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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Doctors urge action to ensure effective blood oxygen monitoring for all

A Food and Drug Administration advisory panel met Feb. 2 to discuss the problems that pulse oximeters pose for patients with dark skin, including Black and Hispanic individuals. Advocates and experts said urgent action is needed, but change has not been forthcoming.

Studies as far back as 2005 show that the medical devices, which measure blood oxygen levels at the fingertip, often overestimate the number in people with dark skin. Melanin, the pigment in skin, absorbs the light the devices rely on for readings. 

Pandemic-era research, indicating the devices missed low oxygen levels in some Black patients and delayed or impeded care, helped bring the issue to the fore. 

“The lack of swift action by the FDA has been frustrating to many health equity advocates, consumer advocates, and a group of state attorneys general,” writes Usha Lee McFarling at STAT. The latter group sent the FDA a letter in November, stating, “It is imperative that the FDA act now to prevent additional severe illness and mortalities among darker skinned people.”

Panelists heard from experts who said that some devices on the market today fail to meet current standards. Engineers are working on devices that would provide more accurate results for all skin types, reports Cassandra Willyard at MIT Technology Review. 

Speakers also testified that many physicians and consumers still aren’t aware of the problem. 

“As someone who’s intimately aware of this issue, I still don’t know what to do for my patients,” Dr. Tom Valley of the University of Michigan told STAT. “These are devices used every day, all the time, that continue to place Black patients at risk of harm.”

Patients told the committee about receiving puzzling, inconsistent readings that made it difficult to manage health conditions.

FDA scientists proposed new rules that would raise the number of individuals manufacturers must test the devices in from 10 to 24, and to ensure subjects’ coloration spans the 10-shade Monk Skin Tone Scale.

Some advisory committee members weren’t convinced that 24 subjects was sufficient, reports Max Kozlov at Nature, and other scientists are still testing whether the Monk Skin Tone Scale is the most appropriate measure. 

The FDA will now consider the panel’s advice, but hasn’t released a deadline for the new rules.

“The longer these changes aren’t made, the longer that patients are put at risk,” Dr. Michael Sjoding of the University of Michigan told Nature.

New series shines light on Black mental health 

Word in Black, a news collaborative focused on Black people, put the spotlight on mental health in early February with a series of articles addressing happiness and the challenges and opportunities for help and treatment.

Recent data from the Pew Research Center indicate that more than 80% of Black adults are somewhat or very happy. But income makes a significant difference, reports Bria Overs. 

More than half of Black adults in the upper-income category — those earning more than $143,400 a year — reported being very or extremely happy. But just a quarter of lower-income Black adults, making $47,800 or less, said the same.

For those seeking mental health help, it can be hard to find a therapist who understands the experiences of people of color, writes Marlene F. Watson, director of training for therapists at the Ackerman Institute for the Family in New York.

Recent news provides an example: A new study reports that Black people are more likely than others to report sleep loss in the months after police killings of unarmed Black individuals. 

Just 4% of therapists are Black, Watson notes, even though Black people account for nearly 13% of the U.S. population. Some white therapists have told Watson they avoid the race issue, which doesn’t serve their clients.

And though Black children are at growing risk of hate crimes, homicide and suicide, advocates say states aren’t putting up sufficient funds to help them, reports Joseph Williams. 

The American Foundation of Suicide Prevention just launched a new program focused on mental health in Black communities, called L.E.T.S. Save Lives for Listening, Empathy, Trust, and Support. The initiative is a free presentation, meant to engender discussions and highlight resources, that will be available through the Foundation’s chapters, media partners, historically Black colleges and universities, and virtually, reports Anissa Durham.  

Black people are more likely to seek counsel from religious leaders than mental health professionals, and frequently deny problems such as depression or anxiety, Vic Armstrong, vice president for health equity at the American Foundation of Suicide Prevention, told Durham.

In Black women, that mode of thinking can manifest in the “superwoman schema,” report ABC News and Good Morning America, in which women feel they must suppress their emotions and vulnerabilities to focus on taking care of others, but this can cause stress.

