internal-essential

Sanofi-GlaxoSmithKline Covid Vaccine Shows Promise, Firm Says

Sanofi, the French pharmaceutical company, said on Monday that it would move the experimental Covid-19 vaccine it is developing with GlaxoSmithKline into a late-stage trial after the shot produced strong immune responses in volunteers in a mid-stage study.

The findings are encouraging news for a vaccine that has fallen behind in development and has so far disappointed those expecting that it would be crucial in combating the pandemic. If the vaccine can become available in the last three months of this year, as its developers hope, it could still play a central role as a booster shot as well as an initial inoculation in the developing world, where the pace of vaccination is lagging.

The vaccine hit a major setback in December, when its developers announced that it did not appear to work well in older adults and that they would have to delay plans to test it in a Phase 3 trial, the crucial test that will assess the vaccine’s effectiveness.

But the companies modified the vaccine and in February began testing it in a Phase 2 study that included more than 700 volunteers in the United States and Honduras between 18 and 95 years old. Sanofi said the vaccine did not raise any safety concerns and produced a strong immune response across age groups, a finding suggesting it has been successfully tweaked.

Sanofi announced the findings in a statement and said it plans to soon publish the results in a medical journal.

Sanofi and GSK are much more experienced in vaccine development than a number of their rivals that have already won authorization. The two companies used a more established approach than those deployed in other, more swiftly developed Covid vaccines. Their shot is based on viral proteins produced with engineered viruses that grow inside insect cells. GSK is supplying the Sanofi vaccine with an adjuvant, an ingredient used in many vaccines meant to boost the immune response.

Sanofi and GSK’s vaccine was one of six selected for funding from Operation Warp Speed, the Trump administration’s effort to accelerate vaccine development. Last summer, the federal government agreed to give the companies $2.1 billion to develop and manufacture the vaccine, in exchange for 100 million doses once the shot was ready.

Sanofi also has supply deals with the European Union and Canada. It has also agreed to supply 200 million doses to Covax, the program to deliver vaccines to middle- and lower-income countries that has been struggling with a shortfall in expected doses. Sanofi has also announced plans to help manufacture the authorized vaccines made by Pfizer-BioNTech, Moderna and Johnson & Johnson.

Sanofi said its Phase 3 trial of its vaccine will begin in the coming weeks and enroll more than 35,000 adult volunteers around the world. It will test two formulations of the vaccine, one aimed at preventing the original strain of the virus and the other aimed at the B.1.351 variant first seen in South Africa that some vaccines appear to be less effective against.

Su-Peing Ng, Sanofi’s global head of medical for vaccines, told journalists on Monday that the company expects it to be “operationally quite challenging” to enroll unvaccinated participants in the Phase 3 trial as vaccination coverage increases in many nations. Still, she said, vaccine doses are still scarce in many parts of the world, pointing to Latin America and Asia as places where the company may look to enroll volunteers.

The company said that soon after starting the Phase 3 trial it plans to assess whether its vaccine can boost immune responses in people who had been vaccinated months before with authorized vaccines. Those booster studies are expected to enroll volunteers in well-vaccinated parts of the world, including the United States and Europe.

Sanofi and GSK said last year they were preparing to be able to make 1 billion doses annually. Thomas Triomphe, Sanofi’s global head of vaccines, said on Monday that the company’s production this year, if its vaccine is shown to work, would depend on the world’s needs.

The vaccine, he said, has “potential to be a booster of choice for many nations and many different platforms.”

View

C.D.C Confirms More Cases of Rare Blood Clot Disorder Linked to J.&J. Vaccine

Federal health officials have now confirmed 28 cases, including six in men, of a rare blood clotting disorder in adults who have received the Johnson & Johnson Covid-19 vaccine.

Dr. Tom Shimabukuro, the deputy director of the immunization safety office at the Centers for Disease Control and Prevention, presented the new cases on Wednesday at a meeting of a panel of advisers to the C.D.C.

