Dr. Vinay Prasad, who led the agency’s Center for Biologics Evaluation and Research (CBER), officially departed on April 30. The division is responsible for reviewing experimental vaccines and other biologic products submitted for federal approval.

    Following his exit, Katherine Szarama, previously the center’s deputy director, has been elevated to serve as acting director, according to a spokesperson for the U.S. Department of Health and Human Services, which oversees the FDA.

    Dr. Tracy Beth Hoeg, who currently leads another FDA center in an acting capacity, publicly thanked Prasad for his work, describing his tenure as “transformational” in a post on X.

    Prasad had originally been brought into FDA leadership in 2025 by Commissioner Marty Makary, following the resignation of former CBER chief Peter Marks amid reported disagreements with Health and Human Services Secretary Robert F. Kennedy Jr..

    A professor at the University of California, San Francisco, Prasad gained national attention during the COVID-19 pandemic for questioning aspects of federal health policy, including the broad push for vaccinations among younger populations.

    His tenure at the FDA has not been without turbulence. He initially stepped away from the agency shortly after taking the role, following scrutiny over past social media activity. According to Makary, Prasad chose to step aside at the time to avoid becoming a distraction amid media coverage.

    He later returned in August 2025 to lead CBER, with federal officials emphasizing that the agency’s work would continue despite outside criticism.

    CBER plays a central role in evaluating vaccines, gene therapies and other biologic treatments, weighing potential risks and benefits before granting approvals. In recent months, some of its decisions have drawn criticism from lawmakers on both sides of the aisle.

    Sen. Ron Johnson has publicly questioned the FDA’s handling of treatments for rare diseases, including its decision not to approve ataluren for Duchenne muscular dystrophy.

    The agency has also faced pushback over its rejection of a skin cancer treatment developed by Replimune. Speaking to senators in April, Kennedy said the drug appeared ineffective based on internal FDA assessments and discussions with Makary, adding that the decision was made independently by the agency.

    With new leadership now in place at CBER, attention is likely to remain on how the FDA navigates ongoing debates over drug approvals, vaccine oversight and regulatory standards.

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Democratic presidential candidate Robert F. Kennedy Jr. rose to prominence during the COVID-19 pandemic because of his strident opposition to vaccines. Yet, he insists he’s not anti-vaccine. He has associated with influential people on the far right – including Tucker Carlson, Steve Bannon and Michael Flynn – to raise his profile.

Yet, he portrays himself as a true Democrat inheriting the mantle of the Kennedy family. As he challenges President Joe Biden, the stories he tells on the campaign trail about himself, his life’s work and what he stands for are often the opposite of what his record actually shows.

Though Kennedy’s primary challenge to a sitting president is widely considered a longshot, he’s been sucking up media attention due to his famous name and the possibility that his run could weaken Biden ahead of what is expected to be a close general election in 2024. He’s drawn praise from Republican presidential candidates like Donald Trump and Florida Gov. Ron DeSantis.

Meanwhile, Trump supporters, including his longtime ally Roger Stone, have ginned up interest by floating a Trump-Kennedy unity ticket. Debra Duvall, 62, who lives in Fort Myers, Florida, and said she serves on the Lee County GOP executive committee, described herself as a longtime Trump supporter, but said she’s torn for 2024. “I’ll take Trump or RFK. Either one,” she said, explaining that she was drawn to both because she believes they can’t be bought.

That kind of support has demonstrated some of the contradictions in Kennedy’s candidacy. He has said he wants to “reclaim” the Democratic Party, while aligning himself with far right figures who have worked to subvert American democracy.

He touts his credentials as an environmentalist, yet pushes bitcoin — a cryptocurrency that requires massive amounts of electricity from supercomputers to generate new coins, prompting most environmental advocates to loudly oppose it. And though he peppers his speeches, podcast appearances and campaign materials with invocations of the Democratic Party legacies of his uncle President John F. Kennedy and his father, Robert F. Kennedy, his relatives have distanced themselves from him and even denounced him. “He’s trading in on Camelot, celebrity, conspiracy theories and conflict for personal gain and fame,” Jack Schlossberg, President Kennedy’s grandson, said of his cousin in an Instagram video in July. “I’ve listened to him. I know him. I have no idea why anyone thinks he should be president. What I do know is, his candidacy is an embarrassment. ”Kennedy’s recent comments that COVID-19 could have been “ethnically targeted” to spare Ashkenazi Jews and Chinese people — which he denies were antisemitic but concedes he should have worded more carefully — also drew a condemnation from his sister Kerry Kennedy.

The contradictions between what Kennedy says and his track record were nowhere more apparent than when he testified before a congressional committee in July at the invitation of Republican members. Anti-vaccine activists, some who work for Kennedy’s nonprofit group Children’s Health Defense, sat in the rows behind him, watching as he insisted “I have never been anti-vaxx. I have never told the public to avoid vaccination.” But that’s not true. Again and again, Kennedy has made his opposition to vaccines clear. In July, Kennedy said in a podcast interview that “There’s no vaccine that is safe and effective” and told FOX News that he still believes in the long-ago debunked idea that vaccines can cause autism.

In a 2021 podcast he urged people to “resist” CDC guidelines on when kids should get vaccines. “I see somebody on a hiking trail carrying a little baby and I say to him, better not get them vaccinated,” Kennedy said. That same year, in a video promoting an anti-vaccine sticker campaign by his nonprofit, Kennedy appeared onscreen next to one sticker that declared “IF YOU’RE NOT AN ANTI-VAXXER YOU AREN’T PAYING ATTENTION.” A close examination of Kennedy’s campaign finance filings shows that the anti-vaccine movement lies at the heart of his campaign.

