WASHINGTON (AP) — The U.S. approved the first vaccine for RSV on Wednesday, shots to protect older adults against a respiratory virus that’s most notorious for attacking babies but endangers their grandparents, too.

The Food and Drug Administration decision makes GSK’s shot, called Arexvy, the first of several potential vaccines in the pipeline for RSV to be licensed anywhere.

The move sets the stage for adults 60 and older to get vaccinated this fall — but first, the Centers for Disease Control and Prevention must decide if every senior really needs RSV protection or only those considered at high risk from the respiratory syncytial virus. CDC’s advisers will debate that question in June.

After decades of failure in the quest for an RSV vaccine, doctors are anxious to finally have something to offer — especially after a virus surge that strained hospitals last fall.

“This is a great first step … to protect older persons from serious RSV disease,” said Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases, who wasn’t involved with its development. Next, “we’re going to be working our way down the age ladder” for what’s expected to be a string of new protections.

The FDA is considering competitor Pfizer’s similar vaccine for older adults. Pfizer also is seeking approval to vaccinate pregnant women, so their babies are born with some of mom’s protection.

There isn’t a vaccine for kids yet but high-risk infants often get monthly doses of a protective drug during RSV season — and European regulators recently approved the first one-dose option. The FDA also is considering whether to approve Sanofi and AstraZeneca’s one-shot medicine.

“This is a very exciting time with multiple potential RSV solutions coming out after years of really nothing,” said Dr. Phil Dormitzer, chief of vaccine research and development for GSK, formerly known as GlaxoSmithKline.

RSV is a cold-like nuisance for most people but it can be life-threatening for the very young, the elderly and people with certain high-risk health problems. It can impede babies’ breathing by inflaming their tiny airways, or creep deep into seniors’ lungs to cause pneumonia.

In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year and several hundred die. Among older adults, as many as 177,000 are hospitalized with RSV and up to 14,000 die annually.

Why has it taken so long to come up with a vaccine? The field suffered a major setback in the 1960s when an experimental shot worsened infections in children. Scientists finally figured out a better way to develop these vaccines — although modern candidates still were first tested with adults.

GSK’s new vaccine for older adults trains the immune system to recognize a protein on RSV’s surface, and contains an ingredient called an adjuvant to further rev up that immune reaction.

In an international study of about 25,000 people 60 and older, one dose of the vaccine was nearly 83% effective at preventing RSV lung infections, and reduced the risk of severe infections by 94%.

To see how long protection lasts, GSK is tracking study participants for three years, comparing some who get just one vaccination during that time and others given a yearly booster.

Shot reactions were typical of vaccinations, such as muscle pain and fatigue.

There was a hint of a rare but serious risk — one case of Guillain-Barre syndrome, which can cause usually temporary paralysis, and two cases of a type of brain and spinal cord inflammation. The FDA said it was requiring the company to continue studying if there really is a link to the vaccine.

If the CDC ultimately recommends the vaccination for some or even all seniors, it will add another shot for the fall along with their yearly flu vaccine – and maybe another COVID-19 booster.

“We’ll have to educate the population that this virus that not everyone has heard about is actually an important threat to their health in the wintertime,” said Schaffner, an infectious disease expert at Vanderbilt University. ___

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

Latino teens take the lead in vaccine education

Community health groups are deputizing teenagers to get the word out about COVID vaccines and testing, reports Heidi de Marco at Kaiser Health News.

“Teenagers communicate differently, and they get a great response,” said Sandra Celedon, CEO of Fresno Building Healthy Communities, a nonprofit that helped design an internship program. “During outreach events, people naturally want to talk to the young person.”

More than 84% of Latino and Hispanic adults have completed the primary vaccine series, but fewer than 13% have received the updated bivalent booster, according to CDC data. And de Marco reports that vaccine hesitancy and mistrust remain a challenge in some communities,  particularly for those who speak Spanish at home.

Spanish-speaking advocates and promotoras — non-licensed community health workers that help people access health resources and make good choices — are particularly effective in Latino communities.

