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Covid-19: Several Vaccine Production Sites Approved in E.U. - The New York Times

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A line for vaccines in Munich this week. Only about 10 percent of Europeans have received a first dose.
Credit...Laetitia Vancon for The New York Times

The European Union's stumbling Covid-19 vaccination drive, badly shaken by the recent AstraZeneca safety scare, got a boost Friday from the European Medicines Agency, which approved new AstraZeneca, Pfizer-BioNTech and Moderna vaccine production sites.

The agency, an arm of the European Union and Europe's top drug regulator, approved sites in the Netherlands, Germany and Switzerland. It also loosened regulations for how long the Pfizer vaccine must be stored at ultralow temperatures.

The moves could speed up the Continent's lagging vaccine production and distribution, which have been plagued by delays and setbacks.

Though the European Union is flush with cash, influence and negotiating heft, only about 10 percent of its citizens have received a first dose, compared with 26 percent in the United States and 44 percent in Britain. The bloc of 27 nations was comparatively slow to negotiate contracts with drugmakers, and regulators were cautious and deliberative in approving some vaccines. And it has been stymied by supply disruptions and shortages.

Europe also experienced a scare over the safety of the AstraZeneca vaccine and distribution in several countries was temporarily halted. Most of those countries have resumed using it, after the E.U. drug agency vouched for its safety. But public confidence in the shot has been severely undermined.

The agency said a new warning label would be added to the vaccine so that people in the medical community could watch for rare complications that could lead to blood clots and brain bleeds.

Trust in the AstraZeneca vaccine is essential to fighting the pandemic worldwide. The shot is more easily stored and less expensive than Pfizer's or Moderna's, and for now, it is sold without the goal of earning a profit.

The European Union has exported more vaccine doses than it has administered. On Wednesday, it revealed emergency legislation that would curb exports of Covid-19 vaccines manufactured in its countries for the next six weeks.

Ursula von der Leyen, president of the European Commission, posted on Twitter on Thursday that the European Union had shipped out 77 million doses since early December, that 88 million were expected to be distributed internally by the end of the week and that 62 million shots had been administered within member nations.

A drive-through inoculation site in Cleveland, Miss., last week.
Credit...Rory Doyle for The New York Times

States are racing to vaccinate as many people as possible as the United States' coronavirus infection curve continues its plateau for a third week at more than 55,000 new cases per day, a level that health experts warn could rapidly escalate into a new wave.

Kansas, Minnesota and South Carolina announced on Friday that they would open vaccine eligibility to residents 16 years and older next week. But Minnesota's health department said there would not be enough vaccines on Tuesday to meet the immediate demand. The state is expecting more doses delivered in the coming weeks.

New Jersey, which has seen a 25 percent increase in new cases, compared with the average two weeks earlier, also announced vaccine eligibility would expand beginning on April 5 for residents 55 and older. At that time, New Jersey also plans to open eligibility for those 16 years and older with developmental disabilities and residents who work in the higher education sector.

And Oregon announced plans to expand eligibility for certain residents, including front-line workers, beginning April 5. Gov. Kate Brown said April 5 is two weeks ahead of what the state had planned for this group of residents. She said this was possible "thanks to increasing supplies."

State officials are able to broaden their eligible pools thanks to a steady increase in vaccine shipments. Federal officials say that Pfizer and Moderna, whose vaccines require two doses, are now together supplying about 24 million doses a week.

16+ or 18+

40+ or 45+

50+ or 55+

60+ or 65+

Eligible only in some counties

Restaurant workers

Eligible only in some counties

High-risk adults

Eligible only in some counties

Jeffrey D. Zients, the White House's chief pandemic adviser, told reporters during a White House virus briefing on Friday that he is expecting an end-of-the-month burst of supply from Johnson & Johnson, whose vaccine requires only one shot. The company has supplied a very limited number of doses so far but will deliver at least 11 million doses next week, he said.

Some 25 states are reporting persistently high case numbers, according to a New York Times database, and state officials have been easing restrictions.

The number of deaths continue to trend downward, averaging about 1,000 a day, down from more than 2,000 each day a month ago. But eight states are seeing rising deaths: Kentucky, Maryland, Montana, Nebraska, New Hampshire, Ohio, Utah and West Virginia.

"It's clear, there is a case for optimism, but there is not a case for relaxation," Mr. Zients said.

At least 34 states have pledged to make vaccines universally available to their adult populations by mid-April, and at least 14 more have announced plans to expand eligibility on or before May 1, a goal set by Mr. Biden. Alaska, Mississippi, Utah and West Virginia have already made all adults eligible to receive shots, and some local jurisdictions have also begun vaccinating all adults.

