transcript
transcript
N.Y. Will Open Vaccines to People With Certain Health Conditions
Gov. Andrew M. Cuomo said New York would allow Covid-19 vaccinations beginning Feb. 15 for people with some chronic health conditions that put them at greater risk of death from the virus.
-
The hospitals have had eight weeks to focus on their staff, and that’s how we achieve the 75 percent. We’re giving them one more week to do the last workers, please go back and appeal to them one more time — the people who haven’t taken it. Then what we’re going to do is reallocate the doses that were set aside for the hospital workers. And we will then give that allocation to the local health departments to do people with comorbidities. And that will start Feb. 15. Ninety-four percent of the people who die from Covid are people with comorbidities or other underlying conditions — 94 percent. So why don’t we do this group of workers, why don’t we do this group of workers? You do every group in this state when you do people with comorbidities. If you are a carpenter with a comorbidity, if you are a teacher with a comorbidity, if you are a homemaker with a comorbidity, if you’re a lawyer with a comorbidity, whoever you are, 94 percent of the deaths are people with comorbidities. We’re working with the C.D.C. to establish the comorbidities list. What is a comorbidity, how do you define it? C.D.C. has guidance on that. We’re working with the C.D.C. to clarify some definitions, but we’re basically going to follow the C.D.C. guidance.
New York State will begin allowing people with some chronic health conditions that put them at greater risk of severe illness from the coronavirus to receive a vaccine on Feb. 15, Gov. Andrew M. Cuomo said on Friday.
The governor did not provide any details on which conditions, or comorbidities, would qualify people to be eligible for the vaccine, saying that the state would be working with the Centers for Disease Control and Prevention to clarify the details.
Melissa DeRosa, a top aide to Mr. Cuomo, later tweeted a list of the conditions that would qualify a person for a vaccine, though she cautioned they may change. The list included cancer, heart conditions, lung diseases, liver disease, diabetes, obesity, diabetes and pregnancy. (The C.D.C.’s advisory committee has told pregnant women to consult with their doctors before receiving the vaccine.)
NY’ers w the following co-morbidities/underlying conditions are eligible for COVID-19 vaccine starting Feb 15 👇🏻
This list is subject to change as additional scientific evidence is published & as NYS obtains and analyzes additional state specific data pic.twitter.com/JWrjl1rA5H
— Melissa DeRosa (@melissadderosa) February 5, 2021
Mr. Cuomo’s announcement came as he said that state health data showed that 75 percent of New York’s hospital workers had received at least one dose of the vaccine. The state will give hospitals one more week to inoculate remaining employees before it begins to reallocate vaccine doses to give them to people with comorbidities.
The widening of restrictions on vaccine eligibility came as a much-anticipated vaccination site opened at Yankee Stadium in the Bronx, which New York City and state health officials hope will boost inoculation rates among local people of color and battle the spread of the virus in the borough, which currently has the city’s highest positive test rates.
In New York City, the average positivity rate citywide was at 8.51 percent as of Wednesday, the latest day for which data was available, Mayor Bill de Blasio said on Friday. Since late last month, the seven-day average positive test rate in the Bronx has hovered over 10 percent, according to the city’s data. The state, which calculates the positive test rate differently, said the Bronx’s seven-day average positive test rate was at 6.67 percent on Friday.
The Bronx “has been persistent in its high positivity,” Gov. Andrew M. Cuomo said at a news conference.
The vaccination site, a partnership between the city and the state, is meant to only serve residents of the Bronx. Roughly 13,000 of the 15,000 available appointments have been filled, Mr. de Blasio said at a news conference at the stadium on Friday afternoon, though concerns remained among some lawmakers that the city’s outreach is lacking in an area with a population that is heavily Black, Latino and low-income.
transcript
transcript
Opening Day at Yankee Stadium for Vaccinations
Friday was opening day at Yankee Stadium as a brand new mass vaccination site aimed at inoculating Bronx residents, one of the most virus-stricken areas in New York City.
