Johnson & Johnson plans to test its coronavirus vaccine in infants and even in newborns, as well as in pregnant women and in people who have compromised immune systems.
The bold plan for expanded clinical trials met with the approval of Dr. Ofer Levy, director of the Precision Vaccines Program at Harvard’s Boston Children’s Hospital and a member of the Food and Drug Administration advisory committee that reviewed the company’s vaccine data.
When Dr. Levy saw the outlines of the planned trials, “they turned my head,” he said. They were reported as part of the company’s application to the F.D.A. for emergency use approval and discussed at the F.D.A. meeting.
“They did not get into a lot of detail about it but did make it clear they will be pursuing pediatric and maternal coronavirus immunization studies,” Dr. Levy said. They referred committee members to their briefing materials where, on page 34, the company mentioned the planned studies.
A spokesman for Janssen Biotech, the Johnson & Johnson subsidiary that is manufacturing the vaccine, confirmed that the company planned to extend clinical trials to children.
PfizerBioNTech and Moderna, whose coronavirus vaccines are now being given to adults, plan to gradually test them in younger and younger age groups. Those vaccines are now being tested in children 12 and older.
Johnson & Johnson will first test its vaccine in children older than 12 and under 18, but plans to immediately after begin a study that includes newborns and adolescents. The company then will test its vaccine in pregnant women, and finally in immunocompromised people. Like the other companies, Johnson & Johnson will analyze safety and immune responses.
Unlike the Covid-19 vaccines currently in use, which use a new technology involving messenger RNA, the Johnson & Johnson vaccine utilizes a method that has been widely tested for years. It relies on a disabled adenovirus, similar to viruses that cause the common cold, to deliver instructions to cells to briefly make copies of the virus’s spike protein. The recipient’s immune system then makes antibodies against the spike protein. The coronavirus needs its spike proteins to infect cells, so the antibodies can block a Covid infection before it starts.
Existing adenovirus vaccines include one for Ebola that has been safely administered to babies as young as 1 year old, and another for respiratory syncytial virus that was safely given to newborns. Nearly 200,000 people have received adenovirus vaccines, with no serious safety issues, Dr. Levy said. He said that Johnson & Johnson mentioned that safety record at the F.D.A. meeting.
Most of the world’s vaccine market is for pediatric vaccines.
Dr. Levy added that in his opinion children need not be immunized in order for schools to open. But many parents are afraid to send their children to school without a vaccine. And, he noted, vaccinating children will help the country reach herd immunity.
A third effective weapon was added to America’s arsenal against the coronavirus on Saturday when the Food and Drug Administration granted emergency use authorization for a vaccine developed by Johnson & Johnson.
The company said it would start shipping millions of doses early this week, and would provide the United States with 100 million doses by the end of June. Together with 600 million doses of the nation’s first two authorized vaccines, made by Pfizer-BioNTech and Moderna, that are due to be delivered over the next four months, that ought to be enough to cover every American adult who wants to be vaccinated.
The new vaccine differs markedly from the two already in use in the United States. Here is how they compare.
One shot instead of two
The Johnson & Johnson vaccine is administered in a single shot, while the Pfizer-BioNTech and Moderna vaccines are given in two shots several weeks apart.
The way it works
The Johnson & Johnson vaccine uses a different method to prime the body to fight off Covid-19: a viral vector called Ad26. Viral vectors are common viruses that have been genetically altered so that they do not cause illness but can still cause the immune system to build up its defenses. The Pfizer-BioNTech and Moderna vaccines use messenger RNA to do that.
How well it works
The Johnson & Johnson vaccine is rated as highly effective at preventing serious illness and death, as the Pfizer-BioNTech and Moderna vaccines are. It is also very effective at preventing milder illness, though a bit less so than those two. It appears to do well against the highly contagious B.1.351 variant, first identified in South Africa, that has given at least one other vaccine candidate trouble.
