Scientific advisers to the Centers for Disease Control and Prevention will take up a thorny challenge on Thursday: Who qualifies for the new Pfizer-BioNTech coronavirus booster and why?
On Wednesday evening, the Food and Drug Administration authorized booster shots of the vaccine for people over 65 who received their second at least six months earlier. The agency also authorized boosters for adult Pfizer-BioNTech recipients who are at high risk of severe Covid-19, or who are at risk of serious complications because of exposure to the virus in their jobs.
Roughly 22 million Americans are at least six months past their second Pfizer dose, according to the C.D.C. About half are 65 or older.
But who exactly risks becoming severely ill? What does it mean to be exposed on the job? Do teachers count as exposed, or just frontline health care workers? And what about Americans who got the Moderna and Johnson & Johnson shots?
Those are questions scientists on the C.D.C.’s Advisory Committee on Immunization Practices will debate on Thursday, and their decisions will shape the federal government’s guidance. The committee’s recommendations are not binding, and state officials sometimes implement their own criteria. Still, its decisions are likely to influence who gets the booster shots in practice.
In its deliberations on Wednesday, the C.D.C.’s advisory committee zeroed in on unanswered questions.
A third dose undoubtedly amps up antibody levels, the experts concluded. But it’s unclear so far how long that increase lasts, whether it translates to meaningful extra protection against severe disease, and whether it can significantly decrease transmission of the virus.
Scientists on the committee also noted the paucity of safety data, especially among younger people. And several advisers said they believed the goal of the boosters should be to prevent severe illness, hospitalization and death, rather than stave off infection.
“I don’t think there’s any hope that vaccines such as the ones we have will prevent infection after the first, maybe, couple weeks that you have those extraordinary immediate responses,” said Dr. Sarah Long, a pediatric infectious disease expert at Drexel University College of Medicine in Philadelphia.
The advisers also wrestled with the practicalities of endorsing a booster shot of Pfizer’s vaccine, but not of Moderna or Johnson & Johnson’s. Recipients of those vaccines may hear that boosters are necessary — but they can’t have them yet.
“That’s a big public health panic that we would like to avoid,” Dr. Long said.
Moderna has applied for F.D.A. authorization of booster shots, but at half the dosage given in the first two.
Mixing first shots of the Moderna vaccine with a Pfizer booster — or vice versa — is untested ground, and federal agencies are always reluctant to make moves that the evidence doesn’t explicitly support.
Some global health experts have criticized the Biden administration for pushing booster shots when much of the world has yet to receive a first dose. But on Wednesday, Jen Psaki, the White House press secretary, argued that was a “false choice.”
On Wednesday morning, President Biden said the United States would buy 500 million more doses of the Pfizer-BioNTech vaccine to donate worldwide, doubling up on a purchase in July.
“We’re now donating three shots globally for every one shot we put in the arm of an American, and our view continues to be that we can do both,” Ms. Psaki said. “Our view also continues to be that frankly the rest of the world needs to step up and do more.”
Sharon LaFraniere and Noah Weiland contributed reporting from Washington. Daniel E. Slotnik contributed reporting from New York.
African public health experts on Thursday hailed President Biden’s plan to expand global coronavirus vaccine donations, but warned that his ambitious goals would not be met without timelier deliveries and greater transparency about when and how many doses are coming.
Africa, the continent with the lowest Covid-19 vaccination rate, has suffered not only from a shortage of vaccines but also from delayed and inconsistent deliveries. Although supplies are increasing — with four million doses arriving over the past week from Covax, the global vaccine-sharing facility — African countries have received only one-third of the doses pledged for this year, experts said at a virtual briefing held by the World Health Organization.
“The first thing to say is we appreciate all the donations that were pledged by the rich countries and those who have doses to offer, but we call for a commitment to deliver on those, and deliver in a timely manner,” said Githinji Gitahi, chief executive of Amref Health Africa, a charity.
At a summit on Wednesday, Mr. Biden pledged to donate an additional 500 million doses of the Pfizer vaccine, nearly doubling the United States’ total committed donations to 1.1 billion doses, more than any other country. But only 300 million are expected to be shipped this year, leaving poorer nations with the prospect of an ever-longer wait.