Black women think, “Everything that comes my way, I should be able to handle it,” said Zoeann Finzi-Adams, a psychologist at Howard University. “That’s exhausting, because no one is able to do everything.”

Survey finds growing health care inequities for transgender Americans

While most transgender individuals are healthy, nearly half have had negative experiences with health care providers, according to the preliminary results of the 2022 U.S. Trans Survey. 

Of respondents who had transitioned, 94% said doing so improved life satisfaction.

The survey, which included more than 92,000 transgender people in the United States, was conducted by the National Center for Transgender Equality, an advocacy organization in Washington, D.C., and its partners.

It’s one of few efforts to spotlight the trans experience, report Orion Rummler and Kate Sosin at The 19th. 

The U.S. Census Bureau didn’t ask Americans about gender identity until 2021.

It’s important to collect data from transgender people themselves, because it’s often cisgender individuals who are shaping public thinking, Sandy James, the lead researcher on the survey, said in a press call.

“At best, we’re working in a vacuum,” added Rodrigo Heng-Lehtinen, executive director of the National Center for Transgender Equality. “At worst, we’re combating dangerous misinformation being spread by anti-trans extremists.”

Topline health results from the survey highlight issues transgender Americans face with providers and insurance companies. 

Of those survey respondents who’d seen a health care provider in the past year, 48% reported problems including being spoken to harshly, misgendered, physically abused or refused care. That’s up from 33% in the previous survey in 2015.

In addition, 26% of those surveyed said they’d experienced insurance problems such as denial of coverage for routine or gender-affirming care. The number was 25% in 2015.

Economic factors can also impact health; the number of respondents living in poverty rose from 29% in 2015 to 34% in 2022.

And 10% of people who took the new survey said they’d moved to a new region to avoid discrimination, with 5% crossing state lines over legislation cutting access to bathrooms, sports or health care.

“A steady condition, environment, has been created in which people are not able to thrive,” the lead researcher James said in a New York Times article by Azeen Ghorayshi.

More data and a more in-depth report will be released in the future.

“Advocates say the updated survey is overdue and direly needed as anti-transgender bills flood state legislatures,” write The 19th’s Sosin and Rummler.

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U.S. health officials recalled three more brands of whole and pre-cut cantaloupes Friday as the number of people sickened by salmonella more than doubled this week.

Nearly 100 people in 32 states have gotten sick from the contaminated fruits. Arizona, Missouri, Minnesota, Wisconsin and Ohio have the highest number of cases. Two people have died of the infections in Minnesota, and 45 people are hospitalized nationwide.

The U.S. Food and Drug Administration’s original recall included Malichita brand whole cantaloupe, Vinyard brand pre-cut cantaloupe and ALDI whole cantaloupe and pre-cut fruit products. Rudy brand whole cantaloupes and Freshness Guaranteed brand and RaceTrac brand pre-cut cantaloupes joined the list Friday.

Health officials say anyone who bought the recalled fruits should throw them away and wash surfaces that touched them with hot, soapy water or in a dishwasher.

Most people infected with salmonella develop diarrhea, fever and stomach cramps within six hour to six days after consuming food contaminated with the bacteria. Illnesses typically last four to seven days. Vulnerable people, including children, people older than 65 and those with weakened immune systems may develop severe illnesses that require medical care or hospitalization.

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A new version of the popular diabetes treatment Mounjaro can be sold as a weight-loss drug, U.S. regulators announced Wednesday.

The U.S. Food and Drug Administration approved Eli Lilly’s drug, named Zepbound. The drug, also known as tirzepatide, helped dieters lose as much as 40 to 60 pounds in testing.

Zepbound is the latest diabetes drug approved for chronic weight management, joining Novo Nordisk’s Wegovy, a high-dose version of its diabetes treatment Ozempic. Both are weekly injections.

The FDA approved Lilly’s drug for people who are considered obese, with a body mass index of 30 or higher, or those who are overweight with a related health condition, like high blood pressure, high cholesterol or diabetes. The drug should be paired with a reduced-calorie diet and regular exercise, the FDA said.

