F.D.A. Panel Is Scrutinizing Data on Moderna Boosters

A recommendation is expected to follow on whether to authorize a third dose for recipients of the Moderna vaccine. Here’s the latest virus news.,

ImageMatthew Thomas received his second dose of the Moderna vaccine in April at Leupp Field Clinic in Leupp, Ariz.
Matthew Thomas received his second dose of the Moderna vaccine in April at Leupp Field Clinic in Leupp, Ariz.Credit…Sharon Chischilly for The New York Times

A key federal advisory committee began two days of meetings that are expected to strongly influence decisions on whether at least some recipients of the Moderna and Johnson & Johnson coronavirus vaccines will soon be eligible for booster shots.

After hearing from Moderna officials, Food and Drug Administration scientists, members of the public and others, the panel of outside experts advising the F.D.A. is scheduled to vote Thursday on whether to recommend emergency authorization of a third shot for recipients of Moderna’s vaccine. (You can watch the meeting here.)

The panel will vote Friday on Johnson & Johnson’s request for emergency authorization of a second dose. They will also discuss, but not vote on, whether a booster dose of both the Pfizer-BioNTech or Moderna vaccines should be offered to people who are not elderly or in high-risk categories. That would broaden the eligibility categories that the government set for a Pfizer booster last month.

While regulators are not obligated to follow the panel’s recommendations, they typically do.

The panel may be more skeptical of a booster shot for Moderna recipients than for Johnson & Johnson. Some vaccine experts have long argued that Johnson & Johnson should be a two-dose vaccine since its effectiveness is lower than those of the shots produced by both Moderna and Pfizer-BioNTech.

Pfizer-BioNTech won authorization for a booster shot for many recipients last month after arguing that its vaccine, while highly protective in the early months, lost some potency against severe Covid-19 and hospitalization over time.

But Moderna’s potency against hospitalization has held up better over time than Pfizer’s, according to a recent study by the Centers for Disease Control and Prevention.

In documents released Tuesday, Moderna did not argue that its vaccine requires a booster to prevent severe disease or hospitalization. Instead, it concentrated its arguments on preventing infection and mild to moderate disease.

Moderna said the mean antibody level of participants in its study was 1.8 times higher after the booster than it was after the second shot. In another measurement, the booster raised neutralizing antibodies at least fourfold in 87.9 percent of people compared to after the second dose, narrowly failing to meet the agency’s requirement of 88.4 percent.

Given that Moderna’s vaccine appears to still strongly protect against severe disease, at least some committee members are expected to balk at recommending a third dose. “Maybe it won’t be a slam dunk,” said Dr. Peter J. Hotez, a vaccine expert at the Baylor College of Medicine, of the panel’s vote. “Maybe we should wait a little bit longer on Moderna, let it drop off more first before we boost.”

One of the first presentations Thursday came from Israeli health officials, who said their booster campaign offering a third shot to recipients of Pfizer-BioNTech’s vaccine significantly lowered rates of infection and severe disease.

The Biden administration has been closely watching Israel’s experience because the country has a nationalized health care system that allows it to closely track recipients.

Since Israel’s data deal only with Pfizer’s vaccine, it was not clear how much weight committee members will give it. But it did provide them with more information than they had last month before voting to recommend a booster for a broad swath of Pfizer recipients. Several panel members described the data as compelling.

Israeli scientists analyzed rates of infection and of severe illness among 4.6 million people from July 30, when the country first began offering booster shots, to Oct. 6. They compared rates of both among people who got a third dose to those among people who did not, and said they used the same definition of severe disease as the one used by the National Institutes of Health.

Israeli officials said they found a booster dose improved protection against infection across all age groups about tenfold.

Rates of severe illness were six to 20 fold lower for those 60 years or older and three to 20-fold lower for those aged 40 to 60, the researchers said, although the number of severely ill people in the latter group was very small even before boosters were given. Death rates were three to 10-fold lower among the elderly, they said.

A crucial question that was not clearly answered during the Israelis’ presentation, though, was whether the recent drop in cases there could be at least partly due to the retreat of the highly contagious Delta variant.

The Israeli results have been published by a preprint service but have not been peer-reviewed.

Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration, who will issue the agency’s decision on boosters.Credit…Stefani Reynolds for The New York Times

An independent panel of experts advising the Food and Drug Administration is meeting regarding Moderna’s coronavirus vaccine booster shot on Thursday, and on Johnson & Johnson’s on Friday. Each day will culminate in a vote by the panel on whether to recommend emergency authorization for that booster for recipients of that vaccine.