The figure is an increase from the 15 confirmed cases, all of which were in women, that were reported at last month’s meeting.

Although officials have now identified a handful of cases in men, women — especially those between the ages of 30 and 49 — appear to remain at elevated risk. “The trend is that the reporting rates are higher in females compared to males in all age categories,” Dr. Shimabukuro said at the meeting.

lifted the suspension 10 days later and added a warning about the potential risks to the vaccine’s label, which notes that a connection between the vaccine and the condition is “plausible.”

Twenty-two of the confirmed cases so far have been in women, and six have been in men. All were in adults between the ages of 18 and 59 who received the vaccine before the national pause. (There was also one additional case recorded in a 25-year-old man who participated in the clinical trial.)

Three people have died and four remain hospitalized, including one who is in intensive care. No new deaths have been documented since last month’s meeting, Dr. Shimabukuro said.

The overall risk remains exceedingly low. More than 9 million doses of the Johnson & Johnson vaccine have now been administered in the United States.

There have been 12.4 cases per million doses among women between the ages of 30-39 and 9.4 cases per million doses among women between 40 and 49, the two demographic groups that appear to be at highest risk. Among older women and men of all ages, there were fewer than 3 cases per million doses.

Among the 28 confirmed cases, 12 people who developed the disorder had obesity, 7 had high blood pressure, 3 had diabetes, and 3 were taking estrogen, though it is not yet clear whether any of those factors might substantially increase the risk of the disorder.

Officials will continue to monitor for cases of the clotting disorder in people who have been vaccinated, Dr. Shimabukuro said.

There have been no confirmed cases of the clotting disorder following the Pfizer-BioNTech or Moderna vaccines, which employ a different technology, Dr. Shimabukuro said.

View

AstraZeneca’s Covid-19 vaccine has generated $275 million in sales so far this year.

The Covid-19 vaccine developed by AstraZeneca and the University of Oxford brought in $275 million in sales from about 68 million doses delivered in the first three months of this year, AstraZeneca reported on Friday.

AstraZeneca disclosed the figure, most of which came from sales in Europe, as it reported its first-quarter financial results. It offers the clearest view to date of how much money is being brought in by one of the leading Covid vaccines.

AstraZeneca, which has pledged not to profit on its vaccine during the pandemic, has been selling the shot to governments for several dollars per dose, less expensive than the other leading vaccines. The vaccine has won authorization in at least 78 countries since December but is not approved for use in the United States.

The Covid vaccine represented just under 4 percent of AstraZeneca’s revenue for the quarter; it was nowhere near the company’s biggest revenue generator. By comparison, the company’s best-selling product, the cancer drug Tagrisso, brought in more than $1.1 billion in sales in the quarter.

said this week that it would make available to the rest of the world up to 60 million doses of its supply of AstraZeneca shots, pending a review of their quality.

If the company does win authorization from the U.S. Food and Drug Administration, it could help shore up confidence in a vaccine whose reputation been hit by concerns about a rare but serious side effect involving blood clotting. The F.D.A.’s evaluation process is considered the gold standard globally.

Johnson & Johnson, whose vaccine was authorized for emergency use at the end of February, reported last week that its vaccine generated $100 million in sales in the United States in the first three months of the year. The federal government is paying the company $10 a dose. Like AstraZeneca, Johnson & Johnson has pledged to sell its vaccine “at cost” — meaning it won’t profit on the sales — during the pandemic.

Vaccines from Pfizer and Moderna cost more, and neither company has said that it will forego profits. Pfizer has said that it expects its vaccine to bring in about $15 billion in revenue this year; Moderna said it anticipates $18.4 billion in sales.

Both companies are scheduled to report their first-quarter results next week.

View

Ireland and Spain lose Euro 2020 games over coronavirus restrictions.

Plans to play some European soccer championship matches this summer in Dublin and in Bilbao, Spain, have been abandoned after the local authorities were unable to guarantee that a sufficient number of fans could attend because of coronavirus restrictions.

