The one-shot coronavirus vaccine made by Johnson & Johnson provides strong protection against severe disease and death from Covid-19, and may reduce the spread of the virus by vaccinated people, according to new analyses posted online by the Food and Drug Administration on Wednesday.
The vaccine had a 72 percent overall efficacy rate in the United States and 64 percent in South Africa, where a highly contagious variant emerged in the fall and is now driving most cases. The efficacy in South Africa was seven points higher than earlier data released by the company.
The vaccine also showed 86 percent efficacy against severe forms of Covid-19 in the United States, and 82 percent against severe disease in South Africa. That means that a vaccinated person has a far lower risk of being hospitalized or dying from Covid-19.
The analyses confirmed that Americans are likely to benefit soon from a third effective coronavirus vaccine developed in under a year, as demand for inoculations greatly outstrips supply. The F.D.A. could authorize the vaccine as early as Saturday, depending on a vote of its vaccine advisory panel on Friday after it discusses the newly released documents.
“With a J&J vaccine, we’ll be able to accelerate the vaccine rollout for our country and for the world,” said Dan Barouch, a virologist at Beth Israel Deaconess Medical Center in Boston who led much of the early research on the vaccine last year.
Johnson & Johnson’s vaccine can be stored at normal refrigeration temperatures for at least three months, making its distribution considerably easier than the authorized vaccines made by Moderna and Pfizer-BioNTech, which require two doses and must be stored at frigid temperatures.
But access to the new vaccine could be severely limited at first. Dr. Richard Nettles, the vice president of U.S. medical affairs at Janssen Pharmaceuticals, the drug development arm of Johnson & Johnson, told lawmakers on Tuesday that nearly four million doses would be ready for shipment after the F.D.A. authorizes the vaccine, far below the 12 million it had originally pledged to give the federal government by the end of February.
White House officials had an even lower estimate on Tuesday, telling governors on a weekly call that around two million doses would be available next week, according to an administration official.
Dr. Nettles said on Tuesday that a total of 20 million doses would be ready by the end of March. The company has a contract to deliver 100 million doses by the end of June.
Johnson and Johnson’s vaccine has a lower efficacy rate than the vaccines from Moderna and Pfizer-BioNTech, which are both around 95 percent.
But in South Africa, the Johnson & Johnson vaccine is so far the clear winner. Novavax’s shot had an efficacy of 49 percent in South Africa. And a small trial in South Africa of the AstraZeneca-Oxford vaccine found that it did not offer much protection at all. The negative results led the South African government to abandon its plan of giving a million doses of AstraZeneca vaccines to health care workers. Last week, the government started giving Johnson & Johnson’s vaccines instead, and has so far administered more than 32,000.
The newly released documents, which include the F.D.A.’s first technical analysis of the company’s 45,000-person clinical trial, presented evidence that the vaccine was safe, with noticeably milder side effects than the Pfizer and Moderna vaccines and without any reports of severe allergic reactions like anaphylaxis.
The vaccine’s protection was consistent across Black, Hispanic and white volunteers, and also across different ages. The trial indicated a lower efficacy, of 42.3 percent, for people over 60 who had risk factors like heart disease or diabetes. But this figure came with a large amount of statistical uncertainty, the F.D.A. noted.
Although several vaccines can protect people from getting sick with Covid-19, it is unclear whether the shots can also prevent people from getting infected and passing the virus to others, leading to a debate about how quickly society can return to normal after inoculations begin.
Moderna’s trial found some hints that vaccinated people were less likely to develop an infection without symptoms. And AstraZeneca found that its vaccine reduced asymptomatic infections by about half.
Johnson & Johnson looked for asymptomatic infections by checking for coronavirus antibodies 71 days after volunteers got a vaccine or a placebo. The new analyses estimate that the vaccine has an efficacy rate of 74 percent against asymptomatic infections. But that calculation was based on a relatively small number of volunteers, and the F.D.A. noted that “There is uncertainty about the interpretation of these data and definitive conclusions cannot be drawn at this time.”