-
“I was trying to schedule an appointment for him for weeks now, and was getting nowhere because the appointments were all filled up. So I think enough people have been, you know, agreeing that they want to go get the vaccine.” “I was on a wait list for three weeks, desperate to get a vaccine. I was unsuccessful. But today I’m here.” “Now they’re here, and they want us to get the vaccine. We are clear — that you can see the people here are the people from the neighborhood getting the vaccine.”
“We’re going to bring this city back,” Mr. de Blasio said. “But it will only work if it’s a recovery for all of us: Not just Manhattan, for the Bronx as well.”
Health officials had hoped to prioritize these groups in the rollout but have struggled. Black and Latino people are more likely to contract the virus than white people, yet many communities of color have been hesitant or suspicious regarding the vaccine, particularly in light of the country’s history of unethical medical research.
Mr. Cuomo released data on Friday showing that the percentage of eligible Black New Yorkers who had received a dose of the vaccine lagged behind white ones. The governor did not provide raw totals, but said that 17 percent of the essential workers eligible to receive the vaccine were Black, compared to only 5 percent of those who received it. Among those eligible to receive the vaccine because they were over 65 years old, 13 percent were Black, but only 4 percent of those inoculated were Black.
The Yankees’ president, Randy Levine — who appeared at Mr. Cuomo’s news conference along with the manager, Aaron Boone, and the former pitcher Mariano Rivera — said that the team would offer Yankees “trinkets and gifts” to encourage people to come to the stadium for vaccinations.
Mr. de Blasio said on Friday during an interview on WNYC that he was hopeful all available slots at the Bronx site would “be snapped up quickly.”
“We really want to make sure that this is for the people of the Bronx, this is for folks who’ve been hit pretty hard by Covid,” Mr. de Blasio said. “People should take advantage of this opportunity.”
The mayor added later that a mass vaccination site at Citi Field in Queens was “coming in a matter of days,” but he did not address the timetable for a planned location at the Empire Outlets on Staten Island. That borough was a hot spot for the virus last fall, and positive test rates have remained high.
Across the state, more than 2.2 million doses of the vaccine have been given, Mr. Cuomo said. Virus-related hospitalizations stood at 7,937, the lowest number since Jan. 1.
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 to, though potentially 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 scientists did not have enough statistical confidence to know for sure if the vaccine was slightly less effective against the variant.
Andrew Pollard, the lead investigator of Oxford’s vaccine trial, said in a news conference that the new data show that the vaccine has “very similar” levels of efficacy against the original pandemic virus and the variant that has been rapidly in the U.K. and some other countries.
The researchers also conducted laboratory tests on blood samples from clinical trial participants who had been vaccinated. They found a nine-fold reduction in the activity levels of the vaccine-generated antibodies against the B.1.1.7 variant compared to another lineage of the variant. That’s a sign that the vaccine may have less power to neutralize the variant, though it appears to still be potent enough to be protective.
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 are expected in 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.
transcript
transcript
Pentagon Will Deploy Troops to Assist Vaccine Efforts
The White House announced on Friday that Lloyd J. Austin III, the secretary of defense, approved the Federal Emergency Management Agency’s request for support, and will deploy 1,110 active-duty troops to Covid-19 vaccination centers across the country.
-
I want to announce that the secretary of defense, Lloyd Austin, has approved FEMA’s request to augment and expedite vaccinations across the country. He’s ordered the first contingent of more than 1,000 active-duty military personnel to support state vaccination sites. Part of this group will start to arrive in California within the next 10 days to begin operations there around Feb. 15, with additional vaccination missions soon to follow. The military’s critical role in supporting sites will help vaccinate thousands of people per day, and ensure that every American who wants a vaccine will receive one.
The Biden administration on Friday announced that it was sending 1,110 active-duty troops to five federal Covid-19 vaccination centers across the country, a significant escalation in its efforts to take more control of a chaotic and mostly state-led effort to administer the vaccines.
