In recent days, coronavirus cases have been dropping steadily across the United States, with hospitalizations falling in concert. But health officials are growing increasingly concerned that quickly circulating variants of the virus could cause new surges of cases faster than the country is managing to distribute Covid-19 vaccines.
Public health experts likened the situation to a race between vaccination and the virus’s new variants — and the winner will determine whether the United States is approaching a turning point in its battle against the coronavirus, now entering a second year.
“We’re definitely on a downward slope, but I’m worried that the new variants will throw us a curveball in late February or March,” said Caitlin M. Rivers, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health.
Nationwide, new coronavirus cases have fallen 21 percent in the last two weeks, according to a New York Times database, and some experts have suggested this could mark the start of a shifting course after nearly four months of ever-worsening case totals.
This week, the University of Washington’s Institute for Health Metrics and Evaluation, which puts out a predictive model that is widely used for planning, including by some government agencies, released a projection saying new cases in the United States would decline steadily from now on.
“We’ve been saying since summer that we thought we’d see a peak in January and I think that, at the national level, we’re around the peak,” said Dr. Christopher J.L. Murray, director of the institute. Still, Dr. Murray cautioned that variants of the virus could “totally change the story.”
Health officials warned that they have little foresight into what the rest of the winter and spring will bring. President Biden’s new administration has vowed to impose speed and order to what has been a slow, bumpy rollout of vaccinations, in which some 15 million people have received at least one dose of a Covid-19 vaccine. But it is not clear how many vaccines will be available in cities across the country in the coming weeks. The public should still wear masks, officials say, avoid large gatherings and sign up to be vaccinated as soon as they are eligible.
Some experts, looking abroad at how new viral variants sent cases surging in Britain, Ireland, South Africa and northern Brazil, said the United States could merely be in a lull before a new spike begins. Even after an epidemic’s peak, it remains dangerous: Sometimes just as many people are infected after the peak as were before.
Nicolas A. Menzies, one of several scientists running the Prevention Policy Modeling Lab at Harvard’s T.H. Chan School of Public Health, which tracks levels of herd immunity, said he felt it was “more probable than not” that infections would climb again.
It is important to spot regions where variant strains are turning up, he said, since they would be the most likely to have early surges. Thus far, the variant that has been prevalent in Britain and a new variant have been found most often in Southern California and Florida, according to the Centers for Disease Control and Prevention. Cases are slowly declining in both regions. But it’s “still too early to tell,” he said.
The country still continues to average nearly 190,000 new cases each day, more than any point of the pandemic before December. Deaths from the coronavirus are still extraordinarily high, with more than 4,300 deaths announced on Wednesday, the second-highest daily total of the pandemic.
New York State expected to run out of its supply of coronavirus vaccines before the end of Friday, but more doses would arrive in the coming days, Gov. Andrew M. Cuomo announced at a news conference.
“We will — by the end of today fully — utilize all of the dosages that have been delivered,” Mr. Cuomo said Friday.
Ninety-seven percent of New York State’s vaccine inventory, accumulated over the past five weeks, has been administered, the governor noted, and a total of 28,000 first doses were left in inventory Friday morning. Mr. Cuomo added that the state inoculates roughly 80,000 people per day.
Vaccines have been slowly rolling out in the United States and states are dealing with shortages just as new virus variants, some more contagious, are spreading.. The C.D.C. has warned that the more transmissible variant first discovered Britain, which is thought to be 50 percent more contagious, might become the dominant source of infection in the United States by March. Although public health experts are optimistic that the existing vaccines will be effective against that variant, known as B.1.1.7, it may drive up the infection rate if enough people remain unvaccinated.
So far, New York State has found 25 confirmed cases of that variant, but no cases of the variants found in South Africa or Brazil, Mr. Cuomo said.
Mr. Cuomo urged vaccine providers to only schedule appointments based on the number of doses they know they will receive.
“Some providers think if they schedule appointments ahead of time, people will feel more comfortable — not if you cancel those appointments,” Mr. Cuomo said. “So don’t schedule any appointment unless you know you have an approved state allocation coming, and appointments will be honored. “
Some parts of the state — including New York City and the Rochester and Buffalo areas — have had to delay vaccination appointments scheduled for this week because of supply issues.
New York State should receive 250,400 vaccine doses for use next week, with some arriving Friday. If supply allowed, New York State could inoculate 700,000 people each week, Mr. Cuomo said.
On Friday afternoon, Mayor Bill de Blasio sent a letter to President Biden requesting more doses and the “flexibility” to use second doses to vaccinate more New Yorkers sooner.
“While maintaining a secure reserve of second doses (two-week supply), the City is seeking the flexibility during this time to temporarily use the remaining supply of second doses to bridge the gap to a time of increased production, replenishing the second dose supply as production ramps,” Mr. de Blasio’s letter to Mr. Biden read.
But it was not immediately clear whether the Biden administration could guarantee any increase in supply. Federal health officials and corporate executives agree that it will be impossible to increase supply before April because of the lack of manufacturing capacity. And the current vaccination effort, which had little central direction under the Trump administration, has so far sown confusion and frustration. Some areas are complaining they are running out of doses, while others have unused vials sitting on shelves.
When asked about Mr. de Blasio’s request and New York’s dwindling supply of doses during Friday’s new conference, Jen Psaki, the White House press secretary, said the administration has “advocated for releasing additional access from the reserves, but we have really deferred to health and medical experts” about whether it was safe to delay second doses past the tested three to four-week window. She added that the Biden administration has “asked the C.D.C. to look into what the options are.”
According to a senior administration official, Pfizer-BioNTech and Moderna are on track to deliver up to 18 million doses a week. Together, they have pledged to deliver 200 million doses by the end of March.
A third vaccine maker, Johnson & Johnson, is due to report the results of its clinical trial shortly. If approved, that vaccine would also help shore up production. If all of that supply were used, the nation could average well over two million shots a day.
In April and afterward, the outlook brightens. Pfizer and Moderna have each committed to supply another 100 million doses by the end of July; the companies may be able to provide even more. A week ago, Pfizer and BioNTech, its German partner, increased their global production target for the year to two billion doses from 1.3 billion doses.