“I think it’s going to add to the growing evidence that the vaccines really do prevent infection as well as prevent disease,” Dr. Barouch said.
The global sharing program designed to make vaccine access more equal delivered its first major shipment of doses on Wednesday to the West African nation of Ghana, ramping up the largest mass immunization campaign in history.
“Today marks the historic moment for which we have been planning and working so hard,” said Henrietta Fore, the executive director of UNICEF. “In the days ahead, frontline workers will begin to receive vaccines, and the next phase in the fight against this disease can begin.”
The first shipment of 600,000 doses was packed up and labeled in India, then flown to Accra, the Ghanaian capital.
Ghana and other West African countries are to begin vaccinations in coming days, according to officials, the first of 92 low and middle-income countries that will receive free vaccines through Covax, a vaccine-sharing initiative.
The goal is for Covax to deliver some two billion doses of Covid-19 shots this year, which officials said would make it the largest vaccine procurement and supply operation in history.
The shipment arrived in West Africa as studies were released suggesting that the spread of the virus in the region has been much wider than official numbers show.
At least one in five people in Lagos, Nigeria, could have had contracted the coronavirus by October last year, according to findings just released by the Nigeria Center for Disease Control, an infection rate far higher than the one reported through the national surveillance system. A study in Accra released in November had similar findings.
Many public health officials have criticized the unequal distribution of vaccines — with wealthy nations already delivering tens of millions of doses and acquiring vast reserves for their populations.
For instance, while at least 44.5 million Americans and around 18 million people in Britain have already received a shot, as of last week more than 130 countries had yet to vaccinate a single person. The Ghana shipment covers just 1 percent of the population.
The United Nations secretary-general, António Guterres, said last week that the distributions had been “wildly uneven and unfair.”
And high-income countries are not respecting contracts under Covax and are competing with them, reducing the number of doses the initiative can buy, Dr. Tedros Adhanom Ghebreyesus, the head of the World Health Organization, said on Tuesday.
The pandemic will not end, he added, until everyone is vaccinated.
“This is not a matter of charity,” he said. “It’s a matter of epidemiology.”
Last week, the group of wealthy industrialized nations known as the Group of 7 announced that they would intensify their cooperation with the international vaccination drive and raised their overall commitment to the effort to $7.5 billion.
But Dr. Tedros said that there remained a financing gap of $23 billion.
President Emmanuel Macron of France called for even more urgent action on Friday, saying Europe and the United States should send up to 5 percent of their vaccine supplies to developing nations.
But even if things go according to plan, vaccinating the vast majority of the world’s most vulnerable people this year will be a daunting challenge.
Ghana, a nation of more than 30 million people, will get enough vaccines to cover only about 20 percent of its population by the end of 2021. It will have to buy millions more doses separately.
Poorer countries do not pay to purchase vaccines and injection devices under Covax, at least for up to 20 percent of the population. But they do have to pay the costs of delivery within the country.
To receive vaccines, countries had to submit plans saying who they wanted to immunize, how they would go about it and how they would monitor vaccinations. They also had to sign an indemnity agreement with the vaccine manufacturer.
“No country was prioritized,” said Benjamin Schreiber, UNICEF’s coordinator for the Covax program.
Four countries eligible to apply for vaccines under Covax did not do so: Burundi, Eritrea, Madagascar and Tanzania.
A meta-analysis of studies released on Wednesday affirmed what social workers, educators and law enforcement officials have warned about for months: Stay-at-home orders exacerbated domestic violence. Reports increased more than 8 percent since the widespread lockdowns in the United States began last spring.
The report, released by the University of Miami and the National Commission on Covid-19 and Criminal Justice, is based on 18 studies covering communities in the United States and overseas. It compared changes in the number of domestic violence events before and after lockdowns began.
The studies measured changes in police calls for service, crime and incident reports, domestic violence hotline registries, and health records, using data derived from official records. The studies did not use qualitative or anecdotal evidence.