In the U.S., at least 100 million adults and about 15 million children are considered obese.

The drugs tirzepatide in Zepbound and Mounjaro and semaglutide in Wegovy and Ozempic work by mimicking hormones that kick in after people eat to regulate appetite and the feeling of fullness. Both imitate a hormone called glucagon-like peptide-1, known as GLP-1. Tirzepatide targets a second hormone, called glucose-dependent insulinotropic polypeptide, or GIP.

FDA’s approval was based on two large studies: More than 2,500 participants got different strengths of Zepbound and nearly 1,000 people got dummy shots over 16 months. Participants without diabetes who received the highest dose lost about 18% of their weight, or about 41 pounds (19 kilograms), compared to placebo. Those with diabetes, who have a harder time losing weight, cut about 12%, or nearly 27 pounds (12 kilograms), the FDA said.

In another recent study, the drug helped people lose up to a quarter of their weight, or 60 pounds (27 kilograms), when combined with intensive diet and exercise.

Overall, Zepbound appears to spur greater weight loss than Wegovy. Approved for weight loss in 2021, Wegovy helped people lose about 15% of their weight or 34 pounds (15 kilograms), according to study results.

“This would be the most highly efficacious drug ever approved for the treatment of obesity,” said Dr. Fatima Cody Stanford, an obesity medicine expert at Massachusetts General Hospital in Boston.

Touted by celebrities and on social media, semaglutide and tirzepatide drugs have already been in such demand that their manufacturers have struggled to keep up. Both have been listed on the FDA’s drug shortage site for months. All strengths of tirzepatide are currently listed as available, but a company spokesperson said that could vary by location and demand.

Side effects of the new weight-loss drug include vomiting, nausea, diarrhea, constipation and other gastrointestinal problems. In the most recent published trial, about 10% of people taking tirzepatide dropped out of the study because of such problems, compared to about 2% of people taking dummy shots.

While experts lauded approval of Zepbound, they worried that it wouldn’t necessarily mean greater access to the drug, which has been prescribed “off-label” to help people pare pounds.

“Most patients won’t be able to afford Zepbound without insurance coverage and many health plans exclude obesity care,” said Dr. Katherine Saunders, an obesity expert at New York’s Weill Cornell Medicine and co-founder of company focused on obesity treatment.

Eli Lilly and Co. said the list price will be about $1,000 a month, the same as Mounjaro. The drug is expected to be available in the U.S. by the end of the year, the company said. Dosing strengths are the same for Zepbound and Mounjaro.

Kelly Burns, 50, of St. Petersburg, Florida, lost nearly 100 pounds (45 kilograms) using tirzepatide after joining a study of the drug to treat obesity in 2021. When testing ended and she no longer had access to the medication, she struggled, but eventually lost another 50 pounds (23 kilograms).

“My whole life is completely different,” she said. Her health measurements improved and her confidence soared. Now that is is approved for weight loss, Burns plans to ask her insurance company about coverage.

“It would be ridiculous not to,” she said, adding: “I want to stay this way as long as I possibly can.”

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RALEIGH, N.C. (AP) — Most of the destruction from a tornado that tore through eastern North Carolina Wednesday and struck a large Pfizer pharmaceutical plant affected its storage facility, rather than its medicine production areas, the company said Friday.

The drugmaker’s ability to salvage production equipment and other essential materials could mitigate what experts feared would be a major blow to an already strained system as the United States grapples with existing drug shortages.

“We do not expect there to be any immediate significant impacts on supply given the products are currently at hospitals and in the distribution system,” U.S. Food and Drug Administration Commissioner Robert Califf said Friday.

An EF3 tornado touched down Wednesday near Rocky Mount, ripping the roof off a Pfizer factory responsible for producing nearly 25% of the American pharmaceutical giant’s sterile injectable medicines used in U.S. hospitals, according to the drugmaker.