The Centers for Disease Control and Prevention has quietly changed its recommendations for coronavirus immunizations to allow patients to switch the authorized vaccines between the first and second doses in “exceptional situations,” and to extend the interval between doses to six weeks, even though such changes have not been studied in large clinical trials.
The new guidelines were posted on the agency’s website on Thursday with little public notice. With the possibility of vaccine shortages on the horizon and little expectation that supply can be increased before April, the changes may offer a way to vaccinate more people — a high priority for President Biden, who outlined his national Covid-19 strategy on Thursday.
A C.D.C. spokeswoman, Kristen Nordlund, said the agency’s “intention is not to suggest people do anything different, but provide clinicians with flexibility for exceptional circumstances.”
Dr. Anthony S. Fauci, the president’s special adviser for Covid-19, has repeatedly advised against delaying the second dose or making any other changes in vaccination protocol without the data to support them. But on Friday, he seemed open to delaying second doses, at least for short periods.
“What the C.D.C. is saying, sometimes, the situation is stressed where it’s very difficult to be exactly on time,” Dr. Fauci told CNN. “So we’re saying, you can probably do it six weeks later, namely, two additional weeks. Quite frankly, immunologically, I don’t think that’s going to make a big difference.”
Earlier this month, Britain quietly updated its vaccination playbook to allow for a mix-and-match vaccine regimen if the second dose of the vaccine a patient originally received isn’t available, or if the manufacturer of the first shot isn’t known. Some scientists questioned the move at the time, saying Britain was gambling with its new guidance.
In the United States, two vaccines have emergency federal authorization — one by Pfizer and BioNTech, and the other by Moderna — and both rely on the same mRNA technology and call for two doses. Until now, the C.D.C. has strictly adhered to the recommendations from its Advisory Committee on Immunization Practices, which specifically stated that the vaccines were not to be mixed.
The updated C.D.C. guidance still states that the authorized vaccines are “not interchangeable with each other or with other Covid-19 vaccine products.” The agency put the word “not” in bold on its website, and noted that the safety and efficacy of mixing doses has not been studied.
But “in exceptional situations in which the first-dose vaccine product cannot be determined or is no longer available,” the guidelines added, any available mRNA vaccine can be used for the second dose.
With respect to dosing, the guidance says that the second dose should be administered as close as possible to the recommended interval — three weeks for the Pfizer-BioNTech vaccine and four weeks for Moderna. But if that is “not feasible,” the agency wrote, the interval between doses may be extended to six weeks.
The pace of vaccination is critical not just to curbing disease and death, but also to heading off the impact of more infectious forms of the virus. The C.D.C. has warned that one variant, which is thought to be 50 percent more contagious, might become the dominant source of infection in the United States by March.
Although public health experts are optimistic that the existing vaccines will be effective against that variant, known as B.1.1.7, it may drive up the rate of new cases if enough people remain unvaccinated.
At a White House briefing on Thursday — his first since November — Dr. Fauci said that experts are particularly concerned about new variants of the virus in South Africa and Brazil, which have not yet reached the United States. He said vaccines still appear effective against those variants, but the variants may sidestep the immune system to some degree, making it all the more urgent for people to be vaccinated.
“Replicating viruses don’t mutate unless they replicate,” Dr. Fauci said, “and if you can suppress that by a very good vaccine campaign, then you can actually avoid this deleterious effect that you might get from the mutations.”
Federal health officials and corporate executives agree that it will be impossible to increase the immediate supply of vaccines before April because of lack of manufacturing capacity. And the current vaccination effort, which had little central direction under the Trump administration, has so far sown confusion and frustration. Some localities are complaining they are running out of doses, while others have unused vials sitting on shelves.
According to a senior administration official, Pfizer-BioNTech and Moderna are on track to deliver up to 18 million doses a week. Together, they have pledged to deliver 200 million doses by the end of March.
A third vaccine maker, Johnson & Johnson, is due to report the results of its clinical trial shortly. If approved, that vaccine would also help shore up production. If all of that supply were used, the nation could average well over two million shots a day.
In April and afterward, the outlook brightens. Pfizer and Moderna have each committed to supply another 100 million doses by the end of July; the companies may be able to provide even more. A week ago, Pfizer and BioNTech, its German partner, increased their global production target for the year to two billion doses from 1.3 billion doses.
The Hong Kong authorities said on Saturday that they had locked down part of a densely packed neighborhood and started to test everyone there, one of the most dramatic measures the Chinese territory has taken since the coronavirus surfaced there last winter.
The local government said on Saturday that it had restricted access to some parts of the Jordan district and that people there would be prevented from leaving until they had been tested, the first such lockdown in Hong Kong. Battalions of police officers were seen guarding the perimeter as health workers in head-to-toe protective gear walked inside.
About 200 buildings in the Jordan area were affected, and more than 1,700 police and other officers were expected to be deployed, The South China Morning Post reported. Jordan — which includes a mix of office buildings, residential towers and dilapidated walk-ups — is one of Hong Kong’s most crowded districts.
Officials said that 162 confirmed coronavirus cases had been recorded across 56 buildings in Jordan in the first 20 days of January.
The government plans to finish testing residents in the restricted area within 48 hours, in time for residents to get to work on Monday morning. In a statement, it described the measures as an attempt to “completely cut the local transmission chains and ease residents’ worries and fear.”
During much of the pandemic, the daily caseload in Hong Kong, a financial hub of 7.5 million people, has been relatively low compared with other cities its size. Even now, it has recorded fewer than 10,000 total coronavirus cases, along with 168 deaths.
But new infections in recent months have prompted the government to revert to its harshest social-distancing measures and to require mandatory testing in some areas, including Jordan. As of Saturday, Hong Kong was averaging 55 daily cases over the past week.
Walgreens, one of the big pharmacy chains tapped by federal officials to help vaccinate the residents and staff of nursing homes and other long-term care centers against Covid-19, acknowledged on Friday that the rollout had not gone as smoothly or as quickly as had been promised.
The company said it had administered more than 1 million shots across the country to long-term care residents. “We’re already seeing the impact of those vaccinations,” noted Rina Shah, a group vice president at Walgreens.
Federal officials and states have made vaccinating the roughly three million people who live in long-term care facilities and those who care for them a priority group for inoculation. Long-term care residents are particularly vulnerable, and these facilities account for nearly 40 percent of the nation’s Covid-19 deaths.