“We were able to quantify, in large and small U.S. cities and some worldwide, a broad view of the impact that the pandemic has had on domestic violence,” Alex R. Piquero, a sociology professor at the University of Miami and the lead author of the report, said in an interview.
Even before this study, with only limited data available, the situation was deemed so grave that the World Health Organization and the United Nations called for action to protect children from violence amid lockdowns.
When the researchers factored in data from a few countries outside the United States — including Argentina, Italy, Mexico and Sweden — they found that the rate of domestic violence was only slightly lower.
Given that domestic violence is one of the most underreported crimes, Mr. Piquero said that the report’s findings were most likely an underestimate.
“This is a floor, not a ceiling, with regard to the true veracity of what the pandemic did to domestic violence,” he said.
The report reiterated what was already evident in anecdotal accounts of domestic violence during the pandemic: The lockdowns forced adults and children to stay in close quarters with their abusers, and the orders cut them off from friends, neighbors, colleagues and others who could report signs of abuse or help victims escape violent situations.
The economic impact of the pandemic also exacerbated factors already associated with domestic violence, including male unemployment, financial insecurity, and alcohol and other substance use, according to the study.
The group that compiled the study, the National Commission on Covid-19, was created by the Council on Criminal Justice, a think tank that studies criminal justice policies. It is led by a bipartisan pair of former attorneys general: Alberto Gonzales, a Republican, and Loretta Lynch, a Democrat.
The commission aims to assess the pandemic’s impact on the justice system; it includes judges, law enforcement officials, a defense lawyer, a researcher, and community and religious leaders.
The commission said that its findings highlighted a serious need for more domestic abuse prevention and services for survivors. It said the need was especially urgent among historically marginalized groups and those likely to be disproportionately isolated during the pandemic, such as older adults, people struggling with mental illness and chronic health conditions, and women and children with past experiences of violence and abuse.
If you’re lucky enough to have traveled by air to, say, Kauai or the British Virgin Islands, your quarantine may include the option of roaming relatively freely on a resort’s expansive grounds while waiting for a negative coronavirus test.
But travel by air to Australia, New Zealand, mainland China or Tunisia, and you will generally find yourself confined to your room, 24 hours a day, for up to two weeks (assuming you test negative, that is). And with some exceptions, you are footing the bill — quarantine in New South Wales, Australia, for example, costs 3,000 Australian dollars, or about $2,300, for a two-week quarantine for one adult, and up to 5,000 dollars for a family of four.
Quarantine might seem manageable for those who have been living under shelter-in-place orders and working from home. Pete Lee, a filmmaker based in San Francisco, was not concerned about the quarantine when he flew to Taiwan for work and to visit family.
“I was a little bit cocky when I first heard about the requirement,” Mr. Lee said, during his eighth day at the Roaders Hotel in Taipei, Taiwan. “I was inside my San Francisco apartment for 22 out of 24 hours a day! But it’s a surprisingly intense experience. Those two hours make a big difference.”
Joy Jones, a coach and educator who is based in San Francisco, traveled to New Zealand with her husband, a New Zealand citizen, and two young daughters in January. She learned before their departure that they would have no say where they would be quarantined.
“That was probably the hardest part,” she said. “I could put together a bag of activities for my older daughter, and plan on doing laundry in the sink. But not having an answer to where we’d be — after more than 21 hours of flying, with masks — would we have to get another flight? A three-hour bus ride?” They didn’t. Ms. Jones and her family were taken to Stamford Plaza in Auckland, just 25 minutes from the airport.
The challenge is managing the tedium.
“We decorated a paper horse that we hung in our window — every day, a different part of it — that was a favorite activity. We’d have dance parties. And we’d watch a movie every night. We did what we could to bring some fun into it,” Ms. Jones said.
She documented her family’s quarantine experience on her private Instagram account, showing forts made of blankets, paper airplane competitions and “bowling” with water bottles and a crumpled ball made of paper. She was touched that friends and family sent her family meals, treats and toys in response to her posts.
“It was a really cool way to feel love, and connection, from such an isolated space,” she said.