So what happens after the panel votes? There are further steps at the F.D.A., then steps at the Centers for Disease Control and Prevention, and the process ends with the states. Here’s how it breaks down:

The F.D.A.

  • The F.D.A., a federal agency of the Department of Health and Human Services that controls and supervises medications and other elements related to public health, takes up the advisory panel’s recommendation, which includes the question of who should be eligible. The advisory panel’s votes are not binding, but the F.D.A. typically follows them.

  • The F.D.A.’s top official — its acting commissioner, Dr. Janet Woodcock — issues the agency’s final determination on whether to authorize the boosters and for whom. Such decisions are typically issued within a few days of advisory committee meetings.

The C.D.C.

  • An advisory panel to the Centers for Disease Control and Prevention, the United States’ public health agency, reviews the F.D.A.’s decision. On Thursday and Friday of next week, that panel is scheduled to meet and vote on its recommendations regarding boosters.

  • The C.D.C. takes up that panel’s recommendations, and the agency’s director, Dr. Rochelle P. Walensky, issues the agency’s guidance on whether boosters should be used and who should be eligible. That guidance is deeply influential for states, doctors, pharmacies and other health care institutions and the general public. As with the process at the F.D.A., the panel’s recommendations are not binding, but the C.D.C. usually follows them.

    However, there was a rare exception last month: When a C.D.C. advisory panel rejected the F.D.A.’s recommendation that frontline workers be included among those eligible for the Pfizer-BioNTech booster, Dr. Walensky overrode her own agency’s advisers and sided with the F.D.A.

Dr. Rochelle P. Walensky, the C.D.C. director, issues guidance for states and the general public. Credit…Stefani Reynolds for The New York Times

The states

State health departments generally follow the recommendations of the C.D.C. In the case of the Pfizer-BioNTech booster, the shots began being administered widely immediately after Dr. Walensky announced the C.D.C.’s guidance to allow them for people over 65, patients in nursing homes and other institutional settings, those with underlying medical conditions, and frontline workers.

The Brooklyn Nets guard Kyrie Irving in New York in June.Credit…Adam Hunger/Associated Press

Kyrie Irving, the N.B.A. star who has been indefinitely barred from practicing or playing with the Brooklyn Nets because of his refusal to get the Covid-19 vaccine, spoke out publicly on Wednesday night for the first time since the team decided to keep him off the court, saying his refusal was a matter of personal freedom.

“You think I really want to lose money?” Irving, who is set to earn about $40 million in salary this season, said on his Instagram feed in a meandering monologue that included incorrect medical information. More than 90 percent of players in the league are vaccinated, a proportion much higher than in the general population of the United States.

“You think I really want to give up on my dream to go after a championship?” Irving, 29, said. “You think I really just want to give up my job? You think I really want to sit at home?”

On Tuesday, the Nets said they had barred Irving from playing until he becomes “eligible to be a full participant.” New York City requires most teenagers and adults to have at least one vaccination shot to enter facilities such as sports arenas, and Irving has not practiced with the Nets in Brooklyn. Irving joined the Nets in 2019 as they built a team of superstars that includes Kevin Durant and James Harden.

Irving asked that his decision to remain unvaccinated be respected and said that he has no plans to retire. He couched his refusal to get vaccinated in his opposition to mandates, saying nobody should be “forced” to do it.

Irving falsely claimed his decision to remain unvaccinated does not harm other people. The highly contagious Delta variant has quickly spread in areas with low vaccination rates. And hospitals in those areas have been overrun with unvaccinated patients, leaving few beds and staff members to treat other patients.

Lucenia Williams Dunn found it hard to separate the painful history of the Tuskegee syphilis study from the creation of Covid-19 vaccines, though the specifics are quite different.Credit…Matthew Odom for The New York Times

By the time vaccines for the coronavirus were introduced late last year, the pandemic had taken two of Lucenia Williams Dunn’s close friends. Still, Ms. Dunn, the former mayor of Tuskegee, contemplated for months whether to be inoculated.

It was a complicated consideration, framed by the government’s botched response to the pandemic, its disproportionate toll on Black communities and an infamous 40-year government experiment for which her hometown is often associated.

“I thought about the vaccine most every day,” said Ms. Dunn, 78, who finally walked into a pharmacy this summer and rolled up her sleeve for a shot, convinced after weighing with her family and doctor the possible consequences of remaining unvaccinated.

“What people need to understand is some of the hesitancy is rooted in a horrible history, and for some, it’s truly a process of asking the right questions to get to a place of getting the vaccine.”

In the first months after the vaccine rollout, Black Americans were far less likely than white Americans to be vaccinated. In addition to the difficulty of obtaining shots in their communities, their hesitancy was fueled by a powerful combination of general mistrust of the government and medical institutions, and misinformation over the safety and efficacy of the vaccines.