Five teams of 222 troops from the Air Force, Marine Corps, Navy and Army will deploy to the sites, which are run by the Federal Emergency Management Agency. Each team will include vaccinators, nurses, clinical staff and other operational positions, the Pentagon said.
At a White House news conference, Andy Slavitt, a pandemic adviser, said that Lloyd J. Austin III, the secretary of defense, had approved the request. Mr. Austin said at his confirmation hearings last week that he would increase military support for the federal government’s pandemic response.
Mr. Slavitt said that troops would arrive in California within 10 days, to begin operating around Feb. 15. Other assignments would be announced soon, he added.
“The military’s critical role in supporting sites will help vaccinate thousands of people per day, and ensure that every American who wants a vaccine will receive one,” Mr. Slavitt said.
FEMA, a part of the Department of Homeland Security, has said it hopes to set up roughly 100 vaccine sites nationwide as early as this month, and on Wednesday night requested that the Pentagon support the effort. The agency has said it would spend $1 billion on vaccine measures, including community vaccination sites.
The sites, and the use of the military within them, would require the approval of state governments, some of which have been openly hostile to the idea of the military assisting the efforts. The National Guard has already staffed large vaccination sites — over half of states and territories have used members to give shots — but the Pentagon’s role has been largely behind the scenes.
Federal officials also announced what they described were the administration’s first steps in activating a Korean War-era law, the Defense Production Act, to attempt to speed up the manufacturing of vaccines, test and supplies — what amounted at least in part to a continuation of a strategy deployed during the Trump administration.
Tim Manning, a former FEMA official and the White House’s supply chain coordinator, said the administration was using the law to ensure that suppliers of pumps and filtration units will prioritize orders from Pfizer so it can meet its production targets.
The Trump administration invoked the act to help Pfizer secure critical supplies in late December — months after Pfizer first asked for that support — and used it extensively to help other vaccine manufacturers. Mr. Manning said the latest moves would expand on that earlier effort to bolster Pfizer’s production. The law is used in part to allow federal contractors to jump ahead of other companies and secure supplies to meet the government’s needs.
The Trump administration used the law 18 times to hasten the production of vaccine supplies, Dr. Moncef Slaoui, the scientific lead of its vaccine development program, told Bloomberg News in a recent interview.
Mr. Manning also said that the government would begin building American plants to make raw materials for surgical gloves, and that the aim was for more than a billion nitrile gloves to be made every month to in the U.S. by the end of the year.
“We’re nearly 100 percent reliant on overseas manufacturers to export to us our country’s surgical gloves that protect health care workers. That’s unacceptable,” he said. “We’ll now make enough to satisfy half of all of the U.S. health care community demands right here on U.S. shores.”
Scientists have been sounding the alarm about new variants of the coronavirus that carry a handful of tiny mutations, some of which seem to make vaccines less effective.
But the novel coronavirus also has a propensity to mix large chunks of its genome when it makes copies of itself. Unlike the small mutations, which are like typos in the sequence, a phenomenon called recombination resembles a major copy-and-paste error in which the second half of a sentence is completely overwritten with a slightly different version.
A flurry of new studies suggests that recombination may allow the virus to shapeshift in dangerous ways.
The coronavirus mutations that most people have heard about, such as those in the B.1.351 variant first detected in South Africa, are changes in a single “letter” of the virus’s long genetic sequence, or RNA. Because the virus has a robust system for proofreading its RNA code, these small mutations are relatively rare.
Recombination, in contrast, is rife in coronaviruses.
Researchers at Vanderbilt University Medical Center recently studied how things go awry during replication in three coronaviruses, including SARS-CoV-2, which causes Covid. The team found that all three viruses showed “extensive” recombination in the laboratory.
Scientists worry that recombination might allow for different variants of the coronavirus to combine into more dangerous versions inside a person’s body. The B.1.1.7 variant first detected in Britain, for example, had more than a dozen mutations that seemed to appear suddenly.