Pfizer said Friday that a warehouse for raw materials, packaging supplies and finished medicines awaiting release had endured most of the damage to its 1.4 million square foot plant. An initial inspection by the company found no major damage to its medicine manufacturing areas, and all 3,200 local employees are safe and accounted for.

Pfizer Chairman and CEO Dr. Albert Bourla said staff are rushing products to nearby sites for storage and identifying sources to rapidly replace raw materials lost in the storm. The drug company says it is also exploring alternative manufacturing locations across its U.S. network to fill gaps in production while the North Carolina site remains closed for repairs.

The FDA’s initial analysis identified fewer than 10 drugs for which Pfizer’s North Carolina plant is the sole source for the U.S. market, Califf said.

The Rocky Mount plant produces anesthesia and many other drugs needed for surgeries but does not make or store Pfizer’s COVID-19 vaccine or the Comirnaty and Paxlovid treatments. Medications produced at that facility alone account for nearly 8% of all sterile injectables used in U.S. hospitals, Pfizer said on its website.

The FDA said it will complete in the coming days a more extensive evaluation of the products that might be affected and the current domestic supply of those medications. “Many weeks’ worth” of the destroyed drugs should be available in Pfizer’s other warehouses, Califf said.

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Hannah Schoenbaum is a corps member for the Associated Press/Report for America Statehouse News Initiative. Report for America is a nonprofit national service program that places journalists in local newsrooms to report on undercovered issues.

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WASHINGTON (AP) — U.S. health officials on Wednesday approved the first pill made from healthy bacteria found in human waste to fight dangerous gut infections — an easier way of performing so-called fecal transplants.

The new treatment from Seres Therapeutics provides a simpler, rigorously tested version of stool-based procedures that some medical specialists have used for more than a decade to help hard-to-treat patients.

The Food and Drug Administration cleared the capsules for adults who face risks of repeat infections with Clostridium difficile, a bacteria that can cause severe nausea, cramping and diarrhea.

C. diff is particularly dangerous when it reoccurs, leading to between 15,000 and 30,000 deaths per year. It can be killed with antibiotics but they also destroy good bacteria that live in the gut, leaving it more susceptible to future infections. The new capsules are approved for patients who have already received antibiotic treatment.

More than 10 years ago, some doctors began reporting success with fecal transplants — using stool from a healthy donor — to restore the gut’s healthy balance and prevent reinfections.

The FDA approved the first pharmaceutical-grade version of the treatment last year from a rival drugmaker, Ferring Pharmaceuticals. But that company’s product — like most of the original procedures — must be delivered via the rectum.

Cambridge Massachusetts-based Seres will market its drug as a less invasive option. The treatment will be sold under the brand name Vowst and comes as a regimen of four daily capsules taken for three consecutive days.

Both of the recent FDA approvals are the product of years of pharmaceutical industry research into the microbiome, the community of bacteria, viruses and fungi that live in the gut.

Currently most fecal transplants are provided by a network of stool banks that have popped up at medical institutions and hospitals across the country.

While the availability of new FDA-approved options is expected to decrease demand for donations from stool banks, some plan to stay open.

OpenBiome, the largest stool bank in the U.S., said it will keep serving patients who aren’t eligible for the FDA-approved products, such as children and adults with treatment-resistant cases. It has supplied more than 65,000 stool samples for C. diff patients since 2013.

“OpenBiome is committed to maintaining safe access to ‘fecal transplantation’ for these patients as a vital last line of defense,” said Dr. Majdi Osman, the group’s medical chief.

OpenBiome’s standard stool treatment costs less than $1,700 and is typically delivered as a frozen solution within days of ordering. Seres did not disclose the price it will charge for its capsules in a statement Wednesday evening.

“We want to make the commercial experience for physicians and patients as easy as possible,” said Eric Shaff, the company’s chief financial officer, in an interview ahead of the announcement. “Ease of administration — in our view — is one of the aspects of the value we’re delivering.”

Seres will co-market the treatment with Swiss food giant Nestle, which will also split the profits. Seres said it will receive a $125 million milestone payment from Nestle in connection with the FDA approval.

