transcript
transcript
E.U. Regulator Argues to Continue J&J Vaccine With a Warning Label
The European Union’s drug regulator said that the Johnson and Johnson vaccine should carry a warning of potential risk for rare blood clots on the label, but did not recommend stopping the vaccine, saying the benefits of the vaccine outweighed the risks.
After a careful review of the cases of blood clots combined with low platelets reported after vaccination with Johnson’s Covid-19 vaccine, the PRAC has concluded that there is a possible link between the occurrence of these blood clots, combined with the low levels of blood platelets, thrombocytopenia, and the vaccination with the Covid-19 vaccine, Johnson. The product information will be updated to reflect this information, and will include a warning and an update of the side effects. The reported cases occurred mostly in women under 60 years, and within the first three weeks after the vaccination. A fatal outcome has been reported. The careful review of the cases, and other available evidence, have led the committee to the conclusion that these blood-clotting disorders are very rare side effects of the vaccine. However, our work does not stop here. We will analyze any new data and any new evidence as it becomes available, and provide updated guidance as needed. At this moment, it’s not possible to identify clear risk factors for the occurrence of these very rare events, such as gender or age.
BRUSSELS — Johnson & Johnson said Tuesday that it would resume the rollout of its coronavirus vaccine in Europe after the European Union’s drug regulator said that a warning should be added to the product indicating a possible link to rare blood clots, but that the shot’s benefits outweigh the risks.
The company decided to delay distribution in the bloc’s 27 member states last week, after regulators in the United States suspended use of the vaccine there amid concerns about the potential side effects.
The E.U. drug regulator’s endorsement — even with the caveat — not only clears a path for Johnson & Johnson in Europe, but could presage how the United States will handle the vaccine in the days to come.
On Friday, an advisory panel to the Centers for Disease Control and Prevention is scheduled to meet for a second time to decide whether to recommend lifting a “pause” on the vaccine’s use in the United States, perhaps with a similar warning.
That would free up millions of doses for the fierce battle against the a virus that still spreading and mutating. Almost eight million Americans have already had the Johnson & Johnson vaccine.
But some health experts worry that the headline-grabbing pause, which began over a week ago, might discourage some people from getting vaccinated, even though the risks from Covid-19 are far greater than the risk from a clot.
“You’ve put a scarlet letter on the Johnson & Johnson vaccine,” said Dr. Paul A. Offit, a vaccine expert at Children’s Hospital of Philadelphia.
After clotting concerns associated with another vaccine, produced by AstraZeneca, were reported in Europe, Dr. Offit noted, some grew leery of it, overestimating the threat. For the Johnson & Johnson vaccine, the clot risk has been put at an estimated one in a million.
“If you take a theoretical million people who are infected with Covid, five thousand will die,” Dr. Offit said. “Therefore, the benefits of this vaccine clearly outweigh its risks.”
A loss of confidence in the Johnson & Johnson vaccine may carry a particular cost.
The vaccine has been greeted warmly by many health workers because it requires just a single shot, unlike the ones from Moderna or Pfizer-BioNTech, and is easier to store than some other vaccines. It is especially useful for hard-to-reach or transient populations.
“There is no doubt in my mind that there are groups for whom this vaccine is of benefit,” Dr. Offit said, “meaning that they’re more likely to get this vaccine than the other vaccines, whether it’s because of where they live, or because they’re homebound, or it’s hard to get a second dose.”
If that changes, he said, “then you have probably elevated a rare risk above a much more common risk, and you’ve done harm.”
In clearing the way for the vaccine’s use, the E.U.’s drug regulator, the European Medicines Agency, said the blood clots, which have been reported in a very small group of people, are “very similar” to those associated with the AstraZeneca vaccine.
The E.M.A.’s recommendation is not binding, but it is the first indication of what might happen next with the European rollout of the Johnson & Johnson vaccine.
The agency said that authorities in individual E.U. member states should decide how to proceed, taking into account their particular case load and vaccine availability. Poland is the only E.U. country that defied the company’s guidance and went ahead and administered some Johnson & Johnson doses over the past week.
All the rare cases of blood clots reviewed by the European regulator were reported in the United States, but the agency proceeded with its recommendations Tuesday before U.S. regulators acted.
