WHO: Monkeypox Cases Drop 21%, Reversing Month-Long Increase

WHO: Monkeypox Cases Drop 21%, Reversing Month-Long Increase
WHO: Monkeypox Cases Drop 21%, Reversing Month-Long Increase

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GENEVA — The number of monkeypox cases reported globally dropped by 21% in the last week, reversing a month-long trend of rising infections and a possible signal the outbreak in Europe may be starting to decline, according to a World Health Organization report issued Thursday.

The U.N. health agency reported 5,907 new weekly cases and said two countries, Iran and Indonesia, reported their first cases. To date, more than 45,000 cases have been reported in 98 countries since late April.

Cases in the Americas accounted for 60% of cases in the past month, WHO said, while cases in Europe comprised about 38%. It said infections in the Americas showed “a continuing steep rise.”

The Africa Centers for Disease Control and Prevention said Thursday the continent had 219 new cases reported in the past week, a jump of 54%. Most were in Nigeria and Congo, the agency said.

In early July, just weeks before the agency declared the international spread of the disease to be a global emergency, WHO’s Europe director said countries in the region were responsible for 90% of all laboratory confirmed cases of monkeypox.

British health authorities said last week after seeing a decline in the number of new cases getting reported daily that there were “early signs” the country’s monkeypox outbreak was slowing.

The U.K.’s Health Security Agency downgraded the country’s monkeypox outbreak last month, saying there was no evidence the once rare disease was spreading beyond men who were gay, bisexual or had sex with other men.

Since monkeypox outbreaks in Europe and North America were identified in May, WHO and other health agencies have noted that its spread was almost exclusively in men who have sex with men.

Read More: How the Monkeypox Virus Does—and Doesn’t—Spread

Monkeypox has been endemic in parts of Africa for decades and experts suspect the outbreaks in Europe and North America were triggered after the disease started spreading via sex at two raves in Spain and Belgium.

WHO’s latest report said 98% of cases are in men and of those who reported sexual orientation, 96% are in men who have sex with men.

“Of all reported types of transmission, a sexual encounter was reported most commonly,” WHO said. “The majority of cases were likely exposed in a party with sexual contacts,” the agency said.

Among the monkeypox cases in which the HIV status of patients was known, 45% were infected with HIV.

WHO has recommended that men at high risk of the disease temporarily consider reducing their number of sex partners or refrain from group or anonymous sex.

Monkeypox typically requires skin-to-skin or skin-to-mouth contact with an infected patient’s lesions to spread. People can also become infected through contact with the clothing or bedsheets of someone who has monkeypox lesions.

With globally limited vaccine supplies, authorities in the U.S., Europe and the U.K. have all begun rationing doses to stretch supplies by up to five times.

WHO has advised countries that have vaccines to prioritize immunization for those at high risk of the disease, including gay and bisexual men with multiple sex partners, and for health workers, laboratory staff and outbreak responders.

While Africa has reported the most suspected deaths from monkeypox, the continent has no vaccine supplies apart from a very small stock being tested in a research study in Congo.

“As we know, the situation with monkeypox vaccine access is very topical, but there are not enough doses of vaccines,” Nigeria Center for Disease Control Director-General Ifedayo Adetifa said this week. Potentially, a lot more more doses will become available, but because of challenges with manufacturing factories and unexpected uptick in monkeypox cases, the vaccine may actually not be available until 2023.”

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Chinedu Asadu in Abuja, Nigeria, contributed reporting.

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If I Got a Second Booster, Can I Get the New Omicron One?

If I Got a Second Booster, Can I Get the New Omicron One?
If I Got a Second Booster, Can I Get the New Omicron One?

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Back in March, people 50 and over—and younger people with weakened immune systems—became eligible to receive a second booster shot. If you got your second booster recently, can you still get the new Omicron-specific booster that health officials are expecting in September or October?