California will open up vaccine eligibility on Thursday to any resident 50 or older and will expand that to residents 16 or older on April 15, state officials said. Florida said that any state resident 40 or older would be eligible starting on Monday, and that the minimum age would drop to 18 on April 5.

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Residents in West Virginia shared their feelings about being allowed to mix again after months of isolation.

In Connecticut, which is among the most-vaccinated states in the country, the governor said that all residents 16 and above would be eligible beginning on Thursday.

Kentucky plans to open vaccinations to those 40 and older starting on Monday.

Mr. Biden, who initially promised to have "100 million shots in the arms" of Americans by his 100th day in office, said on Thursday that he was doubling the target. As of Friday, more than 120 million shots have been administered since Jan. 20. And with an average of 2.6 million shots administered per day, and more supply increases expected next month, the White House is fully expected to meet the new target, Mr. Zients said on Friday.

Vaccine hesitancy could slow progress, cautioned Francis Collins, the director of the National Institutes of Health. The goal of reaching a point in the country when enough people have had the virus or have been vaccinated could be jeopardized by people who "will basically say, 'No, not for me,'" he said Thursday on Fox News.

"That could basically cause this pandemic to go on much longer than it needs to," he said.

The campus of the University of Florida, in Gainesville, last December. The university is one of more than 20 where students are being recruited for a large-scale study that aims to answer an urgent question: Can the vaccinated still spread the virus? 
Credit...Charlotte Kesl for The New York Times

Can people immunized against the coronavirus still spread it to others? A new study will attempt to answer the question by tracking infections in vaccinated college students and their close contacts, researchers announced on Friday.

The results are likely to be of intense interest, because they may help determine how careful vaccinated people need to be — whether they can throw away their masks, for example, or must continue to wear them to protect unvaccinated people.

More than 87 million have received at least one dose of a coronavirus vaccine, according to a New York Times database. The Centers for Disease Control and Prevention has advised that fully vaccinated Americans may gather indoors in small groups without precautions, including masks, but should still wear masks in public.

The reason is that it's not yet certain that vaccinated people cannot briefly be infected and transmit the virus. Clinical trials of the vaccines were designed only to assess whether the vaccines prevent serious illness and death. The manufacturers are now collecting information on whether the vaccines can also thwart infections, swabbing volunteers' noses every two weeks.

But that method falls short, because the testing is too infrequent to catch all infections and will not track the spread of the virus to the participants' contacts, said Dr. Larry Corey, an expert in vaccine development at the Fred Hutchinson Cancer Research Center in Seattle and a leader of the new study.

"The only way you do that is by very frequent sampling, and we're covering our bases by doing it every day," Dr. Corey said. "It's going to be the most thorough look at the issue."

The new study will include more than 12,000 college students immunized with the Moderna vaccine at more than 20 universities across the United States. Half of the students will be randomly selected to receive the vaccine right after they are enrolled, while the other half will get the vaccine four months later.

All of the participants will swab their noses daily to check for the virus, provide periodic blood samples to screen for antibodies, and answer questions through an app. Scientists will follow the students for five months.

By monitoring the students so closely, the scientists expect to be able to track infections in the first 24 or 48 hours, and determine how long an infected person may transmit the virus to others, Dr. Corey said. Over time, the scientists expect to ask about 25,500 close contacts of the participants to swab their noses daily for two weeks, provide two blood samples and answer weekly questionnaires.

College students are an ideal population in which to study transmission after vaccination. They have among the highest rates of coronavirus infection, in large part because they live in tightly packed dormitories and have more social contacts than older adults do, while fortunately, hospitalizations and deaths are comparatively low. American colleges and universities have reported more than 530,000 cases since the beginning of the pandemic.

Nurses prepare to distribute Covid-19 vaccinations at The Forum vaccination super site in Los Angeles last week.
Credit...Allison Zaucha for The New York Times

The Biden administration's relatively smooth coronavirus vaccine distribution effort is about to hit a snag.

Vaccine manufacturers have been steadily increasing their output, and states have snapped up new doses as quickly as the government could deliver them. But officials expect the supply of vaccines to outstrip U.S. demand by mid-May, if not sooner, and are grappling with what to do with looming surpluses when scarcity turns to glut.

President Biden has promised enough doses by the end of May to immunize all of the nation's roughly 260 million adults. But between then and the end of July, the government has locked in commitments from manufacturers for enough vaccine to cover 400 million people — about 70 million more than the nation's entire population.