Several of his campaign staff and consultants have worked for his anti-vaccine group Children’s Health Defense, including Mary Holland, the group’s president on leave, campaign spokeswoman Stefanie Spear, and Zen Honeycutt, who hosted a show for the group’s TV channel, CHD TV. Children’s Health Defense currently has a lawsuit pending against a number of news organizations, among them The Associated Press, accusing them of violating antitrust laws by taking action to identify misinformation, including about COVID-19 and COVID-19 vaccines.

The campaign paid KFP Consulting, a Texas-based company run by Del Bigtree, head of the anti-vaccine group ICAN, and a leading voice in the movement, more than $13,000 for communications consulting, the AP found. Bigtree appeared to still be working for the campaign last week, when an AP reporter saw him helping facilitate a Kennedy event in New York.

Kennedy also has received substantial support from activists who have spread misinformation about the coronavirus and vaccines, including Steve Kirsch, an entrepreneur who has falsely claimed COVID-19 vaccines kill more people than they save, chiropractors Patrick Flynn and Kevin Stillwagon, and others. Ty and Charlene Bollinger, who run an anti-vaccine business and who the AP has previously reported have had a financial relationship with Kennedy, gave more than $6,000.

The couple, along with Kennedy’s communication consultant Bigtree, were involved in hosting a rally near the Capitol on Jan. 6, and Ty Bollinger has said he was among the people who crowded at the Capitol doors in an attempt to get inside, though he said he did not enter. The couple is a part of the Children’s Health Defense lawsuit against AP and other media outlets.

American Values 2024, a super PAC supporting Kennedy, is run by close associates to Kennedy who have propped up anti-vaccine ideas — the former head of the New York chapter of Children’s Health Defense John Gilmore is its CEO and Kennedy’s publisher Tony Lyons is its co-chair. The Kennedy campaign did not return emails seeking comment about a number of questions, including how he can say he is not anti-vaccine given his record and his support from anti-vaccine activists. Kennedy’s run is also getting plenty of financial support from the right.

A super PAC supporting Kennedy’s presidential run, called Heal the Divide PAC, has deep ties to Republicans, F ederal Election Commission records show. The committee’s address is listed in the care of RTA Strategy, a campaign consulting firm that has been paid for its work to help elect Republicans including Georgia Rep. Marjorie Taylor Greene and the former Georgia Senate candidate Herschel Walker.

The PAC’s treasurer, who works for RTA Strategy, is Jason Boles, a past donor to Trump and many other Republicans who includes “MAGA” and “AmericaFirst” in his bio on the platform X, formerly known as Twitter. Kennedy denied knowing Boles or the Heal the Divide PAC when it came up at the congressional hearing, saying, “I’ve never heard of Mr. Boles, and I’ve never heard of that super PAC.” But video available online shows he was a guest speaker at a Heal the Divide event just two days earlier.

The video features a “Heal the Divide 2024” logo with clips of him speaking at length about plans to back the U.S. dollar with bitcoin and precious metals. Kennedy says that as president, he would fight for government honesty and transparency, heal the political divide, reverse economic decline, end war and preserve civil liberties. He has made freedom of speech a major part of his platform, arguing that the government’s communication with social media companies unfairly censors protected speech. Kennedy’s press office did not respond to several messages asking about his support from the far right.

It also did not respond to questions about whether his stance on bitcoin was at odds with being an environmentalist. Kennedy lists the environment as one of six top priorities on his campaign website and has spent many years speaking against pollution and climate change as an environmental lawyer. Yet he has made supporting the energy-intensive cryptocurrency bitcoin a key part of his platform. Bitcoin mining, the process of generating new coins, uses massive amounts of electricity — more than some entire countries use, said Scott Faber of the Environmental Working Group.

That’s because it works by tasking a network of supercomputers with solving complex mathematical puzzles — even as some other cryptocurrencies have adopted far more energy efficient mining methods. “No one who claims to be an environmentalist could support a digital asset that needlessly consumes more electricity than all Americans use to power the lights in our homes,” Faber said. “In fact, bitcoin produces more climate pollution than any other digital asset.” Despite the environmental downsides of bitcoin, some Democrats, including elected officials, have advocated for the currency. Kennedy, for his part, told a crowd at Bitcoin 2023 that environmentalists like himself “will continue to pressure you to improve.”

Online, he has promoted the argument that demand for bitcoin will boost investment in new renewable energy projects. Regardless, his financial disclosure documents show he has already personally invested between $100,001 and $250,000 in bitcoin, and he promised at Bitcoin 2023 that he wouldn’t let the environmental argument hinder the currency’s use. “As president, I will make sure that your right to hold and use bitcoin is inviolable,” he said. During the past several years, Kennedy has cultivated his ties to the far right. He has appeared on Infowars, the channel run by Sandy Hook conspiracy theorist Alex Jones. He has granted interviews to Trump ally Steve Bannon and Tucker Carlson.

After he headlined a stop on the ReAwaken America Tour, the Christian nationalist road show put together by former Trump national security adviser Michael Flynn, he was photographed backstage with Flynn, Charlene Bollinger and Trump ally Roger Stone. Those appearances have led to goodwill on the right, and he has found enthusiastic support among a segment of Trump’s base, with some suggesting him as a potential vice presidential pick.