The coronavirus pandemic has crippled economies, shut down travel and claimed hundreds of thousands of lives, transforming the world in ways that would have been unthinkable a year ago. The Biden administration’s first days were inevitably dominated by discussion of how his team would tackle the crisis, as the U.S. death toll continued its inexorable climb to a staggering milestone: 500,000 deaths.
Here’s a look at the key figures on President Biden’s Covid-19 response team, and some of their plans to try to stop the spread of the virus and regain some semblance of normalcy.
Dr. Anthony S. Fauci, chief medical adviser. The longtime head of the National Institute of Allergy and Infectious Diseases, Dr. Fauci said he accepted the president’s offer to be his chief medical adviser “right on the spot.” Considered the nation’s leading infectious disease expert, he has been an adviser to every president since Ronald Reagan, and was awarded the Presidential Medal of Freedom by George W. Bush for his work fighting H.I.V./AIDS. But he became a household name only after the start of the pandemic, when he emerged as a trusted authority in countless news briefings, interviews and public appearances.
Dr. Rochelle P. Walensky, director of the Centers for Disease Control and Prevention. Dr. Walensky, previously chief of the division of infectious diseases at Massachusetts General Hospital and a professor at Harvard Medical School, replaced Dr. Robert R. Redfield. She has also focused on H.I.V./AIDS in her career, and has served as chair of the Office of AIDS Research Advisory Council at the National Institutes of Health, and as an adviser to the World Health Organization. Dr. Walensky has pledged to restore public trust in the agency and to provide accurate information “even when the news is bleak, or when the information may not be what those in the administration want to hear.”
Xavier Becerra, nominee for secretary of health and human services. Mr. Becerra was appointed as attorney general of California in 2017, when his predecessor, Kamala Harris, joined the Senate, and he was elected to a full term in 2018. He became known as a lead attacker in the Trump resistance, filing roughly 100 lawsuits against the administration on issues including climate change, gun control and health care. Notably, he led 20 states and the District of Columbia in a campaign to protect the Affordable Care Act. Before serving as attorney general, he spent 24 years in Congress, representing a Los Angeles district. If confirmed, he would be the first Latino to run the mammoth department, which has a budget of more than $1 trillion. He pledged at a Senate confirmation hearing on Tuesday to find “common cause” with his critics, and is scheduled to appear on Wednesday before the Senate Finance Committee.
Dr. Vivek H. Murthy, nominee for surgeon general. Dr. Murthy served as surgeon general under President Barack Obama — he was one of the youngest ever — and is Mr. Biden’s nominee for the same position. He is a physician who has taught at Harvard Medical School and served as vice admiral of the U.S. Public Health Service Commissioned Corps. Dr. Murthy has been outspoken about linking public health and wellness. His book “Together: The Healing Power of Human Connection in a Sometimes Lonely World” was published last year. His confirmation hearing is scheduled to begin Thursday.
Dr. Marcella Nunez-Smith, chair of the Covid-19 Health Equity Task Force. A physician and public health specialist at Yale University, Dr. Nunez-Smith is leading a team of 12 experts advising the president on how to address the disproportionate impact of Covid-19 on vulnerable communities. Dr. Nunez-Smith grew up in the U.S. Virgin Islands and came from a family of health care providers. She has spoken in interviews about how seeing her father suffer a debilitating stroke in his 40s, caused by untreated high blood pressure, spurred her to work in public health.
Jeffrey D. Zients, coordinator of the administration’s Covid-19 response. Mr. Zients, an entrepreneur and consultant, joined the Obama White House in 2009 and became known as a Mr. Fix-It with strong operational skills. He was tapped to untangle the messy rollout of the Affordable Care Act’s online insurance marketplace in 2013. After Mr. Obama left office, Mr. Zients joined the private equity fund Cranemere as chief executive and also served on Facebook’s board.