Overseeing the fledgling industry of U.S. stool banks has created regulatory headaches for the FDA, which doesn’t traditionally police homemade products and procedures used in doctor’s offices. In the early days of the trend, the FDA warned consumers about the risks of potential infections from the fecal transplants, as some people sought out questionable “do it yourself” methods from videos and websites.

Seres executives say their manufacturing process relies on the same techniques and equipment used to purify blood products and other biologic therapies.

The company starts with stool provided by a small group of donors who are screened for various health risks and conditions. Their stool is likewise tested for dozens of potential viruses, infections and parasites.

The company then processes the samples to remove the waste, isolate the healthy bacteria and kill any other lingering organisms. Thousands of capsules can be made from each stool sample, making it a more efficient process than current fecal transplants, according to the company.

The FDA warned in a release Wednesday that the drug “may carry a risk of transmitting infectious agents. It is also possible for Vowst to contain food allergens,” the agency noted.

The FDA approved the treatment based on a 180-patient study in which 88% of patients taking the capsules did not experience reinfection after 8 weeks, compared with 60% of those who received dummy pills.

Common side effects included abdominal swelling, constipation and diarrhea.

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Follow Matthew Perrone on Twitter: @AP_FDAwriter ___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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WASHINGTON (AP) — Food and Drug Administration regulators on Tuesday approved a first-of-a-kind drug for a rare form of Lou Gehrig’s disease, though they are requiring further research to confirm it truly helps patients.

The FDA approved Biogen’s injectable drug for patients with a rare genetic mutation that’s estimated to affect less than 500 people in the U.S. It’s the first drug for an inherited form of ALS, or amyotrophic lateral sclerosis, a deadly disease that destroys nerve cells needed for basic functions like walking, talking and swallowing.

Approval came via FDA’s accelerated pathway, which allows drugs to launch based on promising early results, before they’re confirmed to benefit patients. That shortcut has come under increasing scrutiny from government watchdogs and congressional investigators.

The FDA is requiring Biogen to continue studying the drug in a trial of people who carry the genetic mutation but do not yet have ALS symptoms.

ALS patients hope the decision could lay the groundwork for more expedited approvals to fight the disease, which affects 16,000 to 32,000 people in the U.S. The FDA has long used accelerated approval to speed the availability of drugs for cancer and other deadly conditions.

The drug, tofersen, is designed to block the genetic messengers that produce a toxic form of protein that is thought to drive the disease in about 2% of ALS patients. Cambridge, Massachusetts-based Biogen will sell it under the brand name Qalsody. Patients receive three initial spinal injections of the drug over a two-week period, followed by a monthly dose. The most common side effects linked to the drug were pain, fatigue and increased spinal fluid.

Biogen’s 100-person study failed to show that the drug significantly slowed the disease compared with a dummy treatment. Patients were tracked for more than six months using a scale that measures the decline of basic movements, including writing, walking and climbing stairs.

But those who received tofersen showed significant changes in levels of the toxic protein and a second neurological chemical that is considered a key indicator of the disease’s progression.

“The findings are reasonably likely to predict a clinical benefit in patients,” the FDA said in a statement announcing the approval.

Last month an outside panel of FDA advisers voted unanimously that those changes warranted granting conditional approval while more data is gathered to confirm the drug’s benefit. The same panel said Biogen’s current data, including the failed patient study, wasn’t strong enough to warrant full approval.

FDA regulators have the authority to pull accelerated approval from drugs that fail to live up to their expected promise, though until recently, they rarely used that power. In recent years, the FDA has stepped up efforts to force unproven drugs off the market, amid criticism that too many expensive, ineffective medications remain available for years.

At the same time, the FDA has shown increased “regulatory flexibility” in approving drugs for rare and debilitating neurological diseases, including Alzheimer’s and ALS.

In September, the FDA granted full approval to another ALS drug based on one small, mid-stage study in which patients appeared to progress more slowly and survive several months longer. Normally, the FDA requires two large studies or one study suggesting a “very persuasive” improvement in survival.