Whether to keep, modify or redirect those orders is a question with significant implications, not just for the nation's efforts to contain the virus, but also for how soon the pandemic can be brought to an end. Of the vaccine doses given globally, about three-quarters have gone to only 10 countries. At least 30 countries have not yet injected a single person.

And global scarcity threatens to grow more acute as nations and regions clamp down on vaccine exports. With infections soaring, India's government is holding back nearly all of the 2.4 million daily doses manufactured by the Serum Institute of India, the private company that is one of the world's largest producers of the AstraZeneca vaccine. That action follows the European Union's decision this week to move emergency legislation that would curb vaccine exports for the next six weeks.

Biden administration officials who are inclined to hold on to the coming U.S. surplus point to unmet need and rising uncertainty: Children and adolescents are still unvaccinated, and no one is certain whether or when immunity could wear off, which could require scores of millions of booster shots.

Vaccine manufacturers and some top federal officials say decisions about what to do with extra vaccine orders must be made within weeks, or the uncertainty could slow production lines.

The manufacturing process can take up to 10 weeks, so changes for a foreign market need time. The regulatory rules that govern vaccine shipments present another hurdle, as does the limited storage life of the drug substances that make the vaccine.

Senior officials say the administration is leaning toward keeping the doses it has ordered, and at some point directing the excess to other nations in one-off deals or giving it to Covax, an international nonprofit backed by the World Health Organization that is trying to coordinate equitable vaccine distribution. The Biden administration has already donated $4 billion to that international effort.

Dr. Robert Redfield discussing vaccines in January in Washington. 
Credit...Pool photo by Patrick Semansky

The former director of the Centers for Disease Control and Prevention said in a CNN clip on Friday that he favored a theory, decried by many scientists and rejected as "extremely unlikely" by at least one World Health Organization international expert, that the coronavirus escaped from a lab in Wuhan. The former official, Dr. Robert Redfield, offered no evidence and emphasized that it was his opinion.

"I am of the point of view that I still think the most likely etiology of this pathogen in Wuhan was from a laboratory, escaped. The other people don't believe that. That's fine. Science will eventually figure it out," Dr. Redfield told Dr. Sanjay Gupta in the video clip, referring to the origin of the virus. A formal report from the W.H.O. team and the Chinese scientists it worked with, on the origins of the pandemic and on the coronavirus in humans, is expected next week.

Despite Dr. Redfield's comments, officials briefed on the intelligence say there is no new evidence that would cause American spy agencies to reassess their views. There is no new information that bolsters the so-called lab theory, according to officials briefed on the intelligence.

During the Trump administration, then-Secretary of State Mike Pompeo, and to a lesser extent the president himself, pushed the theory that the coronavirus had escaped from a lab.

Mr. Pompeo pressed the spy agencies to investigate the lab theory and Richard Grenell, then the acting director of national intelligence, convened a review of what was known about the origin of the novel coronavirus.

Some in the Trump administration shared Mr. Pompeo's suspicions that an accident had occurred, and coronavirus samples being researched had inadvertently infected workers who then spread it in Wuhan. These officials pointed to some scientific reports that they said bolstered their feelings.

The claims that the virus was created or modified intentionally in a lab were dismissed by scientists and U.S. intelligence officials. The Office of the Director of National Intelligence in the Trump administration concurred "with the wide scientific consensus that the Covid-19 virus was not man-made or genetically modified."

Although that statement was diplomatically worded, the message from the intelligence agencies was clear that, despite pressure from the Trump administration, they had no evidence that the coronavirus had escaped from the lab. And many intelligence officials remained far more skeptical than Mr. Pompeo, telling colleagues there was simply not enough information to say where the coronavirus came from, and certainly not enough to challenge the scientific consensus that was skeptical of the lab theory.

The C.I.A. and other intelligence agencies have been skeptical that China was sharing all that it knew about the virus, although that was at least in part because of local officials withholding critical information from Beijing at key moments at the beginning of the outbreak.

A group of scientists who remain convinced of the possibility of a lab leak wrote an open letter in early March when the W.H.O. team report was first anticipated demanding a thorough investigation of Chinese labs. Virologists who have studied the evolution of coronaviruses and the way they have jumped to humans in the past causing SARS and MERS continue to argue that the evidence for a natural origin apart from a lab leak is overwhelming.

The Chinese government, prominent Chinese scientists and many virologists, who study the evolution of viruses and the appearance of infectious diseases, have said the lab leak theory was very unlikely, citing genetic evidence and the many opportunities for natural infection in human interactions with animals like bats, where the virus is believed to have originated.

