Covid-19 Information: Dwell Updates – The New York Occasions
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The Covid-19 vaccine developed by AstraZeneca and the University of Oxford protected people against a new, more contagious coronavirus variant at similar levels to the protection it offered against other lineages of the virus, Oxford researchers said in a paper released on Friday.
The paper, which has not yet been peer-reviewed, said that the vaccine had 74.6 percent efficacy against the new variant, which was first detected in Britain and is known as B.1.1.7. That was similar, though slightly lower, than its efficacy against other lineages of the virus.
The encouraging, albeit preliminary, findings suggest that all five of the leading vaccines may offer at least some protection against new variants of the virus spreading around the globe. Still, the mounting evidence suggests that mutant viruses can diminish the efficacy of vaccines, increasing the pressure on countries to quickly vaccinate their populations and outrace the variants taking hold across the globe.
In clinical trials, the AstraZeneca-Oxford vaccine protected all participants against severe illness or death.
The Oxford scientists behind the vaccine took weekly swabs from the nose and throat of participants enrolled in their clinical trial in Britain. To determine the vaccine’s efficacy against the new variant, they sequenced the viral particles from several hundred swabs between Oct. 1 and Jan 14, a period when the new variant was known to be present in Britain.
The vaccine had 84 percent efficacy against other lineages of the virus, compared to 74.6 percent against the new variant, though the small sample sizes created a broad range of estimates.
Andrew Pollard, the lead investigator of the Oxford vaccine trial, said in a statement that data from the research released on Friday “indicate that the vaccine not only protects against the original pandemic virus, but also protects against the novel variant, B.1.1.7, which caused the surge in disease from the end of 2020 across the U.K.”
The researchers also studied blood samples from clinical trial participants who had been vaccinated, and they determined that the variant may be more adept at dodging antibodies generated by the vaccine.
The variant first detected in Britain has since been reported in more than 70 other countries. Public Health England has estimated that the variant’s rate of infection is 25 percent to 40 percent higher than that of other forms of the coronavirus.
Preliminary data from lab tests of the vaccines from Pfizer and Moderna suggest that they offer good protection against the B.1.1.7 variant. Novavax, which sequenced testing samples from its clinical trial participants in Britain while the variant was circulating widely there, found that its vaccine was highly effective against the B.1.1.7 variant.
The paper released on Friday did not address the AstraZeneca vaccine’s protective power against another fast-spreading coronavirus variant, known as B.1.351, that was first identified in South Africa. Researchers are conducting similar lab tests to try to measure the effect of that variant on the vaccine’s potency.
AstraZeneca’s vaccine has been authorized in nearly 50 countries around the globe but not the United States, where the Food and Drug Administration is waiting on data from a clinical trial that enrolled more than 30,000 participants, mostly Americans. Results from that study may come this month, and AstraZeneca is expected to have enough safety data to seek emergency authorization from the F.D.A. around the first week of March.
In the United States, the B.1.1.7 variant has been identified in 33 states, but the full extent of its spread is unknown because of the lack of a national surveillance program. Federal health officials have warned that it could become the dominant form of the virus in the United States by March.
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In the most extensive real-world test so far, Israel has demonstrated that a robust, rapid coronavirus vaccination program can have a quick and powerful impact, showing the world a plausible way out of the pandemic.
Cases of Covid-19 and hospitalizations dropped significantly among people who were vaccinated within just a few weeks, according to new studies in Israel. And early data suggests that the vaccines are working nearly as well in practice as they did in clinical trials.
But as the world races to curb the virus before more dangerous mutations spread, dire vaccine shortages may prevent other countries from replicating Israel’s success, or from stopping new variants from emerging.
And even Israel, which has outpaced every other nation in vaccinating its people, is far from out of the woods. The country extended its third nationwide lockdown on Thursday.
Still, researchers found hope in the vaccine’s ability to quickly drive down cases among Israelis getting the shots.