Storage and handling
The Johnson & Johnson vaccine does not have to be stored at extremely low temperatures like the Pfizer-BioNTech vaccine. It can safely be kept in an ordinary refrigerator for three months, much longer than the Moderna vaccine, which spoils after a month if not kept frozen.
Side effects
The Johnson & Johnson vaccine appears to be less prone than the Pfizer-BioNTech and Moderna vaccines to trigger the kinds of side effects that require monitoring after the injection, which may make it more suitable for use at drive-through vaccination sites. There have been reports that side effects tend to be felt more strongly after second doses, which the Johnson & Johnson vaccine does not require.
A committee of expert advisers to the Centers for Disease Control and Prevention voted as expected on Sunday afternoon to recommend distribution of the Johnson & Johnson vaccine to all adults in the United States.
The committee’s approval echoed the Food & Drug Administration’s decision Saturday evening to authorize the vaccine for emergency use. It is the third Covid-19 vaccine to be authorized for Americans in less than a year. The first shipments are expected to reach states by Tuesday.
The committee did not weigh in on whether states should prioritize the one-shot vaccine for any particular population groups, or how they should deploy it compared with the other two authorized vaccines.
“That is not a decision that we’re ready to make,” said Dr. José Romero, Arkansas’s top health official and the committee’s chair.
The panel voted 12 in favor of the vaccine and none against, with one recusal.
The committee acted with little debate following presentations showing the vaccine was 85 percent protective against severe Covid-19 disease across all clinical trial sites and provided complete protection against hospitalizations and deaths.
Experts pointed out that the Johnson & Johnson vaccine will be simpler to distribute than the other two vaccines, which are made by Moderna and Pfizer with its German partner BioNTech. It requires just one shot instead of two and can be stored in standard refrigerators instead of freezers. Health professionals have noted that it could be particularly well-suited to remote areas and clinics as well as drive-through mass vaccination sites.
The committee weighed those advantages against the shot’s somewhat lower efficacy rate in clinical trials. Pfizer and Moderna’s shots each were shown to be about 95 percent protective against symptomatic Covid disease, whereas Johnson & Johnson’s was 72 percent efficacious against moderate to severe disease in U.S. trial sites.
Direct comparisons between the vaccines are problematic, however, because the trials were conducted in different locations at different times. For instance, Pfizer’s and Moderna’s vaccines were tested before troubling new variants of the virus emerged in Britain, South Africa and elsewhere.
The panel, the Advisory Committee on Immunization Practices, reviewed one recent survey showing that, given a choice between a two-dose vaccine as effective as Pfizer’s or Moderna’s or a single dose vaccine as effective as Johnson & Johnson’s, only 7 percent of respondents picked Johnson & Johnson’s. Twenty-one percent said they would take either.
Importantly, though, of the 58 percent of respondents who said they preferred a vaccine like Pfizer’s or Moderna’s, nearly half said they would take a vaccine like Johnson & Johnson’s rather than wait a month for one of the other two.
The committee met almost exactly one year after the first death associated with Covid-19 in the United States. The committee is expected to meet again on Monday and discuss all three vaccines, including how they might be best deployed among different population groups.
Kentucky expects to be the first state in the nation to fully vaccinate every teacher who wants a shot, Gov. Andy Beshear said on the CBS program “Face the Nation” on Sunday.
Mr. Beshear said the state had rushed teachers to the front of the line, faster than the Centers for Disease Control and Prevention’s guidance had recommended, in order to get students back in school. Kentucky has pushed to reopen all its schools for in-person learning by Monday.
“For us, this was a work force issue, it was development for our children scholastically, emotionally, and socially,” he said, noting that deciding who qualifies as an essential worker and prioritizing some people above others is a contentious process.
“We made this call early on, we stuck to it, and no matter what you decide during Covid, some are going to oppose it,” he said. “But it’s about trying to do the right thing, the best thing for your people, and then to let the consequences be what they’ll be.”
