Benefits of J.&J. Vaccine Outweigh Risks, E.U. Regulator Says
Older adults have been eligible for vaccines for months, but some of the most vulnerable have still not had one shot. Here’s the latest on Covid-19.,
BRUSSELS — Johnson & Johnson said Tuesday that it would resume the rollout of its coronavirus vaccine in Europe after the European Union’s drug regulators said 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 reported combination of blood clots and low blood platelets is very rare, and the overall benefits of Covid-19 Vaccine Janssen in preventing Covid-19 outweigh the risks of side effects,” the European Medicines Agency said in a statement, referring to the division of Johnson & Johnson that develops vaccines, Janssen. The rare clots were “very similar,” the agency added, to those associated with the AstraZeneca vaccine, for which the agency made a similar recommendation.
Johnson & Johnson decided to delay its rollout in the bloc’s 27 member states last week, after regulators in the United States called for a pause on the vaccine following concerns about the potential serious side effect.
The EMA’s recommendation is not binding, but it is the first indication of what might happen next with the European rollout of the much-anticipated, single-shot vaccine that’s already been given to nearly eight million people in the United States. The agency said that regulators in individual E.U. member states should decide how to proceed taking into account their particular case load and vaccine availability.
The agency said it had come out with its recommendations ahead of U.S. regulators doing so because it had built some confidence in how to respond in having spent much time reviewing similar cases that arose with the AstraZeneca vaccine.
In its statement, the agency stressed the importance of treating the potential side effect and issued guidelines to health care professionals on the lookout for the rare clotting disorder.
“Health care professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination.”
The agency, using already available data, said one possible explanation was that the blood disorder was an immune response.
The temporary suspension of the Johnson & Johnson rollout in the European Union compounded the bloc’s woes with the AstraZeneca vaccine. Vaccination efforts have fallen behind in Europe partly because the British-Swedish pharmaceutical company was unable to deliver the number of doses expected in the first quarter of the year. The AstraZeneca vaccine was then suspended due to very similar blood-clotting concerns as those that regulators are now investigating for Johnson & Johnson’s product.
Even though the E.U. regulator eventually found that the benefits of the AstraZeneca vaccine outweighed risks, and that E.U. members should use it, the damage had been done. Many Europeans have been refusing to take the vaccine, and several E.U. countries have limited its use to older people.
The E.U. last week announced it was boosting its supply of the Pfizer-BioNTech vaccine, and was negotiating a new deal for future booster shots with the company for 2022 and 2023, signaling it was going to prioritize vaccines, like Pfizer’s and Moderna’s, that use the mRNA technology.
But the Johnson & Johnson vaccine has been an important component of vaccination plans from the United States to South Africa.
U.S. health officials called for a pause in the vaccine’s use on April 13 to examine a rare blood-clotting disorder that emerged in a small number of recipients. Johnson & Johnson suspended its E.U. rollout immediately afterward. E.U. countries had just begun receiving their first shipments of the vaccine, and all but Poland followed the company’s guidance and have not began administering it.
In the United States, the Centers for Disease Control and Prevention said Monday that while federal health officials were investigating “a handful” of new, unconfirmed reports that had emerged since the pause nationwide, “no additional cases of the rare form of blood clots post-vaccination with the Johnson & Johnson vaccine have been confirmed.”
Dr. Anthony S. Fauci, the United States’ leading infectious disease expert, said previously that he anticipated a decision about whether to resume administering the Johnson & Johnson vaccine this Friday, when an expert panel that is advising the Centers for Disease Control and Prevention is scheduled to meet.
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 he 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.”
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, 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 Covid-19 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.
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 coronavirus, 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 in an effort 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:
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. On Saturday, a 59-year-old Greek mechanic who had developed Covid-19 symptoms while working on the ship, the Heroic, was flown to a hospital on Rhodes, where he tested positive, Greece’s shipping ministry said. Both men had been confined to their cabins after displaying “health problems,” the ministry said.
India reported 1,761 deaths from the coronavirus in 24 hours, its highest single-day toll, 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 currently the world’s most severe outbreak, with an average of nearly 200,000 new infections recorded daily for the past week.
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.