The answer is yes. The U.S. Food and Drug Administration (FDA) and U.S. Centers for Disease Control and Prevention (CDC) considered this very scenario in the spring before authorizing a second booster for this group, since they knew Omicron-specific boosters were likely forthcoming. They decided that taking a second booster would not preclude people from also getting the Omicron booster if and when it was authorized.

The reason for that is because boosters are an important way to enhance waning immunity, and more studies show that the initial surge in virus-fighting antibodies that vaccines produce can decline over time. Topping off these levels with a booster shot is crucial in order to protect vulnerable people from getting seriously ill with COVID-19, and that’s what the vaccines have been doing—keeping people out of the hospital and dying of the disease. Getting a second booster shores up this protection, and when those antibody levels inevitably wane again, people would be eligible for the new Omicron-specific booster. It’s not a matter of getting one or the other, but getting both when the time comes.

Read More: Why You Shouldn’t Wait for Updated COVID-19 Boosters

If you qualify for one, getting a second booster as soon as possible is a good idea. “The threat to you [from BA.5] is now,” said Dr. Anthony Fauci, chief medical advisor to the White House, in a July press briefing. If you are not vaccinated to the fullest—namely, not gotten boosters according to the recommendations—you are putting yourself at increased risk.” Cases and deaths are still relatively high across the country; BA.5 is more transmissible than past variants and while vaccines won’t protect you from getting infected in the first place, they will provide some defense from getting hospitalized and getting severe COVID-19.

The booster doses that the FDA is reviewing now—made by Pfizer-BioNTech and Moderna—are different from those that people have received so far. They are bivalent vaccines, meaning they’re directed against two strains of the virus: the original strain of SARS-CoV-2 that previous vaccines targeted, as well as the Omicron BA.4 and BA.5 subvariants, which now account for nearly all new infections in the U.S. Recent data show that even people who are vaccinated and boosted with the original strain are still susceptible to developing mild-to-moderate COVID-19 from the Omicron variants, so experts hope that the new booster shot will better protect people from getting sick from these circulating Omicron viruses.

FDA and CDC officials have not yet decided who would qualify for Omicron boosters (though Pfizer-BioNTech recently asked for authorization of their shots for all Americans 12 and up, and Moderna submitted its application for adults 18 and older), when they would be available, and how long after a previous dose people should wait before getting it. The CDC’s vaccine advisory committee is scheduled to meet on September 1 and 2 and may issue more guidance then.

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Moderna Sues Pfizer Over Patents Behind COVID-19 Vaccine

Moderna Sues Pfizer Over Patents Behind COVID-19 Vaccine
Moderna Sues Pfizer Over Patents Behind COVID-19 Vaccine

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COVID-19 vaccine maker Moderna is suing Pfizer and the German drugmaker BioNTech, accusing its main competitors of copying Moderna’s technology in order to make their own vaccine.

Moderna said Friday that Pfizer and BioNTech’s vaccine Comirnaty infringes on patents Moderna filed several years ago protecting the technology behind its preventive shot, Spikevax. The company filed patent infringement lawsuits in both U.S. federal court and a German court.

A Pfizer spokeswoman declined to comment, saying the company had not been served with a copy of the litigation.

Moderna and Pfizer’s two-shot vaccines both use mRNA technology to help patients fight the coronavirus.

The mRNA vaccines work by injecting a genetic code for the spike protein that coats the surface of the coronavirus. That code, the mRNA, is encased in a little ball of fat, and instructs the body’s cells to make some harmless spike copies that train the immune system to recognize the real virus.

Moderna CEO Stephane Bancel said in a prepared statement that the vaccine developer pioneered that technology and invested billions of dollars in creating it.

The company said it believes its rivals’ vaccine infringes on patents Moderna filed between 2010 and 2016.

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Why Omicron Boosters Weren’t Tested in People

Why Omicron Boosters Weren’t Tested in People
Why Omicron Boosters Weren’t Tested in People

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With nearly all the new COVID-19 infections in the U.S. coming from the Omicron BA.4 and BA.5 subvariants, it makes sense that health officials are considering switching to a different vaccine to protect the public.

