COVID-19

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Trump admin picks COVID critic to be top FDA vaccine regulator

COVID-19, fda, health, nazis, pandemic, vinay prasad / /

Oncologist Vinay Prasad, a divisive critic of COVID-19 responses, will be the next top vaccine regulator at the Food and Drug Administration, agency Commissioner Martin Makary announced on social media Tuesday.

Prasad will head the FDA’s Center for Biologics Evaluation and Research (CBER), which is in charge of approving and regulating vaccines and other biologics products, such as gene therapies and blood products.

“Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER—a significant step forward,” Makary wrote on social media.

Prasad, a professor in the department of epidemiology and biostatistics at the University of California, San Francisco, is perhaps best known for his combative social media postings and criticism of the mainstream medical community. He gained notoriety amid the COVID-19 pandemic for assailing public health responses, such as masking and vaccine mandates.

In an October 2021 newsletter, titled “How Democracy Ends,” Prasad compared the country’s pandemic responses to the rise of Adolf Hitler’s Third Reich. The post led New York University bioethicist Arthur Caplan to rebuke Prasad, writing in The Cancer Letter that the comparison is “ludicrous, dangerous, and offensive,” before adding “imbecilic.”

Prasad has also criticized the FDA for approving COVID-19 booster vaccines. Last year, he accused his predecessor as the head of the CBER, Peter Marks, of being “either incompetent or corrupt” for allowing the approvals.

“Absurd”

More recently, Prasad has heaped praise on new FDA Commissioner Makary, while continuing to criticize Marks. In early March, Prasad called Makary “smart, thoughtful, and disciplined” and “exactly what we need at the FDA.” Later in the month, he continued to take shots at Marks, writing: “You could replace Peter Marks with a bobblehead doll that just stamps approval and you would have the same outcome at FDA with lower administrative fees. Maybe something DOGE should consider.”

Trump admin picks COVID critic to be top FDA vaccine regulator Read More »

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Seasonal COVID shots may no longer be possible under Trump admin

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Under President Trump, the Food and Drug Administration may no longer approve seasonal COVID-19 vaccines updated for the virus variants circulating that year, according to recent statements by Trump administration officials.

Since the acute phase of the pandemic, vaccine manufacturers have been subtly updating COVID-19 shots annually to precisely target the molecular signatures of the newest virus variants, which continually evolve to evade our immune responses. So far, the FDA has treated these tweaked vaccines the same way it treats seasonal flu shots, which have long been updated annually to match currently circulating strains of flu viruses.

The FDA does not consider seasonal flu shots brand-new vaccines. Rather, they’re just slightly altered versions of the approved vaccines. As such, the regulator does not require companies to conduct lengthy, expensive vaccine trials to prove that each slightly changed version is safe and effective. If they did, generating annual vaccines would be virtually impossible. Each year, from late February to early March, the FDA, the Centers for Disease Control and Prevention, and the World Health Organization direct flu shot makers on what tweaks they should make to shots for the upcoming flu season. That gives manufacturers just enough time to develop tweaks and start manufacturing massive supplies of doses in time for the start of the flu season.

So far, COVID-19 vaccines have been treated the exact same way, save for the fact that the vaccines that use mRNA technology do not need as much lead time for manufacturing. In recent years, the FDA decided on formulations for annual COVID shots around June, with doses rolled out in the fall alongside flu shots.

However, this process is now in question based on statements from Trump administration officials. The statements come amid a delay in a decision on whether to approve the COVID-19 vaccine made by Novavax, which uses a protein-based technology, not mRNA. The FDA was supposed to decide whether to grant the vaccine full approval by April 1. To this point, the vaccine has been used under an emergency use authorization by the agency.

Seasonal COVID shots may no longer be possible under Trump admin Read More »

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“Lab leak” marketing page replaces federal hub for COVID resources

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After obliterating the federal office on long COVID and clawing back billions in COVID funding from state health departments, the Trump administration has now entirely erased the online hub for federal COVID-19 resources. In its place now stands a site promoting the unproven idea that the pandemic virus SARS-CoV-2 was generated in and leaked from a lab in China, sparking the global health crisis.