But a wave of pro-vaccine campaigns and a surge of virus hospitalizations and deaths this summer, mostly among the unvaccinated and caused by the highly contagious Delta variant, have narrowed the gap, experts say. So, too, have the Food and Drug Administration’s full approval of a vaccine and new employer mandates. A steadfast resistance to vaccines in some white communities may also have contributed to the lessening disparity.

A shipment of AstraZeneca’s coronavirus vaccine arriving in Seoul in May.Credit…Yonhap/EPA, via Shutterstock

South Korea plans to ship almost 1.6 million doses of AstraZeneca’s coronavirus vaccine to Vietnam and Thailand this week, the foreign ministry announced Tuesday, as the Southeast Asian nations struggle to contain the spread of the virus.

The donation comes as South Korea’s vaccination program has accelerated rapidly, with 70 percent of the population expected to be inoculated by the end of the month.

About 62 percent of South Korea’s total population has been fully vaccinated, according to the Ministry of Health and Welfare, and the nation is expected to ease the most severe restrictions by next month. Thailand has fully vaccinated 33 percent of its population and Vietnam about 17 percent.

About 1.1 million doses will go Vietnam and 470,000 to Thailand, South Korea’s government said.

South Korea was among the last of the world’s wealthiest nations to start a vaccination program, leading to frustration among citizens who had already spent a year living under restrictions to control the spread of the virus. Eight months later, the country has inoculated more people per capita than the United States, which has secured the largest supply of vaccines in the world.

The U.S. government invested about $1.2 billion in the development of AstraZeneca’s vaccine, hoping that it would be one of many in an arsenal. Instead, federal officials have yet to approve the use of the shot and million of doses are sitting unused, likely destined to be exported. President Biden promised to donate up to 60 million doses of the AstraZeneca vaccine to countries in Latin America, Southeast Asia and Africa.

AstraZeneca’s vaccine is cheaper and easier to store than the mRNA vaccines produced by Pfizer-BioNTech and Moderna, but it has been dogged by production mishaps, questions about its efficacy and reports of very rare blood clots. Amid the concerns, South Korea temporarily suspended use of the vaccine in April, but cleared it for use again several days later.

Vehicles in line to cross the International Rainbow Bridge from Niagara Falls, N.Y., into Niagara Falls, Ontario, in August after Canada opened border crossings to vaccinated visitors.Credit…Tara Walton for The New York Times

Fall has traditionally been a fat time for businesses in New York’s North Country, as Canadian visitors flood into the region to celebrate holidays like Canadian Thanksgiving, taking in dazzling displays of foliage and feasting on big sales at local retailers.

That influx has been stymied at the border for much of the last two years by strict controls implemented because of the coronavirus. On Wednesday, however, businesses all along the state’s northern border were celebrating the news that in November, fully vaccinated Canadians would again be allowed into the United States via the two nations’ heavily trafficked land crossings.

“A simple ‘Yahoo!’ seems to be the right answer,” said Kristy Kennedy, the vice president of marketing and tourism for the North Country Chamber of Commerce, in Plattsburgh, about 25 miles south of Quebec. “We could not be happier.”

That sentiment spread across the state to Niagara Falls and other western New York towns and cities, where the border restrictions — and burdensome rules for American travel to Canada — had crippled usually robust business relationships as well as personal ones, separating some extended families for a year or longer.

A Walgreens advertises Covid-19 shots in Greeneville, Tenn., in April.Credit…Erin Schaff/The New York Times

Walgreens Boots Alliance administered coronavirus vaccinations at a higher-than-expected rate, delivering 13.5 million vaccinations in the three months that ended in September, which helped bolster its sales, the company reported on Thursday.

The company also announced that it would invest an additional $5.2 billion into VillageMD, a venture that aims to reach underserved communities, to support its rollout of at least 600 primary care practices at Walgreens in the United States.

Shares of Walgreens Boots Alliance jumped by more than 3 percent in early trading after the announcement.

The company reported that same-store sales grew 8.9 percent in its fiscal fourth quarter compared with the same period last year. Health and wellness sales increased 14 percent, strengthened by at-home coronavirus tests and cold and flu products.

“Comparable U.S. pharmacy and retail sales both saw robust growth, and recovery continued in our U.K. business as Covid-19 restrictions eased in the quarter,” Rosalind Brewer, the chief executive of Walgreens Boots Alliance, said in a statement.