When Dr. Anthony S. Fauci, the United States' top infectious disease expert, was asked at a White House news conference on the pandemic on Friday about Dr. Redfield's comments, he noted that the remarks were only an opinion. Dr. Fauci said that there are different ways viruses could become adapted to humans.

"You know one of them is in the lab and one of them, which is the more likely, which most public health officials agree with, is that it likely was below the radar screen, spreading in the community in China for several weeks if not a month or more, which allowed it, when it first got recognized clinically to be pretty well adapted," Dr. Fauci said.

At the same news conference on Friday, Dr. Rochelle Walensky, the director of the C.D.C., said she was looking forward to reviewing the upcoming joint report from the W.H.O. experts and Chinese scientists.

President Biden later declined to weigh in.

"I have theories, but I'm not a scientist," he said. "I'm going to wait until the scientific community makes that judgment."

Zachary Montague and Isabella Grullón Paz contributed reporting.

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Kenya Places Stringent Restrictions on Nairobi and Surrounding Areas

President Uhuru Kenyatta of Kenya said on Friday that travel in and out of Nairobi and four surrounding counties would be prohibited as part of new measures to combat a third wave of Covid-19.

There shall be a cessation of all movement by road, rail or air into and out of the disease-infected area as one zoned, area comprising of the counties of Nairobi, Kajiado, Machakos, Kiambu and Nakuru. Effective midnight tonight, therefore, meaning effective Saturday, the 27th of March, 2021. The third wave of Covid-19 is at hand in Kenya. The positivity rate is the highest since the pandemic hit us last year. The death rate is devastating by all measures. And the stress that the pandemic is placing on our health system is unparalleled. Whereas the foregoing measures will indeed have some adverse effects on our economy and constrain our usual way of life, the measures are temporary and necessary to contain the spread of the disease and therefore, to stop further loss of life. I am personally convinced that the cost of not acting now would be far much greater.

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President Uhuru Kenyatta of Kenya said on Friday that travel in and out of Nairobi and four surrounding counties would be prohibited as part of new measures to combat a third wave of Covid-19.CreditCredit...Thomas Mukoya/Reuters

Kenya imposed stringent new restrictions in the capital, Nairobi, and in four other counties, fighting a deadly third wave of Covid-19 infections that has placed its fragile health system under devastating pressure.

In a televised address on Friday, President Uhuru Kenyatta said that a tenfold increase in infection rates since January, coupled with a 52 percent increase in hospital admissions this month, called for "drastic measures."

"Kenya is now squarely in the grip of a third wave of this pandemic," he said.

Several variants have been identified in Kenya, but some were found among travelers, and there is little data to suggest how prevalent they may be or what role they might be playing in the East African nation's surge. They include B.1.1.7, the more transmissible and possibly more lethal variant first identified in Britain; B.1.351, a variant first found in South Africa that may bypass the protection afforded by current vaccines; and A.23.1, a variant that is now dominant in Kenya's neighbor Uganda and nearby Rwanda.

As of midnight, Mr. Kenyatta said, all gatherings are banned in Nairobi and four adjoining counties, which make up a single infection zone. Travel is prohibited in and out of the restricted area, where bars, restaurants and places of worship will close, and a nightly 10 p.m. curfew moves to 8 p.m. However, Nairobi's international airport will remain open.

In the rest of Kenya, sporting activities are suspended, and schools and universities will close until further notice.

The curbs came a week before the Easter holiday when many Kenyans pile into crowded buses to return to their family homes in rural areas.

A vaccination program that started in March raised hopes for an end of the pandemic, which has devastated the country's tourism-dependent economy. One small bright spot in the tourism downturn has been an influx of wealthy Europeans hoping to ride out the pandemic in upmarket resorts along Kenya's coast.

But the soaring rate of infections and deaths has forced the country into a painful new lockdown, Mr. Kenyatta said. As of Thursday, Kenya reported a total of 126,170 cases and 2,092 deaths. The positive test rate hit 22 percent this week, compared with 2 percent in January, he said.

A registered nurse, Nicole Brienza, administering a Covid vaccine on Sunday morning at the Javits Center in Manhattan.
Credit...Kevin Hagen for The New York Times

Just over a hundred days into New York City's vaccination campaign, 30 percent of adults and half of those 65 and older have received at least one dose of a Covid-19 vaccine. Millions more remain left to be vaccinated, and the city will have to overcome already significant disparities in vaccination rates across neighborhoods and demographic groups.

White and Asian New Yorkers have been vaccinated at higher rates than Black and Latino residents, who have been more likely to die from or be hospitalized with Covid-19 both in New York City and nationwide.

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