White House COVID-19 response coordinator Dr. Ashish Jha expects the first Omicron-specific booster to be available in mid-September at the earliest, if the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) authorize and recommend the shot. In late August, both Pfizer-BioNTech and Moderna submitted requests to the FDA for authorization of their Omicron-specific boosters.

But with the fall and winter fast approaching—the seasons when respiratory viruses like SARS-CoV-2 spread even more efficiently, as students return to school and people huddle indoors—getting the booster ready requires a more efficient review and regulatory process. And that includes considering safety and efficacy data from animals, not people.

Back in June, the FDA’s panel of independent vaccine experts met to consider switching the country to a new booster that targets Omicron, given how quickly that variant is dominating new infections. At the time, the two largest COVID-19 vaccine makers, Pfizer-BioNTech and Moderna—which both make mRNA-based vaccines—had developed shots against an earlier Omicron variant, BA.1. The panel decided that if health authorities were going to change the booster shot to target Omicron, the next one should protect against the BA.4 and BA.5 subvariants, which would continue to account for almost all cases in the winter season.

They asked the vaccine manufacturers to develop a new vaccine, one that combined the original vaccine and also targeted Omicron BA.4 and BA.5. At the end of August, both companies submitted data on their new, bivalent vaccines to the FDA for emergency use authorization.

Given the short time they had to develop the shot, however, the data only included information on the safety and efficacy of the booster in animals. Human studies are planned and will be ongoing even if the FDA and CDC decide to authorize the shots and the government starts distributing them. The FDA has also decided to review the animal study data without consulting its advisory committee again.

That has vaccine experts divided. Dr. Paul Offit, a member of the advisory committee, says this strategy makes him “uncomfortable” for several reasons. He notes that the data presented from Pfizer-BioNTech and Moderna in June involving their BA.1 booster shot, which focused on the levels of virus-fighting antibodies the vaccine generated, were underwhelming. “They showed that the neutralizing antibody titers were between 1.5- and two-fold greater against Omicron than levels induced by a booster of the ancestral vaccine,” he says. “I’d like to see clear evidence of dramatic increase in neutralizing antibodies, more dramatic than what we saw against BA.1, before launching a new product. We’re owed at least that.”

While conducting human studies does take more time, Offit says even a small trial involving about 100 people to measure their antibody levels after getting a BA.4/5 booster would be helpful. “You can boost people and measure their neutralizing antibodies two weeks later,” he says. Such information could also be critical in setting realistic expectations for the Omicron booster. The public might feel it’s a panacea that signals the end of the pandemic, but without any data showing how well the booster will protect people from not only getting sick, there might be unrealistic expectations about what the boost can do. “I get a little nervous, frankly, when I hear this [booster] is going to be miraculous,” Offit says.

Other experts see it a little differently. Based on the fact that the mRNA vaccines have been administered to millions of people so far, with relatively few safety concerns, and given that the vaccines have been effective in protecting people from getting hospitalized or dying of COVID-19, even during the latest Omicron surges, they argue that changing the strain of virus in the vaccine doesn’t require the same extensive testing that the original shot did. “The totality of evidence is relevant here,” says Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital, and also a member of the FDA’s vaccine advisory committee. “We are in a situation where we need to pivot as variants emerge, and if we try to be too rigid in our approach, we will always be behind, and not giving the population optimal protection.”

Levy says that the latest Omicron-specific boosters that the FDA is considering contain a combination of mRNA targets against both the original virus and Omicron BA.4/BA.5, so the data on safety and efficacy from the original vaccine in protecting against hospitalization and death is relevant. While the data on this vaccine does come from animals, using that data to decide whether or not to authorize the booster is a matter of “hedging bets.” There is data showing that even vaccinated and boosted people can get mild to moderate COVID-19 disease, because their vaccine-induced protection is waning, so boosting with a shot that is better matched to the Omicron subvariants circulating now is a reasonable bet, even if the data on its efficacy comes from animals and not people. “I think it’s the right decision,” says Levy.

