnson & Johnson doses with the harmless virus that is used to deliver AstraZeneca’s vaccine, which is also manufactured at the plant.

The violations included failure to properly disinfect the factory and its equipment, as well as failure to institute and follow proper procedures designed to prevent contamination of doses and to ensure the strength and purity of the vaccine manufactured there. “There is no assurance that other batches have not been contaminated,” the inspectors wrote.

Their 12-page report cited nine violations, ranging from the design of the building to improperly trained employees. The inspection was finished on Tuesday.

In a statement, the F.D.A. noted that it has not authorized Emergent to distribute any doses of Johnson & Johnson vaccine, and that no vaccine manufactured at the plant has been released for use in the United States.

AstraZeneca’s vaccine is not yet authorized for use in the United States, and all the Johnson & Johnson doses that have been administered in the country so far were manufactured overseas. At the agency’s request, all production at the factory has been halted.

“We will not allow the release of any product until we feel confident that it meets our expectations for quality,” the statement from Dr. Janet Woodcock, the F.D.A.’s acting commissioner, and Dr. Peter Marks, the agency’s top vaccine regulator, said.

The agency said it was working with Emergent to fix the problems.

Emergent is a longtime government contractor that has spent much of the last two decades cornering a lucrative market in federal spending on biodefense. The company’s Baltimore plant is one of two federally designated “Centers for Innovation in Advanced Development and Manufacturing” that were supposed to be at the ready in the event of a pandemic.

The New York Times reported earlier this month that the Trump administration awarded a $628 million contract to the company about ten months ago despite a history of performance problems. The contract mainly allowed the government to reserve manufacturing space in the plant for vaccine production. On Tuesday, the House Select Subcommittee on the Coronavirus Crisis, announced that it will investigate that contract award and other issues involving Emergent, saying the firm had a track record of failing to meet contract requirements.

The inspectors castigated Emergent’s response to the discovery last month that Johnson & Johnson doses had been contaminated with the benign virus used to create AstraZeneca’s vaccine. The incident “has not been fully investigated,” they wrote.

They said Emergent did not thoroughly review whether the cross-contamination was caused by one or more workers who move between AstraZeneca’s and Johnson & Johnson’s manufacturing zones or whether it could be related to how raw materials used in the production of both vaccines are handled.

The inspectors found that workers frequently moved between the manufacturing zones without documenting that they had showered and changed their gowns as required. In one ten-day period in February, for instance, 13 employees moved from one zone to another on the same day, but only one documented having showered, they said. After the Johnson & Johnson doses were found to be contaminated, the report said, only routine cleaning was performed.

Workers also failed to properly handle manufacturing waste, creating risks of contamination in the warehouse where raw materials are stored, the inspectors found. They also cited peeling paint, crowded equipment and other issues with the building. Overall, it “is not maintained in a clean and sanitary condition,” they wrote.

Emergent said in a statement on Wednesday that “while we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them.”

In its own statement, Johnson & Johnson said it had already stepped up its oversight of Emergent, its subcontractor, and that it would “ensure that all of F.D.A.’s observations are addressed promptly and comprehensively.”

One major change has already been made: AstraZeneca will no longer be manufactured at the plant, a move that federal officials insisted upon earlier this month to limit the chance of cross-contamination between two vaccines.

Dr. Jose Romero, the Arkansas health secretary and chairman of the expert panel advising the Centers for Disease Control and Prevention on the future of the Johnson & Johnson vaccine, said in an interview that he was dismayed by the F.D.A.’s findings. The panel is meeting on Friday on whether to lift, modify or retain a pause in the administration of Johnson & Johnson’s vaccine that was instituted last week for an entirely different issue: the discovery that eight U.S. residents developed a rare but dangerous blood clotting disorder after they got shots.

“I’m shocked” Dr. Romero said. “I can’t put it any other way. Inappropriate disinfection, the prevention of contamination — those are significant and serious violations, at least in my mind, and do of course need to be remedied.

“I would not have expected that, given the stringency that we have in this country for good manufacturing practices in these vaccine plants,” he said.

Jackie Robinson Day at Dodger Stadium earlier this month.
Credit…Kirby Lee/USA Today Sports, via Reuters

Fully vaccinated baseball fans will be granted their own section at the Los Angeles Dodgers game this weekend against the San Diego Padres.

The set-aside seats, reported by The Los Angeles Times, are part of the many incentives being offered — from doughnuts to beer — to encourage people to get vaccinated against Covid-19. The Miami Heat and the San Francisco Giants have introduced similar sections at their stadiums.

To prove they are fully vaccinated, fans will have to show government-issued I.D. and documentation like a vaccination card, according to the Dodgers’ website. Everyone 16 years and older will have to show proof that at least two weeks have passed since they were fully vaccinated. Fans younger than 16 will be required to show proof of a negative coronavirus test taken within 72 hours before admission.

Face masks will still be required, but social distancing will not. The team said spectators in the sections for the fully vaccinated will be seated directly next to each other.

The game Saturday won’t mark the first time fans have entered Dodger Stadium since the pandemic began. The team’s home opener on April 9 was attended by fans — just not all that many of them. Attendance was capped at around 11,000, about 20 percent of capacity.

In the past week, there has been an average of more than 2,300 daily coronavirus cases in the state, and Los Angeles County has seen an average of 435 daily cases — a 20 percent drop over the past two weeks, according to a New York Times database.

As of Wednesday, more than 40 percent of Californians had received at least one dose of the vaccine, and more than 20 percent had been fully vaccinated.

On April 15, Gov. Gavin Newsom loosened some restrictions in the state, permitting limited outdoor gatherings and live events, depending on a region’s Covid-19 risk level.

Leave a Reply