Many of the teens in Fresno’s Promotoritos health worker program are children of immigrants, refugees, or immigrants without legal status.

The internships also expose the Hispanic and Latino students to health care career options, where their demographic is underrepresented among physicians, de Marco notes.

FDA advisors look to simpler vaccinations for the future

The FDA is ready to move COVID vaccinations to a flu-like model, in which the agency would release a single booster shot each fall, based on its best guess at what variants will be circulating in winter.

The agency convened its vaccine advisory committee Jan. 26 to discuss the potential shift and the questions it raises.

A key question for the committee was whether the agency should simplify the nation’s vaccine offerings.

Currently, people who get the primary series receive original-formula vaccines, which were designed to match the coronavirus strain that emerged in Wuhan more than three years ago. This fall’s booster, in contrast, is a mix of that vaccine plus one tailored to the omicron strain.

Committee member Dr. David Kim, who directs the Department of Health and Human Services’ National Vaccine Program, noted that the current situation has forced pharmacists and physicians to rely on complex diagrams and flow charts just to pick out the right vial for each patient.

The committee unanimously voted that the FDA should simplify the process by dropping the old vaccine formula and using the current bivalent shot for all vaccinations going forward.

“Bivalent is better, simple is better,” said temporary voting member Dr. Mark Sawyer of UC San Diego.

It’s not clear exactly when the change will take place.

The real-world value of the current bivalent shots remains uncertain, notes Keren Landman, who lays out the latest evidence at Vox.

Experts say it’s not feasible to chase after a vaccine for every new variant, but that improvements to the vaccine over time are still possible.

The FDA floated the idea of picking a new vaccine formula every June, which would give Pfizer and Moderna time to produce new mRNA vaccines by September. Releasing vaccines in early fall would, theoretically, allow the populace to be vaccinated and ready for a winter surge.

But Novavax, which makes a protein-based vaccine, said it would need six months to reformulate its product for a fall campaign. Several committee members urged the FDA not to overlook Novavax, which claims its shots provide broader immunity to variants than the mRNA vaccines.

Committee members also cautioned that the coronavirus is not influenza, and that copying the vaccine design process and schedule from the flu may not be the most appropriate strategy.

Other experts have noted that the coronavirus has yet to settle into a clear seasonal schedule like flu, and that there’s not enough evidence to assume one annual shot is the way to go, as reports Cecelia Smith-Schoenwalder at U.S. News & World Report.

The advisory committee also questioned what the goal of annual vaccination campaigns would be: Are we trying to prevent transmission, severe infection, or deaths?

“The goal is to keep people out of the hospital,” said committee member Dr. Paul Offit of the Children’s Hospital of Philadelphia. Current vaccines, he said, already do that.

Offit echoed his colleagues’ comments when he said the committee needs more data on who’s still dying from the coronavirus to decide “who gets vaccinated, with what, and when.”

Emergency room visits for all three “tripledemic” viruses have declined. CDC

Tripledemic appears to be waning

Americans can breathe easier as COVID, flu, and RSV all seem to be declining. 

“Early waves of respiratory syncytial virus and influenza peaked before the new year,” writes Fenit Nirappil at The Washington Post. “And the expected winter uptick of coronavirus is nowhere close to overwhelming hospitals.”

While it’s difficult to track all infections, a new CDC data dashboard indicates that emergency room visits for all three viruses are at the lowest level in three months, reports Deirdre McPhillips at CNN.

“Being able to look at the proportion of individuals that seek care at an emergency department for these respiratory illness concerns is a really good measure of the respiratory disease season,” said Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.

But winter isn’t over. “Whether that pattern will hold is still up in the air,” warns McPhillips. Respiratory virus activity remains higher than normal in most parts of the U.S. And in some years the flu has a second winter peak.

The CDC currently lists fewer than 4% of U.S. communities at the “high” level of COVID community transmission, but the highly contagious XBB.1.5 variant continues to spread. That variant now makes up more than half of the nation’s variant pool. And less than 16% of the population is up to date on their COVID vaccines.