Andy Slavitt, senior White House pandemic adviser. Mr. Slavitt, a former health care company executive, served as the acting administrator of the Centers for Medicare and Medicaid Services from 2015 to 2017. (His company was also involved in fixing the A.C.A. website before that.) Mr. Slavitt was outspoken in his defense of the Affordable Care Act during the Trump administration — and raised the alarm about the pandemic early in 2020. He’s active on Twitter, writes on Medium, and until recently, hosted a podcast about Covid. He has said that he accepted the White House job “on a short-term basis.”
Dr. David Kessler, chief science officer for the Covid-19 response. Dr. Kessler, a pediatrician and lawyer who was head of the Food and Drug Administration during the presidencies of George Bush and Bill Clinton, will oversee the vaccine program. He will share responsibilities with Gen. Gustave F. Perna, who was the chief operating officer for Operation Warp Speed, the Trump administration’s program to accelerate vaccines and treatments. (The Biden administration later dropped that name.) As F.D.A. commissioner, Dr. Kessler was known for battling the tobacco industry and developing nutrition fact labels on food products. Dr. Kessler is close to Dr. Fauci; the two worked together to speed the development and approval of drugs that changed the course of the AIDS epidemic in the 1990s.
Dr. Janet Woodcock, acting commissioner, Food and Drug Administration. Dr. Woodcock was the longtime head of the F.D.A.’s Center for Drug Evaluation and Review, and worked on Operation Warp Speed. The Biden administration has not yet nominated a permanent commissioner; Dr. Woodcock and Dr. Joshua Sharfstein, a former high-ranking F.D.A. official, are the apparent front-runners.
Afghanistan, whose citizens have largely brushed aside the coronavirus pandemic as exaggerated or an outright hoax, is now preparing to distribute its first batch of vaccines.
A half-million doses of the AstraZeneca-Oxford vaccine, produced by an Indian manufacturer, were delivered to the capital, Kabul, on Feb. 7. But the arrival was greeted with indifference by many Afghans, who have rebuffed government warnings that the virus is a deadly public health threat.
The cheap and easy-to-store AstraZeneca-Oxford vaccine is being delivered as part of the Covax program, a worldwide initiative to buy and distribute vaccines to poor countries free or at a reduced cost. On Feb. 15, the World Health Organization authorized use of the vaccine, which requires two doses per person, clearing the path for Afghanistan to begin its inoculation campaign.
Global trials have found that the vaccine offered complete protection against severe disease and death. But its efficacy against the virus variant first identified in South Africa is in question, after the shot failed in a small trial to prevent study participants from getting mild or moderate illness.
The vaccine arrives as Afghanistan is fighting off a second deadly wave, even as most Afghans go about their daily lives as if the virus never existed. Many people refuse to wear masks and cluster in dense crowds inside bazaars, supermarkets, restaurants and mosques, oblivious to ubiquitous public health posters.
In an impoverished nation battered by war, hunger, poverty and drought, an invisible virus is considered fake — or an afterthought.
“Of course I won’t take the vaccine, because I don’t believe in the existence of the coronavirus,” said Muhibullah Armani, 30, a taxi driver in the southern city of Kandahar.
Expressing a sentiment shared by many Afghans, Mr. Armani added, “When I see people covering their mouth and nose, afraid of Covid, it makes me laugh at them.”
For teenagers and young adults who are anxious by nature or feeling emotionally fragile, the pandemic and its social isolation have pushed them to the brink.
Rates of suicidal thinking and behavior are up 25 percent or more from similar periods in 2019, according to an analysis of surveys of young patients in emergency rooms.
For the young people coming undone, pandemic life presents unusual challenges, pediatricians say. Most are temperamentally sensitive and after months of being socially cut off from friends and activities, they have much less control over their moods.
“What parents and children are consistently reporting is an increase in all symptoms — a child who was a little anxious before the pandemic became very anxious over this past year,” said Dr. Adiaha I. A. Spinks-Franklin, an associate professor of pediatrics at the Baylor College of Medicine. It is this prolonged stress, Dr. Spinks-Franklin said, that in time blunts the brain’s ability to manage emotions.