Despite an optimistic timetable set by health officials in the Trump administration for how quickly people in these facilities would be vaccinated, patients, families and employees have expressed growing frustration over the slow pace of inoculations.
CVS Health is the other major drugstore chain involved in administering Covid vaccines at nursing homes, and said it had vaccinated some 1.6 million residents and staff of long-term care facilities. Walgreens said it would schedule three visits to each facility to ensure that people receive both doses.
“It’s been a monumental effort,” Dr. Shah said. Many facilities had trouble scheduling the vaccinations, and have encountered some hesitancy, especially among staff, toward getting the shots, she added.
But broadening outreach to inoculate people on site, inside drugstore locations, isn’t likely to be entirely in place by late February as had initially been planned. Earlier this week, Dr. Rochelle Walensky, the new director of the Centers for Disease Control and Prevention, warned that the timetable seemed unrealistic and noted the need for sufficient supply and the need to address accessibility and vaccine hesitancy.
Walgreens said it was working closely with federal and state officials to determine who would be eligible for a shot at one of its pharmacies, but acknowledged the process for Americans to figure out how to get vaccinated was “confusing” and “not easy to navigate.” Unlike flu shots, the Covid-19 vaccines would only be given by appointment.
Pfizer, after discovering it could squeeze an extra vaccine dose out of vials that were supposed to contain only five, plans to count the surprise sixth dose toward its previous commitment of 200 million doses of Covid vaccine by the end of July. That means it will be providing fewer vials than once expected for the United States.
And yet, pharmacists at some vaccination sites say they are still struggling to reliably extract the extra doses, which require the use of a specialty syringe.
For weeks, Pfizer executives pushed officials at the Food and Drug Administration to change the wording of the vaccine’s so-called emergency use authorization so that it formally acknowledged that the vials contained six doses, not five.
The distinction was critical: Pfizer’s contract with the federal government requires that it be paid by the dose.
At one point, Pfizer executives lashed out at the top federal vaccine regulator over the government’s reluctance to budge on the request, according to people familiar with the discussions who were not authorized to discuss them.
On Jan. 6, Pfizer got what it wanted. The F.D.A. changed the language in its fact sheet for doctors to confirm that the vials contain a sixth dose. The change mirrors similar labeling updates by the World Health Organization and the F.D.A.’s counterpart in the European Union.
Company officials, including the chief executive, Dr. Albert Bourla, have said that the sixth dose allows Pfizer to stretch its supply of scarce vaccine even further — it was one factor, for example, in the company’s new estimates that it will be able to manufacture two billion doses for the world this year, instead of the 1.3 billion it had originally planned.
The U.S. negotiations come at a particularly harrowing time, as the Biden administration is said to be discussing the purchase of a third round of 100 million doses of Pfizer’s vaccine later in the year. The country is racing to vaccinate as many people as possible before more contagious virus variants become widespread, potentially spurring a wave of new hospitalizations and deaths.
Pfizer announced Friday that it has agreed to sell up to 40 million doses of its Covid-19 vaccine to Covax, a global initiative organizing the purchase of vaccines for 92 poor countries and dozens of other nations, and that a small portion of those doses would start rolling out the first quarter of this year.
The agreement, which has not yet been finalized, comes amid an extraordinary gap in access to the vaccines around the world.
Wealthy countries have laid claim to more than half the vaccine doses that could come on the market by the end of the year, in some cases lining up enough doses to immunize their entire populations multiple times over, and are already rolling out large quantities of the Pfizer and Moderna vaccines. In stark contrast, most poor countries may receive, through Covax, only enough doses to vaccinate 25 percent of their populations this year, and have so far not had access to any vaccines.
In a news conference with the heads of the World Health Organization and two of the organizations leading and implementing Covax, Pfizer’s chief executive, Albert Bourla, said the agreement was an example of the company being “firmly committed to working toward equitable and affordable prices of Covid-19 vaccines for people around the world.” The doses for poor countries will be sold at nonprofit prices, he said.
But it’s unclear exactly when most of those doses will be made available. Gavi, one of organizations running Covax, said Pfizer would provide one million of the doses by the end of March, but could not say when the 39 million doses would materialize. Pfizer refused to provide a timeline other than to say that distribution would occur throughout 2021.
“Details on schedule will not be made public at this time,” Sharon Castillo, a spokeswoman for Pfizer, said in an email.
Some wealthy countries that have deals with Pfizer have complained they weren’t getting access to doses as quickly as they liked. And the company has announced delays for some of its orders because it needed to upgrade its Belgian factory. Pfizer has said it will be able to follow through with all of its commitments. And Mr. Bourla said Friday that it was on track to produce 2 billion doses by the end of the year.
Covax also expects to roll out as many as 150 million doses of the AstraZeneca vaccine to its participating countries in the first quarter. Two separate manufacturers of that vaccine first need to receive the necessary regulatory approvals, which could happen as early as February, Dr. Seth Berkley, chief executive of Gavi, said on Friday. Covax also has agreements to purchase Novavax, Sanofi, and J&J vaccines, which have not yet completed their clinical trials. The initiative expects to eventually receive 2.3 billion vaccine doses this year, with 1.8 billion going to the 92 poor countries, Dr. Berkley said.
The first doses distributed through Covax will go to health care workers, with other priority groups getting access down the line.
The United States had been absent from Covax, which has pulled in financial support from the European Union, Britain and Canada, among other countries. But earlier this month, the U.S. approved $4 billion for the initiative. Thursday, addressing the World Health Organization, Dr. Anthony Fauci, President Biden’s chief medical adviser for the pandemic, said the United States would become an official member of Covax.
For weeks, Britain has reported alarming coronavirus death numbers, hospitals have continued to fill up, and fears have risen that it will take months to control the spread of a more transmissible variant first detected in the Kent region of England last year.
On Friday, Prime Minister Boris Johnson said at a news conference the new variant may also be associated with a slightly higher chance of death, even as he acknowledged it was too soon to be sure, and his own scientific advisers urged restraint in interpreting preliminary evidence.
Patrick Vallance, the government’s chief scientific adviser, said that the data indicating an increase in the risk of death in those infected with the new variant are preliminary and based on small numbers. The absolute risk of dying from Covid-19 still remains low.