Nels Elde, an evolutionary geneticist at the University of Utah, said that recombination may have merged mutations from different variants that arose spontaneously within the same person over time or that co-infected someone simultaneously. For now, he said, that idea is speculative: “It’s really hard to see these invisible scars from a recombination event.” And although getting infected with two variants at once is possible, it’s thought to be rare.
transcript
transcript
‘We’re Still in the Teeth of This Pandemic,’ Biden Says
President Biden called on Congress to act quickly on his proposed $1.9 trillion coronavirus relief package on Friday, in a speech following a weak jobs report.
-
We’re still the teeth of this pandemic. In fact, January was the single-deadliest month of the whole pandemic. We lost nearly 100,000 lives. I know some in Congress think we’ve already done enough to deal with the crisis in the country. Others think that things are getting better, and we can afford to sit back. And either do little or do nothing at all. That’s not what I see. I see enormous pain in this country. A lot of folks out of work, a lot of folks going hungry, staring at the ceiling tonight, wondering, what am I going to do tomorrow? And I believe the American people are looking right now to their government for help, to do our job, to not let them down. So I’m going to act, and I’m going to act fast. I’d like to be — I’d like to be doing it with the support of Republicans. I’ve met with Republicans and some really fine people want to get something done, but they’re just not willing to go as far as I think we have to go. I’ve told both Republicans and Democrats that’s my preference, to work together. But if I have to choose between getting help right now to Americans who are hurting so badly and getting bogged down in a lengthy negotiation or compromising on a bill that’s up to the crisis, that’s an easy choice. I’m going to help the American people who are hurting now. That’s why I’m so grateful to the House and the Senate for moving so fast on the American Rescue Plan. Job No. 1 of the American Rescue Plan is vaccines, vaccines. The second, the American Rescue Plan is going to keep the commitment of $2,000 — $600 has already gone out, $1,400 checks to people who need it. I’m not cutting the size of the checks. They’re going to be $1,400, period. That’s what the American people were promised.
The House gave final approval on Friday to a budget blueprint that included President Biden’s $1.9 trillion stimulus plan, advancing it over unanimous Republican opposition as Democrats pressed forward with plans to begin drafting the aid package next week and speed it through the House by the end of the month.
“Our work to crush the coronavirus and deliver relief to the American people is urgent and of the highest priority,” Speaker Nancy Pelosi, wrote in a letter to Democrats shortly before the bill passed by a 219-to-209 margin.
President Biden, speaking just before the House acted, cited a weak jobs report in justifying the use of a procedural device, called reconciliation, to ram through the measure if Senate Republicans oppose his effort to speed aid to families, businesses, health care providers and local governments.
“It is very clear our economy is still in trouble,” Mr. Biden said during remarks at the White House — amping up the pressure on an upper chamber bracing for former President Donald J. Trump’s impeachment trial next week.
“I know some in Congress think we’ve already done enough to deal with the crisis in the country,” added Mr. Biden, who reiterated his commitment to fund $1,400 direct checks to low- and middle-income Americans. “That’s not what I see. I see enormous pain in this country. A lot of folks out of work. A lot of folks going hungry.”
Mr. Biden’s comments came as the Labor Department’s reported on Friday that the economy added only 49,000 jobs in January, and just 6,000 in the private sector. The labor market remains 10 million jobs below its pre-pandemic levels.
Hours earlier, as the sun rose over the Capitol dome, the Senate approved a fast-track budget measure, with Vice President Kamala Harris cast her first-ever tiebreaking vote after a grinding all-night session. The move, in theory, allows them to enact the package without any Republican votes.
Senate leaders could begin working on their own bill in hopes of delivering a final package to Mr. Biden’s desk before supplemental unemployment benefits are set to expire in mid-March.
Jen Psaki, the White House press secretary, cited poll numbers showing bipartisan support among American voters for the plan, brushing aside criticism the White House was sacrificing bipartisan solidarity for partisan celerity.