At a July 1 rally in the tiny town of Pickens, South Carolina, Adrian Palashevsky – a small businessman who described himself as more of a “libertarian” than a Republican – posited a unity ticket, with Kennedy as his top pick for Trump’s VP. “I think they would get along just fine,” he said. “They’re both anti-establishment, and that’s why they’re under so much attack.” DeSantis, one of Trump’s Republican challengers, has also indulged in praise for the fringe candidate, saying in a recent interview that while he wouldn’t make Kennedy vice president, he would consider appointing him to one of the federal agencies that regulates vaccine safety and protects public health. “If you’re president, you know, sic him on the FDA if he’d be willing to serve, or sic him on CDC,” DeSantis said. Not everyone is buying the Kennedy mystique.

At the annual meeting of the National Association of Latino Elected and Appointed Officials in New York a few weeks ago, Kennedy leaned heavily on his family legacy, mentioning his father’s alliance with labor leader Cesar Chavez and his uncle’s work in Latin American countries. But in his nearly 20-minute speech, he didn’t lay out any plan or policy proposals of his own, or talk about specific issues facing the Latino community. He spent most of his time telling a story about getting arrested with the Mexican American actor Edward Olmos in 2001, an attempt at relating with the community that disappointed both Republicans and Democrats in the audience.

Mario Ceballos, president of a PAC representing LGBTQ+ Latinos, said Kennedy’s speech — and the candidate’s conspiracy theory beliefs — saddened him. “When I was living in Mexico, Kennedy was an American president that my whole family respected,” Ceballos said. “And what he is presenting are esoteric, dangerous options that are actually going to hurt the same people that his father and uncle wanted to help.”

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By Amber Dance

U.S. returns to pre-pandemic immigration policies.

Thousands of people are waiting in Mexican border cities for the anticipated Dec. 21 expiration of a Trump-era restriction on U.S. entry during the pandemic.

Hundreds have already crossed the Rio Grande, reports Lauren Villagran of the El Paso Times.

The Title 42 rule allowed officials to quickly expel migrants at the border, including many of those seeking asylum. It has been applied more than 2.4 million times, reports José Ignacio Castañeda Perez at USA Today.

The policy and arguments over its legality have been tied up in the courts for months. The Biden administration attempted to rescind the policy in May, but was blocked by the courts at
that time.

The rule is now coming to an end in response to a Nov. 15 court ruling that found the “arbitrary and capricious” policy was unlawful and did not protect the U.S. from the coronavirus. The Biden administration has appealed the November ruling, aiming to preserve the CDC’s right to institute similar rules in the future.

A set of Republican-led states has also filed an appeal to keep the policy in place, arguing its termination “will cause an enormous disaster at the border,” reports Suzanne Monyak at Roll Call. The Border Patrol is reportedly unprepared to handle the anticipated surge of migrants. Immigration advocates, who have documented expelled migrants suffering violence in Mexico, will be glad to see the policy end, USA Today reports.

Legal immigration, meanwhile, has rebounded after a pandemic-induced lull in visa approvals, reports Camilo Montoya-Galvez at CBS News. The State Department issued nearly half a million visas to overseas applicants in 2022, a number comparable to totals from 2018 and 2019. “The rebound, an enormous part of it, is the easing of pandemic restrictions and the reopening of consulates,” said Julia Gellat, an analyst with the nonpartisan Migration Policy Institute. “But I also think the Biden administration is really concentrating on this.”

CDC documents thousands of long COVID deaths

Long COVID has led to not only debilitating symptoms, but death for thousands of Americans, according to a new CDC report. 

Researchers scoured death certificates from 2020 through mid-2022 for a medical code referring to COVID-19 and key words related to long COVID, identifying 3,544 such deaths. Long COVID was not necessarily the main cause of death, but could be listed as a contributing factor.

“The results added to growing recognition of how serious long-term post-COVID medical problems can be,” writes Pam Belluck at The New York Times. “The study appeared to be primarily capturing deaths of people who experienced serious initial infection with the coronavirus and who survived that phase but went on to have organ damage and other severe complications.”

Long COVID can exacerbate chronic conditions or boost the risk of heart or vascular disease, reports MuckRock in its own analysis of long COVID deaths in several U.S. regions. (Journalists can analyze the data on their own here.) For example, a COVID infection can create blood clots that can kill well after the virus is gone.

In the CDC’s study, out of more than 1 million death certificates with the COVID-19 code, 0.3% included long COVID terminology.

The count is almost certainly an underestimate, reports Elizabeth Cooney at STAT: “That tiny fraction of records only hints at the whole story, two experts told STAT, while another has doubts about drawing any conclusions from it at all.”

Dr. Eric Topol of the Scripps Research Translational Institute told Cooney that death certificate data are unreliable for tracking any cause of death. They are a particularly problematic source with something like long COVID, a chronic condition that can contribute to death in myriad complex ways.

Long COVID deaths reflected the pandemic’s broader racial and ethnic disparities. The long COVID death rate was highest among American Indian and Alaska Native people, a disparity the CDC study authors attribute to less access to health care in these groups.

But Black and Hispanic people, despite higher death rates from acute COVID infections, did not have higher long COVID death rates. That may be because there were fewer survivors left to
experience long COVID in those populations, the authors suggest.

In both the MuckRock and CDC studies, long COVID deaths were prevalent among older people. Muckrock’s team also found that many people who died of long COVID lacked college degrees and worked blue-collar, frontline or essential jobs.

Vaccines have saved millions of lives

The first COVID-19 vaccines were authorized two years ago, and they’ve saved about 3.2 million lives, according to a new report from The Commonwealth Fund. (The Fund also supports
programs at the Center for Health Journalism.)

Despite that success, vaccine uptake and efficacy are both on the wane. Just over 14% of people have received the latest, updated booster.

And those boosters are already out of date: The BQ strains currently dominating the U.S., as well as the XBB variant on the rise, are “barely susceptible” to the antibodies created by
existing vaccines, according to a new study in the journal Cell.