 Evusheld is out as COVID prophylactic

The FDA has removed authorization for the antibody combination known as Evusheld, which was previously used to protect immunocompromised people who were unable to generate sufficient antibodies after vaccination on their own.

In response, the CDC has urged people with weak immune systems to wear masks and social distance, reports Spencer Kimball at CNBC.

The move was not unexpected, given the Evusheld antibodies are no longer a good match for the most prevalent strains of the coronavirus. 

“Still, the withdrawal amounts to another blow to the nation’s toolkit for fighting the coronavirus,” writes Andrew Joseph at STAT. “The virus’s evolution has also left the country without any antibody therapies for patients once they’re infected.”

Antivirals such as Paxlovid are still an option.

The FDA advised clinics to hold onto Evusheld supplies in case it proves useful against some future variant.

Drugmakers are working on updated antibody treatments. Evusheld provider AstraZeneca says that if all goes well in its trials, a new prophylactic that works against a broader range of variants could be available later this year.

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COVID-19 vaccines tweaked to better match today’s omicron threat are expected to roll out in a few weeks but still up in the air is how much benefit the booster shots will offer, who should get one — and how soon.

Pfizer and rival Moderna both asked U.S. regulators this week to authorize modified versions of their booster vaccine — shots that are half the original recipe and half protection against BA.4 and BA.5, the newest versions of omicron.

The Food and Drug Administration ordered that recipe and now is evaluating what scientists call a “bivalent vaccine,” with a decision expected soon.

Dr. Peter Marks, the FDA’s vaccine chief, said Thursday that once authorized, the tweaked boosters could help right away — while BA.5 infections still are too high — as well as hopefully blunt yet another winter surge.

Marks told the Associated Press that the new boosters could rev up the immune system to prevent not just serious illness but maybe milder infections, too, like the original vaccines did earlier in the pandemic, before super-contagious mutants emerged.

“The hope here is that by better matching things, not only will we get that benefit or even more, but we’ll also have that last for a longer period of time,” he said.

WHY DID FDA ORDER A RECIPE CHANGE?

BA.5 currently is causing nearly all COVID-19 infections in the U.S. and much of the world. Current COVID-19 vaccines match the coronavirus strain that circulated in early 2020. And while those vaccinations still offer strong protection against serious illness or death from COVID-19, there’s little effectiveness against infection from the wildly mutated omicron family.

The first update to the recipe is an an important but expected next step — like how flu vaccines get updated every year. True next-generation vaccines are still in development.

“We need to give a clear, forward-looking set of expectations,” said University of Pennsylvania immunologist E. John Wherry, who compares vaccine tweaks to periodically updating your computer software.

The gamble is that BA.5, or something similar, still will be circulating through the winter. (Vaccines target the spike protein that coat the coronavirus, and the BA.4 and BA.5 spikes are identical although those strains vary in other ways.)

HOW WERE THE MODIFIED SHOTS TESTED?

Pfizer and Moderna both studied an earlier tweak to their vaccines that targets the original omicron, called BA.1, that hit last winter, as well as even earlier variants.

To evaluate the combo shots, FDA is using data from human testing of the BA.1-tweaked doses plus mice tests of the BA.5-targeted version that Marks said show “a very good immune response.”

Human data on the newest tweak will come later in the year, to help assess the value of modified shots — especially whether they offer cross-protection if a new mutant comes along, Marks said. Moderna has started a clinical trial of its BA.5 combo shot; Pfizer and its partner BioNTech expect to open a similar study soon.

WILL THEY WORK BETTER?

No one knows. Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia and an FDA vaccine adviser, said the antibody jump from that earlier BA.1-tweaked candidate was “underwhelming.”

“What the administration is asking us to do is to accept this bivalent vaccine as significantly better” than another dose of today’s vaccine, he said. “It would be nice if there were data to support that.”

But while FDA hasn’t made a final decision, Marks said there’s evidence that the updated boosters are safe and that waiting for more study of their effectiveness would risk another mutant appearing before they could roll out.