“That evidence is not yet strong, it’s a series of different bits of information that come together to support that,” Mr. Vallance said.
Referring to the country’s overstretched National Health Service, Mr. Johnson said that “it’s largely the impact of this new variant that means the N.H.S. is under such intense pressure.”
Yet as Britain’s top health authorities have warned about grim weeks ahead, the latest vaccination figures have offered a glimmer of hope: Nearly 5.5 million people had received a first vaccine dose in Britain as of Friday, according to government data. That amounts to about 8 percent of the population.
By comparison, the United States has vaccinated around 4.5 percent of its population, and most European countries have vaccinated less than 2 percent.
Fewer than 500,000 people in Britain have received a second injection, as the National Health Service is prioritizing first injections and second doses are being given up to 12 weeks after the first. England’s chief medical officer, Chris Whitty, said the first shot of the Pfizer-BioNTech and Astra Zeneca vaccines gave a “great majority of the protection.”
Since the authorities imposed new lockdown restrictions in England this month, Britain has reported its highest daily death figures. The country remains one of the worst-hit in Europe. and the authorities have said that England’s lockdown could remain in place throughout the spring.
“We will have to live with the coronavirus, one way or another, for a long time to come,” Mr. Johnson said on Friday.
The situation is so bleak that, according to British news reports, the authorities are considering offering £500 (about $680) to anyone testing positive for the virus to help them stay in quarantine for the full 10 days, which many currently do not.
There are also fears that cuts in vaccine deliveries from Pfizer, which is retooling a major manufacturing plant in Belgium, may slow down the vaccination campaign, and that variations in vaccination rates are putting some areas of the country at a disadvantage.
In Britain, a racecourse, rugby fields and religious buildings have been turned into vaccination centers, and shots are also being given at 1,200 hospitals and medical offices. More than two million people were vaccinated in the past seven days, twice as many as two weeks ago.
At that rate, Britain could still fall short of its goal to vaccinate 13.9 million people by mid-February, but the authorities have said they can reach the target if they continue to increase the pace.
After issuing a series of executive orders on his first full day in office and pledging a “full-scale wartime effort” to combat the coronavirus pandemic, President Biden on Friday continued apace with two more executive orders aimed at steering additional federal aid to families struggling to afford food amid the pandemic and helping workers stay safe on the job.
Mr. Biden, who has vowed to use the power of the presidency to help mitigate economic fallout from the pandemic, directed the Treasury Department to find ways to deliver stimulus checks to millions of eligible Americans who have not yet received the funds.
Mr. Biden also signed a second executive order that will lay the groundwork for the federal government to institute a $15 an hour minimum wage for its employees and contract workers, while making it easier for federal workers to bargain collectively for better pay and benefits.
“The crisis is only deepening,” Mr. Biden said during remarks at the White House, calling the need to help those out of work and unable to afford enough food “an economic imperative.”
“We have the tools to help people. So let’s use the tools. All of them. Now,” he said.
The executive actions are part of an attempt by Mr. Biden to override his predecessor, former President Donald J. Trump, on issues pertaining to workers, the economy and the federal safety net. The orders Mr. Biden signed on Friday are a break from the Trump administration’s attempts to limit the scope of many federal benefits that Trump officials said created a disincentive for Americans to work.
The orders follow an ambitious raft of measures Mr. Biden took on his first full day in office, on Thursday. He signed a string of executive orders and presidential directives aimed at combating the worst public health crisis in a century, including new requirements for masks on interstate planes, trains and buses and for international travelers to quarantine after arriving in the United States.
During the presidential campaign, he had called for using the Korean War-era law to increase the nation’s supply of essential items like coronavirus tests and personal protective equipment. On Thursday, he signed an executive order directing federal agencies to make use of it to increase production of materials needed for vaccines.
With thousands of Americans dying every day from Covid-19, a national death toll that exceeds 400,000 and a new, more infectious variant of the virus spreading quickly, the pandemic poses the most pressing challenge of Mr. Biden’s early days in office. How he handles it will set the tone for how Americans view his administration going forward, as Mr. Biden himself acknowledged.
In a 200-page document released earlier Thursday called “National Strategy for the Covid-19 Response and Pandemic Preparedness,” the new administration outlined the kind of centralized federal response that Democrats have long demanded and that Mr. Trump had refused.
But the Biden plan is in some respects overly optimistic and in others not ambitious enough, some experts say. It is not clear how he would enforce the quarantine requirement. And his promise to inject 100 million vaccines in his first hundred days is aiming low, since those 100 days should see twice that number of doses available.
Efforts to untangle and speed up the distribution of vaccines — perhaps the most pressing challenge for the Biden administration that is also the most promising path forward — will be a desperate race against time, as states across the country have warned that they could run out of doses as early as this weekend.
Maggie Astor and Alan Rappeport contributed reporting.
transcript
transcript
European Union Wants Vaccinations to Be ‘Accelerated’
European Union leaders on Thursday expressed frustration over the coronavirus vaccine rollout and urged the bloc to accelerate the delivery of more vaccine doses.
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“Leaders want vaccination to be accelerated, and in this respect, commitments on deliveries made by companies must be respected. Leaders reaffirmed the vaccines should be distributed at the same time, and must be on pro rata population basis. And we reaffirmed the need to have a close follow-up of the vaccination process.” “Indeed, across Europe, the health situation remains very serious. And yes, there is reason for hope because of the vaccines. But there’s also strong reason for concern with the new variants we are observing. We must therefore remain focused, and we must remain determined in our response. We must ensure delivery of vaccines from the companies. And we must ensure the quick and efficient use of the available vaccines.”
AstraZeneca informed the European Union on Friday that it would deliver fewer doses of the vaccine it created with the University of Oxford than planned, a fresh blow to the bloc’s efforts to ramp up its sluggish inoculation efforts.
The news comes a week after Pfizer abruptly notified the European Union and several countries outside of the United States that deliveries of its vaccine would be heavily disrupted until the second week of February because of upgrades being made to its facility in Puurs, Belgium, in order to ramp up output.
AstraZeneca said that it still intended to get “tens of millions of doses” to the bloc’s 27 member states in February and March, but that the deliveries would “be lower than originally anticipated due to reduced yields at a manufacturing site within our European supply chain.” AstraZeneca noted that it would eventually ramp up production but did not provide a timeline.