On Tuesday, the White House press secretary Jen Psaki said that a total of 28 million doses were shipping this week to states, jurisdictions and federal programs, as the U.S. vaccination campaign continued with the other two authorized vaccines from Pfizer-BioNTech and Moderna.
The United States has come a long way since Covid-19 vaccines first arrived at hospitals and long-term care facilities in December. More than 209 million doses have been administered.
But the next phase of the rollout will bring new challenges, and some scientists and health officials worry that some of the most vulnerable people — including those 65 and older — may have trouble competing for a shot now that all adults are eligible for inoculation.
Cindy A. Prins, an epidemiologist at the University of Florida, said that adding more younger people into the mix could spur the opening of more mass vaccination sites, but that those sites might be intimidating or uncomfortable for older people or for anyone who is particularly vulnerable to the virus.
“I think there are some folks who want to get the vaccine, but they’re still very worried about getting exposed to other people,” Dr. Prins said. “It’s a little bit of a strange situation where we’re like, ‘Stay away from everyone, but please come here to our massive vaccine clinic.’”
As it stands, older adults are the most vaccinated age group in the country. Yet about a fifth of those 65 and older, a group that is particularly vulnerable to serious complications and death from the virus, have not received even one shot. Among them are some residents of long-term care facilities, which have represented more than a third of overall coronavirus deaths in the United States.
There are many reasons that eligible people may not be vaccinated, including lingering issues of short supply, limited access to vaccination sites and confusing procedures for booking appointments. Some older people may also be hesitant or unwilling to get a shot.
Dr. Prins added that some older adults could be waiting until their regular doctors or other health care providers can give them the vaccine.
“There may be people who are not necessarily homebound, but maybe they don’t drive,” Dr. Prins said. “Maybe it’s not easy and convenient for them to get somewhere to get vaccinated.”
Dr. Lisa Cooper, the director of the Johns Hopkins Center for Health Equity, suggested that health officials might encourage young people to help them vaccinate the older people in their lives.
She said: “We need to start asking the younger folks, ‘Where’s your mom? Your grandmother? Have they all gotten their vaccines yet? If not, we’ve got several slots, and we want your whole family here.’”
A congressional panel has opened an investigation into Emergent BioSolutions, the company whose Baltimore factory ruined millions of doses of the Johnson & Johnson Covid-19 vaccine, focusing on whether it was improperly awarded a $628 million federal contract to manufacture vaccines.
The inquiry will look into whether a Trump administration official steered the work to the company despite questions about its qualifications, according to a statement released late Monday. The investigation was announced by Representatives Carolyn B. Maloney, a New York Democrat who heads the House Committee on Oversight and Reform, and James E. Clyburn, a Democrat from South Carolina who heads a subcommittee on the pandemic response.
Mr. Clyburn requested that Emergent’s two top executives testify at a May 19 hearing and provide a wide array of records.
“Specifically, we are investigating reports that Emergent received multimillion-dollar contracts to manufacture coronavirus vaccines despite a long, documented history of inadequately trained staff and quality control issues,” the statement said. It also said the company had “a track record of raising prices and failing to meet contract requirements.”
The committees said they were also looking into Emergent’s “actions to unduly influence anthrax vaccine assets” in the Strategic National Stockpile, the subject of a New York Times article last month.
The congressional inquiry is the latest in a series of problems for Emergent, a longtime federal contractor that has a reputation for aggressive lobbying tactics. This month, the Food and Drug Administration began an audit of its factory in southeastern Baltimore after workers contaminated a batch of Johnson & Johnson’s vaccine with an ingredient for AstraZeneca’s vaccine, another product manufactured at the plant.
Emergent said on Monday that it had suspended operations at the plant and acknowledged that it needed to make improvements to “restore confidence” in its work. It also said it was quarantining the vaccine substance already produced at the plant until after the inspection ends and the company has had a chance to fix any problems highlighted in the review.
Biden administration officials have said that AstraZeneca’s vaccine will no longer be manufactured at the plant, and Johnson & Johnson has vowed to exert stronger control over Emergent, its subcontractor. The F.D.A. has not certified the facility to distribute any vaccine to the public; all Johnson & Johnson doses that have been administered were manufactured overseas. AstraZeneca’s vaccine is not yet authorized in the United States.