“I find this pretty persuasive that we are seeing actual effects of population-level vaccination,” said William Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health who was not involved with the Israeli study.
The new Israeli research looked at national health statistics for people 60 years and older, who received the Pfizer-BioNTech vaccine first because of their high risk. Analyzing data from six weeks into the vaccination campaign, when the majority of people that age had been vaccinated, they found that the number of new Covid-19 cases dropped by 41 percent compared to three weeks earlier.
That group also experienced a 31 percent drop in hospitalizations from the coronavirus, and a drop of 24 percent of those who became critically ill.
The results are all the more striking, experts said, because Israel is contending with a worrisome new variant of the coronavirus. The variant B.1.1.7, first identified in Britain, now accounts for up to 80 percent of the samples tested in Israel.
Despite its successes, Israel remains vulnerable. After a dip in new cases at the end of January, the average rate is climbing back up again. The contagiousness of the B.1.1.7 variant may be partly to blame, along with lower compliance with the current lockdown compared to previous ones. And all but a handful of Palestinians in the occupied territories are still waiting for vaccines, leaving them and Israelis less protected in any new surges.
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They are called “vaccine hunters,” and they are creating an ethical dilemma for health officials across the country.
With overwhelming demand in the early months of the vaccine rollout and a patchwork of rules devised by local officials, thousands of Americans are crossing state lines in quest of a shot.
“The federal government has created this ‘Hunger Games’ scenario where people are out there doing everything they can to get to the front of as many lines as they possibly can,” said Dr. Francisco García, director of the Pima County Health Department in Tucson, Ariz.
So-called vaccine hunter groups scour the country for places where people can qualify for the vaccine, and then spread the word via social media. Many then show up far from home, with sleeves rolled up.
That has left public health officials grappling with how to respond.
Should strict rules be followed, and outsiders turned away? Or should as many shots be administered as possible, even if some may go to people who are not part of the community?
Some vaccine hunters say the flaws in the vaccine distribution process left them little choice but to take to the road.
“The idea of having to wait an unlimited amount of time in Louisiana to get a vaccine just didn’t work for us,” said Chanel Maronge, 37, a school librarian.
Ms. Maronge, who has hypertension, traveled from her home in Baton Rouge, La., to McComb, Miss., to receive a vaccine. Her husband, who has diabetes, and both her parents were able to get vaccinated, too.
Given the pressing need to vaccinate Americans as efficiently as possible, medical ethicists say it is fine to accept a vaccine out of priority order if offered one.
But cutting the line — or in this case, state lines — to jump ahead crossed not just a geographical boundary but an ethical one, said Nancy Berlinger, a bioethicist at the Hastings Center, an ethics research institute in Garrison, N.Y.
“When we jump the queue,” Dr. Berlinger said. “we’re not only putting ourselves literally in ahead of other people, we are actually working against the health of other people. Because some people came into this pandemic with higher risks.”
In the coming weeks and months, the issue may become less pressing.
The picture has brightened as vaccines arrive across the country in growing numbers, though there is increasing concern about variants that are more resistant to the drug.
On Thursday, Johnson & Johnson applied to the Food and Drug Administration for emergency authorization for its one-dose coronavirus vaccine. The company is now on track to potentially begin shipping it by early March.
The F.D.A. has scheduled a meeting with its outside advisory panel, which will vote on Feb. 26 on whether the agency should authorize the vaccine, according to people familiar with the planning. The company said it expected to supply the 100 million doses it has promised the United States by the end of June.
More than 27 million people in the United States have received at least one dose of a vaccine. It is not known how many people have left their state to get a shot.
But for people still waiting for vaccines, it can be frustrating to see people from outside their community manage to get one.
Lawrence Gretz, 66, a retired correctional transportation officer in Mesa, Ariz., said he had been incensed after seeing news reports that people from out of state, including people spending the winter in Arizona, were getting their shots before him and his mother.
“It’s just not right,” Mr. Gretz said, “and it’s ticking a lot of us off.”