The European health commissioner, Stella Kyriakides, said that the European Union had “expressed deep dissatisfaction” with the company’s announcement. “We insisted on a precise delivery schedule on the basis of which Member States should be planning their vaccination programs,” she said in a tweet, adding that the bloc needed “predictability and stability of deliveries, and acceleration of the distribution of doses.”
The AstraZeneca vaccine is awaiting approval for use in the European Union. The company applied for authorization on Jan. 12, and the European Medicines Agency, the bloc’s drug regulator, has said it will likely make a decision at a meeting on Jan. 29.
The European Union has come under criticism for being slower than the United States and Britain to authorize coronavirus vaccines, and its member states are lagging behind the two countries in rolling out immunizations. Frustrated countries like Austria have pushed for faster approval of the AstraZeneca vaccine, though that would not mean delivery would be any swifter.
Fifteen people have had a severe allergic reaction, anaphylaxis, after receiving Moderna’s coronavirus vaccine, the Centers for Disease Control and Prevention reported on Friday. The reactions have been rare, occurring at a rate of 2.1 cases per million Moderna doses administered, the agency said.
So far, anaphylactic reactions to the Pfizer-BioNTech Covid vaccine appear somewhat more common: 45 have occurred, with a rate of 6.2 cases per million doses given.
The estimated rates for the two vaccines “may change as additional doses of Covid-19 vaccine are administered and C.D.C. continues to collect more information,” the agency said in a statement. It also said no deaths from the reactions had been reported.
When anaphylaxis occurs, it usually starts within minutes of the injection. Symptoms may include breathing trouble, dropping blood pressure, hives, wheezing, nausea and swelling of the tongue. The condition is life-threatening, and vaccination centers must be ready to provide immediate treatment with a shot of epinephrine and transport patients to hospitals, the agency said in a report published on Friday.
The rates are comparable to those for other vaccines, the agency said, and noted that anaphylaxis “is readily diagnosed, and effective treatments are available.”
The vaccines, combined with measures like masks and social distancing, “are one of the best tools we have to fight the pandemic,” the C.D.C. said.
The published report was based on data from Dec. 21 to Jan. 10, and included only 10 cases of anaphylaxis, out of 4,041,396 first shots of the Moderna vaccine given. But the statement issued on Friday updated the total, including five more cases.
The 10 cases in the published report all occurred in people who had previously had allergic reactions to drugs or foods, including five who had had anaphylaxis before, though not from vaccines. All 10 patients were women, ages 31 to 57, which may be partly because more women than men received the vaccine. But the report also noted that 80 percent of anaphylactic reactions to other vaccines reported to the government tracking system were in adult women.
All 10 women received epinephrine. Six were hospitalized, including five in intensive care, four of whom had to be intubated. The published report said follow-up information was available for only eight of the 10, and that those eight “were discharged home or had recovered” at the time their information was submitted.
The report also described 43 allergic reactions that occurred within 24 hours of the vaccination and were not anaphylaxis, with symptoms like rashes, itching, itchy sensations in the mouth and throat, sensations of throat closure and respiratory symptoms. Most of those reactions, 91 percent, occurred in women. Sixty percent of the reactions were considered nonserious.
The report was based on data from the government’s Vaccine Adverse Event Reporting System, which relies on health care providers and patients to submit information.
The Moderna and Pfizer-BioNTech vaccines are the only ones authorized for emergency use in the United States. They are similar, consisting of genetic material called mRNA encased in minute fatty bubbles known as lipid nanoparticles.
A year into the worst global health crisis in a century, and much of the world feels frozen in place.
Countries that had loosened up their frontiers after imposing restrictions earlier in the pandemic are now tightening them again, worried about new, more contagious variants of the coronavirus. Some are tightening travel restrictions or imposing new rules on travelers.
In the United States, President Biden signed a series of executive orders aimed at thwarting the pandemic, including a requirement that travelers coming from abroad quarantine after arriving in the United States, though it is not clear how that will be enforced.
He also signed an order requiring masks for many kind of interstate travel. Travelers will have to wear masks in airports, as well as on commercial airplanes, trains and public maritime vessels, including ferries, and on certain other modes of public transportation like intercity buses.
While the United States is merely making traveling less hospitable, countries in Europe are going further, with plans to tighten its borders.
European Union leaders agreed to limit nonessential travel within the bloc and from nonmember countries in a bid to slow the spread of two variants that are already present in multiple countries in the region.
Leaders from the bloc’s 27 nations, meeting via teleconference late Thursday, agreed to take coordinated action in response to the variants, which scientists believe originated in Britain and in South Africa and appear to be significantly more contagious than others.
Some E.U. countries have already limited access for their neighbors, a move that is generally avoided in the principally borderless bloc but has been tolerated because of the extraordinary circumstances.
After the conference call, President Emmanuel Macron’s office announced that France would make PCR tests compulsory for all travelers coming from other European Union countries, starting Sunday at midnight. The tests must be done no later than 72 hours before departure.
In Britain, which completed its exit from the bloc on Jan. 1, flights from Latin America and Portugal were banned over fears of a variant first discovered in Brazil. Flights from South Africa, where another highly contagious variant was discovered last month, are also banned.
In all, Britain itself is isolated from more than a dozen countries.
And in China, where the virus spiraled out of control during the Chinese Lunar New Year in 2020, officials are discouraging travel over the holiday, which begins Feb. 12. The new year is usually the occasion for the largest annual human migration in the world.
Beijing is restricting the number of passengers allowed on public transit and has extended the quarantine period for travelers returning from overseas. Schools have been closed, and the authorities said on Wednesday that people returning to rural areas for the holiday must test negative for the virus and quarantine at home for 14 days.
Ma Xiaowei, the National Health Commission minister, has blamed the recent outbreak on travelers returning from overseas and on workers handling imported food.
Three locally transmitted coronavirus cases were confirmed on Thursday in Shanghai, China’s largest city, the first in the city in about two months.
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transcript
Fauci Promises Coronavirus Response Based on Science
Dr. Anthony S. Fauci, President Biden’s chief medical adviser for Covid-19, addressed reporters from the White House on Thursday, and warned the nation was “still in a very serious situation” because of the pandemic.