The New York Times reported this month that confidential audits and internal documents showed that Emergent had failed to follow some basic industry standards and identified repeated shortcomings in efforts to prevent contamination. Those records were among the documents that congressional investigators are now seeking.
The inspections flagged a persistent problem with mold in areas required to be kept clean, poor disinfection of some plant equipment, repeated use of raw materials that were not fully tested and inadequate training of employees. In one month, they indicate, workers making AstraZeneca’s vaccine deviated from manufacturing standards an average of over three times a day.
The Emergent Baltimore facility is one of two federally designated “Centers for Innovation in Advanced Development and Manufacturing,” created during the Obama administration, that were supposed to be at the ready in case of a pandemic. The company secured a $628 million contract to manufacture the Johnson & Johnson and AstraZeneca vaccines in June.
The congressional lawmakers said that Dr. Robert Kadlec, who served as assistant health secretary for preparedness and response under President Donald J. Trump and previously worked as a consultant for Emergent, “appears to have pushed for this award despite indications that Emergent did not have the ability to reliably fulfill the contract.”
In an interview Tuesday, Dr. Kadlec said that his consulting work for Emergent in 2013 and 2014 involved educating leaders in South Korea and Saudi Arabia about the risks of bioterrorism, and that he did not promote the company’s products. He said that when he awarded the company the contract in June, he was exercising an option on an earlier contract awarded in 2012 by his predecessor.
Dr. Kadlec said that he knew Emergent was a risky choice, but that federal officials had turned to Emergent because few companies based in the United States were able to make the type of vaccines developed by Johnson & Johnson and AstraZeneca, and because the government already had a contract with the company. He said he also sought to involve Merck, a more experienced manufacturer, but those negotiations did not work out.
“That was the path of fastest action, but we recognized that there were going to be inherent risks with that approach,” he said of working with Emergent, “and we would try to mitigate those risks throughout.”
All but eight of the detainees at Guantánamo Bay have received their first dose of a Covid-19 vaccine, the U.S. Southern Command said on Tuesday.
Biden administration officials said that the Department of Defense had expanded vaccine availability to all 40 detainees starting on Monday, the day that all people 16 years and older became eligible for vaccination in the United States.
The Southern Command, which oversees the detention center, first sought permission from the Trump administration to vaccinate the detainees in a Dec. 23 memo that described the prison population at Guantánamo as “a high-risk community,” and invoked both “the Geneva Convention and Department of Defense guidance.”
“Thirty-two of the detainees have received the first dose of the Covid-19 vaccine,” the command said in a statement. Military officials declined to say whether the other eight detainees were offered the first shot of the two-shot Moderna Covid-19 vaccine but refused.
The vaccines are not mandatory for the military or civilian Defense Department employees and were offered to the detainees on a voluntary basis. Many of them are approaching their second decade in U.S. detention and have chronic illnesses. The oldest is 73 and has a heart condition, diabetes and other geriatric illnesses.
The Biden administration froze initial plans to offer them the vaccine on Feb. 1, because elected officials and families of the victims of the Sept. 11 attacks accused the Defense Department of putting terrorism suspects ahead of the American people, who were only just beginning to get access to the vaccines in substantial numbers at that point.
Vaccination rates have risen substantially since then across the country, which was nearing President Biden’s goal of administering 200 million doses by his 100th day in office.
Defense officials also went forward with vaccinating the detainees this week in part because of what appears to be a significant rate of refusal to take the vaccines by adults at the base of about 5,500 residents, including at the detention center, which has a staff of 1,500 guards and civilians. As of April 1, according to health officials at the base, 47 percent of those eligible had not had a dose.
For more than a year, Cambodia managed to escape the brunt of the coronavirus. Then, the government says, came the quarantine evaders.
In late February, four Chinese nationals who were undergoing mandatory quarantine at a luxury hotel in Phnom Penh, the Cambodian capital, bribed a security guard to let them leave before the end of their two-week stay, according to Prime Minister Hun Sen. Two of the four later tested positive for the coronavirus.