Navigating to COVID.gov brings up a slick site with rich content that lays out arguments and allegations supporting a lab-based origin of the pandemic and subsequent cover-up by US health officials and Democrats.

Previously, the site provided unembellished quick references to COVID-19 resources, including links to information on vaccines, testing, treatments, and long COVID. It also provided a link to resources for addressing COVID-19 vaccine misconceptions and confronting misinformation. That all appears to be gone now, though some of the same information still remains on a separate COVID-19 page hosted by the Centers for Disease Control and Prevention.

While there remains no definitive answer on how the COVID-19 pandemic began, the scientific data available on the topic points to a spillover event from a live wild animal market in Wuhan, China. The scientific community largely sees this as the most likely scenario, given the data so far and knowledge of how previous outbreak viruses originated, including SARS-CoV-1. By contrast, the lab origin hypothesis largely relies on the proximity of a research lab to the first cases, conjecture, and distrust of the Chinese government, which has not been forthcoming with information on the early days of the health crisis. Overall, the question of SARS-CoV-2’s origin has become extremely politicized, as have most other aspects of the pandemic.

“Lab leak” marketing page replaces federal hub for COVID resources Read More »

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RFK Jr. claws back $11.4B in CDC funding amid wave of top-level departures

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Those departures follow Kevin Griffis, head of the CDC’s office of communications, who left last week; Robin Bailey, the agency’s chief operating officer, left late last month; and Nirav Shah, a former CDC principal deputy director.

Pulled funding

Meanwhile, NBC News reported this afternoon that the Department of Health and Human Services (HHS) is pulling back $11.4 billion in funding from the agency, which it allocated to state and local health departments as well as partners.

NBC reported that the funds were largely used for COVID-19 testing and vaccination, and to support community health workers and initiatives that address pandemic health disparities among high-risk and underserved populations, such as rural communities and minority populations. The funds also supported global COVID-19 projects.

“The COVID-19 pandemic is over, and HHS will no longer waste billions of taxpayer dollars responding to a non-existent pandemic that Americans moved on from years ago,” HHS Director of Communications Andrew Nixon said in a statement. “HHS is prioritizing funding projects that will deliver on President Trump’s mandate to address our chronic disease epidemic and Make America Healthy Again.”

State health departments told NBC News that they’re still evaluating the impact of the withdrawn funding. On Monday, some grantees received notices that read: “Now that the pandemic is over, the grants and cooperative agreements are no longer necessary as their limited purpose has run out.”

Since the public health emergency for COVID-19 was declared over in the US on May 11, 2023, over 92,000 Americans died from the pandemic virus, according to CDC data. In total, the pandemic killed over 1.2 million in the US.

RFK Jr. claws back $11.4B in CDC funding amid wave of top-level departures Read More »

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COVID shots protect kids from long COVID—and don’t cause sudden death

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Benefits and a non-existent risk

Using an adjusted odds ratio, the researchers found that vaccination reduced the likelihood of developing long COVID with one or more symptoms by 57 percent, and reduced the likelihood of developing long COVID with two or more symptoms by 73 percent. Vaccination prior to infection was also linked to a 75 percent reduction in risk of developing long COVID that impacted day-to-day functioning. The authors note that the estimates of protection are likely underestimates because the calculations do not account for the fact that vaccination prevented some children from getting infected in the first place.

“Our findings suggest that children should stay up to date with current COVID-19 vaccination recommendations as vaccination not only protects against severe COVID-19 illness but also protects against [long Covid],” the authors conclude.

In a second short report in JAMA Network Open, researchers helped dispel concern that the vaccines could cause sudden cardiac arrest or sudden cardiac death in young athletes. This is an unproven claim that was fueled by anti-vaccine advocates amid the pandemic, including the new US Health Secretary and long-time anti-vaccine advocate Robert F. Kennedy Jr.