Mr. Biden embraced the target of vaccinating 70 percent of the world’s people by the end of 2022, but that would require the pace of vaccinations in Africa to rise sevenfold, to about 150 million doses a month, said Benido Impouma, a program director with the World Health Organization’s Africa program.
“It is in every country’s interest that this happen quickly,” Dr. Impouma said of the continent’s vaccination campaign. “The longer the delay in rolling out the vaccine, the greater the risk of other challenges emerging,” he added, including the rise of more troubling coronavirus variants.
To date, he and others said, vaccine deliveries to Africa have been not only too late and too few, but also unpredictable. Many shipments have arrived with little notice, hampering health systems’ ability to administer them, and with doses soon to expire.
Richard Mihigo, coordinator of the W.H.O. immunizations program in Africa, said that the agency had analyzed the vaccine shipments and found that the average shelf life of doses that reached Africa was two to three months. That wasn’t long enough for health systems to get the doses to people who needed them, many of whom lived far from health facilities, he said.
“Most of time the news about donations comes on short notice, within a couple of days,” Dr. Mihigo said. “Countries do not have time to prepare. To change this paradigm, we need a bit more predictability on doses, how many doses, when they are coming.”
The surfeit of soon-to-expire doses has also contributed to vaccine hesitancy in parts of Africa, said Jean-Jacques Muyembe, director general of the National Institute for Biomedical Research in the Democratic Republic of Congo.
“People consider that a short shelf life, such as three months, is a synonym for bad quality,” he said.
Alaska, once a leader in vaccinating its citizens, is now in the throes of its worst coronavirus surge of the pandemic, as the Delta variant rips through the state, swamping hospitals with patients.
As of Tuesday, the state was averaging 117 new cases a day for every 100,000 people, more than any other in the nation, according to recent data trends collected by The New York Times. That figure has shot up by 42 percent in the last two weeks, and by more than twentyfold since early July.
On Wednesday, the state said it had activated “crisis standards of care,” giving hospitals legal protections for triage decisions that force them to give some patients substandard care. The state also announced an $87 million contract to bring in hundreds of temporary health care workers.
Gov. Mike Dunleavy, a Republican, said that while hospitals were strained, he did not see a need to implement restrictions aimed at curbing transmission. Still, he encouraged people who had not yet received a vaccination to seriously consider it.
“We have the tools available to us for individuals to be able to take care of themselves,” Mr. Dunleavy said. While the state led the nation in vaccinations early in the year, it has been lagging in recent months, with under half of its population fully vaccinated, compared with 55 percent nationally, according to federal data.
Jared Kosin, the head of the Alaska State Hospital and Nursing Home Association, called the surge “crippling” in an interview on Tuesday. He added that hospitals were full, and health care workers were emotionally depleted. Patients are being kept waiting for care in their cars outside overwhelmed emergency rooms.
There is growing anxiety in outlying communities that depend on transferring seriously ill patients to hospitals in Anchorage, Mr. Kosin said. Transfers are getting harder to arrange and are often delayed, he said.
“We are all wondering where this goes, and whether that transfer will be available, even tomorrow,” Mr. Kosin said.
Critically ill people in rural areas, where many Alaska Natives reside, often have to be taken by plane to a hospital that can provide the treatment they need, said Dr. Philippe Amstislavski, an associate professor of public health at the University of Alaska Anchorage.
“Unlike in the lower 48, you don’t have that ability to move people quickly, because of the distances and remoteness,” said Dr. Amstislavski, who was formerly the public health manager for the Interior Region of Alaska, focusing on rural and predominantly Alaska Native communities.
Mr. Kosin said that if hospitalizations rise much further, hospitals and clinics around the state could be forced to apply crisis standards of care and more extreme triage decisions. “That is the worst-case scenario we could be heading to,” he said.
Alaska Natives, who have historically suffered from health disparities in the state, are disproportionately struggling during the latest virus wave, Dr. Amstislavski said.
Dr. Anne Zink, Alaska’s chief medical officer, said several factors may be contributing to the surge, including summer tourists bringing in and spreading the virus.