The cluster, tied to the more contagious B.1.1.7 variant that was first detected in Britain, quickly spread to about 30 more Chinese nationals in Cambodia and then radiated out into the community. On Monday, the Cambodian health authorities reported a record 624 new confirmed infections, with almost 6,500 people infected since the outbreak began on Feb. 20. The death toll stood at 45, all recorded this year.
The World Health Organization representative in Cambodia has said that the outbreak could spiral into a “national tragedy,” given the country’s poor health care services.
In an effort to contain it, Phnom Penh began a two-week lockdown on Thursday that bars people from leaving their homes except for work, grocery shopping and medical treatment. The lockdown began during Khmer New Year, Cambodia’s biggest holiday.
But even as the security guard who allowed the Chinese to break out of quarantine was quickly arrested, the quarantine dodgers were not punished, because there was no law to prosecute them at the time, Mr. Hun Sen said.
That changed last month with the adoption of a new law that makes violations of pandemic measures punishable by up to $5,000 in fines or 20 years in prison. At least a dozen people have been arrested under the new law. Though the government says it is necessary to protect against the virus, human rights groups have criticized the penalties as disproportionate.
They also say that provisions of the law such as a ban on gatherings could easily be abused by Mr. Hun Sen, who has become increasingly authoritarian during his 35 years in power. A state of emergency law that he enacted last April in response to the pandemic gave him extensive powers to restrict civil liberties and target political opponents.
With the nation in lockdown and two of the country’s biggest industries, garment manufacturing and tourism, devastated by the pandemic, Cambodia’s citizens are bracing for more pain. Mao Vet, a security guard in Phnom Penh who makes $200 a month, worries about how long he will be able to keep his job.
“I am very concerned that infection is out of control,” he said.
France is introducing one of Europe’s first Covid-19 vaccine passport initiatives, the authorities said this week, as countries across the continent seek to facilitate travel by the summer.
The initiative will at first be for use on domestic flights to Corsica and then on longer ones to France’s overseas territories, the government said in a statement on Monday. The ultimate goal is to make the digital certificates applicable to travel to other countries.
Starting this week, people in France can get a digitally certified record of coronavirus test results, either by downloading and printing a certificate or by adding it to a smartphone app that the authorities have used for contact tracing. It will be expanded to include proof of vaccination starting on April 29.
The information — such as the type of test or vaccine, along with the date it was administered and by whom — will be digitally recorded with a kind of QR code that France uses to certify official documents and that the police, customs officers, airlines and others will be able to quickly scan.
“This method therefore avoids possible fraud related to the presentation of fake test results,” the government said in the statement.
The digital certificates are part of the European Union’s push for a Digital Green Certificate to enable travelers to move freely around the bloc if they carry proof of a negative test, vaccination or recovery from the virus.
Amid questions over the effectiveness of Chinese-made coronavirus vaccines, researchers in China are testing the safety and efficacy of mixing two different Covid-19 shots.
The trial, which includes 120 healthy participants over age 18, involves administering one dose of a vaccine developed by CanSinoBIO followed weeks later by a shot of a vaccine made by Anhui Zhifei Longcom Biopharmaceutical, according to a clinical trial registration this month. These are two of the five vaccines in use in China.
With more and more vaccines being authorized around the world, researchers have begun testing the efficacy of mixing shots from different vaccine makers. Some shots are being mixed in clinical trials, while others are being tested on animals.
A senior Chinese official said this month that it might be necessary to administer China’s vaccines in greater doses or to use them together with other vaccines because of their lower effectiveness. The official, Gao Fu, later said his comments had been misunderstood.
Brazilian officials have said that the efficacy rate of CoronaVac, made by the Chinese company Sinovac, was 50 percent, barely meeting the World Health Organization threshold for widespread use. The Pfizer-BioNTech and Moderna vaccines have been found to be 90 percent effective, according to researchers.
The distributors in the United Arab Emirates for the Chinese vaccine manufacturer Sinopharm said last month that they were offering some people a third shot after finding that some recipients of two doses had insufficient antibody levels.
The details of the trial were filed to ClinicalTrials.gov, a website under the U.S. National Institutes of Health, and were earlier reported by Reuters.
Global Roundup
The Pacific archipelago of Vanuatu has paused outbound travel from its main island after a body that washed ashore tested positive for the coronavirus.