That reduced efficacy could set the nation up for a surge in breakthrough infections and reinfections, but the shots should hold up against severe disease and hospitalization, reports
Spencer Kimball at CNBC.

Researchers are calling for a new generation of COVID vaccines, reports Aria Bendix at NBC News. Formulas that are given through the nose or mouth might be better at halting transmission, and vaccines that target multiple variants or viral components might reduce the need for ongoing boosters.

“Coming up with a vaccine that’s going to last longer and cover a wider range of the COVID family is a life and death problem,” said Dr. Tom Frieden, former CDC director and president of Resolve to Save Lives, a public health organization.

COVID and flu plague nation

Pediatrician Dr. Christina Lane sums up the fall of 2022: it’s like “a big bomb of viruses went off,” she told Ariana Eunjung Cha at The Washington Post. Cases of both influenza and COVID are on the rise, but RSV may have already peaked. In response, major cities are recommending masking, but a dip in COVID cases in Los Angeles appears to have pulled that county back from the brink of a new mask mandate.

Free tests by mail relaunched

U.S. households can order four more COVID test kits for free by mail this winter as part of the government’s response to the current surge, report Adam Cancryn and David Lim at Politico. The program’s first three rounds of free tests proved popular, but it was put on hold in September to ensure there would be inventory available now. Politico reports that the Biden administration used funds leftover from 2021’s American Rescue Plan to purchase additional tests.

The tests by mail are part of the White House’s latest “Winter Preparedness Plan,” released Thursday. The plan also includes free tests distributed at clinics and community centers, support to deliver vaccines and treatments, and preparations to deploy health care professionals and supplies to areas where they’re needed. The White House has requested more than $9 billion to help fight the ongoing pandemic, but a divided Congress appears unlikely to approve the additional funds.

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The U.S. Food and Drug Administration (FDA) has authorized the Moderna and Pfizer-BioNTech updated vaccines that target the original COVID-19 viral strain and two Omicron variants (BA.4/BA.5) that are currently the most prevalent in the U.S. Individuals are eligible for their updated vaccine shot at least two months after completing at least their primary vaccination series (two doses of Pfizer-BioNTech, Moderna, or Novavax, or one dose of Johnson & Johnson)—regardless of how many monovalent COVID-19 boosters they have received to date.

The updated Moderna vaccine is authorized in individuals 18 years of age and older while the updated Pfizer-BioNTech vaccine is authorized for individuals 12 years of age and older.

The Centers for Disease Control and Prevention (CDC) recently updated its recommendations regarding updated COVID-19 vaccines.

COVID-19 vaccines are the best defense against severe illness, hospitalization and death from the virus. CMS continues to explore ways to ensure maximum access to COVID-19 vaccinations. More information regarding the CDC COVID-19 Vaccination Program Provider Requirements and how the COVID-19 vaccine is provided through that program at no cost to recipients is available at https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html. For information on Medicare payment, billing and codes for the updated vaccine, visit the CMS COVID-19 Provider Toolkit.

For resources to help educate the public about COVID-19 vaccines visit the HHS We Can Do it Campaign.

People can visit vaccines.gov (English) or vacunas.gov (Spanish) to search for vaccines nearby.

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LONDON (AP) — Since May, nearly 90 countries have reported more than 31,000 cases of monkeypox.

The World Health Organization classified the escalating outbreak of the once-rare disease as an international emergency in July; the U.S. declared it a national emergency last week.

Outside of Africa, 98% of cases are in men who have sex with men. With only a limited global supply of vaccines, authorities are racing to stop monkeypox before it becomes entrenched as a new disease.

CAN MONKEYPOX BE CONTAINED?

Theoretically, yes. The virus does not spread easily and there is a vaccine. But there are only about 16 million doses available now and only one company makes the shot.

Except for Africa, there is no sign of sustained monkeypox transmission beyond men who have sex with men, meaning that stopping spread among that group could effectively end the outbreak. Last week, British scientists said there were “early signs” the monkeypox cases in the U.K. — which once had the world’s biggest outbreak outside Africa — had peaked.

IS THIS ANOTHER PANDEMIC?

No. A pandemic means that a disease outbreak has spread to the entire world. Monkeypox does not transmit as quickly as the coronavirus and stopping it will not require dramatic interventions like the COVID-19 lockdowns.

WHO’s Director-General Tedros Adhanom Ghebreyesus said he declared monkeypox an emergency in part to prompt countries to take the epidemic seriously, saying there is still an opportunity to contain the disease before it becomes a global problem.

HOW DOES IT SPREAD?

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

It also can be spread through contact with respiratory droplets, but scientists are still trying to figure out how often that happens. British health officials say they haven’t confirmed any instances of airborne transmission.

WHO IS GETTING INFECTED?

A large percentage of cases have been in gay and bisexual men. The initial outbreaks in Europe and North America were likely triggered by sex at two raves in Spain and Belgium.

According to the U.S. Centers for Disease Control and Prevention, 99% of monkeypox cases in the U.S. are men. Of those, 94% reported sexual contact with other men in the three weeks before they developed symptoms.

Still, anyone can catch the virus if they are in close contact with an infected person or fabrics that touched an infected person.

WHO IS GETTING VACCINATED?

With supplies limited, health officials are not recommending mass vaccination. They are suggesting the shots for health workers, people who have been in close contact with an infected person, and men at high risk of catching monkeypox.

Officials are also trying to stretch supplies of the vaccine, Jynneos. It requires two doses, but many places are only giving one dose.

U.S. health officials on Tuesday authorized a new strategy that would allow health professionals to vaccinate up to five people — instead of one — with each vial. The approach uses just a fraction of the typical amount of vaccine and administers it with an injection just under the skin rather than into deeper tissue. Recipients would still get two shots a month apart.