Teachers are now eligible for the vaccine in 32 states, according to a New York Times tracker, and grocery workers and other essential workers have also begun to receive shots in some states.
Governor Beshear said his state has been expanding its capacity to administer doses, and that the newly authorized Johnson & Johnson vaccine would be a “game changer” because of its single-dose protocol.
More than a week after a powerful winter storm barreled through Texas, some experts say that the conditions — which forced hundreds of people across the state to huddle together in homes, cars and shelters to seek warmth — could lead to an increase in coronavirus cases.
The devastating storm almost collapsed the state’s power grid, leaving millions of people in dark and unheated homes during some of the most frigid temperatures recorded in the state’s history.
Coronavirus case reporting dropped precipitously for a week in Texas during the storm and has subsequently risen again sharply in the week since, so it is still too early too discern any specific growth or decline in case numbers there. But experts say that the conditions created during the storm raised concerns.
“It is possible to see an uptick from the Texas storm,” said Katelyn Jetelina, an epidemiologist at UTHealth School of Public Health in Dallas. “We had a lot of things going against us,” Dr. Jetelina said, noting that she, like many others, had to go from house to house when she lost power.
People stood in long lines for water and food at grocery stores and food distribution sites, stayed overnight in warming centers, and crashed with friends and family while electricity cut out and pipes burst in their homes.
Although it’s unclear how many people are still displaced because of the storm, reports from various cities suggest that thousands across Texas may have been forced to seek shelter.
In Fort Worth, almost 200 hundred people took refuge at a convention center. In Dallas, a convention center housed about 650 people, The Texas Tribune reported, and one site in Houston had almost 800 people, while some 500 people were living in emergency shelters in Austin, officials said. Even in Del Rio, a smaller city, officials reported that almost 40 people had to stay at the city’s warming center.
“There are very real possibilities that the coronavirus either had superspreader events or was more easily transmissible because people were congregated indoors for long periods of time,” Dr. Jetelina said. “It is a little bit worrying.”
But cases could also go the other way, she said, because millions of people were forced to stay home while work and school were largely canceled. With the data reporting lags, it is still too early to tell, she noted, so the full impact from the Texas storm on case numbers will not be known for at least another week. Even then, Dr. Jetelina said, it will be hard to tell whether an uptick in cases is related to the storm or to new, more contagious variants — or to a combination of both.
Although the average rate of daily new cases reported in Texas has returned to pre-storm levels, it remains about half of what it was in January.
That broader decline mirrors the fall in cases nationally in recent weeks, as the average daily new cases in the United States hovers around 70,000 — far below its peak of 250,000 last month.
The stories of people gathering together in desperate search of heat and water were ubiquitous across Texas.
In San Antonio, Diana Gaitan had more water and power than her relatives did. So several of them ended up crashing at her home, she said while waiting in a food distribution line at the San Antonio Food Bank last weekend. At one point, there were a dozen people staying overnight in Ms. Gaitan’s home.
“We were all stuck inside the house,” she said.
JERUSALEM — The Israeli government approved a measure on Sunday to vaccinate tens of thousands of Palestinian laborers, after facing fierce criticism over the small number of inoculations it had provided to Palestinians living under its military occupation.
Israeli medical teams will soon begin vaccinating Palestinians who have permits to work in Israel or in settlements in the occupied West Bank, according to a statement by the Coordinator of Government Activities in the Territories, the Defense Ministry unit that is responsible for liaising with the Palestinians.
There are approximately 80,000 Palestinians who have permits to work in Israel, and about 30,000 who have permits for work in the settlements. Most are construction workers, but some have jobs on farms or in factories, stores, restaurants and other workplaces.
The tens of thousands of Palestinians who work in Israel without official documents would not be eligible for inoculations.