“He didn’t run on a promise to unite the Democratic and Republican Party into one party in Washington,” she said in her Friday briefing at the White House.
Still, Mr. Biden offered one olive twig on Friday, saying his plans could change to win over moderates in both parties, acknowledging that he favored restricting the direct payments to that people earning less than $300,000.
“I’m not cutting the size of the checks,” he said on Friday. “They’re going to be $1,400, period.”
Still, there were warning signs the road ahead would not be entirely traffic-free.
The Senate agreed to a proposal by Senator Joni Ernst, Republican of Iowa, to prohibit any minimum wage increase during the pandemic — which could complicate Mr. Biden’s plan to raise the federal minimum wage to $15 per hour by 2025.
Democrats did not contest Ms. Ernst’s proposal, arguing that it was never their intention to increase the wage immediately, but their reticence to record a vote on the matter was a signal that the wage increase might ultimately lack the support to pass in an evenly split Senate, where at least one Democrat, Senator Joe Manchin III of West Virginia, is on record in opposition.
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.
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.”
Russian news outlets connected to election disinformation campaigns in the United States have set their sights on a new target: convincing Spanish-speaking countries that Russia’s Sputnik V coronavirus vaccine works better than its American competitors, according to researchers and State Department officials.
The Russian campaign has focused on Latin American nations, including Mexico, which this week signed a deal to acquire millions of doses of Sputnik V, and Argentina, which last month began vaccinating its citizens with it.
Conducted on Spanish-language social media and reinforced by the official Twitter account of the Russian Embassy in Mexico City, the campaign signaled a new wrinkle in Russian influence operations, promoting Russian industry and scientific cachet over its competitors as governments around the world race to vaccinate their populations.
Sputnik V is considered less expensive and easier to transport than vaccines made by the American companies Pfizer and Moderna. But some researchers say the criticism in Russian outlets of the Western vaccines has been misleading.
For instance, media outlets backed by the Russian government posted to Facebook and Twitter hundreds of links to news stories that reported potential ties suggesting American vaccines may have had a role in deaths, the researchers said. The accounts left out follow-up reports that found the vaccines most likely played no role in the deaths.
“Almost everything they are promoting about the vaccine is manipulated and put out without context,” said Bret Schafer, a fellow with the Alliance for Securing Democracy, an advocacy group that tracks Russian disinformation. “Every negative story or issue that has come out about a U.S.-made vaccine is amplified, while they flood the zone with any positive report about the Russian vaccine.”
Researchers have tracked similar Russian efforts in Eastern European countries that are still negotiating with Russia to buy the vaccine. Disinformation researchers have also monitored Russia spreading similar narratives in a half-dozen languages, targeting countries in central and Western Africa.
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.
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.
“There are things short of doing full-fledged efficacy trials that we can use to shift or perhaps add components to the existing vaccines,” she said.
Dr. Woodcock said the plans will be released for comment from scientists before they are implemented.
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.
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.
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 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 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.
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.
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.
transcript
transcript
Virginia Schools Must Reopen by Mid-March, Northam Says
Gov. Ralph Northam of Virginia said on Friday that schools across the state should begin to offer in-person classes by March 15, adding that many students were suffering academically and emotionally.
-
When the pandemic started, believe it or not 11 months ago, schools around the country closed. As school divisions began developing plans for the current school year, our guidance to them was that we want students and we wanted our teachers and the staff to be safe. But we encouraged in-person instruction for the students who needed it the most. But we’ve seen more data now, and it suggests that schools don’t have the kind of rapid spread that we’ve seen in some other congregate settings. That tells us it’s time to find a path forward to in-person learning. We also know this plain fact, children learn better in classrooms, and that’s where they need to be. Last month, we issued guidance to our school divisions for how to plan a safe return to in-person learning. And today, I’m saying it needs to start by March the 15th. By that date, I expect every school division to make in-person learning options available in accordance with the guidance.