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First of all, obviously, we are still in a very serious situation. I mean, to have over 400,000 deaths is something that, you know, is unfortunately historic in the very in the very bad sense. When you look at the number of new infections that we have, it’s still at a very, very high rate. Hospitalizations are up. There are certain areas of the country, as I think you’re all familiar with, which are really stressed from the standpoint of beds, from the standpoint of the stress on the health care system. However, when you look more recently at the seven-day average of cases, remember, we were going between three and 400,000, and two and 300,000. Right now, it looks like it might actually be plateauing. One of the things that we’re going to do is to be completely transparent, open and honest. If things go wrong, not point fingers, but to correct them and to make everything we do be based on science and evidence. It was very clear that there were things that were said, be it regarding things like hydroxychloroquine hydroxychloroquine and other things like that, that really was an uncomfortable because they were not based on scientific fact. I can tell you, I take no pleasure at all in being in a situation of contradicting the president. So it was really something that you didn’t feel that you could actually say something, and there wouldn’t be any repercussions about it. The idea that you can get up here and talk about what you know, what the evidence, what the science is, and know, that’s it. Let the science speak. It is somewhat of a liberating feeling.
Dr. Anthony S. Fauci, the longtime government infectious disease expert, has returned to the White House spotlight, offering both reassurances and warnings.
Dr. Fauci, shunned by President Donald J. Trump but embraced by President Biden, appeared in the White House briefing room on Thursday to speak to reporters about the pandemic.
He did not mince words, and appeared to enjoy feeling that he no longer had to.
“Historic, in the very bad sense,” was his take on the pandemic, as total cases in the United States edged near the 25 million milestone.
He warned that the nation was “still in a very serious situation,” even if the number of cases appears to be plateauing, pointing to more infectious variants of the virus that could cause spikes in cases in the coming months.
Dr. Fauci, who is now Mr. Biden’s chief medical adviser for the pandemic, said that the vaccines now in use in the United States appeared effective against the new variants so far.
And even if variants do end up diminishing the vaccines’ effectiveness, the drugs will still provide good protection, he said, citing their considerable “cushion effect.”
If need be, he said, the vaccines can be modified.
“That is not something that is a very onerous thing,” he said. “We can do that given the platforms we have.”
The federal government and the states have stumbled, however, in vaccinating Americans on a large scale. And it is more important than ever to do so, Dr. Fauci said. The more viruses spread, the more opportunities they have to mutate.
“If you can suppress that by a very good vaccine campaign, then you could actually avoid this deleterious effect that you might get from the mutations,” he said.
If the United States can vaccinate 70 percent to 85 percent of the population by the middle or end of the summer, he predicted, “by the time we get to the fall, we will be approaching a degree of normality.”
On Thursday, speaking of the problems ahead without a president glowering over his shoulder, Dr. Fauci appeared to be enjoying his own return to normality. Asked how it felt, he paused a beat or two before delivering his review.
“It is somewhat of a liberating feeling,” he said.
An unusual experiment to prevent nursing home staff members and residents from infection with the coronavirus has succeeded, the drug maker Eli Lilly said on Thursday.
A drug containing monoclonal antibodies — laboratory-grown virus fighters — prevented symptomatic infections in residents who were exposed to the virus, even the frail older people who are most vulnerable, according to preliminary results of a study conducted in partnership with the National Institutes of Health.
The researchers found an 80 percent reduction in infections among residents who got the drug compared with those who got a placebo, and a 60 percent reduction among the staff, Eli Lilly said.
The study included 965 participants at nursing homes: 666 staff members and 299 residents. The data have not yet been peer-reviewed or published. The company expects to present the findings at a future medical meeting and to publish them in a peer-reviewed journal, but did give a timeline.
The drug, bamlanivimab, has an emergency-use authorization from the Food and Drug Administration that allows it to be provided to symptomatic patients early in the course of their infection. This study sought to establish whether the drug could stop infections before they started.
It was an unusual experiment: In trucks equipped with mobile labs, medical workers sped to nursing homes the moment a single infection was detected there. Then they set up temporary infusion centers to administer the drug.
Although the study has ended, Dr. Daniel Skovronsky, Eli Lilly’s chief scientific officer, said the company would continue to rush to nursing homes in its study network when an outbreak is detected.
“Everyone will get the drug,” he said.
The comedian Dave Chappelle has tested positive for the coronavirus and has canceled several upcoming shows at the Stubb’s Waller Creek Amphitheater in Austin, Texas, a spokeswoman told The Associated Press.
The venue’s website showed cancellations for four shows through Tuesday.
Mr. Chappelle, who had been hosting socially distanced shows in Ohio since June, with rapid testing for audience members and himself, moved his shows to Austin during the winter, the spokeswoman said.
Mr. Chappelle is asymptomatic and quarantining, she said.
Joe Rogan, a comedian and podcast host who had been scheduled to perform with Mr. Chappelle on Friday and Saturday, apologized for the cancellations. “We’ll reschedule them as soon as we can,” Mr. Rogan said early Friday in an Instagram post.
Mr. Chappelle’s positive test result came about three months after he hosted “Saturday Night Live” and commented on the pandemic in a monologue that also heavily touched on the presidential election.
“Do you guys remember what life was like before Covid?” Mr. Chappelle said. “I do. There was a mass shooting every week. Anyone remember that? Thank God for Covid. Someone had to lock these murderous whites up and keep them in the house.”
The Hungarian government has for months lauded the opportunities of Russia’s Sputnik vaccine. In November, the foreign minister made public his talks with Russian counterparts about the possibility of manufacturing the Russian vaccine in Hungary. On Thursday, the country approved the Russian vaccine and one made by AstraZeneca for use.
And on Friday, after a meeting in Moscow with his Russian counterpart, Hungary’s foreign minister said that Hungary would buy two million doses of the Russian vaccine.
The moves make Hungary the first European Union nation to move outside the bloc’s supply chain, which the country’s president, Viktor Orban, said was moving too slowly.
“What I need, and what the Hungarian people need, is not an explanation, but a vaccine,” Mr. Orban said. “And if it is not coming from Brussels, then it must come from elsewhere.”