Munich’s role in the tournament, Euro 2020, was also in doubt, but its place was confirmed during an emergency meeting of members of the executive committee for UEFA, soccer’s governing body in Europe. The tournament, which was postponed last year because of the pandemic, is soccer’s No. 2 most-watched competition, after the World Cup. This summer it is being played on a continentwide basis, in 11 cities, for the first time.

Dublin and Bilbao were set to stage three group games and one round-of-16 match. Dublin’s group-stage schedule will move to St. Petersburg, Russia, which had already been selected to host four games. London’s Wembley Stadium, where the tournament’s semifinals and final will be played, will pick up Dublin’s knockout-round game.

Seville will take on the games slated to be played in Bilbao, despite opposition from the authorities in Bilbao, who said they would seek compensation from UEFA after working on hosting the tournament for six years.

View

The U.S. begins closing mass vaccination sites as demand falls.

County health departments that a month ago couldn’t keep up with vaccine demand have now started closing some of their mass vaccination sites for lack of customers, and some counties are declining vaccine shipments.

Now that more than half of adults in the United States have received at least one Covid-19 vaccine dose and the country has surpassed 202 million administered doses, demand for shots appears to be slowing in many areas.

White House and health officials are comparing the next phase of the vaccination campaign to a get-out-the-vote effort.

While every person 16 and older in the country became eligible for a coronavirus vaccination on Monday, dropping demand has pushed Mercer County, Ohio — where 27 percent of adults have at least one dose — to announce the closing of its mass vaccination site on May 7.

“It wasn’t fair to ask our volunteers to keep showing up there when they weren’t being fully utilized — they like to keep busy,” Jason Menchhofer, county health administrator, said in an interview on Thursday about the site on the local fairgrounds.

In the first few months of the year, the site in the county of 41,000, which borders Indiana, would fill up its 400 appointments in an hour or two, he said. “We could even reach down into those who were not age-eligible to get it to come in at the end of the day to come out quickly and get it into someone’s arm,” he said.

But demand has fallen precipitously in the last several weeks, and last week the county ended up wasting two doses, which was a first. “We no longer have a reserve of people who want to be vaccinated to reach into to show up and take those doses,” he added.

The largest vaccination site in Las Vegas, the Cashman Center, will close on May 5 as the list of open appointments grow and the lines to be inoculated have dwindled. The tens of thousands of open appointments at sites across the nation are forcing officials to pivot their outreach strategies and zero in on smaller events.

Palm Beach County in Florida said on Tuesday that it would shut its three mass vaccination sites, which are operating at about half capacity, by the end of May. Of 16,000 appointment slots available this week, only 6,000 were filled, according to health officials. Instead, three mobile units will each aim to give 500 doses a day.

In Galveston County, Texas, a mass drive-through clinic at a county park won’t operate after May 1. The park has been administering 5,000 doses per day, including on Thursday. But demand for appointments has dampened in the last three weeks, according to the county’s chief public health officer. He also asked the state to pause vaccine shipments.

“We’re concerned that some of it may expire before we use it, if we keep getting it,” said Dr. Philip Keiser. “We are trying to figure out how to balance out supply and demand, yet also have enough on hand so that when school kids are able to get back, we can do them.”

There will be much more targeted outreach, down to the Census tract level, Dr. Keiser said, and there might be 100 or 200 injections per day rather than thousands.

“We got about 50 percent of our people vaccinated,” he said, “and we recognize that next 25 percent is going to be a lot harder than the first.”

View

Japan declares a state of emergency in Tokyo and Osaka as cases continue to rise.

TOKYO — Japan on Friday declared states of emergency in Tokyo, Osaka and surrounding areas in an effort to stem a widening coronavirus outbreak three months before the country plans to host the Summer Olympics.

The measures will take effect on Sunday, Prime Minister Yoshihide Suga said, calling them “a short and concentrated measure” to slow the virus’s spread during the Golden Week holiday, traditionally one of the year’s busiest travel periods.