They “essentially refresh the immune response,” he said. “Granted, it’s still a bit of a guess how long it will last but, this is doing our best.”

Given how outdated the current shots are, an update makes sense, said Dr. Walter Orenstein of Emory University, a former vaccine director at the Centers for Disease Control and Prevention. While he’d like to see more data, he plans to get the new booster.

WHO SHOULD GET AN UPDATED SHOT?

That’s up to the CDC, which called a meeting of its influential vaccine advisers next Thursday and Friday to help decide.

Pfizer wants to open its updated boosters to everyone 12 and older who’s already had a primary series of today’s vaccine, while Moderna has applied only for adult use. CDC will determine if people at highest risk should go first. Studies of doses for younger children are expected later in the year.

A government rollout plan anticipates that people who’ve already gotten their initial vaccinations would qualify for one of the new combination shots, regardless of how many boosters they’ve already had.

WHEN SHOULD THOSE ELIGIBLE GET THE NEW BOOSTER?

Marks is aiming for a very simple message: “It’s probably going to be everyone who has not had a booster within the past X number of months should go out and get the booster in a timely manner,” he said. Officials still have to decide just how many months, though.

How long to wait after your last vaccine dose or an infection is a critical decision, immunologists agree. That’s because if you still have a lot of antibodies in your bloodstream, they’ll counteract the brand new antibodies that the vaccine dose is supposed to produce.

So if you already got a booster in July or August and then seek the new combo shot in September, “you’ll receive very little additional boosting from that,” Penn’s Wherry said. He recommends waiting four to six months.

The CDC also will weigh in after after considering how many doses will be available in early September versus later in the fall. The Biden administration has purchased more than 170 million doses.

WILL PEOPLE ROLL UP THEIR SLEEVES AGAIN?

Americans have been reluctant to keep up with COVID-19 vaccinations. While three-quarters of Americans 12 and older have gotten their initial vaccinations, only half got a first booster shot — deemed crucial for the best protection against variants. And just a third of people 50 and older who were advised to get a second booster when omicron arrived did so.

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WASHINGTON (AP) — After weeks of delays, nearly 800,000 doses of the monkeypox vaccine will soon be available for distribution, U.S. health regulators said Wednesday.

The announcement comes amid growing criticism that authorities have been too slow in deploying the vaccine, potentially missing the window to contain what could soon become an entrenched infectious disease.

Nearly two weeks ago, the Food and Drug Administration said it had finished the necessary inspections at Bavarian Nordic’s facility in Denmark, where the company fills vials of the vaccine. The FDA said via Twitter on Wednesday that the certification had been finalized. The doses are already in the U.S. “so that they would be ready to be distributed once the manufacturing changes were approved,” the agency said.

The U.S. already has sent more than 310,000 doses of the two-shot Jynneos vaccine to state and local health departments. But clinics in San Francisco, New York and other major cities say they still don’t have enough shots to meet demand.

There were more than 4,600 reported monkeypox cases in the U.S. as of late Wednesday, according to the Centers for Disease Control and Prevention. The head of the U.S. Department of Health and Human Services said Wednesday officials would announce more vaccine allocations on Thursday.

Officials at the San Francisco Department of Health welcomed the news, saying they need many thousands more vaccine doses than the 7,800 they have received to date. “Without enough vaccine supply, we would have trouble fulfilling our basic duty of keeping our communities safe,” the agency said in a statement.

Washington, D.C., officials said Wednesday they would join their counterparts in San Francisco, New York City and other cities who have stopped offering appointments for second vaccine doses due to short supplies. They said the single-dose strategy would allow them to “vaccinate more people at risk and slow the spread of monkeypox in the community more quickly.”

The monkeypox virus mainly spreads through skin-on-skin contact, but it can also transmit through touching linens used by someone with the infection. The vast majority of cases reported have been in men who have sex with men, though health officials have stressed that anyone can catch the virus.