The European Union has approved two coronavirus vaccines: one made by Moderna and one made by Pfizer and BioNTech. The bloc is expected to decide this month whether to authorize the AstraZeneca vaccine.
Each E.U. member state is allotted vaccine doses based on population size, and the bloc has ordered 2.3 billion doses of several vaccines, some of which are still in development.
But a disruption in Pfizer’s production facility in Puurs, Belgium, has stalled or stopped deliveries in Europe and elsewhere, causing frustration. The company has vowed to resume deliveries by mid-February, and says that production upgrades will enable it to increase its output.
In a radio interview on Friday morning, Mr. Orban called the E.U.’s vaccination rate “simply unacceptable.” He added, “It cannot be that Hungarian people are dying because vaccine procurement in Brussels is slow.”
Some Hungarian experts have expressed concern that the government’s approach might increase vaccine skepticism, which might thwart a national vaccination plan.
“The Hungarian authority suddenly approved these two vaccines under political pressure,” said Dr. Ferenc Falus, Hungary’s former chief medical officer, said in reference to the AstraZeneca and Sputnik vaccines. “It would have been better for them to wait for the approval of the European Union’s medicine agency. This is especially incomprehensible in the case of Astra, which will receive the European Union’s approval within days.”
The European Union drugs regulator, the European Medicines Authority, said that the developer of the Sputnik vaccine had “submitted a request for scientific advice to the agency.” That step comes well before a company is ready to submit data for the regulator’s review of its work, let alone applying for authorization to distribute a vaccine to European Union countries.
KYIV, Ukraine — After a revolution seven years ago, Ukrainians discovered that their ousted president had used public money to build himself a gigantic palace with a private zoo, a golf course and a garage full of antique cars.
To prevent repeats of such corruption, a raft of reforms were put in place, including a requirement that nearly all government contracts be made public, lest secret kickbacks slip into the pockets of high-ranking officials.
The overhaul, widely seen as a rare success in the country’s otherwise halting anticorruption drive, covered tens of millions of dollars in annual medical procurement deals.
But to secure coronavirus vaccine supplies, Ukraine has been forced to largely abandon the rule — a move that the government says is not its choice but rather a demand of the pharmaceutical giants that control the supply.
In negotiating with national governments, drug companies like Pfizer, Moderna and Johnson & Johnson have insisted that many of the deals’ terms amount to trade secrets and must therefore be kept confidential.
Health advocacy groups have criticized those arrangements, saying that governments far better positioned than Ukraine to spend vast sums on doses have been too willing to accept such secrecy.
The requirement has hamstrung the Ukrainian government and forced one state-owned procurement company that was set up to prevent graft in the medical system to be sidelined because it was legally required to disclose the terms of all contracts.
“This is due to extremely strict privacy rules and nondisclosure policies, which the procurement company will not be able to comply with under Ukrainian law,” Svitlana Shatalova, a deputy minister of health, said at a news conference on Thursday.
The nondisclosure agreements allow pharmaceutical companies to negotiate prices, delivery timelines and other conditions for vaccine deals without governments or their citizens comparing the agreements to those struck with other nations.
According to a document that a European official posted on social media in December and quickly deleted, the European Union negotiated a lower price for Pfizer’s vaccine — 12 euros, or about $14.60, per dose — than the U.S. government, which agreed to pay $19.50 per dose. European nations tend to pay substantially lower prices for drugs than the United States does.
global roundup
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transcript
Long Lines as Beijing Starts Mass Coronavirus Testing
The authorities in Beijing set up temporary testing sites after a spike in coronavirus infections. Long lines formed as the city tested nearly two million people on Friday.
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Nearly two million residents of Beijing were being tested for the coronavirus on Friday as the city rushed to stem mainland China’s worst outbreak since the virus was first detected.
Health officials set up temporary testing facilities in two major districts of Beijing, China’s capital, after three locally transmitted cases were confirmed there on Thursday.
The authorities in Shanghai, China’s business capital and biggest city, were also testing hospital employees after two health care workers tested positive on Thursday. Shanghai recorded six new locally transmitted cases on Friday.
New infections were also reported on Friday in four northern provinces — Hebei, Heilongjiang, Jilin and Shanxi — and in the eastern province of Shandong. That brings the total number of new cases across China this week to at least 500.
While the active case count is still far lower than that of the United States and other countries, the outbreak threatens to undermine the government’s success in stamping out the virus and bringing life in China back to normal.
More than 28 million people have been placed under some kind of lockdown across China in recent weeks, mostly in northern areas. Officials fear that new infections could lead to another major outbreak during the Lunar New Year holiday, when hundreds of millions of people travel across the country to celebrate with their families.
Last January, the coronavirus was spread far beyond its original epicenter, the central Chinese city of Wuhan, in part by people traveling home for Lunar New Year — weeks before health officials in Beijing acknowledged the risk of human-to-human transmission.
In Beijing this month, the authorities have closed all schools, limited the number of passengers allowed on public transit and extended quarantine requirements for travelers returning from overseas to three weeks, up from two weeks.
The central authorities are also requiring anyone traveling to rural areas for Lunar New Year to first test negative for the virus and then quarantine for 14 days — a move that could discourage many people from returning to their hometowns for the seven-day holiday.
In other developments around the world:
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Bangladesh will begin a nationwide coronavirus vaccination campaign starting with a gift from India — two million vaccine doses — by next week. Bangladesh, whose population is about 163 million, will also buy 30 million additional doses from India, said Muhibur Rahman, a health ministry secretary. He said that Gavi, the Vaccine Alliance, had pledged to cover doses for 20 percent of Bangladesh’s population. The rollout plan includes “freedom fighters of Bangladesh’s war of independence in the priority list,” Mr. Rahman said, referring to the 1971 conflict with Pakistan that led to Bangladesh’s creation. The country’s health minister told reporters this week that 42,000 volunteers had been trained to carry out the inoculation drive.
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Paraguay’s health minister announced that the country had arranged to buy three million doses of coronavirus vaccines from two pharmaceutical companies and plans to start vaccinations in the second half of February, Reuters reported. The minister, Julio Mazzoleni, said the companies would be named when the contracts are signed. The country plans to purchase another 4.2 million doses through Covax, a World Health Organization program.