Net profit jumped 68 percent in the quarter to $627 million; it was $373 million a year earlier. The company also benefited from digital tools that eased curbside and drive-through pickup, leading to 100 percent growth in revenue for the fourth quarter compared with last year.

Walgreens is one of the largest among dozens of grocery and drugstore chains that are giving vaccines allocated by states and via the federal pharmacy vaccination program. The company brings in revenue from the vaccine administration fees paid by government and private payers as well as from purchases made by shoppers coming in for vaccines.

The company requires people to create a Walgreens account to search online for a vaccine appointment, which helped increase membership in its MyWalgreens program to 85 million members from 75 million members in the previous quarter.

But it faced also complaints in the quarter from customers and the Centers for Disease Control and Prevention about the timing of a second dose of the vaccine developed by Pfizer and BioNTech. Walgreens had been scheduling second doses for that shot four weeks apart, but agreed to follow guidance from federal health officials, who recommend a three-week gap.

Viruses found in bats like this least horseshoe bat are surprisingly good at infecting humans, a new study shows.Credit…Kevin K. Caldwell

Coronaviruses discovered in Laotian bats are surprisingly adept at infecting human cells, showing that such deadly features can indeed evolve outside of a lab, according to a new study.

Virus experts are buzzing about the discovery, which came after scientists traveled to Laos in the summer of 2020 to catch bats that might harbor close cousins of the Covid-19 pathogen.

In the dead of night, they used mist nets and canvas traps to snag the animals as they emerged from nearby caves, gathered samples of saliva, urine and feces, and then released the bats back into the darkness.

The fecal samples turned out to contain coronaviruses, which the scientists studied in high-security biosafety labs, using specialized protective gear and air filters.

Three of the Laos coronaviruses were unusual: They carried a molecular hook on their surface that was very similar to the hook on the virus that causes Covid-19, known as SARS-CoV-2. Like SARS-CoV-2, the bat viruses’ hook allowed them to latch onto human cells.

“It is even better than early strains of SARS-CoV-2,” said Marc Eloit, a virologist at the Pasteur Institute in Paris who led the study, referring to how well the hook on the Laos coronaviruses bound to human cells. The study was posted online last month and has not yet been published in a scientific journal.

Some experts suspect that these SARS-CoV-2-like viruses may already be infecting people from time to time, causing only mild and limited outbreaks. But under the right circumstances, the pathogens could give rise to a Covid-19-like pandemic, they say.

The findings have significant implications for the charged debate over Covid’s origins, experts say. Some people have speculated that SARS-CoV-2’s impressive ability to infect human cells could not have evolved through a natural spillover from an animal. But the new findings seem to suggest otherwise.

“That really puts to bed any notion that this virus had to have been concocted, or somehow manipulated in a lab, to be so good at infecting humans,” said Michael Worobey, a University of Arizona virologist who was not involved in the Laotian bat study.

A baby is vaccinated against tuberculosis, polio and measles in the village of Tanarake, Madagascar, in September.Credit…Rijasolo/Agence France-Presse — Getty Images

Deaths from tuberculosis, the world’s biggest infectious disease killer until the Covid-19 pandemic arrived, have increased for the first time in more than a decade, totaling more than 1.5 million people in 2020. That trend is expected to worsen in 2021 and 2022, according to a report released on Thursday by the World Health Organization.

The report confirmed the warnings from the W.H.O. and other global health organizations that the Covid-19 pandemic would reverse years of progress against other infectious diseases, including TB, H.I.V. and malaria.

“This is alarming news that must serve as a global wake-up call to the urgent need for investments and innovation to close the gaps in diagnosis, treatment and care for the millions of people affected by this ancient but preventable and treatable disease,” Dr. Tedros Adhanom Ghebreyesus, the W.H.O.’s director general, said in a statement.

Reported diagnoses of TB also dropped sharply, to 5.8 million cases in 2020 from 7.1 million in 2019, suggesting that many more cases than before are going undiagnosed and untreated — a trend that is likely to have a long-term effect on TB deaths. And only 2.8 million people were given preventive treatment for TB in 2020, a 21 percent decrease from 2019.

In many poor countries, health care workers, funds and testing equipment that would normally be dedicated to TB were redirected to cope with Covid-19, according to the W.H.O. report. Lockdowns and disruptions in supply chains also interrupted access to treatment and care.

At the same time, global funding for TB has fallen to $5.3 billion from $5.8 billion, less than half of what’s needed, according to the W.H.O. report.

There were some glimmers of good news amid the sobering statistics. In the Russian Federation, the incidence of TB fell by 6 percent a year between 2010 and 2020, and the W.H.O. European Region overall exceeded the 2020 goal with a decrease of 25 percent.

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