In addition to Tokyo and Osaka, the states of emergency cover the neighboring prefectures Kyoto and Hyogo and will be in place until May 11. Together, the four prefectures are home to roughly a quarter of Japan’s 126 million people.

Japan has managed the pandemic better than many other large economies, but a stubborn fourth wave, propelled by more infectious variants of the virus, has produced the most daily cases since January. Officials began imposing looser restrictions in early April over parts of 10 prefectures, but those steps have failed to corral the outbreak.

going ahead with the Olympics, which were rescheduled from last year. Organizers have said the event will take place without spectators from abroad, and have barred crowds from parts of the ceremonial torch relay. Still, in surveys, more than 70 percent of Japanese say the games should be postponed again or canceled.

slower than in many other countries, with less than 1 percent of the population fully inoculated, according to a New York Times database.

View

Patients and hospitals beg for help as a catastrophic second wave batters India.

NEW DELHI — A catastrophic second wave of the coronavirus is battering India, which is reporting the world’s highest number of new infections as hospitals and patients beg for fast-diminishing oxygen supplies and other emergency aid.

India recorded more than 330,000 coronavirus cases in 24 hours, the health ministry said on Friday, the second consecutive day that the country has set a global record for daily infections.

Canada has joined Britain, Hong Kong, Singapore and New Zealand in barring travelers coming from India. And the U.S. State Department advised people against going to India after the Centers for Disease Control raised the risk level to its highest measure.

Facing a barrage of criticism for his government’s handling of the second wave, Prime Minister Narendra Modi canceled plans to travel to West Bengal for a campaign rally as an election takes place in that state.

continued to hold mass rallies with thousands of people unmasked. The government has also allowed an enormous Hindu festival to draw millions of pilgrims despite signs that it has become a superspreader event.

The catastrophe in India is playing out vividly on social media, with Twitter feeds and WhatsApp groups broadcasting hospitals’ pleas for oxygen and medicines, and families’ desperate searches for beds in overwhelmed Covid-19 wards. With many hospitals short of ventilators, television reports have shown patients lying inside ambulances parked outside emergency rooms, struggling to breathe.

Swati Maliwal, an activist and politician in Delhi, tweeted that her grandmother had died while waiting to be admitted outside a hospital in Greater Noida near New Delhi.

“I kept standing there for half hour and pleading for admission and nothing happened,” she wrote. “Shame! Pathetic!”

The death toll from the virus rose more than 2,200 on Friday, a new high.

On Thursday, Fortis Healthcare, one of India’s top hospital chains, tweeted an S.O.S. message to Mr. Modi and his chief deputy, Amit Shah, the minister for home affairs, appealing for more oxygen at a hospital in Haryana State on the Delhi border.

At least 22 patients were killed in a hospital in the city of Nashik on Wednesday after a leak cut off their oxygen supplies.

Beginning on Saturday, Indians age 18 or older can register for a Covid-19 vaccine, but demand is expected to far outstrip supply. So far, more than 135 million people have received at least one dose, about a tenth of India’s population of nearly 1.4 billion. Two vaccines have received emergency use authorization, with at least five others in the pipeline.

View

Johnson & Johnson Vaccinations to Resume in South Africa

South Africa will resume the use of the Johnson & Johnson vaccine to inoculate health care workers next week, offering some relief to the country that has suffered a series of blows to its vaccination efforts in recent months, according to South African authorities.

The country suspended an early-access Johnson & Johnson vaccination program last week after health officials in the United States put a pause on the vaccine amid concerns of rare blood clots that emerged in a handful of people who received it.

South Africa’s decision to move forward again was the second green light this week for Johnson & Johnson. On Tuesday, the European Union drug regulator also recommended resuming the rollout of the company’s vaccine.

Now, many eyes are on Washington, where a federal advisory panel is scheduled to meet Friday to discuss whether to lift the pause in the United States.

told reporters on Thursday.

Health experts welcomed the resumption of the vaccine campaign in South Africa, which has recorded more coronavirus cases than any other country on the continent and has suffered serious setbacks in its attempt to combat the virus in recent months.