While previous analyses have failed to find a link between COVID-19 vaccines and sudden cardiac deaths, the new study took a broader approach. The study, led by researchers at the University of Washington, looked at whether the number of sudden cardiac arrests (SCA) and sudden cardiac deaths (SCD) among young athletes changed at all during the pandemic (2020–2022) compared with prior years (2017–2019). The researchers drew records from the National Center for Catastrophic Sports Injury Research. They also collected medical records and autopsy reports on cases among competitive athletes from the youth, middle school, high school, club, college, or professional levels who experienced sudden cardiac arrest or death at any time.

In all, there were 387 cases, with no statistically significant difference in the number of cases in the years prior to the pandemic (203) compared with those during the pandemic (184).

“This cohort study found no increase in SCA/SCD in young competitive athletes in the US during the COVID-19 pandemic, suggesting that reports asserting otherwise were overestimating the cardiovascular risk of COVID-19 infection, vaccination, and myocarditis,” the authors conclude.

COVID shots protect kids from long COVID—and don’t cause sudden death Read More »

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Louisiana officially ends mass vaccinations as RFK Jr. comes to power

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“Rather than instructing individuals to receive any and all vaccines, LDH staff should communicate data regarding the reduced risk of disease, hospitalization, and death associated with a vaccine and encourage individuals to discuss considerations for vaccination with their healthcare provider,” he wrote.

“Ripped in half”

Susan Hassig, an infectious disease epidemiologist and professor emerita at Tulane University’s School of Public Health, told the Times-Picayune that this is problematic advice. Many people don’t have primary care providers. “They go to an urgent care or a clinic,” Hassig said. “In Louisiana, they go to the emergency room.”

The memo lands amid widespread fear that Kennedy’s appointment will lead to further erosion of America’s trust in vaccination and its vaccination rates. Already, rates of routine childhood vaccination in kindergartners across the nation have slipped into the range of 92 percent, woefully below the 95 percent threshold to prevent onward disease spread. Exemptions from school vaccination requirements are at an all-time high.

Further, the country is also in the midst of the worst flu season in 15 years. The percent of doctor’s visits for influenza-like illnesses (a standard metric for flu season) hit 7.8 percent this week, a high not seen since the 2009–2010 season amid the emergence of the H1N1 swine flu. The Centers for Disease Control and Prevention estimates that there have been at least 29 million illnesses, 370,000 hospitalizations, and 16,000 deaths from flu so far this season. This week, 11 children died of flu, bringing the 2024–2025 pediatric death toll to 68.

Among the recent deaths was a healthy 9-year-old girl in North Carolina, who died from flu complications on January 29. “I literally feel like my heart has been ripped in half,” her mother told WRAL News.

Seasonal flu shots significantly reduce the risk of death, particularly in children.

Louisiana officially ends mass vaccinations as RFK Jr. comes to power Read More »

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Protection from COVID reinfections plummeted from 80% to 5% with omicron

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“The short-lived immunity leads to repeated waves of infection, mirroring patterns observed with common cold coronaviruses and influenza,” Hiam Chemaitelly, first author of the study and assistant professor of population health sciences at Weill Cornell Medicine-Qatar, said in a statement. “This virus is here to stay and will continue to reinfect us, much like other common cold coronaviruses. Regular vaccine updates are critical for renewing immunity and protecting vulnerable populations, particularly the elderly and those with underlying health conditions.”

Chemaitelly and colleagues speculate that the shift in the pandemic came from shifts in evolutionary pressures that the virus faced. In early stages of the global crisis, the virus evolved and spread by increasing its transmissibility. Then, as the virus lapped the globe and populations began building up immunity, the virus faced pressure to evade that immunity.

However, the fact that researchers did not find such diminished protection against severe, deadly COVID-19 suggests that the evasion is likely targeting only certain components of our immune system. Generally, neutralizing antibodies, which can block viral entry into cells, are the primary protection against non-severe infection. On the other hand, immunity against severe disease is through cellular mechanisms, such as memory T cells, which appear unaffected by the pandemic shift, the researchers write.