Despite early successes in handling the pandemic, Germany’s health authorities have now registered a total of 50,000 Covid deaths since the virus was first detected in the country nearly a year ago. And 30,000 of those deaths have occurred since Dec. 9.
“These are not just numbers. These are people who died in loneliness,” Chancellor Angela Merkel said at a news conference on Thursday. “These are families who mourn them. We have to be aware of that, too, again and again.”
Daily reported new infections in the country are decreasing amid a weekslong lockdown, with the authorities registering 17,862 new cases on Thursday, almost 4,500 fewer than a week earlier. But rising death tolls typically trail behind spikes in infection numbers.
In response to the coronavirus’s first wave, Germany locked down early and effectively. Experts attributed the country’s relatively low early fatality rate to high testing rates, well-equipped hospitals and the young age of many of the first people to become infected there.
Since mid-December, however, the daily tolls have regularly surpassed 1,000, in a country of about 83 million people.
Early this month, pictures taken inside a mortuary in Meissen, in the east of the country, showed coffins stacked three-high. And on Thursday of last week — the country’s worst pandemic day so far — 1,244 people died from Covid in 24 hours.
Mongolia’s prime minister has resigned after protests in the country’s capital, Ulaanbaatar, over the government’s pandemic response.
The country’s Parliament on Friday approved the resignation of Prime Minister Khurelsukh Ukhnaa, who will be replaced by the chief cabinet minister, the state news media reported. The deputy prime minister and health minister also submitted their resignations.
Protesters took the streets on Wednesday after a widely circulated video showed a Covid-19 patient and her newborn baby being hastily escorted from a hospital to a quarantine facility. Demonstrators were protesting the treatment of the patient, who was still wearing a nightgown and slippers when she was escorted out of the hospital. Some protesters wore nightgowns and slippers in a show of support for the woman.
The World Health Organization praised Mongolia early on in the pandemic for its quick response, with the country shutting down its borders and ceasing much of its coal mining activity. Mining makes up nearly half of its export revenue and provides some of the best-paying jobs in the country.
And although Mr. Khurelsukh won landslide elections last year, the government has faced dissatisfaction over a flailing economy and unemployment. He said in a resignation letter that he would “accept the demand of the public.”
Laura M. Holson, a Times reporter and editor, caught Covid-19 during the New York City outbreak last April, but the acute phase of the illness was just the beginning. Here, she tells her story.
I remember the second time I thought I would die.
The first time was April 17, 2020, when, after finding out I had Covid-19 nine days earlier with aches and a cough, my fever shot up to 101.8, I could barely breathe, and my family doctor told me I had bacterial pneumonia.
The second time I thought I would die was different, yet eerily the same. It was June 22, nearly three months after the initial diagnosis. By then the cough had softened, and I was well past the acute phase of Covid-19, having tested negative twice. The chest tightness had passed, supplanted by a nagging ache. I had lost eight pounds as nausea tamped my appetite, and my heart seemed to race without reason. I was so tired I sometimes fell asleep upright in my chair. And my fever persisted, too.
On that cloudless day in June, the temperature outside hovered at a pleasant 85. I was seated on the couch, working on my laptop when, at about 4 p.m., the crushing chest pain I experienced during Covid’s earliest days suddenly returned. My pulse began to quicken, and a shawl of heat gathered around my shoulders, crept up my neck and swallowed my head. I began to sweat. It felt as if the air was being squeezed out of my lungs. Breathe, I told myself. BREATHE. I stood up, gasping, and walked to the window to look outside.
Could this really be happening again?
About 1,500 people from Pacific Island nations are due to be flown into the Australian state of Victoria to pick fruit on farms. And although the move will help alleviate a shortage of farm hands that has plagued the industry for months because of the coronavirus, it also underscores the greater health risks and economic effects that poorer and non-white populations have faced in the pandemic.
Victoria is one of the last states in Australia to allow Pacific Islanders in to help on farms. Nearly 200 workers from Vanuatu flew into the Northern Territory to harvest mangos in August, and other states have since followed.
Over the summer, the country has been flooded with news reports of fruit and vegetables being left to rot in fields amid a shortage of workers to pick them.
Farmers say they have had difficulty attracting locals to do the work, while some Australians counter that farmers have been unwilling to employ locals because they are “not as exploitable as a foreigner.” The sector has also been the subject of recent reports of underpaying and exploiting workers.
The supply of backpackers and foreign seasonal workers who typically make up the majority of the industry has been cut off since the country shut its borders last March in an effort to stop the spread of the virus.
Before arriving in Victoria, the Pacific Islander workers will be required to quarantine for two weeks on the Australian island state of Tasmania, Victoria’s government said on Friday. In exchange, 330 Tasmanians who have been stuck overseas will be able to return to the country and quarantine in Melbourne hotels.
Victoria has eased its pandemic restrictions after 16 consecutive days with no cases of community infection.
The party is coming to an end — or at least to a pause — in Dubai, which allowed its hotels, restaurants and clubs to continue offering live entertainment for the last half-year in the hope of sustaining its economically vital tourism industry. On Thursday, Dubai, one of the seven sheikhdoms that make up the United Arab Emirates, said that it would immediately suspend issuing new entertainment permits because coronavirus cases were mounting.
The resurgence of the virus in Dubai has forced the city to backtrack on promoting itself as one of the world’s few remaining havens for fun during the pandemic. Though it imposed a strict lockdown early on, Dubai reopened to tourists in July, and by the winter holidays, tourism had come alive again as bars and clubs filled with people escaping lockdowns in other countries.
Industry analysts reported that hotels there were 71 percent full in December, and the Emirates had begun inoculating its population with vaccines from Pfizer and Sinopharm faster than any other country except Israel. Much of the Emirates’ population is young, which may have helped hold down the country’s death toll.
But as reports of new coronavirus cases began to rise in recent weeks, Dubai’s greatest source of tourists, Britain, announced that it would start requiring anyone who returned from Dubai to quarantine. Israel, which sent thousands of tourists to Dubai after the Emirates and Israel agreed to normalize relations late last year, imposed the same restriction.
The Emirates announced 3,529 new cases on Thursday, setting a record for the 10th straight day.
Bars and restaurants in Dubai remain open, but the city’s tourism office said it would stop issuing permits for live performances and concerts in the interest of “public health and safety.” It did not say when the permits might resume.