There’s no guarantee that the FDA will authorize the new bivalent vaccines, although all signs point to an authorization that could come in a week or so. If the shots are released and people get boosted, health officials will be carefully monitoring data from those vaccinees to ensure that the assumptions they made about the safety and efficacy of the booster hold. And hospitalization rates in the coming winter will reveal whether betting on the new Omicron-specific booster was the right decision.

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Taking Psychedelics May Reduce Anxiety About Death

Taking Psychedelics May Reduce Anxiety About Death
Taking Psychedelics May Reduce Anxiety About Death

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Out-of-body and other mystical experiences can be life-changing, and research suggests they can even make people less afraid of dying. But such experiences are rare, and tend to occur accidentally and in the most extreme circumstances—such as at the brink of death.

There might be another way to mimic the near-death experience: scientists have identified striking parallels between these experiences and the effects of psychedelic drugs. According to a new survey conducted by researchers at Johns Hopkins Medicine, published Aug. 24 in the journal PLOS ONE, people’s attitudes about death change after both a psychedelic drug experience and a non-drug-related out-of-body experience. The researchers split more than 3,000 participants into two groups: those who had previously had an extraordinary non-drug experience, and those who had used a psychedelic drug: psilocybin (found in magic mushrooms), lysergic acid diethylamide (LSD), ayahuasca, or N,N-dimethyltryptamine (DMT). They found that about 90% of people in both groups were less afraid of death than they had been before their experiences.

These findings build upon previous research showing that psychedelics, especially when combined with therapy, can relieve anxiety about the end of life. That includes a 2016 randomized clinical trial that found that psilocybin lessened depression and anxiety among 51 patients with life-threatening cancer. Co-author Roland Griffiths, a professor in the departments of psychiatry and neurosciences at the Johns Hopkins University School of Medicine, is hopeful that psychedelics could one day be used to help anyone who’s struggling with the fear of death. Treatment “could significantly reduce suffering in individuals with or without a life-threatening illness,” he says, including by lessening the emotional pain some people feel at the end of their lives, such as depression, anxiety, and isolation.

Evidence suggests that psychedelics can affect the brain, including by promoting neuroplasticity, which refers to its ability to modify, change, and adapt. It’s harder to determine how near-death experiences impact the brain. However, both experiences—nearly dying and taking psychedelics—can be profound. About half of each group in the new study said that they’d encountered something they might call “God”—48% among the non-drug group, and 56% among people who’d used psychedelics. In the non-drug group, 85% said the experience was in the top five most meaningful of their lives, compared to 75% of the psychedelic group.

The study isn’t a perfect representation of the range of what happens when people take psychedelics or have an unusual non-drug experience. For instance, the study authors point out that the participants were mostly white and American. They also opted to join the survey, which means they might have been especially motivated to share their experiences. Plus, there are signs that at least some people could be negatively affected by these experiences; about 1 in 20 people in each group said that they were more afraid of death afterwards.

The next step is additional scientific research, says Griffiths, including broad surveys of the general population. For now, however, the new findings add hope that while death will always be inevitable, suffering at the end doesn’t need to be.

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Fauci to step down in December after decades of public service : Shots

Fauci to step down in December after decades of public service : Shots
Fauci to step down in December after decades of public service : Shots

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Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, listens as then-President Donald Trump answers questions in the press briefing room with members of the White House Coronavirus Task Force.

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Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, listens as then-President Donald Trump answers questions in the press briefing room with members of the White House Coronavirus Task Force.

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Dr. Anthony Fauci, who played a critical role in steering humanity through the two pandemics of our time, AIDS and COVID-19, announced Monday he is stepping down from his role in the federal government.

As of December, he will leave the position he’s held for 38 years as the director of the National Institute of Allergy and Infectious Diseases, as well as his job as chief of the NIAID Laboratory of Immunoregulation, and his role as chief medical adviser to President Biden.