Some insurers have limited access to the new drug, Relyvrio, citing its uncertain benefit and $158,000-per-year cost.

Biogen did not announce a price for its drug Tuesday but said it will be “comparable to other recently launched ALS treatments.”

The ALS Association and other patient groups hailed the approval.

“This is the second time in less than a year our community gets to celebrate the approval of a new drug to treat ALS and we have great hope for the future,” said Calaneet Balas, the group’s president and CEO.

Since last year’s approval of Relyvrio, ALS patients and advocates have continued to press the FDA to consider more treatments for the disease. That includes an experimental stem cell treatment from tiny drugmaker Brainstorm Cell Therapeutics.

In a rare move, the FDA recently agreed to hold a public meeting on the treatment, despite previously refusing to consider the company’s application, citing failed results from its principal study.

The FDA has now approved four medications for ALS, only one of which has been shown to extend life. The disease gradually destroys nerve connections needed for basic movements and — eventually — breathing. There is no cure and most people die within three to five years of diagnosis.

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WASHINGTON (AP) — U.S. regulators on Tuesday cleared another booster dose of the Pfizer or Moderna COVID-19 vaccines for older Americans and people with weak immune systems.

The Food and Drug Administration also took steps to make coronavirus vaccinations simpler for everyone, saying that anyone getting a Pfizer or Moderna dose — whether it’s a booster or their first-ever vaccination — will get the newest formula, not the original shots.

The FDA said those 65 or older can opt to roll up their sleeves again for another booster as long as it’s been at least four months since their first dose of the so-called bivalent vaccine that targets omicron strains.

And most people who are immune-compromised also can choose that extra spring booster at least two months after their first, with additional doses in the future at the discretion of their physician, the agency said.

If the Centers for Disease Control and Prevention signs off, those spring boosters could begin within days. The CDC’s advisers are set to meet Wednesday.

“COVID-19 remains a very real risk for many people,” FDA vaccine chief Dr. Peter Marks said.

It’s too soon to know if younger, healthy people will eventually be offered yet another shot but the extra dose for the most vulnerable is one of several steps FDA is taking to simplify COVID-19 vaccinations going forward.

Here are some things to know:

ONE FORMULA FOR PFIZER AND MODERNA SHOTS

COVID-19 vaccines have saved millions of lives but protection wanes over time and as new, more contagious variants have popped up. So last fall, Pfizer and Moderna rolled out updated “bivalent” boosters that added protection against omicron strains then circulating to the original vaccine recipe. Tuesday, the FDA said that updated formula will be used for anyone getting a Pfizer or Moderna vaccine. For unvaccinated adults, that means one combo shot would replace having to get several doses of the original vaccine first.

WHO NEEDS A BOOSTER?

Anyone who’s gotten their original vaccinations but hasn’t had an updated booster yet can still get one. Only 42% of Americans 65 and older — and just 20% of all adults — have gotten one of those updated boosters since September. “Those individuals certainly could go out and get a bivalent booster now to improve their protection,” Marks said.

SOME PEOPLE ARE AT HIGHER RISK

For many Americans, COVID-19 has become less of a health fear and more of an inconvenience, and masking, routine testing and other precautions have largely fallen by the wayside. But at least 250 people in the U.S. a day still die from COVID-19, and high-risk Americans who last got a dose in the fall have anxiously wondered when they could get another.

Letting seniors and the immune-compromised get an extra booster dose puts the U.S. in line with Britain and Canada, which also are offering certain vulnerable populations a spring shot. It’s a reasonable choice, said Dr. Matthew Laurens of the University of Maryland School of Medicine.

“We do have vaccines that are available to protect against these severe consequences, so why not use them?” he said. “They don’t do any good just sitting on a shelf.”

WILL YOUNGER, HEALTHIER PEOPLE GET A FALL DOSE?

Stay tuned. The FDA will hold a public meeting in June to consider if the vaccine recipe needs more adjusting to better match the latest coronavirus strains — just like it adjusts flu vaccines every year. And part of that discussion will be whether younger, healthier people also need a booster.