A heated debate has raged for weeks over whether Israel bears responsibility for the health of Palestinian in the occupied West Bank and the blockaded Gaza Strip. Human rights groups have argued that international law requires Israel to provide Palestinians with the same access to vaccines as its own citizens receive. But supporters of Israel’s policies have contended that the Palestinians assumed responsibility for health services when they signed the Oslo Accords in the 1990s.
As of Sunday, the Palestinian Authority in the West Bank has received 2,000 doses from Israel and 10,000 from Russia, according to Palestinian officials. Israel has put the number of doses it sent at 2,200, and promised to hand over another 3,000.
The Hamas-controlled Gaza Strip has obtained 20,000 doses from the United Arab Emirates and 2,000 from the Russian shipment to the Palestinian Authority.
In the final months before this summer’s Tokyo Olympics, organizers and government health officials are grappling with how best to address vaccinations for athletes. How they proceed could determine whether the Olympics unfold as a cathartic mass celebration of international sports, or a monthlong global super-spreader event.
A foremost challenge is one of bioethics. In any other year, the athletes — young, healthy and obviously very fit — would be ushered to the back of the line. But after Japan’s rising case counts forced many of the country’s largest cities into a state of emergency last month, the question has become rather more vexing.
A growing number of countries, a group as diverse as India, Hungary and Israel, have announced that they will push their Olympians to the front of their vaccination lines. Mexico’s president this month placed his country’s athletes in a priority group alongside medical workers and teachers. Lithuania began administering vaccine shots to its Olympians weeks ago.
But in countries including the United States, Britain and Italy, there is opposition to the idea that athletes should be given priority, as counter to their duty to be role models.
“Athletes in the U.S. agree that they should wait their proper place in line,” said Bree Schaaf, a former Olympian who is now the chair of Team USA Athletes’ Advisory Council.
The debate pits those appealing to rigid ideas of bioethical morality against others calling for common-sense exceptions in extraordinary times. The Olympics will, after all, bring together representatives of more than 200 countries for several weeks, and then send them home to every corner of the globe.
“Athletes are essential workers,” said Arthur Caplan, a professor of medical ethics at the New York University School of Medicine, echoing views expressed recently by the governments of Denmark, Serbia and the Philippines, who have all said they will usher prospective Olympians toward the front of the vaccination line.
Caplan said that while the focus of this pandemic had rightly been on the physical consequences of the deadly virus, not enough attention was being paid to the psychosocial side effects of widespread lockdowns. He said sports, in that regard, provided a healthy distraction.
“Maybe we should do what we need to do to make it possible for them to entertain us, to help us bear up under tough isolation circumstances,” he said.
For 10 nights, Barcelona’s streets, long quiet from pandemic curfews, have erupted in sometimes violent demonstrations that have spread to Madrid and other Spanish hubs.
What began as a protest over the arrest in mid-February of Pablo Hasél, a Spanish rapper known as a provocateur, has become a collective outcry by a generation that has struggled through years of economic hardship and that faces a lost future even after the pandemic ends.
The frustration is not limited to Spain. Across Europe, university life has been deeply altered by the limitations of virtual classes. Social isolation is endemic. Anxiety and depression have reached alarming rates among young people nearly everywhere, mental health experts and studies have found. The police and mostly young protesters have also clashed in other parts of Europe, including last month in Amsterdam.
“It’s not the same now for a person who is 60 — or a 50-year-old with life experience and everything completely organized — as it is for a person who is 18 now and has the feeling that every hour they lose to this pandemic, it’s like losing their entire life,” said Enric Juliana, an opinion columnist with La Vanguardia, Barcelona’s leading newspaper.
Barcelona was once one of the best places in Europe to be young, with all-night bars and music festivals on the beach. But the crisis, which devastated tourism and shrank the national economy by 11 percent last year, was a catastrophe for Spain’s young adults.
For those who lived through the financial crisis of 2008, which took one of its heaviest tolls in Spain, the pandemic brings a strong sense of déjà vu. Once again, young people have had to move back into the homes of their parents, with entry-level jobs being among the first to vanish.