Overall, the study “highlights the dynamic interplay between viral evolution and host immunity, necessitating continued monitoring of the virus and its evolution, as well as periodic updates of SARS-CoV-2 vaccines to restore immunity and counter continuing viral immune evasion,” Chemaitelly and colleagues conclude.

In the US, the future of annual vaccine updates may be in question, however. Prominent anti-vaccine advocate and conspiracy theorist Robert F. Kennedy Jr. is poised to become the country’s top health official, pending Senate confirmation next week. In 2021, as omicron was rampaging through the country for the first time, Kennedy filed a petition with the Food and Drug Administration to revoke access and block approval of all current and future COVID-19 vaccines.

Protection from COVID reinfections plummeted from 80% to 5% with omicron Read More »

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Louisiana bars health dept. from promoting flu, COVID, mpox vaccines: Report

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Louisiana’s health department has been barred from advertising or promoting vaccines for flu, COVID-19, and mpox, according to reporting by NPR, KFF Health News, and New Orleans Public Radio WWNO.

Their investigative report—based on interviews with multiple health department employees who spoke on the condition of anonymity for fear of retaliation—revealed that employees were told of the startling policy change in meetings in October and November and that the policy would be implemented quietly and not put into writing.

Ars Technica has contacted the health department for comment and will update this post with any new information.

The health department provided a statement to NPR saying that it has been “reevaluating both the state’s public health priorities as well as our messaging around vaccine promotion, especially for COVID-19 and influenza.” The statement described the change as a move “away from one-size-fits-all paternalistic guidance” to a stance in which “immunization for any vaccine, along with practices like mask wearing and social distancing, are an individual’s personal choice.”

According to employees, the new policy cancelled standard fall flu vaccination events this year and affects every other aspect of the health department’s work, as NPR explained:

“Employees could not send out press releases, give interviews, hold vaccine events, give presentations or create social media posts encouraging the public to get the vaccines. They also could not put up signs at the department’s clinics that COVID, flu or mpox vaccines were available on site.”

“We’re really talking about deaths”

The change comes amid a dangerous swell of anti-vaccine sentiment and misinformation in Louisiana and across the country. President-elect Trump has picked Robert F. Kennedy Jr.—a high-profile anti-vaccine advocate and one of the most prolific spreaders of vaccine misinformation—to head the US Department of Health and Human Services.

Louisiana bars health dept. from promoting flu, COVID, mpox vaccines: Report Read More »

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Idaho health district abandons COVID shots amid flood of anti-vaccine nonsense

COVID-19, health, idaho, misinformation, Science, Uncategorized, vaccines / /

Slippery slope

In the hearing, board member Jennifer Riebe (who voted to keep COVID-19 vaccinations available) worried about the potential of a slippery slope.

“My concern with this is the process because if this board and six county commissioners and one physician is going to make determinations on every single vaccine and pharmaceutical that we administer, I’m not comfortable with that,” she said, according to Boise State Public Radio. “It may be COVID now, maybe we’ll go down the same road with the measles vaccine or the shingles vaccine coverage.”

Board Chair Kelly Aberasturi, who also voted to keep the vaccines, argued that it should be a choice by individuals and their doctors, who sometimes refer their patients to the district for COVID shots. “So now, you’re telling me that I have the right to override that doctor? Because I know more than he does?” Aberasturi said.

“It has to do with the right of the individual to make that decision on their own. Not for me to dictate to them what they will do. Sorry, but this pisses me off,” he added.

According to Boise State Public Radio, the district had already received 50 COVID-19 vaccines at the time of the vote, which were slated to go to residents of a skilled nursing facility.

The situation in the southwest district may not be surprising given the state’s overall standing on vaccination: Idaho has the lowest kindergarten vaccination rates in the country, with coverage of key vaccinations sitting at around 79 percent to 80 percent, according to a recent analysis by the Centers for Disease Control and Prevention. The coverage is far lower than the 95 percent target set by health experts. That’s the level that would block vaccine-preventable diseases from readily spreading through a population. The target is out of reach for Idaho as a whole, which also has the highest vaccination exemption rate in the country, at 14.3 percent. Even if the state managed to vaccinate all non-exempt children, the coverage rate would only reach 85.7 percent, missing the 95 percent target by nearly 10 percentage points.