The updated Pfizer and Moderna shots being used now target the BA.4 and BA.5 omicron versions, which have been replaced by an ever-changing list of omicron descendants. Still, while protection against mild infections is short-lived, those updated doses continue to do a good job fighting severe disease and death even against the newest variants, Marks said.

Whether the recipe gets adjusted again or not, Tuesday’s move “is essentially preparing to have a simpler, more straightforward way of going about vaccinating people,” he said. “It’s essentially a single dose of the appropriately strained vaccine as we move into the fall and winter months.”

TWEAKS TO CHILD SHOTS, TOO

Millions of U.S. children still haven’t gotten their initial COVID-19 vaccinations but Tuesday’s step means they, too, can get the most updated version of the shots. Tots ages 6 months through 5 years who are unvaccinated can choose two Moderna shots or three of the Pfizer-BioNTech version. Children who are 5 years old can get two Moderna doses or a single Pfizer shot.

Children already fully or partially vaccinated with the original Pfizer or Moderna shots may get a bivalent vaccine, but how many doses will depend on their vaccination history, the FDA said.

WHAT ABOUT THE NOVAVAX VACCINE?

Novavax makes a more traditional type of COVID-19 vaccine, and its original formula remains available for people who don’t want the Pfizer or Moderna option. Novavax said Tuesday it also is getting ready in case FDA urges a fall update, by manufacturing several additional formulas.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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By Amber Dance

FDA, CDC will likely back another booster for at-risk groups

After weeks of rumors about spring boosters, the FDA is expected to approve a second round of omicron-specific shots for people who are 65 and older or immunocompromised, report Laurie McGinley and Lena H. Sun at The Washington Post.

The official announcement and CDC endorsement is expected within weeks, officials told the reporters.

The FDA will not specifically recommend the shots, but will allow anyone in those high-risk groups who is at least four months out from their first omicron booster to get another.

About 42% of people 65 and older have received the initial omicron booster shot.

These shots will be free since the federal government still has an ample stockpile of the boosters.

POC, non-English speakers at higher risk to lose Medicaid

As of April 1, a handful of states have begun removing people from Medicaid rolls for the first time in three years, as a pandemic-aid program that prevented them from doing so has come to an end.

Other states are expected to begin cutting people from their Medicaid lists this spring or summer.

Medicaid and the Children’s Health Insurance Program gained about 20 million enrollees during the pandemic, reports Noah Weiland at The New York Times.

An estimated 15 million stand to lose that coverage over the next 14 months as states gradually step up programs to verify eligibility.

Many of those kicked off Medicaid will likely sign up for other coverage via the Affordable Care Act, but others will likely wind up without insurance. Those who earn too much for Medicaid but not enough for Obamacare subsidies are particularly at risk.

About 7 million of those who are likely to lose coverage are probably still eligible for Medicaid but will fail to reenroll for one reason or another.

For example, if they’ve moved, crucial letters might not reach their new address.

“Whenever these sorts of moments happen, it’s people of color, it’s kids, it’s people that don’t speak English that are always hit the hardest,” Natalie Davis of the nonpartisan advocacy group United States of Care told The Times.

As pandemic-era benefits like Medicaid and food stamps return to their pre-COVID levels, low-income Americans will spend less, which could damage the economy overall, notes Abha Bhattaraj at The Washington Post.

FDA authorizes new medication for severe cases

Physicians have a new option for severely ill COVID patients, reports Ingrid Hein at MedPage Today.

The FDA has granted emergency use authorization for an antibody that should tamp down the overactive immune response that endangers people with severe COVID.

Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, called the medicine a “potentially life-saving treatment option for the sickest COVID-19 patients.”

While the immune system is needed to fight off the virus, too much immune activity can worsen the disease, causing inflammation and blood clots.

The new antibody, called vilobelimab, sticks to one of the early cellular activators of that inflammation to stop it.

In an international trial, vilobelimab reduced the death rate for critically ill COVID patients by about 19%.