WHAT ELSE CAN I DO TO LOWER MY RISK?

WHO’s Tedros recommended that men at risk of catching monkeypox consider making “safe choices” and reducing their sexual partners “for the moment.”

Britain’s Health Security Agency has advised people to check themselves for monkeypox lesions before they have sex or go to a social event, noting that most of the country’s cases are believed to have originated at festivals, saunas and other venues where sex has taken place. Anyone with monkeypox lesions should isolate until they are completely healed, which can take up to three weeks.

WHAT’S THE CONNECTION TO AFRICA?

Monkeypox has been endemic for decades in parts of central and west Africa, where people have mostly been sickened after contact with infected wild animals like rodents and squirrels. The acting director of Africa’s top public health agency said last week that sex among gay and bisexual men was “not relevant” to the continent’s outbreak, with about 40% of cases among women.

Scientists think the monkeypox outbreaks in Europe and North America originated in Africa long before the disease started spreading. Samples from cases in Europe show dozens of mutations, suggesting the initial virus was silently spreading for months or years before the current epidemics were detected.

The version of monkeypox spreading in Europe and North America has a lower fatality rate than the one circulating in Africa. Countries that didn’t see many monkeypox cases before this outbreak have reported a handful of deaths, while Africa has had at least 100 suspected deaths this year.

WHO IS AT HIGHER RISK FOR SERIOUS ILLNESS?

Most people infected with monkeypox recover without treatment, but it can cause more severe symptoms like brain inflammation and in rare cases, death.

Monkeypox can be serious in children, pregnant women and people with underlying health conditions, like cancer, tuberculosis or HIV. In the U.S., the CDC says about 40% of people with monkeypox also have HIV.

The longer the current outbreaks continue, the greater the chances the virus could spread in other communities, similar to how HIV was first spotted in gay men before becoming established more widely.

“There is some crossover between the sexual networks of gay and bisexual men and networks of heterosexual people with high sexual activity, so it is possible we could see monkeypox more widely,” said Dr. Paul Hunter, a professor of medicine at Britain’s University of East Anglia. “If that happens, we may have a much bigger problem.”

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WASHINGTON (AP) — More than two years into the COVID-19 pandemic, U.S. health officials are beginning to grapple with how to keep the vaccines updated to best protect Americans from the ever-changing coronavirus.

On Wednesday, a panel of vaccine advisers to the Food and Drug Administration spent hours debating key questions for revamping the shots and conducting future booster campaigns. They didn’t reach any firm conclusions.

The questions facing the experts included: How often to update the vaccines against new strains, how effective they should be to warrant approval and whether updates should be coordinated with global health authorities.

Last week, the FDA authorized a fourth dose of the Pfizer or Moderna vaccines for anyone 50 or older and for some younger people with severely weakened immune systems. It’s an effort to get ahead of another possible surge.

But the FDA’s vaccine chief Dr. Peter Marks acknowledged at the meeting “we simply can’t be boosting people as frequently as we are.” He called the latest booster update a “stopgap” measure to protect vulnerable Americans while regulators decide whether and how to tweak the current vaccines.

Marks cautioned that waning vaccine protection, new variants and colder weather in the fall could raise the risk of more surges.

“Our goal here is to stay ahead of future variants and outbreaks and ensure we do our best to reduce the toll of disease and death due to COVID-19,” said Marks, adding that he expects more meetings of the vaccine panel in coming months.

Some of the key questions the panel discussed:

HOW SHOULD THE U.S. DECIDE WHEN TO LAUNCH FUTURE ROUNDS OF BOOSTER SHOTS?

One area where experts appeared to agree is that vaccines should be judged on their ability to prevent severe disease that leads to hospitalization and death.

“We need to focus on the worst case, which is severe disease, and we need to change strains when we’re losing that battle,” said Dr. Mark Sawyer of the University of California San Diego.

By that measure, the current vaccines have held up remarkably well.

During the last omicron-driven surge, two vaccine doses were nearly 80% effective against needing a breathing machine or death — and a booster pushed that protection to 94%, federal scientists recently reported.

But only about half of Americans eligible for a third shot have gotten one. And many experts said it was unsustainable to continue asking Americans to get boosted every few months.

A panelist from the Centers for Disease Control and Prevention suggested that the 80% protection from severe disease could become the standard for evaluating the vaccines.

“I think we may have to accept that level of protection and then use other alternative ways to protect individuals with therapeutics and other measures,” said Dr. Amanda Cohn, CDC’s chief medical officer.

Presentations at the meeting by government health officials and independent researchers underscored the challenges of predicting when the next major COVID-19 variant might appear.

Trevor Bedford, a disease modeler with the Fred Hutchinson Cancer Research Center, said a major new strain like omicron could emerge anywhere from every 1.5 years to once a decade, based on currently available data. Given that unpredictability, researchers will need methods to quickly determine whether current vaccines work against emerging variants.

WHAT’S THE PROCESS FOR UPDATING VACCINES TO ADDRESS NEW VARIANTS?

All three COVID-19 vaccines now used in the U.S. are based on the original coronavirus version that emerged in late 2019. Updating the vaccines will be a complex task, likely requiring coordination between the FDA, manufacturers and global health authorities.

To speed the vaccines to market, the FDA relied on research shortcuts to judge effectiveness, mainly looking at their early impact on the immune system’s antibody levels. A number of panelists said Wednesday they wanted more rigorous data from studies that track patients over time to see who gets sick or dies.

But that approach would likely be too time consuming.