Idaho health district abandons COVID shots amid flood of anti-vaccine nonsense Read More »

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Lab owner pleads guilty to faking COVID test results during pandemic

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Justice —

Ill-gotten millions bought a Bentley, Lamborghini, Tesla X, and crypto, among other things.

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Residents line up for COVID-19 testing on November 30, 2020 in Chicago.

Enlarge / Residents line up for COVID-19 testing on November 30, 2020 in Chicago.

The co-owner of a Chicago-based lab has pleaded guilty for his role in a COVID testing scam that raked in millions—which he used to buy stocks, cryptocurrency, and several luxury cars while still squirreling away over $6 million in his personal bank account.

Zishan Alvi, 45, of Inverness, Illinois, co-owned LabElite, which federal prosecutors say billed the federal government for COVID-19 tests that were either never performed or were performed with purposefully inadequate components to render them futile. Customers who sought testing from LabElite—sometimes for clearance to travel or have contact with vulnerable people—received either no results or results indicating they were negative for the deadly virus.

The scam, which ran from around February 2021 to about February 2022, made over $83 million total in fraudulent payments from the federal government’s Health Resources and Services Administration (HRSA), which covered the cost of COVID-19 testing for people without insurance during the height of the pandemic. Local media coverage indicated that people who sought testing at LabElite were discouraged from providing health insurance information.

In February 2022, the FBI raided LabElite’s Chicago testing site amid a crackdown on several large-scale fraudulent COVID testing schemes. In March 2023, Alvi was indicted by a federal grand jury on 10 counts of wire fraud and one count of theft of government funds. The indictment sought forfeiture of his ill-gotten riches, which were listed in the indictment.

The list included five vehicles: a 2021 Mercedes-Benz, a 2021 Land Rover Range Rover HSE, a  2021 Lamborghini Urus, A 2021 Bentley, and a 2022 Tesla X. There was also about $810,000 in an E*Trade account, approximately $500,000 in a Fidelity Investments account, and $245,814 in a Coinbase account. Last, there was $6,825,089 in Alvi’s personal bank account.

On Monday, the Department of Justice announced a deal in which Alvi pleaded guilty to one count of wire fraud, taking responsibility for $14 million worth of fraudulent HRSA claims. He now faces up to 20 years in prison and will be sentenced on February 7, 2025.

Lab owner pleads guilty to faking COVID test results during pandemic Read More »

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Can addressing gut issues treat long COVID in children?

COVID-19, health, long COVID, Science, syndication / /
Child holding his stomach

Frazao Studio Latino/ Getty Images

Four years after the outbreak of the COVID-19 pandemic, doctors and researchers are still seeking ways to help patients with long COVID, the persistent and often debilitating symptoms that can continue long after a COVID-19 infection.

In adults, the most common long COVID symptoms include fatigue and brain fog, but for children the condition can look different. A study published last month suggests preteens are more likely to experience symptoms such as headaches, stomach pain, trouble sleeping, and attention difficulties. Even among children, effects seem to vary by age. “There seems to be some differences between age groups, with less signs of organ damage in younger children and more adultlike disease in adolescents,” says Petter Brodin, professor of pediatric immunology at Imperial College London.

While vast sums have been devoted to long COVID research—the US National Institutes of Health have spent more than a billion dollars on research projects and clinical trials—research into children with the condition has been predominantly limited to online surveys, calls with parents, and studies of electronic health records. This is in spite of a recent study suggesting that between 10 and 20 percent of children may have developed long COVID following an acute infection, and another report finding that while many have recovered, some still remain ill three years later.

Now, what’s believed to be the first clinical trial specifically aimed at children and young adults with long COVID is underway, recruiting subjects aged 7 to 21 on which to test a potential treatment. It builds on research that suggests long COVID in children may be linked to the gut.