People with monkeypox may experience fever, body aches, chills and fatigue. Many in the outbreak have developed zit-like bumps on many parts of the body.

The sluggish federal response has drawn comparisons to the initial days of the COVID-19 outbreak, but experts have pointed out that the U.S. had one huge advantage: more than 1 million doses of vaccine in the strategic national stockpile.

But it turned out U.S. officials had only about 2,000 doses on hand when the outbreak was first identified in May. Shipping and regulatory delays have meant only a portion of the rest were deployed.

“There’s not enough doses,” said Dr. Perry Halkitis, a public health specialist at Rutgers University. “I think with some quicker action on the part of federal government we might not be in the situation we are now.”

The doses previously shipped came from a separate facility in Denmark that already had FDA clearance. Another 786,000 doses made at a newly opened Bavarian Nordic facility were awaiting the U.S. certification announced Wednesday.

The FDA requires inspections of all vaccine manufacturing plants to assure safety, sterility and consistency of production.

U.S. officials announced orders this month for 5 million more doses, though most of those are not expected to arrive until next year

Officials have recommended the shots be given to people who know or suspect they were exposed to monkeypox in the previous two weeks.

The Jynneos vaccine has never been widely used in response to an outbreak like this, and the government will track how well it’s working.

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It was while picking my 2-year-old’s pancakes from my 4-year-old’s hair last week that I got the email: After two days in school since our last quarantine, my daughter’s preschool class was in quarantine again.

Omicron has thrown everyone. It’s thrown medical professionals. It’s thrown politicians. And it’s thrown parents of children under 5 back to March 2020, when we were expected to work full-time jobs while quarantining toddlers. Now we’re doing it again. Unless the childcare quarantine rules change, we’ll keep doing it, a week at a time, again and again.

This whiplash is due to health guidance requiring unvaccinated people to quarantine following any COVID exposure. Because preschool- and day care-age kids are mostly ineligible for vaccines, this means that anytime one of the 27 students and staff in my daughter’s preschool class or the dozen children and staff in my son’s day care tests positive, my kid must quarantine for a week.

Given that approximately 1 in 10 Bay Area residents had an asymptomatic COVID infection at the height of the surge, and our preschool tests students twice weekly, it is no wonder my daughter was in preschool 10 days of the last four weeks.

It doesn’t have to be this way. It isn’t this way for school-aged kids. California and the CDC allow unvaccinated children to stay in school after an in-school exposure if the students were masked and the exposed student is asymptomatic and tested. Bay Area jurisdictions have embraced that policy despite the Omicron surge, insisting schools stay open.

Why is childcare treated differently? It can’t be vaccination eligibility, as the K-12 rules apply to unvaccinated students. It can’t be risk of severe disease, as children under 5 have very low risk of COVID hospitalization, like their school-aged counterparts. It can’t be masking rules, as the child care quarantine-at-home rule applies regardless of a child care center’s masking policy. (In my daughter’s preschool class, where mask compliance is high, not one exposed child has tested positive during any quarantine this year.)

I suspect part of the rationale for treating child care and school differently may be that K-12 students risk formal education loss if quarantined at home. But that minimizes the social and emotional learning that younger children do in childcare settings — learning that prepares them for elementary school and beyond. If you think early-learning experiences aren’t important to kids, I’ll put you on speakerphone the next time my son talks about doing the party freeze dance with Zoe and Nicco.

Such distinctions between child care and school also miss the parents’ perspective. It’s hard to overstate how difficult it is to work while caring for someone whose favorite game is called “one, two, three, KABOOM!” Many of my friends with small kids now wonder — again — if they should quit their jobs. We’re told this isn’t March 2020, but it can sure feel like it.

I don’t doubt the seriousness of this surge or COVID restrictions generally. But this policy just doesn’t seem right. Not when vaccines are widely available, and therapeutics help the most vulnerable. For Pete’s sake, we now allow young children to attend NBA games where, if even 1 in 40 attendees has COVID, a child has a greater than 25% chance that someone within a two-seat radius of them is infected. And yet, we don’t allow parents to send children to day care if one since-removed child tested positive.