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President Biden plans to address the state of the nation’s economy on Friday, hours after the release of the first monthly jobs report of his tenure, a weak showing of only 49,000 jobs added in January. Mr. Biden is expected to use the limited job gains to make a case for the urgency of his $1.9 trillion stimulus plan, a version of which the Senate advanced in a resolution before dawn after a 15-hour overnight voting session.
Vice President Kamala Harris had to cast the tiebreaking vote, the first of what is likely to be many in the evenly divided Senate.
The Labor Department reported on Friday morning that the unemployment rate fell to 6.3 percent. The small gains followed December’s setback when the economy shed jobs for the first time since April. December’s loss, originally stated at 140,000, was revised on Friday to 227,000.
The release of the monthly jobs report capped a week in which Democrats continued to move ahead with plans to enact another far-reaching stimulus plan, the first major legislative undertaking of Mr. Biden’s presidency. The latest report is certain to affect the debate in Washington over further federal intervention.
After a morning meeting in the Oval Office with Ms. Harris and House Democratic leaders and committee leaders who are helping to put together the stimulus legislation, the president is scheduled to speak midday Friday about the economy and the need for his relief package.
The blueprint advanced by the Senate — without Republican support — largely mirrors Mr. Biden’s $1.9 trillion proposal, but without a measure that would raise the federal minimum wage to $15 an hour.
Lawmakers also left in Mr. Biden’s plan direct checks for as much as $1,400. But Democrats and the administration are discussing phasing them out for higher-income Americans at a faster rate than the $600 payments that Congress approved in December, meaning that those earning more would get smaller checks.
Mr. Biden has proposed starting to phase out the payments for individuals earning $75,000 a year and couples earning $150,000 a year. Lawmakers have discussed reducing those thresholds to $50,000 for individuals and $100,000 for couples.
A group of Senate Republicans pitched a scaled-down relief package this week, but their $618 billion plan fell far short of what Mr. Biden is seeking.
Credit…Lauren Justice for The New York Times
Confronted with the possibility of coronavirus variants that may evade current vaccines, therapies and tests for the virus, the Food and Drug Administration is readying a plan for action in the next few weeks.
The Pfizer and Moderna vaccines have so far proven to be effective against known variants of the coronavirus, but they are less potent against the variant first identified in South Africa. That variant has only been confirmed in three people in the United States so far, but the country’s surveillance is thin and may be missing other cases.
As of Thursday, all but seven of the 618 coronavirus variant cases identified in the United States so far have involved a fast-spreading variant first observed in Britain, according to data from the Centers for Disease Control and Prevention.
“If variants emerge that are not prevented, that the vaccines have poor efficacy against, then we will need to rapidly change,” Janet Woodcock, the F.D.A.’s acting director, said in a call with reporters on Thursday. New versions of the vaccine would need to be rapidly manufactured, tested and distributed.
Officials at Pfizer and Moderna have said that they are prepared to tweak their vaccines as needed and that the process could be complete in as little as six weeks.
Dr. Woodcock declined to reveal any details about how the F.D.A. planned to evaluate the tweaked vaccines, but she said that the agency would probably require smaller and shorter trials than in the original trials run by Pfizer and Moderna.
If the current vaccines prove ineffective against a new variant, “we can’t go through more 30,000 patient trials,” she said. “There are things short of doing full-fledged efficacy trials that we can use to shift or perhaps add components to the existing vaccines.”
Dr. Woodcock said the plans will be released for comment from scientists before they are implemented. The agency may also look to an advisory committee to help guide any changes to existing vaccines.
The F.D.A. also plans to release guidance documents for monoclonal antibody treatments and for tests of the virus. The monoclonal antibody made by Eli Lilly and one of the two antibodies in the cocktail made by Regeneron are powerless against the variant circulating in South Africa, according to a recent study.
“We knew from the very beginning that monoclonals were vulnerable to this type of strain shift,” Dr. Woodcock said.