In May 2021, Lael Yonker, a pediatric pulmonologist at Massachusetts General Hospital in Boston, published a study of multisystem inflammatory syndrome in children (MIS-C), which she says is now regarded as a more severe and acute version of long COVID. It showed that these children had elevated levels of a protein called zonulin, a sign of a so-called leaky gut. Higher levels of zonulin are associated with greater permeability in the intestine, which could enable SARS-CoV-2 viral particles to leak out of the intestines and into the bloodstream instead of being excreted out of the body. From there, they could trigger inflammation.

As Yonker began to see more and more children with long COVID, she theorized that many of the gastrointestinal and neurological symptoms they were experiencing might be linked. But her original study also pointed to a possible solution. When she gave the children with MIS-C a drug called larazotide, an existing treatment for people with issues relating to a leaky gut, the levels of viral particles in their blood decreased and their symptoms improved.

Can addressing gut issues treat long COVID in children? Read More »

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COVID shot now or later? Just getting it at all is great, officials respond.

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Viral defences —

As the summer wave peaks, officials are prepping for the coming winter wave.

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A 13-year-old celebrates getting the Pfizer-BioNTech COVID-19 vaccine in Hartford, Connecticut, on May 13, 2021.

Enlarge / A 13-year-old celebrates getting the Pfizer-BioNTech COVID-19 vaccine in Hartford, Connecticut, on May 13, 2021.

With the impending arrival of the 2024–2025 COVID-19 vaccines approved yesterday, some Americans are now gaming out when to get their dose—right away while the summer wave is peaking, a bit later in the fall to maximize protection for the coming winter wave, or maybe a few weeks before a big family event at the end of the year? Of course, the group pondering such a question is just a small portion of the US.

Only 22.5 percent of adults and 14 percent of children in the country are estimated to have gotten the 2023–2024 vaccine. In contrast, 48.5 percent of adults and 54 percent of children were estimated to have gotten a flu shot. The stark difference is despite the fact that COVID-19 is deadlier than the flu, and the SARS-CoV-2 virus is evolving faster than seasonal influenza viruses.

In a press briefing Friday, federal health officials were quick to redirect focus when reporters raised questions about the timing of COVID-19 vaccination in the coming months and the possibility of updating the vaccines twice a year, instead of just once, to keep up with an evolving virus that has been producing both summer and winter waves.

“The current problem is not that the virus is evolving so much, at least in terms of my estimation,” Peter Marks, the top vaccine regulator at the Food and Drug Administration, told journalists. “It’s that we don’t have the benefits of the vaccine, which is [to say] that it’s not vaccines that prevent disease, it’s vaccination. It’s getting vaccines in arms.” When exactly to get the vaccine is a matter of personal choice, Marks went on, but the most important choice is to get vaccinated.

Estimates for this winter

The press briefing, which featured several federal health officials, was intended to highlight the government’s preparations and hopes for the upcoming respiratory virus season. The FDA, the Centers for Disease Control and Prevention, and the Department of Health and Human Services (HHS) are urging all Americans to get their respiratory virus vaccines—flu, COVID-19, and RSV.

CDC Director Mandy Cohen introduced an updated data site that provides snapshots of local respiratory virus activity, national trends, data visualizations, and the latest guidance in one place. HHS, meanwhile, highlighted a new outreach campaign titled “Risk Less. Do More.” to raise awareness of COVID-19 and encourage vaccination, particularly among high-risk populations. For those not at high risk, health officials still emphasize the importance of vaccination to lower transmission and prevent serious outcomes, including long COVID. “There is no group without risk,” Cohen said, noting that the group with the highest rates of emergency department visits for COVID-19 were children under the age of 5, who are not typically considered high risk.

So far, CDC models are estimating that this year’s winter wave of COVID-19 will be similar, if not slightly weaker on some metrics, than last year’s winter wave, Cohen said. But she emphasized that many assumptions go into the modeling, including how the virus will evolve in the near future and the amount of vaccine uptake. The modeling assumes the current omicron variants stay on their evolutionary path and that US vaccination coverage is about the same as last year. Of course, beating last year’s vaccine coverage could blunt transmission.

COVID shot now or later? Just getting it at all is great, officials respond. Read More »