“We’re hoping that as the snow falls and we have less people visiting, those numbers will settle down,” Dr. Zink said in an interview Tuesday night.
On the other hand, she noted that cooling weather drives residents indoors, where the virus spreads more readily.
The state’s Canadian neighbors to the east, Yukon and British Columbia, have not suffered such severe outbreaks, Dr. Amstislavski said, possibly because of that country’s stricter travel restrictions and less strained health care system.
Prime Minister Jacinda Ardern said that she wants New Zealand to get as close as possible to vaccinating 90 percent of its total population, a level that she said would allow the nation to avoid future lockdowns in response to the coronavirus.
The government is reviewing a new study, which has yet to be peer-reviewed, that shows that lockdowns would not be necessary once vaccination levels reached 90 percent, Ms. Ardern said in Auckland on Thursday.
She declined to set a target, instead urging residents to get a shot and saying that she hoped New Zealand would have one of the highest vaccination rates. So far, about a third of the nation has received at least one dose of a vaccine.
“The more people are vaccinated, the fewer restrictions we will have to live with in the future,” Ms. Ardern said. “It all comes down to vaccination.”
New Zealand has committed itself to eliminating the virus through lockdowns, quarantines and closing of borders. Cases have remained extremely low, and Ms. Ardern has been one of the few world leaders to find their reputation enhanced by their handling of the pandemic. But the approach has put pressure on residents across the country who have been confined to their home for periods of as long as five weeks during outbreaks.
Leaders across the Asia Pacific region have admitted in the past few weeks that a strategy to keep Covid cases at zero is not sustainable more than 18 months into the pandemic. In Australia, the government is considering opening borders before Christmas. And Singapore has started loosening quarantine rules, while Hong Kong is allowing more vaccinated travelers to enter.
New Zealand’s health minister said this week that a full Covid-elimination strategy may not be possible anymore.
“We may not get back to zero but the important thing is we are going to keep finding any infections and basically continue to contact trace, test and isolate people so that we stop the virus circulating in the community,” Ashley Bloomfield, the country’s director general of health, told Radio New Zealand on Wednesday.
Australia’s second most populous state announced that some residents stranded in surrounding regions because of the pandemic would be able to travel back home starting Sept. 30.
On Thursday, the state premier, Daniel Andrews, said that people who had been stuck in New South Wales for “a lengthy period of time” could return to Victoria, if they were fully vaccinated and tested negative for the coronavirus. They must quarantine for 14 days.
“We have on numerous occasions sent our apologies to them and made it clear we understand just how challenging it is and we wish things were different,” he said.
Australia has imposed some of the harshest restrictions in the world to help contain the spread of the virus, with individual states employing lockdowns that have prevented people from returning to their cities.
The daily average of new cases has dropped 13 percent in the past two weeks in Australia, which has lived through several lockdowns since the start of the pandemic. While its vaccination kickoff had a slow start, the nation has to date fully vaccinated 39 percent of its population. Recently the country began vaccinating children as young as 12.
While travel restrictions have eased for many Australians, and the tourism ministry has even announced a possible reopening of its borders by Christmas, the country is still facing setbacks with new infections breaking out.
A makeup artist working on an Australian reality television program tested positive for the coronavirus earlier this week, sending over 130,000 Australians into yet another lockdown, according to Chris Cherry, the mayor of Tweed Shire, part of the area in northern New South Wales that has been placed under restrictions for seven days.
According to ABC News, the 31-year-old woman visited various businesses like restaurants and cafes without checking in via QR code. The police have charged her with breaching several public health regulations, including her work travel exemption guidelines.
Michael Lyon, the mayor of neighboring Byron Shire, shared his frustration over going back into lockdown in a Facebook post on Wednesday.
“It is so devastating to be in lockdown again and it is clear the ‘honour’ system relied on by the state government is deeply flawed,” he wrote. “Perhaps our calls for a tightening of restrictions will now finally be heeded.”
When the Biden administration announced a mandate that employees be vaccinated or tested regularly at companies with 100 or more employees, business leaders responded with a barrage of questions. Among smaller companies, one loomed especially large: Why 100?