“We’re looking at a conundrum here in that it’s going to hard to generate all the data we want in short order when a new variant emergences,” said Dr. Ofer Levy of Harvard Medical School.

A representative for the U.S. Biomedical Advanced Research and Development Authority laid out the narrow window that manufacturers could face to reformulate, study and mass produce an updated vaccine by September.

“If you’re not on your way to a clinical trial by the beginning of May, I think it’s going to be very difficult to have enough product across manufacturers to meet demand,” said Robert Johnson, deputy assistant secretary of BARDA.

The process for updating annual flu vaccines offers one possible model, as laid out by a representative from the World Health Organization.

Twice a year, WHO experts recommend updates to flu vaccines to target emerging strains. The FDA then brings those recommendations to its own vaccine panel, which votes on whether they make sense for the U.S., setting the stage for manufacturers to tweak their shots and begin mass production.

But COVID-19 hasn’t yet fallen into a predictable pattern like the flu. And as the coronavirus evolves, different strains may become dominant in different regions of the world.

Several experts said they would need more meetings with more data and proposals from the FDA to decide on a strategy.

“We’ve never been here before. We’re all working together to do the best we can and it’s very complex,” said Oveta Fuller of the University of Michigan’s Medical School.

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NEW YORK (AP) — A new study in two states that compares coronavirus protection from prior infection and vaccination concludes getting the shots is still the safest way to prevent COVID-19.

The study examined infections in New York and California last summer and fall and found people who were both vaccinated and had survived a prior bout of COVID-19 had the most protection.

But unvaccinated people with a past infection were a close second. By fall, when the more contagious delta variant had taken over but boosters weren’t yet widespread, that group had a lower case rate than vaccinated people who had no past infection.

The Centers for Disease Control and Prevention, which released the study Wednesday, noted several caveats to the research. And some outside experts were cautious of the findings and wary of how they might be interpreted.

“The bottom line message is that from symptomatic COVID infection you do generate some immunity,” said immunologist E. John Wherry of the University of Pennsylvania. “But it’s still much safer to get your immunity from vaccination than from infection.”

Vaccination has long been urged even after a prior case of COVID-19 because both kinds of protection eventually wane — and there are too many unknowns to rely only on a past infection, especially a long-ago one, added immunologist Ali Ellebedy at Washington University in St. Louis.

“There are so many variables you cannot control that you just cannot use it as a way to say, ‘Oh, I’m infected then I am protected,’” Ellebedy said.

The research does fall in line with a small cluster of studies that found unvaccinated people with a previous infection had lower risks of COVID-19 diagnosis or illness than vaccinated people who were never before infected.

The new study’s findings do make sense, said Christine Petersen, a University of Iowa epidemiologist. She said a vaccine developed against an earlier form of the coronavirus is likely to become less and less effective against newer, mutated versions.

However, experts said, there are a number of possible other factors at play, including whether the vaccine’s effectiveness simply faded over time in many people and to what extent mask wearing and other behaviors played a part in what happened.

Another thing to consider: The “staunchly unvaccinated” aren’t likely to get tested and the study only included lab-confirmed cases, Wherry said.

“It may be that we’re not picking up as many reinfections in the unvaccinated group,” he said.

CDC officials noted other limitations. The study was done before the omicron variant took over and before many Americans received booster doses, which have been shown to dramatically amplify protection by raising levels of virus-fighting antibodies. The analysis also did not include information on the severity of past infections, or address the risk of severe illness or death from COVID-19.

The study authors concluded vaccination “remains the safest strategy” to prevent infections and “all eligible persons should be up to date with COVID-19 vaccination.”

The researchers looked at infections in California and New York, which together account for about 18% of the U.S. population. They also looked at COVID-19 hospitalizations in California.

Overall, about 70% of the adults in each state were vaccinated; another 5% were vaccinated and had a previous infection. A little under 20% weren’t vaccinated; and roughly 5% were unvaccinated but had a past infection.

The researchers looked at COVID-19 cases from the end of last May until mid-November, and calculated how often new infections happened in each group. As time went on, vaccine-only protection looked less and less impressive.

By early October, compared with unvaccinated people who didn’t have a prior infection, case rates were:

— 6-fold lower in California and 4.5-fold lower in New York in those who were vaccinated but not previously infected.

— 29-fold lower in California and 15-fold lower in New York in those who had been infected but never vaccinated.

— 32.5-fold lower in California and 20-fold lower in New York in those who had been infected and vaccinated.

But the difference in the rates between those last two groups was not statistically significant, the researchers found.

Hospitalization data, only from California, followed a similar pattern.

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By Amber Dance

Children of color vulnerable to disease, loss of caretakers

The pandemic’s racial disparities know no age limit, and children of color have been more deeply affected than their white peers, reports Edwin Rios at Mother Jones. Rios leads with a recent study from the journal Pediatrics, which found nearly two-thirds of the more than 140,000 U.S. children who lost a caregiver during the pandemic were from racial or ethnic minorities. American Indian and Alaska Native children were particularly affected, as were Black and Hispanic children. “For every four COVID-19 deaths, one child was left behind without a mother, father and/or a grandparent,” study author and CDC epidemiologist Susan Hillis told NPR. The study covered deaths through the end of June 2021; she now estimates around 175,000 kids have lost a caregiver.