Schools should begin to offer in-person classes across the state of Virginia by March 15 and make plans to offer summer courses to families who would like it, Gov. Ralph Northam said at a news conference on Friday morning.
Speaking both as a governor and a pediatrician, Mr. Northam, a Democrat, said research showed that schools can be safe if they practice mitigation strategies, such as masking and social distancing.
He hailed teachers’ difficult work in transitioning to online learning over the past year, but said it was a subpar form of education that had left students suffering academically and emotionally. Only 15 of the state’s 132 school divisions are offering in-person instruction to all students at least four days per week, and 42 are operating remotely. The rest are in-person and at-home hybrids.
“We know this plain fact: Children learn better in classrooms, and that’s where they need to be,” the governor said, adding that he expected that most of the state’s teachers would have the opportunity to be vaccinated by the March reopening date, or soon after.
Summer school could be funded by federal stimulus dollars, he said, and should prioritize students who have fallen behind the most.
The call by Mr. Northam echoes that of President Biden, who has said that all K-8 schools should work to reopen by April, and who is expected to ask Congress to increase funding for summer programs. Nationwide, more than a third of students attend schools that are currently operating only online, according to data from Burbio, a firm that collects and analyzes information from local schools.
Politics, and not local virus rates, have largely determined whether schools are open or closed across the country. Places with powerful teachers’ unions have tended to resist reopening, arguing that teachers should first be vaccinated.
Teachers in Virginia currently lack collective bargaining rights, something that is slated to change later this year in the increasingly liberal state. But unions can wield influence even without collective bargaining, in part because districts are understaffed and mass work stoppages, leave requests, retirements and resignations can be crippling.
An increasingly loud group of parents across the state, particularly in affluent suburbs like Fairfax County, outside Washington, are demanding a widespread return to classrooms. But many other families, particularly families of color, have said that they are not yet convinced in-person education is safe as the virus continues to rage, with new, highly contagious variants emerging.
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 Feb. 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.
The report card for vaccination in long-term-care facilities, whose residents supposedly stood at the front of the line, shows a mixed performance.
Nationally, almost 3.4 million long-term-care residents and staff members have received at least one shot, the Centers for Disease Control and Prevention reported on Thursday; close to 800,000 had gotten two.
By mid-January, Medicare data showed that cases in long-term-care facilities had dropped by almost 46 percent compared with four weeks earlier, reflecting the decline in cases across the country but probably also the impact of vaccination.
But experts, noting that an estimated five million people live or work in long-term care, have expressed intense frustration at the slow initial rollout. “There’s been nothing warp speed about long-term care,” said David Grabowski, a health policy researcher at Harvard Medical School.
They also worry about the even more sluggish rate at assisted-living facilities, and about workers who are suspicious of vaccination. The C.D.C. reported that at nursing homes with clinics, only a median 37.5 percent of staff members were vaccinated in the first month.
“People who live in nursing homes would do just about anything to reconnect with the outside world and the people they love,” said Dr. Kathleen Unroe, a geriatrician at the Indiana University School of Medicine who also practices at Northwest Manor, a nursing home in Indianapolis.
One of her patients initially had doubts. “I didn’t want to be a guinea pig,” said Norma Ware, 86. “I’m not crazy about shots, anyway.” But after conversations with her family and “a very friendly nurse,” she received both doses and became a believer.
Last fall, the Trump administration contracted with the two big pharmacy chains to administer vaccinations, the pace of which has picked up substantially since December.
Company executives emphasized that while the Centers for Disease Control and Prevention prioritized long-term care for vaccinations, individual states determined when programs began. While nearly all states activated nursing home clinics on Dec. 21 or 28, most didn’t launch assisted living clinics until January, often weeks later.
The virus didn’t wait. Infections in long-term care reached a peak in December, according to a Kaiser Family Foundation analysis.
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.
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.”