It’s an appealingly round, easy-to-remember number, and it captures a broad section of the American work force. President Biden estimated that his order would apply to 80 million employees and cover two-thirds of all workers.
But as a dividing line between a “big” business and a “small” one, it’s a threshold not found in any other major federal or state law. There was no explanation for how or why the number was chosen. And for entrepreneurs who employ a smattering of workers, that’s an increasingly common challenge: Every time lawmakers invent a new regulation, they also make up a new definition of which businesses count as small.
The Affordable Care Act set 50 as the number of workers after which employers would be required to offer health insurance. That edict, which took full effect in 2016, led to an intense, vocal backlash from owners who feared that the requirement would bankrupt them, with some even paring back their business to keep their employee roster under the limit.
The mandate’s actual costs turned out to be fairly muted for most — the law helped stabilize insurance prices in the notoriously erratic market for small-group plans — and, after surviving many legal and political efforts to dismantle it, the health care law has become a bedrock piece of federal policy. So why not use 50 employees as the boundary for the vaccination mandate?
The White House isn’t saying; officials did not respond to repeated questions about the 100-person criterion. The Labor Department’s Occupational Safety and Health Administration, which is responsible for drawing up the rules, has not yet explained how and when the mandate will be enforced.
The fate of unvaccinated employees in New York City’s largest private hospital system was uncertain Wednesday night, as the deadline to get a first shot of a Covid-19 vaccine drew near.
New York State’s vaccination mandate for workers at hospitals and nursing homes doesn’t require a first shot until Monday, Sept. 27. But NewYork-Presbyterian, the city’s largest private hospital network, has ordered its 48,000 employees to get vaccinated on a faster timeline, requiring a first dose no later than Wednesday.
In recent weeks, the hospital had warned employees that those who remained unvaccinated without a legitimate exemption “will be deemed to have opted to resign,” according to an email sent to some employees.
A hospital spokeswoman, Alexandra Langan, declined to comment on Wednesday afternoon about how many employees faced the loss of their jobs.
More than 90 percent of NewYork-Presbyterian employees had gotten a first dose by early last week, according to a court affidavit by Shaun E. Smith, NewYork-Presbyterian’s chief human resources officer. In recent days, more holdouts have gotten vaccinated, according to interviews. But that still left hundreds, if not thousands, of employees unvaccinated.
About 200 employees have valid medical exemptions, according to Mr. Smith’s affidavit. And at least 1,364 employees had sought religious exemptions, Mr. Smith said. The hospital had granted about 129 of those requests before the state’s Department of Health reversed course in late August and said religious beliefs no longer qualified for an exemption.
A federal judge has since temporarily ordered the state to refrain from enforcing that policy. For now, NewYork-Presbyterian has said it will not take action against unvaccinated employees who had previously received a religious exemption or had a request pending, according to court filings.
One nurse in an intensive care unit, Maureen A. Buckley, said in a lawsuit that NewYork-Presbyterian suspended her without pay last week because she remained unvaccinated against Covid-19. In court papers, she said that the hospital system denied her a medical exemption and ignored her efforts to obtain a religious exemption. Reached by phone Wednesday evening, she declined to comment further, explaining that she was “still in the middle of negotiating with the hospital.”
At more than 90 percent, the vaccination rate within the NewYork-Presbyterian system is higher than at many other hospitals. At St. Barnabas Hospital, an independent safety-net hospital in the Bronx, just under 80 percent of staff are vaccinated against Covid-19, the hospital’s chief medical officer, Eric Appelbaum, said. He expressed hope the rate would climb as Monday — the state-mandated deadline — approached. “Some folks are like that: ‘If the deadline is Friday morning, I’ll do it Friday morning,’” he said.
Holdouts at New York hospitals have cited a range of reasons for not getting vaccinated: some say they distrust the safety of the vaccine, or worry about fertility, while others object to the use of cell lines derived from aborted fetuses in the development or production or testing of Covid-19 vaccines, according to interviews and court records.
Another major New York hospital network, Mount Sinai Health System, had told employees to get vaccinated by Sept. 13, but a spokeswoman said she did not know if anyone had yet been placed on leave or fired for not complying.