The straight-talking scientist and physician was the government’s top infectious disease doctor for decades, and one of the few scientists that many Americans knew by name.

Fauci, 81, served under seven U.S. presidents and helped lead the country through numerous health crises. He was instrumental in combatting the AIDS epidemic, starting as the youthful director of NIAID in the early 1980s. He also took center stage in a politically fraught response to the nation’s COVID-19 pandemic, and he was both praised and assailed for his tell-it-like-it-is philosophy.

Biden hailed him as a “dedicated public servant” in a statement issued Monday. “Because of Dr. Fauci’s many contributions to public health, lives here in the United States and around the world have been saved,” the president said.

Department of Health and Human Services Secretary Xavier Becerra, who took leadership of the agency a year into the COVID pandemic, said he relied on Fauci’s counsel and praised him for “his ability to break down complex science in simple terms to the American people to save lives.”

As AIDS crisis grew, he led by listening

Fauci’s actions during the AIDS epidemic helped marshal a scientific and government response that saved millions of lives. His approach to engaging AIDS activists also transformed the way patients and activists interacted with medical science for many diseases.

“Tony Fauci is a really interesting character in the history of the AIDS epidemic,” said Jon Cohen, a journalist at Science magazine who wrote a book about Fauci’s passionate but ultimately unsuccessful effort to develop an AIDS vaccine. “He becomes the voice of science, he can translate science into English better than anyone, and he can speak to every president, every congressperson, every world leader, and he can speak to patients,” Cohen said in an interview.

Those abilities emerged during the earliest days of the AIDS epidemic, when the Reagan administration tried to downplay or ignore the deadly disease afflicting particularly gay men and users of drugs by injection, as well as people with hemophilia who died because their medication was derived from contaminated blood products.

Dr. Fauci served as a panelist at the National AIDS Update Conference on Oct. 12 1989 at the San Francisco Civic Auditorium in San Francisco, Calif.

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Dr. Fauci served as a panelist at the National AIDS Update Conference on Oct. 12 1989 at the San Francisco Civic Auditorium in San Francisco, Calif.

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Part of Fauci’s strategy was to engage the patients and activists who were demanding not only answers but a rapid federal response.

“He was one of the few [powerful people in Washington] that opened his doors early to us to listen and to hear us out,” said Peter Staley, one of the founding members of Act Up New York, a prominent AIDS activist group. “And he was one of the few that wasn’t afraid of us, and thought we had something to bring to the table.”

Staley recalls regular dinners that Fauci held in the home of a gay man who worked in his office. Those dinners “would last for many hours over many bottles of wine, and we debated these issues, and it would sometimes get very heated,” Staley said. They didn’t always agree, “but I came to respect the man intensely during that period.”

The AIDS activists pushed for being part of the research and having a seat at the table, as scientists and government officials figured out how to develop drugs and test vaccines to control the AIDS epidemic.

A gifted communicator

Fauci also oversaw a laboratory at the NIH and saw patients throughout his long career, keeping connected to the science as well as the human dimensions of infectious disease.

“Tony won the respect of the angriest, most frustrated people because they saw him as an ally and because he listened to them and he incorporated them — he made them part of finding solutions,” Cohen said. And that approach “radically overhauled how we think about disease and research and patients, not just AIDS.”

Breast cancer activists adopted this cooperative approach and many other disease advocates followed suit.

Fauci was also instrumental in an effort, undertaken by the George W. Bush administration, to make AIDS medicines available globally. The multibillion-dollar program, called the President’s Emergency Plan for AIDS Relief, or PEPFAR, has saved millions of lives, primarily in Africa.

Fauci’s gift for communication put him at the center of many public health crises, in Republican as well as Democratic administrations. Those included viral outbreaks ranging from Zika and West Nile disease to the annual flu. To help calm a jittery American public during the Ebola scare in 2014, Fauci stepped up to the cameras and embraced an Ebola patient — a nurse, Nina Pham — who had been treated at the NIH.