To be sure, some parents will not send their child back to child care after an in-school exposure. But let that be our decision, based on our circumstances. We can’t keep doing this.

Cynthia Stein, of Oakland, is an attorney and mother of two kids under 5 years old.

CYNTHIA STEIN | Contributed

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Mt. San Jacinto College Superintendent/President Dr. Roger Schultz addressed CalRTA Division 33 members at their February 8th general meeting and shared the extensive growth and improvements made since 2001 when he first joined MSJC as a Vice President of Student Services. Schultz now oversees approximately 24,000 students at four MSCJ campuses in its 1,700-square-mile district, including the San Jacinto, Menifee Valley, San Gorgonio Pass, and Temecula Valley campuses. In the fall of 2022, a new Beaumont Middle College High School campus is due to launch under a partnership between Mt. San Jacinto College and the Beaumont Unified School District.

Schultz shared MSJC’s record-breaking graduation statistics, upward trends, and future construction plans, including STEM (science, technology, engineering, math) buildings and an Animated Makerspace (animatronics) for the Menifee Valley and San Jacinto campuses as well as a Kinesiology and Athletics Complex – including a new 5000 seat stadium – at the Menifee campus. Schultz also touted MSJC’s Mobile Career Center, numerous career education programs, Criminal Justice Lab, top-notch nursing program, and its “MSJC Promise” program, which provides qualifying first-time, full-time students with free tuition.

Those who attended the presentation were quick to share their amazement at the many changes to the once-small MSJC district. Long-time CalRTA member Mary Daniel stated, “I went to my first class at MSJC back in 1963. This school is a wonderful asset for the kids in our local communities.” Division 33 Board member Elizabeth Midyett was impressed that students in the nursing program were able to use their skills to assist during the COVID crisis, while Board Member at Large Tim Mathos shared that he “never realized just how large the MSJC system was in terms of serving so many traditionally underrepresented students, and the heroic efforts the faculty and staff have put forth to make the college experience accessible to all students, regardless of previous academic struggles.” Division 33 President Gayle Mattson was most impressed with MSJC’s tremendous expansion, partnerships with high schools and Cal State sites, and the incredible advances to our “once small community college.” CalRTA member Sherri Domenigoni, who is also an MSJC Ambassador, alum and recent past president for the MSJC Foundation, said, “Dr. Schultz’s presentation on the growth of MSJC was truly amazing! With four campuses now, MSJC is truly a community-changing jewel, serving thousands. It has changed countless lives for the better, including mine!” With these changes, and more on the horizon, the future certainly looks bright for higher education in our region!

Sue Breyer, CalRTA Division 33 Vice President

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This is the first time that Medicare has covered an over-the-counter test at no cost to beneficiaries. There are a number of issues that have made it difficult to cover and pay for over-the-counter COVID-19 tests. However, given the importance of expanding access to testing, CMS has identified a pathway that will expand access to free over-the-counter testing for Medicare beneficiaries. This new initiative will enable payment from Medicare directly to participating pharmacies and other participating entities to allow Medicare beneficiaries to pick up tests at no cost. CMS anticipates that this option will be available to people with Medicare in the early spring.

Until then, people with Medicare can access free tests through a number of channels established by the Biden-Harris Administration. Medicare beneficiaries can:

Request four free over-the-counter tests for home delivery at covidtests.gov. Access COVID-19 tests through healthcare providers at over 20,000 free testing sites nationwide. A list of community-based testing sites can be found here. Access lab-based PCR tests and antigen tests performed by a laboratory when the test is ordered by a physician, non-physician practitioner, pharmacist, or other authorized health care professional at no cost. In addition to accessing a COVID-19 lab test ordered by a health care professional, people with Medicare can also already access one lab-performed test without an order, also without cost sharing, during the public health emergency.