The body, identified as a Filipino man, was found last week after a tanker ship leaving the capital, Port Vila, reported one of its crew members missing. Officials in the Philippines said that the body was that of the missing seaman and that they had contacted his family.
On Sunday, after tests showed that the body was infected with the virus, the government banned air and sea travel out of the island of Efate until Wednesday as authorities carry out contact tracing. Twenty-four people have been placed into quarantine, according to the Daily Post, a newspaper in Vanuatu. Health officials say that the risk of community transmission is low, but the island nation’s prime minister, Bob Loughman, said the case was a reminder that “the fight against coronavirus is not over yet.”
Vanuatu, a collection of volcanic islands roughly 1,100 miles northeast of Australia that is home to about 300,000 people, has largely managed to avoid the pandemic, recording just three infections before this one. The first was reported in November in someone who had flown home from the United States.
Like other South Pacific island nations with limited health infrastructure, Vanuatu closed its borders early to keep the virus off its shores. The closures have mostly succeeded: The Solomon Islands has recorded just 20 coronavirus cases, Samoa only three.
But the latest case in Vanuatu shows how the virus can still spread. According to ABC News of Australia, the Filipino seafarer had been working aboard a gas tanker, the British-flagged Inge Kosan, which had docked in Australia and Papua New Guinea before arriving in Port Vila on April 7. Three days later, the tanker set off for the Solomon Islands, but then stopped after the captain discovered that the crew member was missing.
In other news around the world:
India reported its highest single-day death toll of the pandemic, 1,761 fatalities, as health officials prepared to make everyone over age 18 in the country eligible for a vaccine starting on May 1. Questions persist over whether Indian vaccine manufacturers can meet the demand or whether the government can procure significant quantities of foreign-made doses to rapidly expand its inoculation effort. Indian officials have said that mass vaccinations may be the only way to slow what is now the world’s most severe outbreak, with an average of nearly 200,000 new infections recorded daily for the past week.
President Andrés Manuel López Obrador of Mexico publicly received AstraZeneca’s Covid-19 vaccine on Tuesday, touting its safety after several countries limited its use after rare cases of blood clots, Reuters reported. Mexico issued emergency use of the AstraZeneca vaccine in January. As of Tuesday, about 9 percent of Mexicans have received at least one dose and about 3 percent are fully vaccinated, according to a New York Times database.
Prime Minister Mark Rutte of the Netherlands announced Tuesday that his country would ease monthslong lockdown measures though it continues to grapple with high numbers of cases, according to Reuters. Starting April 28, a nationwide curfew will be lifted and bars and restaurants will be allowed to serve small groups outdoors from between noon and 6 p.m. About 7,800 cases have been recorded daily in the Netherlands for the past week.
In Greece, a Coast Guard spokesman said on Monday that a Greek cargo ship traveling to Colombia from Egypt had been quarantined off Crete after a 55-year-old Filipino sailor was found dead in his cabin and others tested positive for the coronavirus.
New data shows that the pandemic appears to have prompted an unusually large flow of residents out of New York and San Francisco, two regions with a high share of jobs that can be done remotely.
But about 30 million change-of-address requests to the U.S. Postal Service in 2020 show that for the most part, migration patterns during the pandemic have looked a lot like migration patterns before it.
Some smaller regional metro areas and vacation hubs benefited, but areas that were already attracting new residents kept attracting them.
Those that were losing migrants lost more, and there are few examples — at least so far — of previously down-and-out regions drawing people in.
The past year has crushed independent restaurants across the United States and underscored how many were unprepared for a digital world.
It’s no longer enough to maintain basic websites or Instagram accounts with well-lit food photos. Chefs and owners have had to add to-go ordering, delivery scheduling, gift card sales and other e-commerce options.
It’s therefore a prime moment for “restaurant tech.” Dozens of companies determined to help independent restaurants and grocers survive have started or scaled up sharply as they found their services in urgent demand.
Thousands of people have been left stranded in the streets of Nairobi, the capital of Kenya, each night since Saturday, as the authorities strictly enforced curfew restrictions that have been criticized by human rights groups.
Police officers have set up roadblocks on several of Nairobi’s major highways at night, and told drivers on the roads after the 8 p.m. curfew that they would have to camp there until the curfew ended at 4 a.m.