In February, health officials scrapped plans to use the AstraZeneca vaccine after it proved ineffective against a variant of the virus now dominant in South Africa. The decision came a week after a million doses of the vaccine arrived in the country and amid a devastating second wave of virus cases.

Though the Johnson & Johnson vaccine has not yet been approved for general use in South Africa, it has been used as part of a research study offering early access to the vaccine to the country’s 1.2 million health care workers.

South African health officials are gearing up to extend vaccinations to the general public starting in May. In a first step to launching a national rollout, the country last week opened its vaccine registration to people over 60 years old, who will be among the first to be inoculated.

That plan depends on tens of millions of doses of the Pfizer-BioNTech vaccine, which requires two doses and will be used in major cities. The single-shot Johnson & Johnson vaccine, which is easier to store and better for hard-to-reach populations, will be used in the country’s rural areas.

View

New York Road Runners Announces a New Race

New York Road Runners, the club that puts on the New York City Marathon, has announced the return of its first regularly scheduled race since the beginning of the pandemic.

On Thursday, the club said that it would hold the annual New York Mini 10K on June 12. The 10-kilometer, women-only race has been held annually since 1972, with the exception of last year.

“This is our first real table setting,” said Kerin Hempel, the organization’s interim chief executive. “It’s starting to feel like ‘OK, we’re back, we’re coming back.’”

This will not be the first race the club has held since the onset of the pandemic.

The organization has held a series of “return to racing” events as pilots starting last fall, allowing very small fields to run with safety protocols in place. Among other measures, the races had temperature checks, staggered starts and different corralling of runners.

Sara Hall, will return to defend her title.

The announcement comes as runners look ahead — with cautious optimism — to the return of major road races. Ms. Kempel anticipated the question on the minds of many: What does this mean for the New York City Marathon?

“We’ve been saying the marathon is going to happen,” she said. “It’s more about what it’s going to look like, and how many people we can accommodate on the course.”

View

India Sets Covid-19 Daily Case Record

Marking a grave new milestone in the coronavirus pandemic, India recorded 312,731 new infections in a 24-hour period, the Indian health ministry said on Thursday. It is the highest daily case count in a single country since the virus surfaced in China more than a year ago.

India’s total eclipsed the previous single-day high of 300,669 cases, set in the United States on Jan. 8, according to a New York Times database.

Over the past two months, the outbreak in India has exploded, with reports of superspreader gatherings, oxygen shortages and ambulances lined up outside hospitals because there are no ventilators for new patients.

As cases worldwide reach new weekly records, 40 percent of the infections are coming from India, a sobering reminder that the pandemic is far from over, even as infections decline and vaccinations speed ahead in the United States and other wealthy parts of the world. India has surpassed 15.6 million total infections, second most after the United States.

at least 22 people died in an accident in the central city of Nashik when a leak in a hospital’s main oxygen tank cut the flow of oxygen to Covid-19 patients.

The picture is staggeringly different from early February, when India was recording an average of just 11,000 cases a day, and domestic drug companies were pumping out millions of vaccine doses. More than 132 million Indians have received at least one dose, but supplies are running low and experts warn that the country is unlikely to meet its goal of inoculating 300 million people by the summer.

Critics say Prime Minister Narendra Modi, who imposed a harsh nationwide lockdown in March 2020 in the early stages of the pandemic, failed to prepare for a second wave or to warn Indians to remain vigilant against the virus, especially as more infectious variants began to spread.

Mr. Modi’s Hindu nationalist government has also allowed a massive Hindu festival to take place, drawing millions of pilgrims to the banks of the Ganges River, and his party has held jam-packed political rallies in several states.

wrote in The New York Times on Tuesday.

The hardest hit region is Maharashtra, a populous western state that includes the financial hub of Mumbai. On Wednesday, the state’s top leader ordered government offices to operate at 15 percent capacity and imposed new restrictions on weddings and private transportation to slow the spread of the virus.

View