For teenagers in a mental health crisis, there aren’t many places to turn. They need help, but it is hard to come up with a psychiatric diagnosis. They are trying to manage a surprise interruption in their lives, a vague loss. And without a diagnosis, reimbursement for therapy is hard to come by. And that is assuming parents know what kind of help is appropriate, and where to find it.
When a crisis does hit, many of these teenagers end up in the local emergency department — the one place desperate families so often go to for help.
Many E.R. departments across the country are now seeing a surge in such cases. Through most of 2020, the proportion of pediatric emergency admissions for mental problems, like panic and anxiety, was up by 24 percent for young children and 31 percent for adolescents compared to the previous year, according to a recent report by the Centers for Disease Control and Prevention.
The local emergency department is frequently unprepared for the added burden. Workers often are not specially trained to manage behavioral problems, and families don’t have many options for where to go next, leaving many of these pandemic-insecure adolescents in limbo at the E.R.
“This is a national crisis we’re facing,” Dr. Rebecca Baum, a developmental pediatrician in Asheville, N.C. “Kids are having to board in the E.R. for days on end, because there are no psychiatric beds available in their entire state, never mind the hospital. And of course, the child or adolescent is lying there and doesn’t understand what’s happening in the E.R., why they’re having to wait there or where they’re going.”
global roundup
Thailand, which has lagged behind some of its Southeast Asian neighbors in obtaining coronavirus vaccines, received its first shipment Wednesday: 200,000 doses of the CoronaVac shot from China.
Prime Minister Prayuth Chan-ocha and most of his cabinet were on hand at Suvarnabhumi International Airport outside Bangkok to greet the arrival of a Thai Airways cargo plane delivering the doses. The CoronaVac shot was developed by a private Chinese company, Sinovac Biotech, and has faced scrutiny over a lack of data from late-stage clinical trials.
The Thai officials stood in front of a banner proclaiming: “Covid-19 Vaccine: Returning Smiles to Thailand.” The country has long promoted itself as a tourist destination with the slogan “The Land of Smiles.”
Thailand’s Food and Drug Administration approved Sinovac’s vaccine for emergency use on Tuesday. Sinovac is expected to send two million doses in total, with health workers receiving the first inoculations.
So far, only a few governments in Asia have approved CoronaVac for use. Several more have said they would only do so after receiving full trial data from the manufacturer.
In a statement before the CoronaVac shipment arrived, Mr. Prayuth said that 65 million doses of vaccines were planned so far, and that vaccines from other manufacturers would arrive soon. Thailand approved the AstraZeneca vaccine in late January.
Vietnam, which has also been relatively successful in containing the virus but slow to obtain vaccines, received its first shipment Wednesday: 117,000 doses of the AstraZeneca-Oxford vaccine.
Thailand has been among the most successful countries in containing the virus, with fewer than 26,000 cases and 83 deaths since the start of the pandemic. More than 80 percent of the cases have been recorded since December, when the country experienced its most serious outbreak at a seafood market in Samut Sakhon Province. Since then, the number of new cases has fallen to below 100 a day and the government has been gradually easing restrictions.
Thailand’s vaccination plan has been less ambitious than its program of contact tracing and containment. The government has called for inoculating half the country of roughly 70 million people by the end of the year.
In contrast to Thailand’s slow start, Singapore began vaccinations in late December, Indonesia started six weeks ago, and Myanmar nearly a month ago, although its program has been disrupted by the Feb. 1 military coup.
Thailand’s tourism sector, which accounts for about 20 percent of the economy, has pushed for a more aggressive vaccination program to help reopen the country to foreign visitors.
Since the beginning of the outbreak, Thailand has required nearly everyone arriving from overseas to undergo quarantine for 14 days. Mr. Prayuth said on Wednesday that the government was considering whether to allow foreigners who have been vaccinated to skip quarantine.
In other international news:
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Taiwan said on Wednesday that it would resume allowing short-term business travelers from certain “low-risk” countries to apply to isolate for less than the usual two weeks upon arrival — an exemption that it canceled two months ago amid concerns about the pandemic’s severity. The self-governing island is still closed to tourists and most other nonresidents.
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