The roadblocks caused extensive traffic snarls in the city. Videos posted on social media showed parents stranded in traffic while trying to rush children to the hospital and high school students who were unable to get home.
The police measures have infuriated many Kenyans, who say the 8 p.m. deadline does not give them enough time to get home from work through Nairobi’s often gridlocked roads, some of which are undergoing major construction. Twitter users in the country expressed their anger using the hashtag #UnlockOurCountry.
Human rights organizations have urged the government to review the enforcement methods and to uphold citizens’ rights.
Covid-19 “prevention is reliant on adequate communication that affirms citizens’ role and works with health professionals in seeking compliance — as opposed to punishment and attacks on the people to force compliance,” the Kenya office of Amnesty International said in a statement posted on Twitter Monday night.
Kenya has reported 151,523 coronavirus cases and 2,519 deaths so far in the pandemic, and is in the midst of a third major wave of infections. The authorities increased restrictions last month in an effort to slow the virus’s spread, including curbs on movement in and out of Nairobi and four other counties. Places of worship and bars were closed and sporting and recreational activities suspended.
Britain barred the entry of most travelers from Kenya on April 9, and the United States has advised its citizens not to travel to the country because of Covid and security concerns.
New York City health officials estimate that nearly a quarter of adult New Yorkers were infected with the coronavirus during the catastrophic wave of last spring, and that the toll was even higher among Black and Hispanic residents.
The estimates, based on antibody test results for more than 45,000 city residents last year, suggest that Black and Hispanic New Yorkers were twice as likely as white New Yorkers to have had antibodies to the coronavirus — evidence of prior infection.
Hispanic New Yorkers had the highest rate, with about 35 percent testing positive for antibodies, according to the study, whose authors include officials and researchers at the city Health Department and the National Institute for Occupational Safety and Health. Among Black New Yorkers, 33.5 percent had antibodies. Among Asian New Yorkers, the rate was about 20 percent. For white New Yorkers, the rate was 16 percent.
Antibody surveys of segments of the population have become a useful way to gauge what percentage of people were infected and what groups were most at risk, especially since there was limited testing for the virus during the first wave.
The new paper, which has been accepted by the Journal of Infectious Diseases, has substantial limitations: Of the 45,000 New Yorkers in the study, fewer than 3,500 were Black, a major underrepresentation. And the participants were recruited partly through advertisements online, which the study’s authors acknowledge may have attracted people who believed they had been exposed to Covid-19.
But the study adds to experts’ understanding of the disproportionate toll that the pandemic has taken on Black and Latino people.
Its findings also come amid a push to vaccinate more people in the United States. A recent survey conducted by the Kaiser Family Foundation found that the number of Americans, particularly Black adults, who want to get vaccinated has continued to increase. According to an analysis last month by The New York Times, Black people were still being inoculated at half the rate of white people. The disparities are especially alarming as Black and Latino people and Native Americans have been dying at twice the rate of white people.
In New York City, about 44 percent of white adults have received at least one dose of a Covid-19 vaccine, while 26 percent of Black adults and 31 percent of Latino adults have, according to city data.
Experts and community leaders across the country say that over all, the lower vaccination rates are linked to technological and linguistic barriers and disparities in access to vaccination sites. Other factors include social media misinformation and a hesitancy to be vaccinated. Hesitancy among African-Americans, experts say, can be tied to a longstanding mistrust of medical institutions that have long mistreated Black people.
The recent data from New York “show how frontline workers bore the brunt of the first wave of the pandemic,” said Dr. Wafaa El-Sadr, a professor of epidemiology and medicine at Columbia Mailman School of Public Health, who was not involved in the study. She noted that many jobs with higher levels of exposure — like grocery store employees, child-care providers and transit workers — have comparatively fewer white workers.
“These were the people who did not have the luxury of being able to work virtually,” she said.
Dr. Kitaw Demissie, who is dean of the School of Public Health at SUNY Downstate Medical Center in Brooklyn and was not involved in the study, noted that household crowding may have also contributed to differing infection rates. Some predominately Latino neighborhoods which were particularly hard hit in the first wave had high rates of household crowding.
More than 32,000 people in New York City have died from Covid-19 in total, according to a New York Times database.