In addition:

Medicare Advantage plans may offer coverage and payment for over-the-counter COVID-19 tests as a supplemental benefit in addition to covering Medicare Part A and Part B benefits, so Medicare beneficiaries covered by Medicare Advantage should check with their plan to see if it includes such a benefit. All Medicare beneficiaries with Part B are eligible for the new benefit, whether enrolled in a Medicare Advantage plan or not.

For more information, please see these Frequently Asked Questions, https://www.cms.gov/files/document/covid-19-over-counter-otc-tests-medicare-frequently-asked-questions.pdf (PDF)

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By Amber Dance

COVID is devastating Black oral history

People of color are at least twice as likely to die of COVID as white people. In the Black community, the loss of so many lives also means the loss of oral history, as Janell Ross writes at Time.

“As we mark Black History Month, we know that a crucial part of that history has, in these last few years, been lost,” Ross writes. “Eyewitness accounts of the civil rights movement go un-gathered. Recipes passed down through the generations but never written down will never be cooked again.”

And the Black midwives she focuses on won’t be able to learn about post-birth rituals from their elders.

Oral history is essential to Black communities, tracing back to the time when Black people were not allowed to read or write, Ross explains.

“Oral history can tell us things that written records often cannot,” said Kelly Elaine Navies of the Smithsonian’s National Museum of African American History and Culture. “Not just when something happened or that someone was at a certain place but how did they feel about it?”

FDA seeks to speed up vaccination of youngest children

The FDA wants vaccines for younger children, and it wants them ASAP. In a move that’s been described as “highly unusual,” “extraordinary” and “bizarre,” the agency asked Pfizer to request emergency authorization for its two-dose protocol for children younger than 5 — even though the trial didn’t meet its goal for robust antibody production the 2 to 5 age group. 

Pfizer’s original plan, back in December, was to try a third dose in those children to boost immunity, with data expected in late March.

The new plan is to authorize two shots now, with the assumption that a third will be necessary, effective and authorized shortly after the trial data arrives.

What’s changed? Omicron, an FDA spokesperson told STAT’s Helen Branswell.

More than 3.5 million children tested positive for COVID in January, according to the American Academy of Pediatrics.

Omicron also tends to settle in the upper respiratory tract, causing mucus and swelling to clog kids’ smaller windpipes, leading to wheezing and croup, reports Marla Broadfoot at Scientific American.

But all those cases might have made it easier and faster for Pfizer to collect data on the vaccine’s real-world efficacy in kids who fell ill.

“Maybe Pfizer found that fewer kids among those who received the actual vaccine in the trial were getting infected or sickened by the virus,” speculates Katherine J. Wu at The Atlantic.

We don’t know yet, because the data have not yet been made public. But an anonymous source told The New York Times that efficacy against infection was 50% for children between 6 months and 2 years old, and 57% for children between 2 and 4. This was based on fewer than 100 symptomatic cases total in the study, add Times reporters Sharon LaFraniere and Noah Weiland.

The FDA’s vaccine advisory committee will meet Feb. 15. Thus far, the committee has been conservative about giving the nod to vaccines without strong evidence of benefits outweighing risks.

Side effects from Pfizer’s two-dose study in this age group, such as fever and chills, were generally mild and comparable to those of other childhood vaccines.

Dr. Paul Offit, a member of the vaccine committee, told Kristina Fiore at MedPage Today that the group will want to see “clear evidence” that two doses provide protection. “We wouldn’t say yes on the promise that three doses [will be] of value.”

But the plan has potential to backfire if parents think the vaccine was rushed through without all the proper testing. Parents are already skeptical about vaccinating their children.

Vaccine uptake in older kids has been lackluster. Only one-third of parents say their 5-to-11-year-olds have had at least one shot, according to the latest data from the Kaiser Family Foundation Vaccine Monitor, and Pfizer’s vaccine has been authorized for that age group since November. And 31% of parents of children younger than 5 said they’d schedule a vaccination as soon as possible. (That was before this authorize-first, data-later plan was on the table, though.)

“The FDA must be crystal clear and leave no gaps or uncertainties,” wrote the Editorial Board of The Washington Post. “A vaccine should never be a shot in the dark.”