Laboratory tests for the coronavirus that rely on a technique called P.C.R. seem to detect the new variants accurately, but if that were to change, they could easily be altered, Dr. Woodcock said. But it would be “much more complicated” to determine whether antigen tests that are manufactured en masse were missing variants.
Credit…Andrew Testa for The New York Times
The coronavirus vaccines currently being distributed in Britain are as safe as predicted in clinical trials, the country’s medicine regulator reported on Friday as part of continuous monitoring of the inoculation campaign.
The latest data, released by the Medicines and Healthcare Products Regulatory Agency, an independent body, found that the vaccines “meet strict regulatory standards for safety” and noted that “the benefits continue to far outweigh any known side effects.”
Two vaccines — one from Pfizer-BioNTech and one from AstraZeneca — are in use in Britain, and the vast majority of reported side effects have been mild and short lasting, reflecting a normal immune response, according to the regulator. The safety update report is based on the analysis of data from the beginning of the rollout in December until Jan. 24.
By that date, 5.4 million people had received a first dose of the Pfizer-BioNTech vaccine and another 1.5 million had been given the AstraZeneca vaccine. About three people out of every 1,000 who received a shot reported side effects.
Britain has made huge strides in its vaccine campaign. If it continues at its current rate, the nation is on track to offer an inoculation to all adults by the end of June. As of this week, more than 15 percent of the population had been given at least one coronavirus vaccine shot.
“Vaccines are the most effective way to protect against Covid-19 and save lives and prevent serious complications from this terrible virus,” said June Raine, the chief executive of the regulatory agency in a statement released with the report. “The data we have collected provides further reassurance that the Covid-19 vaccines are safe and continue to meet the rigorous regulatory standards required for all vaccines. We remain confident that the benefits of these vaccines outweigh any risks.”
People with a previous history of severe allergic reactions to any ingredients of the vaccine should not receive it, the regulator noted, but that guidance had already been issued, and no new safety concerns were identified.
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Johnson & Johnson on Thursday submitted to the Food and Drug Administration an application for emergency authorization for its one-dose coronavirus vaccine, putting the company on track to potentially begin shipping it by early March.
The agency has scheduled a meeting with its outside advisory panel, which will vote on Feb. 26 on whether the F.D.A. should authorize the vaccine, according to people familiar with the planning.
That leaves regulators about three weeks to pore over a large and complex application that includes clinical and manufacturing data. A decision on whether to authorize the vaccine could come within days of that meeting.
A similar timeline was used for the review of two-dose vaccines made by Pfizer-BioNTech and Moderna, which were authorized by the F.D.A. in December.
Dr. Paul Stoffels, Johnson & Johnson’s chief scientific officer, said in a statement that the application was a “pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic.” He said Johnson & Johnson was ready to ship the vaccine as soon as the F.D.A. cleared it.
Last week, the company announced promising results from its clinical trial, which showed that the vaccine provided strong protection against Covid-19. The trial found it was 85 percent effective in preventing severe disease in all three regions where the vaccine was studied: the United States, Latin America and South Africa. After 28 days, none of the vaccinated participants who developed Covid-19 had to be hospitalized.
But the results came with an ominous note: The vaccine’s efficacy rate was 72 percent in the United States, but only 57 percent in South Africa, where a highly contagious variant of the coronavirus is driving most cases. Preliminary studies have shown that some coronavirus vaccines are less effective against that variant.
There is also still uncertainty about how many doses Johnson & Johnson will be able to provide in the days and months after getting emergency clearance, when the company may have only about seven million ready, according to federal officials familiar with its production. About 30 million doses, made at facilities in the Netherlands and in Baltimore, could be available by early April.
The company said on Thursday that it expected to supply the 100 million doses it has promised the United States by the end of June.
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European soccer’s hopes that its showpiece tournament, the Champions League, might run as normal — even as the continent grapples with the second wave of the pandemic — have been damaged by confirmation that at least one game will have to be rearranged because of travel restrictions designed to prevent the spread of new variants of the coronavirus.