Because of an editing error, a caption for a photograph in an earlier version of this article incorrectly stated the number of employees in the NewYork-Presbyterian Hospital network. There are 48,000, not 36,000.
It was a tailgate unlike any other on Sunday morning, as a strange truck circled the Bank of America Stadium in Charlotte, N.C.
“Don’t get vaccinated,” the side of the truck said, much to the bewilderment of the Carolina Panthers fans who were there to watch a game against the New Orleans Saints.
Underneath that text was the name of the apparent sponsor, Wilmore Funeral Home, with a link to its website and a phone number.
Images of the mobile advertising truck quickly drew widespread attention on Twitter, as people who were in on the joke applauded the advertisement. “Dope ad campaign,” one tweet said.
The twist was that Wilmore Funeral Home was a fictional business, and its website sent visitors to a vaccine registration page. The phone number belonged to Crenshaw Visions, the advertising agency that owned the truck.
“My voice mail is filled up,” said Garrett Crenshaw, the president of the agency. People have been calling him for days to criticize or compliment the ad, or simply to ask questions about the Covid vaccine.
That discourse is exactly why BooneOakley, a North Carolina advertising agency, created and funded the ad, said David Oakley, the president of the agency.
“A lot of the advertising that’s out there right now is just, ‘Get the shot,’” he said. “We wanted something that made people think.”
The advertisement was created as government officials across the country struggle to vaccinate people who are hesitant about the vaccine’s origins and side effects, among other things. In North Carolina, just under half of all people are fully vaccinated, according to a New York Times database.
Mr. Oakley said that the company didn’t realize how much the message would resonate with people.
An hour after the truck left the company’s parking lot on Sunday, pictures of the ad were already drawing attention on social media.
“Clearly, it has hit a chord,” he said. “For every penny that we spent for the board, if one person got vaccinated for it, it would have been worthwhile.”
Sunday’s ad wasn’t the agency’s first to draw widespread attention. In October 2000, just weeks before the presidential election, BooneOakley ran a billboard advertisement for a job-listing site that said “Gore 2000” next to a picture of George W. Bush.
A few days later, it added a banner at the bottom of the ad that said, “Today’s job opening: proofreader.”
The United States Olympic & Paralympic Committee announced on Wednesday that all athletes and team staff members who use the organization’s training centers and facilities must be fully vaccinated against Covid-19 by Nov. 1.
The organization, which encouraged but did not require vaccinations ahead of the Tokyo Games this summer, also said that by Dec. 1, any athletes vying to represent the country at the Winter Games, scheduled to begin on Feb. 4 in Beijing with the Olympics followed by the start of the Paralympics on March 4, will need to show proof of vaccination to be able to join the Team U.S.A. delegation.
The International Olympic Committee has not announced a vaccine requirement for the Beijing Games.
The U.S.O.P.C.’s new policy arrived amid swirling speculation about the rules that athletes, officials, team staff members and journalists will face in China, where widespread lockdowns and strict quarantines have been fairly common during the pandemic.
The new policy, first reported by The Associated Press, takes the U.S.O.P.C. a step farther than the major North American professional sports leagues, none of which has required athletes to be vaccinated to compete.
In July, Jonathan Finnoff, the U.S.O.P.C.’s chief medical officer, said that about 83 percent of American Olympians had been vaccinated for the Tokyo Olympics. And the I.O.C. estimated that more than 80 percent of all Olympians staying at the athletes’ village in Tokyo were fully vaccinated.
Twenty-eight athletes tested positive in Tokyo in the lead-up to the Summer Olympics and during the competition, as did 13 athletes in Tokyo for the Paralympics.
COVID-19 - Latest - Google News
September 23, 2021 at 09:13PM
https://ift.tt/3AAExnt
C.D.C. Is Set to Decide Who Qualifies for Booster Shots After F.D.A. Approval - The New York Times
COVID-19 - Latest - Google News
https://ift.tt/2SmHWC3
Bagikan Berita Ini
0 Response to "C.D.C. Is Set to Decide Who Qualifies for Booster Shots After F.D.A. Approval - The New York Times"
Post a Comment