But the pandemic has cut deeper than past economic downturns. It hit at a time when unemployment in Spain for people under 25 was already high, at 30 percent. Now 40 percent of Spain’s youth are unemployed, the highest rate in Europe, according to statistics by the European Union.
For many young people, the arrest of the rapper Mr. Hasél — and his rage-against-the-machine defiance — has become a symbol of the frustration of Spain’s young people.
With the nation’s coronavirus vaccine supply expected to swell over the next few months, states and cities are rushing to open mass vaccination sites capable of injecting thousands of shots a day into the arms of Americans, an approach the Biden administration says will be crucial for reaching herd immunity in a nation of 330 million.
The Federal Emergency Management Agency has joined in, too: It recently helped open seven megasites in California, New York and Texas, relying on active-duty troops to staff them, and it plans to open many more.
Some mass sites, including those at Dodger Stadium in Los Angeles and State Farm Stadium in suburban Phoenix, aim to inject at least 12,000 people a day once sufficient supplies are in hand; the site in Phoenix already operates around the clock.
On Saturday, the Food and Drug Administration gave emergency authorization to Johnson & Johnson’s single-dose vaccine, and both Moderna and Pfizer had promised much larger weekly shipments of vaccines by early spring.
In addition to using mass sites, President Biden wants pharmacies, community clinics that serve the poor and mobile vaccination units to play major roles in increasing the vaccination rate.
With only about 9 percent of adults fully vaccinated to date, the kind of scale that mass sites provide may be essential in meeting the huge demand, as more people become eligible for the vaccines and as more infectious variants of the virus proliferate in the United States.
But there are clear signs that they won’t be able to address a different challenge lying ahead: the many Americans who are more difficult to reach and who may be reluctant to get the shots.
Drive-through clinics can be better than indoor sites for infection control, some experts say — people roll down their car windows only for the injection — and are more comfortable for recipients than standing in line would be. But a month after a drive-through mass vaccination site opened in East Hartford, Conn., the approach’s weaknesses are also clear.
Traffic can get snarled on the busy road leading to the site, and bad weather can shut it down, requiring hundreds of appointments to be rescheduled on short notice. Spotty vaccine supply, which forced sites in California to close for a few days recently, can also wreak havoc.
More significantly, you need a car, gas money and, for some people, a driver to get to and from the site
The sometimes-chaotic vaccine rollout has come with a maze of confusing registration pages and clunky health care websites. And the technological savvy required to navigate the text alerts, push notifications and email reminders that are second nature to the digital generation has put older adults who need the vaccine the most at a disadvantage. As a result, people who lack tech skills are missing out on potentially lifesaving shots.
The digital divide between generations has always been stark, but the pandemic’s abrupt curtailing of in-person interactions has made that division even more apparent.
Advocates for older Americans, 22 million of whom lack wired broadband access at home, say it is ridiculous that a program that has vaccinating vulnerable older people as one of its top priorities would be set up to depend on internet know-how, Twitter announcements and online event pages.
“We’re running into a crisis where connectivity is a life-or-death alternative for people,” said Tom Kamber, the executive director of Older Adults Technology Services, a nonprofit organization that trains older people to use technology. “It couldn’t get much more stark than people being told, ‘If you go outside, you’re likely to be at risk of dying.’”
People in nursing homes, among the first to get vaccines, had staff members to assist them. But when vaccines became available to a wider group of older adults in late December and early January, many who lived alone had to navigate the rollout by themselves.
Federal agencies like the Administration for Community Living, a division of the Department of Health and Human Services, as well as nonprofit groups, say they are doing what they can to guide older adults, but they are stretched thin.
As of Thursday, about 24 million Americans ages 65 and older, or about 41 percent, had received at least one coronavirus vaccine dose, according to population and Centers for Disease Control and Prevention data compiled by the Kaiser Family Foundation.
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