Liverpool, the reigning English champion, was due to travel to Germany to face RB Leipzig on February 16 in the competition’s first knockout round. On Friday, though, the German government confirmed that it would not offer an exemption for elite sporting events from new legislation — in place until Feb. 17 at the earliest — barring entry to visitors from Britain.
Leipzig is confident that an alternative venue for the game — the first of two, home-and-away legs — can be found, with sites in Budapest; Salzburg, Austria; and even London under consideration. It has until Monday to present the competition’s organizer, UEFA, with a plan, or risk forfeiting the game.
Even if a solution is found, it is unlikely to be the only game affected by the logistical challenge of staging a monthslong, cross-continental competition at a time when international travel is subject to severe restrictions.
Manchester City, the leader of the Premier League in England, is scheduled to play another German team, Borussia Mönchengladbach, the following week; that fixture, too, will have to be relocated if the German government’s measures are extended. Atlético Madrid is also considering alternative venues for its meeting with Chelsea, in case the Spanish authorities decree that a British team cannot enter.
Arsenal’s game with the Portuguese team Benfica, in the second-tier Europa League, is also believed to be under threat because of a British ban on travel to Portugal. Both tournaments resume after a winter hiatus this month, and are not scheduled to reach their conclusions until May.
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LONDON — Britain is on a pace to give the first shot of a two-dose coronavirus vaccine to its entire population by the end of June, if it can avoid supply and logistical issues that threaten to slow one of the world’s fastest rollouts.
The most vulnerable will get their first doses much sooner — probably over the next two weeks — which could drastically reduce deaths. People over 70, nursing home residents and workers, health and social care workers, and those whose health problems make them extremely vulnerable are all on schedule to receive their first vaccine shots before Feb. 15. Together, these groups have accounted for 88 percent of all Covid-19 deaths.
The timeline shows the promise of vaccination as a path out of the deadliest stage of the pandemic in the countries that are moving quickly. Early data out of Israel shows a significant drop in infection after just one shot, and a recent analysis suggested that the AstraZeneca-Oxford vaccine not only provides good protection against illness and death but also has potential to reduce transmission of the virus. Scientists have said that the results are promising but must still be confirmed.
As of Wednesday, Britain had vaccinated more than 15 percent of its population, a higher proportion than anywhere in the world, aside from Israel and the United Arab Emirates. The United States was about 8 percent, and the European Union was below 3 percent.
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The politicization of mask wearing reached fever pitch in Wisconsin on Thursday when the State Legislature repealed Gov. Tony Evers’s statewide mask mandate, only to have the governor issue a new one an hour later.
“Wearing a mask is the most basic thing we can do to keep each other safe,” Mr. Evers said in a recorded video on Twitter. “If the Legislature keeps playing politics and we don’t keep wearing masks, we’re going to see even more preventable deaths and it’s going to take even longer to get our state and our economy back on track.”
The back-and-forth pandemic management was just another example of the partisan politics that have dogged the state during the pandemic, with a Republican-controlled legislature and a Democratic governor.
The Legislature has fought Mr. Evers over his response to the coronavirus since it began. Republicans successfully sued the governor in April to block the extension of a stay-at-home order, discussed removing his public health secretary and amplified protesters’ calls last spring to reopen the state.
The Republican-sponsored repeal would have ended a monthslong requirement to wear masks in many settings that came into effect as part of emergency orders issued by Mr. Evers. Republicans in both chambers had argued that the mandate was unconstitutional and that Mr. Evers cannot issue emergency orders indefinitely.
The original mask order went into effect in August, but has been extended multiple times.
The political roundelay seems likely to continue.
After the governor issued his new mask order on Thursday, State Senator Steve Nass, a Republican, said that he was drafting a new resolution to block the emergency order issued by Mr. Evers and that he was considering filing an emergency action in the Wisconsin Supreme Court.