“I want to tell you what a great pleasure, and in many respects a privilege it has been for me and the staff here … to have had the opportunity to treat and care for and get to know such an extraordinarily courageous and lovely person,” he said in his distinctive Brooklyn accent.

His political acumen stood him in good stead with seven presidential administrations, starting with Ronald Reagan. No other leading federal scientist in modern times held a top position for as many years as Fauci did.

Fauci even got a shout-out from George H.W. Bush during a 1988 vice presidential debate. The candidates had been asked to name their heroes, and Bush included Fauci in his list. “You probably never heard of him,” Bush said. “He’s a very fine researcher, top doctor at the National Institute[s] of Health. Working hard, doing something about research on this disease of AIDS.”

Diplomacy and politics in the early days of COVID

Fauci’s biggest political challenge came during the Trump administration. Early in the COVID-19 pandemic, Trump frequently brought Fauci to the White House as a member of the Coronavirus Task Force, to participate in meetings and press conferences. But as the disease spiraled out of control, the president tired of Fauci’s warnings. Fauci found diplomatic ways to correct the president’s often errant statements about the coronavirus, for example when Trump wondered whether COVID-19 could be treated with bleach injections or by shining ultraviolet light into people.

The relationship hit a low point a few days before Election Day, 2020, when a crowd at a Trump campaign rally in Opa-Locka, Fla., started changing “Fire Fauci! Fire Fauci!”

Trump replied, “Don’t tell anybody, but let me wait until a little bit after the election. I appreciate the advice. He’s been wrong on a lot,” Trump continued. “He’s a nice man but he’s been wrong on a lot.”

Trump did not fire Fauci, who had made some missteps during the early days of the pandemic.

At first, scientists didn’t fully understand how the virus spread or how to contain it. Fauci initially misjudged the degree to which the virus spread from people who had no symptoms of disease. He quickly changed his view as scientists learned more. Like many scientists, he was also uncertain about the value of masks early on.

But he never wavered in his view that people needed to stop gathering in large numbers, to wash their hands, isolate if ill and otherwise to take personal responsibility to avoid spreading the virus. Those positions earned him the ire of some Americans, who felt public health guidance infringed on their personal freedom. It was also inconsistent with Trump’s false claim that the pandemic was being overblown.

Fauci had amassed a powerful following among people committed to a science-based response to COVID-19. His face popped up on T-shirts, coffee mugs and yard signs — and on Tony Fauci bobbleheads.

He was even invited to throw the ceremonial first pitch at the start of the Washington Nationals’ 2020 home opener, five months short of his 80th birthday. Suffice it to say it was outside the strike zone, a fact which the president noted among his complaints about Fauci’s performance. (He redeemed himself two years later throwing a cleaner pitch this month in game between the Seattle Mariners and the New York Yankees, in Seattle.)

Fauci threw the ceremonial first pitch before a game between the Seattle Mariners and the New York Yankees at T-Mobile Park on Aug. 9 in Seattle, Wash.

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Fauci threw the ceremonial first pitch before a game between the Seattle Mariners and the New York Yankees at T-Mobile Park on Aug. 9 in Seattle, Wash.

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With Biden’s election, Fauci became the president’s chief medical adviser. Fauci admitted in the administration’s very first press briefing that it was a relief to work for a president who took the science seriously.

“I can tell you I take no pleasure at all in being in a situation of contradicting the president,” he said. “So, it was really something that you really feel you couldn’t say something and there wouldn’t be any repercussions. The idea that you can get up here and talk about what you know, and what the science is and that’s it. Let the science speak. It is somewhat of a liberating feeling.”

Fauci’s gift for communication made him a media star and a household name.

But his fame also made him a target for critics of the federal government’s COVID response and even for death threats. In January, at a Senate hearing on COVID, Fauci blamed rhetoric from Sen. Rand Paul, R-Ky., for sparking death threats against him and his family.