It’s authorized for hospitalized patients who require machines to support their breathing or blood circulation.

The FDA warned the medicine comes with downsides: It can lower the body’s ability to fight off other infections and cause allergic reactions.

Long COVID researchers push for more funding

Investigators studying long COVID have called for a much larger investment in the problem, which they say affects one in 13 U.S. adults.

The researchers, part of the NIH’s Researching COVID-19 to Enhance Recovery (RECOVER) Initiative, say the current health care system isn’t set up to help people with long COVID. 

There are no best practices for clinical care of long COVID, nor is there a coordinated national effort to develop such practices.

“Long COVID sufferers must navigate health care resources on their own,” write the collaborators in their call to action. “Many don’t know where to go or whom to call.”

The investigators are calling for $37.5 million from Congress to establish a network of long COVID care centers to study the condition, educate other providers, reach out to people with long COVID, and help coordinate their treatment.

The RECOVER program has also drawn fire for planned studies on exercise therapy, reports Rachel Fairbank at Nature.

Patient advocates note that many people with long COVID have symptoms that are exacerbated by exercise, so the study could put them at risk.

“In a world where there’s hundreds of things to trial, why are we choosing this one thing that we know has the potential to cause harm to a substantial portion of patients?” asked Lisa McCorkell, co-founder of the Patient-Led Research Collaborative advocacy group.

Advocates asked the NIH to release the exercise study’s rationale and protocol, and invite public commentary, before proceeding. They also urged researcher to screen out patients whose symptoms are likely to get worse after exertion.

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WASHINGTON (AP) — The Food and Drug Administration on Thursday ordered the immediate market withdrawal of a drug intended to prevent premature births, which has remained available for years despite data showing it doesn’t help pregnant women.

The decision follows repeated efforts by Swiss drugmaker Covis Pharma to keep Makena on the U.S. market while it conducted additional studies. The medication was the only drug approved in the U.S. to help reduce the risk of early births in women with a history of preterm deliveries.

In recent months, Covis finally bowed to FDA pressure, proposing a “winding down” period of several months so that women taking the drug could complete their treatment. The FDA rejected that and said Thursday that the action against Makena and several generic versions should take effect immediately.

“Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce,” the agency said in a statement.

The injectable drug is a synthetic version of the hormone progesterone, which helps the uterus sustain pregnancy. It can cause side effects, including blood clots, depression and allergic reactions. Given those risks, FDA staffers previously concluded there was no upside to keeping the drug available, given its lack of confirmed benefit.

The final decision by FDA Commissioner Robert Califf and the agency’s chief scientist marks the first time the agency formally forced the removal of a drug that it initially approved based on promising early data. In all prior cases, drugmakers voluntarily pulled medications after the FDA made clear it intended to order removal.

The FDA expedited Makena’s approval in 2011 based on a small study suggesting it reduced rates of premature birth in women who had previously had trouble bringing a pregnancy to term. But results from a 1,700-participant study completed in late 2018 showed the drug neither reduced premature births — as originally thought — nor resulted in healthier outcomes for babies.

The FDA has been working to get the drug off the market since then, though Covis repeatedly appealed for more time to conduct further research.

In October, the company failed to convince a panel of outside FDA advisers that the drug should stay on the market for women who face higher risks of early deliveries, including Black women.

About 10% of U.S. births come too early — before 37 weeks, raising the risk of serious health problems and even death in infants.

“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes,” Califf said in a statement Thursday. Women who have a current prescription for the drug should direct any questions to their doctor, the agency said.

The FDA has faced pressure to crack down on unproven drugs cleared under its accelerated approval program, which since the early 1990s has allowed dozens of drugs to launch based on early results.

The flipside of the program means removing drugs if their initial promise isn’t confirmed by later studies. Researchers and government watchdogs have chronicled problems with FDA’s oversight, including delays in quickly removing drugs with failed or missing confirmatory studies. In the last two years the FDA has stepped up efforts to remove unproven approvals, mainly from cancer therapies.

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