“The rule of law and the Wisconsin Constitution require Evers to recognize the Legislature ended his emergency powers,” Mr. Nass said in a statement. “Instead, Tony Evers now acts no differently than a dictator in control of a banana republic.”
Doctors and health care professionals have widely condemned the resolution, saying that masks are the best way to prevent the spread of the virus until people are vaccinated. They cited evidence from repeated studies.
Without a statewide mask mandate, local officials would be left to choose whether or not to adopt their own, creating a patchwork of policies across towns and counties.
Before Thursday’s vote, lawmakers sent Mr. Evers a letter saying they would support a more limited mask mandate that applies to places “susceptible to transmission of the virus.”
In a statement, Representative Jim Steineke, a Republican, said Mr. Evers had opted “for continued authoritarian rule.”
“I’m disappointed that the governor would rather continue issuing orders that he knows to be illegal as opposed to working with the Legislature to keep Wisconsinites safe,” said Mr. Steineke.
Nine states, including Florida and South Dakota, do not have a statewide mask requirement, according to the National Academy for State Health Policy.
As of Thursday afternoon, there have been at least 595,756 cases and 6,500 deaths in Wisconsin since the beginning of the pandemic, according to a New York Times database. Around 7.9 percent of the state’s population has received at least one dose of the vaccine, according to a New York Times tally.
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On the N.F.L.’s march to complete a 269-game schedule amid a pandemic, more than 700 players, coaches and other team personnel tested positive for the coronavirus.
Only one of the league’s 32 teams remained untouched by the virus: the Seattle Seahawks. And how they made it through the long season virus-free, in Washington State, is a testament to innovative thinking and procedures.
“They invented a playbook for a safe practice environment at a time when the future was deeply uncertain and people were questioning the wisdom of pro sports starting up,” said Vin Gupta, a pulmonologist who has helped organizations respond to the coronavirus and informally advised the Seahawks.
The Seahawks faced perhaps the most arduous circumstances in the N.F.L. Their 2020 schedule included five cross-country flights, which meant they would log more miles than any other N.F.L. team. And when they were home, the Seahawks trained not far from Kirkland, Wash., the nation’s first coronavirus “hot spot.”
That made them witnesses to the pandemic well before the season kicked off. Sam Ramsden, the team’s director of player health and performance, cared for his wife, Lisa, in March, when, doctors believe, she had Covid-19.
Starting in late spring, Ramsden, Coach Pete Carroll and other team leaders used a combination of pragmatism, flexibility and gamesmanship to duck, bob and weave through the pandemic.
The team’s football operations department created a schedule for who would be tested and when. (Almost 36,000 tests were ultimately given.) Each morning, trainers and others handed out sensors that tracked how close players, coaches and staff members were to one another and for how long. The travel coordinator made sure the team’s drivers were tested and buses were disinfected.
“It was like a band of brothers,” said Ramsden, who often wore a T-shirt that read, “Stay Negative or Stay Home.”
Out-of-town visitors had to be tested immediately upon arriving in Seattle, remain in a hotel for 24 hours and get a second test. Only those who tested negative twice could see a player, coach or staff member.
Beyond common-sense initiatives, Ramsden and Carroll pieced together uniquely Seahawkian ways to keep coronavirus safety a priority. Carroll is known for his mantra messaging — his favorite is “Everything is a competition” — so he told players that each position group would contend for the title of fewest close contacts, hammering home a message that the team was only as secure as its weakest link. (The wide receivers won.)
“I realized that we were going to have to create our own bubble,” Carroll said. “Everything that one person did, everybody did, if we were together and connected.”
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Nearly a year after New Zealand closed its borders to noncitizens, the country said on Friday that it would resume admitting some refugees, with 35 people expected to arrive by the end of February.
New Zealand’s refugee program has effectively been on hold since its borders closed in March. Only 50 people who arrived as part of an “emergency priority” program have been permitted entry since October, the Immigration Department said in a statement.