Paul and other congressional Republicans have raised the idea of investigating Fauci after the midterm elections, if they win back control of the House or Senate.

A scientist ‘in his very soul’

Throughout the COVID pandemic, and the nonstop media attention he received, Fauci continued to run one of the major institutes at the NIH.

“He in his very soul was a laboratorian, was a bench scientist,” said Dr. Georges Benjamin, longtime head of the American Public Health Association. “Here was a guy who loved that kind of work. And while he handled the administration and the bureaucracy well, that wasn’t necessarily what he got up for every morning to do.”

Indeed, under Fauci’s guidance, scientists at his institute aggressively pursued a vaccine for COVID-19. And, in an astonishing span of less than a year, they brought one into being, in partnership with the drug company Moderna. It was even more effective than Fauci had dared hope, achieving an efficacy of over 90%.

“He was giddy with laughter,” Benjamin recalls. “I remember watching him on TV with the joy of a new parent who has something that’s just precious, and understood just how valuable that vaccine was going to be.”

In a statement, Fauci said it had been “the honor of a lifetime to have led the NIAID.” He said he’ll continue to work after departing from his current government positions.

“After more than 50 years of government service, I plan to pursue the next phase of my career while I still have so much energy and passion for my field,” he said.

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New COVID shot aimed at omicron strains could be ready in time for fall : Shots

New COVID shot aimed at omicron strains could be ready in time for fall : Shots
New COVID shot aimed at omicron strains could be ready in time for fall : Shots

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The new booster shot would be an update to Pfizer’s current version of the shot, which was designed for the original strain of the coronavirus.

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The new booster shot would be an update to Pfizer’s current version of the shot, which was designed for the original strain of the coronavirus.

Nam Y. Huh/AP

The U.S. is one step closer to having new COVID-19 booster shots available as soon as this fall.

On Monday, the drugmakers Pfizer and BioNTech announced that they’ve asked the Food and Drug Administration to authorize an updated version of their COVID-19 vaccine — this one designed specifically to target the omicron subvariants that are dominant in the U.S.

More than 90% of cases are caused by the BA.4 and BA.5 subvariants, which took off this summer, but the vaccines being used were designed for the original coronavirus strain from several years ago.

Pfizer and BioNTech said they have submitted pre-clinical data on vaccine efficacy to the FDA, but did not share the data publicly.

The new “bivalent” booster — meaning it’s a mix of two versions of the vaccine — will target both the original coronavirus strain and the BA.4 and BA.5 omicron subvariants.

If the vaccine is authorized by the FDA, distribution could start “immediately” to help the country prepare for potential fall and winter surges of the coronavirus, Pfizer CEO Albert Bourla said in a statement.

Following the FDA’s guidance, the data the drugmakers are submitting represents a departure from what’s been used in earlier vaccine authorizations.

Instead of waiting for results from human trials, the FDA asked the drug companies to initially submit only the results of tests on mice, as NPR reported last week. Regulators will rely on those results — along with the human neutralizing antibody data from earlier BA.1 bivalent booster studies — to decide whether to authorize the boosters.

“We’re going to use all of these data that we’ve learned through not only this vaccine but decades of viral immunology to say: ‘The way to be nimble is that we’re going to do those animal studies,” Deepta Bhattacharya, an immunobiologist at the University of Arizona College of Medicine in Tucson, told NPR recently. “We’re really not going out too far on a limb here.”

Pfizer and BioNTech also report that they expect to start a human study on the safety and immunogenicity of the BA4/BA5 bivalent vaccine this month.

Earlier this year, vaccine makers presented U.S. and European regulatory authorities with an option for a bivalent vaccine that targeted an earlier version of the omicron variant, BA.1. While the plan was accepted in the U.K., U.S. regulators instead asked the companies to update the vaccines to target the newer subvariants.

Scientists say the development of COVID-19 vaccines may go the way of flu vaccines, which are changed every year to try to match the strains that are likely to be circulating.

NPR’s Rob Stein contributed to this report.

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