This is just one of the ways the pandemic has disproportionately impacted children of color, writes Rios: “This racist reality isn’t limited to adults.” Black and Latino children are more likely to contract COVID, to have health conditions that raise risk for severe disease, to require hospitalization, and to develop the chronic, post-COVID inflammatory condition called MIS-C. Black children are more likely to die of the disease than white kids. The same pattern holds true for the flu, reports Catherine Roberts at The Washington Post, with the greatest racial disparities seen in children younger than 5. That’s partly due to lower rates of flu vaccination among children of color, a disparity unlikely to change with COVID vaccines. Though COVID-19 vaccines may be authorized for children as young as 5 in a matter of weeks, access will probably be a challenge for many children of color, writes Nada Hassanein in USA Today. “It’s not a surprise this is happening,” said Dr. Georges Benjamin, executive director at the American Public Health Association. “We obviously had disparities with their parents, so why shouldn’t we have disparities with their kids?”

FDA committee supports boosters on slim data

On Thursday, the FDA’s advisory committee recommended authorization of Moderna’s half-dose booster for people over 65, and those over 18 and at higher risk due to health conditions or riskier jobs. That would match the eligibility guidelines for Pfizer boosters. The committee also recommended boosters for all adults who initially received the Johnson & Johnson vaccine.

Both votes were unanimous, but the committee struggled with limited information. For example, Moderna’s booster data was based on 149 people.

“The data are not perfect, but these are extraordinary times and we have to work with imperfect data,” said FDA committee member Dr. Eric Rubin of the Harvard School of Public Health.

A study released last Friday suggests that all three authorized vaccines—Moderna’s, Johnson & Johnson’s, and Pfizer’s — produce robust, cell-based immunity for at least eight months without a booster, reports Sony Salzman at ABC News. Johnson & Johnson’s single-dose shot led to lower levels of long-lasting antibodies, while the miRNA vaccines led to a high peak of efficacy before a drop-off. Waning antibodies could allow breakthrough infections, but the body’s T cells would then keep that infection mild, Salzman explains.

Moderna’s data showed that as time elapsed after recipients’ first two shots, antibody levels dropped and breakthrough infections did occur. But compared to Pfizer’s shot, Moderna has held up significantly better against severe disease and hospitalization, so the company concentrated its presentation on prevention of mild and moderate disease. A Moderna booster shot did amp up antibody levels fourfold in 87.9% of subjects — narrowly missing the FDA’s target threshold of 88.4%, reports Sharon LaFraniere at The New York Times. Moderna says the half-size dose should minimize side effects such as fever and aches.

Johnson & Johnson’s U.S.-based study found that a two-shot regimen raised the efficacy of the vaccine to more than 90%. However, that trial took place pre-delta, calling into question its relevance now, and studies in other locales did not show such a change. In this case, the committee recommended a second dose two or more months after the first, for anyone over 18 who received that vaccine.

Many of the FDA advisors suggested this dose should more properly be thought of as the second in a two-shot series, rather than a ‘booster.’ “I think, frankly, this was always a two-dose vaccine,” said Dr. Paul Offit of the Children’s Hospital of Philadelphia. The company has not applied for two-dose (non-booster) authorization, because its one-and-done appeal remains high in many parts of the world, writes Helen Branswell at STAT.

Neither decision is final — the CDC’s advisory committee will weigh in next this Thursday. (Watch the livestream here).

Booster shots have already proven popular. Since Aug. 13, more than 9 million people have received a third dose — either because they are immunocompromised or because they were deemed eligible for a third Pfizer shot by the CDC on Sept. 24 (or just because they wanted one). During October, more people are getting an additional dose than either first or second shots.

Some answers on mixing and matching vaccines

At its Friday meeting, the FDA’s vaccine committee discussed but did not vote on data from a new study that gave people boosters that didn’t necessarily match their initial vaccine brands. The preprint report, from scientists at the National Institute of Allergy and Infectious Diseases and collaborators, has not yet been reviewed by other scientists.

The research involved nine groups of people (about 50 per group) who got an initial series of one of the three authorized vaccines, and were then randomly assigned to one of the three vaccines for a booster (epidemiologist Katelyn Jetelina has a handy diagram on her blog). Mixing brands appears to be safe, though it didn’t allow participants to dodge flu-like side effects. And the winning combination among study participants — at least as imperfectly measured by antibody levels — was J&J first, then Moderna as a boost. A Pfizer booster was also effective for people who initially received Johnson & Johnson. For those who received Pfizer first, a Pfizer booster was good but Moderna was even better; either mRNA vaccine was fine as a booster for people who started with a Moderna course.

The FDA has not had time to analyze the study in detail, so no decision could be made yet. At the meeting, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, suggested emergency authorization of boosters that differ from initial vaccines is possible. Other experts have voiced similar thoughts, reports The New York Times: Immunologist Scott Hensley of the University of Pennsylvania said, “Folks having the Johnson & Johnson should probably get an mRNA booster.”

CDC urges pregnant people to get vaccinated

Low vaccination rates among pregnant people, combined with high risk for severe illness, recently prompted the CDC to release a health advisory promoting vaccination among those who are pregnant, recently were pregnant, or may soon become pregnant. The agency cited COVID-19 risks not only to the health of the pregnant person but also to the baby, such as preterm birth and stillbirth. More than 22,000 pregnant people have been hospitalized, and at least 180 have died since the pandemic began. “I really can’t blame these women for being confused and not feeling comfortable taking the vaccine,” Dr. Nida Qadir of the Ronald Reagan UCLA Medical Center told Brittany Shammas at The Washington Post. The CDC did not formally recommend the vaccine for pregnant people until August, and vaccine trials with pregnant subjects are only underway now.

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YouTube is wiping vaccine misinformation and conspiracy theories from its popular video-sharing platform.

The ban on vaccine misinformation, announced in a blog post on Wednesday, comes as countries around the world continue to offer free immunizations for COVID-19 to a somewhat hesitant public. Public health officials have struggled to push back against a steady current of online misinformation about the COVID-19 shot since development of the immunization first got underway last year.