“With health protocols in place and safe travel routes, we are ready to welcome small groups of refugee families as New Zealand residents to this country, to begin their new lives,” Fiona Whiteridge, the department’s general manager of refugee and migrant services, said in the statement.
New Zealand has all but eliminated local transmission of the coronavirus and now imposes almost no restrictions on daily life. The country has reported 2,315 cases and 25 deaths since the start of the pandemic.
People arriving in New Zealand, including refugees, must spend two weeks quarantining in one of 32 hotels that have been repurposed as isolation facilities. The hotels, which are booked out until June, have become a source of contention for overseas New Zealanders who face lengthy waits for spots.
Border closures and other pandemic-related measures have slowed the global process of refugee resettlement to a crawl. Only 22,700 refugees, out of nearly 1.5 million displaced people worldwide, were resettled through the United Nations refugee agency in 2020, the lowest figure in almost two decades, according to the agency’s data.
At the same time, tens of thousands of people have been displaced by conflict in Central Africa and Yemen, among other places. Many refugee camps have faced funding cuts or increasingly cramped conditions amid coronavirus outbreaks. In September, frustrated migrants at a camp on the Greek island of Lesbos set fires in protest of squalid lockdown conditions, accidentally destroying thousands of tents and leaving 12,000 migrants homeless.
President Biden is expected this week to announce an increase in the number of refugees admitted to the United States each year, a cap that former President Donald J. Trump steadily lowered from 110,000 people a year to just 15,000. But officials and experts have warned that the country’s resettlement system, stripped of personnel and weakened by the coronavirus, lacks the necessary resources to cope with a significant increase in the quota.
From 1987 to 2018, New Zealand had an annual refugee quota of just 750 people a year. The government announced last summer that it would raise its refugee quota from 1,000 to 1,500.
Still, New Zealand does not expect to fill its quota of 1,500 places this year because of the pandemic, a spokeswoman for the Immigration Department said.
In other news:
A snap lockdown in Perth, Australia, was scheduled to end on Friday evening after a fifth consecutive day in which no new coronavirus cases were recorded. The lockdown was brought in on Sunday after a hotel quarantine worker tested positive, shuttering Perth, Australia’s fourth-largest city, and two nearby regions, Peel and South West. The case was the first that the state of Western Australia had found outside quarantine in almost 10 months. Earlier this week, some of the more than two million people under stay-at-home orders were forced to break restrictions as they fled a wildfire that was ravaging the city’s outskirts.
Pfizer has withdrawn its application for emergency-use authorization in India for the coronavirus vaccine that it developed with the German company BioNTech.
The U.S. pharmaceutical giant said on Friday that it decided to pull out of the approval process after meeting with regulators from India two days earlier.
“Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” the company said in a statement.
“Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future,” it added.
India last month authorized a vaccine developed by the University of Oxford and AstraZeneca, and another made by the Indian company Bharat Biotech. Days later, it began the world’s largest inoculation campaign.
The Serum Institute of India, the world’s largest vaccine manufacturer, is churning out huge batches of the AstraZeneca vaccine for the government and for export through Covax, an international group that negotiated vaccine purchases for less wealthy countries. It has also signed bilateral deals with a handful of countries.
If a manufacturer seeks approval in India for a foreign-made vaccine, Indian regulators require a domestic clinical trial to determine that the drug is safe and produces an immune response in local patients. Pfizer had not undertaken such a trial and did not intend to, according to the regulator’s minutes from the meeting on Wednesday.
More than 4.4 million people in India had received a shot of one of the two approved vaccines as of Friday.
India has reported nearly 11 million cases during the pandemic, the world’s second-highest tally, after the United States, but new coronavirus infections and deaths have fallen sharply nationwide in recent weeks.
A coronavirus antibody survey conducted in January in New Delhi, the Indian capital, estimated that more than half of the city’s 20 million residents had already had the coronavirus. And a government survey released on Friday estimated that one in five people in the country of 1.3 billion had contracted the coronavirus by mid-December.