In the year since the coronavirus began its march around the world, China has done what many other countries would not or could not do. Using coercion and persuasion, it has mobilized its vast Communist Party apparatus to reach deep into the private sector and the broader population, in what the country’s leader, Xi Jinping, has called a “people’s war” against the pandemic — and won.
China is now reaping long-lasting benefits that few expected when the virus first emerged in the central city of Wuhan, positioned the country, economically and diplomatically, to push back against the United States and others worried about its seemingly inexorable rise. It has also emboldened Mr. Xi, who has offered China’s experience as a model for others to follow.
While officials in Wuhan initially dithered and obfuscated for fear of political reprisals, the authorities now leap into action at any sign of new infections. In Hebei this January, the authorities deployed their well-honed strategy to test millions and isolate entire communities — all with the goal of getting cases, officially only dozens a day in a population of 1.4 billion, back to zero.
China is the only major economy that has returned to steady growth. The government has poured money into infrastructure projects, its playbook for years, while extending loans and tax relief to support business and avoid pandemic-related layoffs.
The government offered land, loans and subsidies for new factories to make vaccines and fast-tracked approvals. Two Chinese vaccines are in mass production; more are on the way. While they have shown weaker efficacy rates than those of Western rivals, 24 countries have already signed up for them. The pharmaceutical companies have, at Beijing’s urging, promised to deliver them quickly.
“They were able to pull together all of the resources of the one-party state,” said Carl Minzner, a professor of Chinese law and politics at Fordham University. “This of course includes both the coercive tools — severe, mandatory mobility restrictions for millions of people — but also highly effective bureaucratic tools that are maybe unique to China.”
Among the Communist Party leaders, a sense of vindication is palpable. In the final days of 2020, the seven members of the Politburo Standing Committee, the country’s top political body, gathered in Beijing for the equivalent of an annual performance review.
Far from even hinting at any shortcomings — the rising global distrust toward China, for example — they exalted the party leadership.
“The present-day world is undergoing a great transformation of the kind not seen for a century,” Mr. Xi told officials at another meeting in January, “but time and momentum are on our side.”
New research published by the Centers for Disease Control and Prevention on Friday shows that statewide mask-wearing mandates were associated with a decline in the growth rate of Covid-19 hospitalizations. The study provides additional evidence that wearing of masks can help minimize transmission of the coronavirus.
The research, published in the Morbidity and Mortality Weekly Report by the agency, found that in three weeks or more following a mask mandate, Covid-19 hospitalization growth rates fell by 5.5 percent in people aged 18 to 64.
The research focused on 10 states — California, Colorado, Connecticut, Maryland, Michigan, Minnesota, New Mexico, New York, Ohio and Oregon — that implemented mask mandates in the period from April to June of 2020. Hospitalization growth rates fell for adults 40 to 64 two weeks or more after the mandates were put into place, the research showed. There are currently 34 states with mask mandates.
Mask orders are “helping to protect people and helping the cases coming down,” said Dr. Rochelle Walensky, director for the C.D.C., in a briefing on Friday by the White House Covid-19 Response team. She added that the data remains somewhat open to interpretation in light of a multitude of changing factors taking place during the period these mandates were implemented.
The C.D.C.’s Morbidity and Mortality Weekly Report also published another study on Friday showing that college students appear to doing an impressive job responding to the public health rallying cry to wear masks.
From September to November, observers at six universities, five universities in the South and one in the West, found that 85.5 percent of 17,200 people on campus wore masks, with nearly 90 percent wearing them correctly (“If the mask completely covered the nose and mouth and was secured under the chin.”). Proper mask-wearing rates were higher indoors, 91.7 percent, the research found.
The participating schools included five public universities with student populations ranging from 29,000 to 52,000, and one private university with 2,300 students. The rates of mask-wearing compliance were not specific by university; the research also noted that proper use of the masks varied by the type of covering: 96.8 percent or N95-type masks, 92.2 percent for cloth and 78.9 percent for “bandanas, scarves, and similar face coverings.”