YouTube’s new rules will prohibit misinformation about any vaccine that has been approved by health authorities such as the World Health Organization and are currently being administered. The platform had already begun to crack down late last year on false claims about the COVID-19 vaccine.

YouTube, which is owned by Google, will delete videos that falsely claim vaccines are dangerous or cause health issues, like cancer, infertility or autism — a theory that scientists have discredited for decades but has endured on the internet. As of Wednesday, popular anti-vaccine accounts, including those run by Robert F. Kennedy Jr., were kicked off YouTube.

“We’ve steadily seen false claims about the coronavirus vaccines spill over into misinformation about vaccines in general, and we’re now at a point where it’s more important than ever to expand the work we started with COVID-19 to other vaccines,” YouTube said in a prepared statement.

The new rule will apply to general claims about vaccines as well as statements about specific vaccines, such as those given for measles or flu.

Claims about vaccines that are being tested will still be allowed. Personal stories about reactions to the vaccine will also be permitted, as long as they do not come from an account that has a history of promoting vaccine misinformation. ___

Associated Press writer David Klepper in Providence, Rhode Island, contributed to this report.

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As coronavirus cases surge again across the country, driven by the highly contagious Delta variant, a small number of hotels in the United States have announced that they will require proof of vaccination from guests and staff.

Accommodations such as PUBLIC Hotel, Equinox Hotel and Wythe Hotel, all in New York City, Urban Cowboy Lodge in Big Indian, N.Y., a hamlet in the Catskill Mountains, and Pilgrim House in Provincetown, Mass., are among the first in the United States to announce that they will require evidence of vaccination, via a physical card or a digital verification, from their guests.

The precedent for hotels requiring vaccination is already being set beyond the contiguous United States. In August, Puerto Rico issued an island-wide vaccine mandate that requires guests and staff at all hotels, guesthouses and short-term rentals, including Airbnb, to provide proof of vaccination or a negative PCR or antigen test taken within 72 hours before their visit. If a person is staying longer than a week, they will need to present negative tests to hotel staff on a weekly basis.

Elite Island Resorts, a Florida-based company that runs a collection of all-inclusive Caribbean resorts stretching from Antigua to Panama, announced that all guests over the age of 12 would be required to show proof of Covid-19 vaccination upon arrival beginning on Sept. 1.

“It’s imperative for us to protect the hospitals of these smaller island nations, and while they have had a good track record so far with Covid-19, we must remain vigilant, and all do our part to become part of the solution,” wrote Robert A. Barrett, the founder and chief executive of Elite Island Resorts, in the company’s announcement. Although European destinations are rolling out various vaccine mandates, hotels are mostly not requiring proof of immunization. In Portugal, however, hotel guests need to show proof of vaccination or a negative Covid-19 test.

In the United States, PUBLIC Hotel, a boutique accommodation on Manhattan’s Lower East Side owned by the hotel magnate Ian Schrager, earlier this month became one of the country’s first hotels to mandate proof of vaccination from its guests and staff. The requirement will begin on Sept. 5, with only medical and religious exemptions.

“We need to beat Covid-19 together,” Mr. Schrager said in a news release that announced his decision. “After all, looking after people is our business. We just didn’t see how to fulfill this responsibility without taking action.” At Equinox Hotel New York, the first hotel by the luxury fitness company, guests will be required to show proof of first vaccination from Sept. 13. Equinox is also requiring on-site staff to be vaccinated.

“Equinox Hotels has always and will continue to listen to infectious disease experts as well as local governments to guide our decision making,” said Chris Norton, the chief executive of Equinox Hotels, in an email. The American Hotel and Lodging Association, an industry trade group, issued safety guidelines based on guidance from the Centers for Disease Control and Prevention, which includes encouraging employees to get vaccinated.

“A.H.L.A. urges everyone who is eligible to be vaccinated as soon as possible, including industry employees,” said Chip Rogers, president and chief executive of the association.

While industry leaders may be encouraging vaccination, some hospitality experts aren’t convinced that there will be a widespread movement of hotels requiring vaccination.

“At the current stage, I don’t think we will see broad vaccine requirements by hotels,” said Christopher K. Anderson, a professor at the Cornell University School of Hotel Administration.

“At present not even all major hotel brands are requiring their employees to be vaccinated — let alone guests,” Mr. Anderson said in an email. He added that boutique hotels are likely to find controlling vaccine mandates easier than the larger chains.

As of late August, the larger U.S. hotel chains, including Marriott International, Hyatt and Hilton, are not requiring guests to be vaccinated. While guests at Marriott hotels are not required to be vaccinated, proof of vaccine verification may be required by local jurisdictions, according to Sarah Brown, a spokeswoman of Marriott International. And the company is offering incentives for its employees to get vaccinated.

“In March, Marriott announced the creation of the Vaccination Care Program, which provides a financial award to U.S. and Canadian associates at its managed properties who get vaccinated for Covid-19, the flexibility for vaccination appointments and education on the benefits of vaccination,” Ms. Brown said in an email. “Employees receive the equivalent of four hours of pay upon completion of the vaccination.”

After being closed for more than a year, PUBLIC reopened in early June and has seen a significant boom in business, Mr. Schrager said.

Recognizing the risk to business by mandating vaccines, he said the decision was about his responsibility to protect his staff and guests, as well as the future reputation of his hotel.

“There are some people that are not going to be happy with it,” Mr. Schrager said. “I’m not looking to force them to do anything they don’t want to do. But I do have the right to say: If you want to work here, if you want to come here, you have to be vaccinated.”

Following the lead of accommodations abroad, some U.S. hotels are starting to require proof of vaccination for guests and staff.

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