The story of kids’ vaccines overshadowed other vaccine news last week: Moderna’s vaccine, Spikevax, is now fully approved for adults, though still delayed for teens and younger children while the agency assesses risk of myocarditis.

And Novavax, after its own series of delays, has now officially requested emergency authorization — only for adults at the moment, though trials in children are underway.

Spotify mired in misinformation mess

Musician Neil Young headlines a growing list of artists and podcast hosts departing Spotify’s streaming service over the COVID misinformation aired by the platform’s Joe Rogan podcast.

Among the claims made on Rogan’s popular podcast: that a COVID vaccine will alter a person’s DNA, that ivermectin cures the disease, and that young people risk more from vaccination than COVID infection. None of those are true, notes BBC News’ Reality Check team.

But the misinformation out there has real effects; Adrianna Rodriguez at USA Today reports that hundreds of doctors are still prescribing ivermectin for COVID. And according to a recent paper in JAMA, insurers are bearing the cost.

Reuters also landed in hot water last week when it mistakenly reported that a Japanese clinical trial found ivermectin works on COVID; the error was swiftly corrected.

In response to the outcry from the likes of Joni Mitchell and the Duke and Duchess of Sussex, not to mention hundreds of medical experts, Rogan says he’s “not trying to promote misinformation” and Spotify has promised to put a content warning, linking to factual information, on all podcasts that touch on COVID-19.

The creators of the “Science Vs.” podcast, also hosted by Spotify, called the lack of sanctions for Rogan’s program a “slap in the face.” They promised to focus all new episodes on debunking misinformation from Rogan and other Spotify hosts until the company makes bigger changes.

As Mathew Ingram explains at Columbia Journalism Review, the issue comes down to whether Spotify is a platform, with no remit to moderate or censor content, or a publisher that should selectively curate its content.

Other platforms-cum-publishers have come up against the similar issues with COVID misinformation, and there are big bucks at stake. Anti-vaccine newsletters hosted by Substack earn the company about $2.5 million annually, reports Kristina Fiore at MedPage Today. Rogan’s exclusive deal with Spotify is reportedly worth more than $100 million.

“In that sense, Spotify is his publisher,” writes Ingram.

It’s the financial stakes that complicate Spotify’s position as a platform, write Lauren Hirsch and Michael J. de la Merced in The New York Times. While other hubs like Facebook don’t pay people to post less-than-verifiable ideas, Spotify does. “To some,” the pair write, “that puts an extra onus on Spotify to act like a media company and take responsibility for content.”

And it seems like the company is taking some publisher-like responsibility: it was reported over the weekend that Spotify has quietly removed dozens of episodes of Rogan’s podcast over his past use of a racial slur.

Opinion writer Roxane Gay has also removed her podcast from Spotify. “Spotify does not exist in a vacuum, and the decisions it makes about what content it hosts have consequences,” she writes in The Times. “To say that maybe Mr. Rogan should not be given unfettered access to Spotify’s more than 400 million users is not censorship, as some have suggested. It is curation.”

White House, HHS Secretary under fire for pandemic response

A handful of articles last week criticized the federal government’s pandemic approach.

Steven Phillips, vice president of science and strategy for the COVID Collaborative, writes in Time that ongoing “chaos and conflict over the reopening of American institutions and commerce reflect the absence of a coherent national plan.” The first step, he suggested, was to set a clear definition of what “public safety” even means.

In The Washington Post, reporters Dan Diamond, Yasmeen Abutaleb and Tyler Pager take aim at Health and Human Services Secretary Xavier Becerra, who has been widely criticized for his job performance during the pandemic. Physician-scientist Eric Topol told the trio he’s been “like a ghost” during the pandemic. 

Unlike past HHS secretaries and other top officials in the COVID response, Becerra hasn’t appeared on any Sunday morning television programs, and the Association of Health Care Journalists complained in November that Becerra wasn’t making himself available for questioning during regular press briefings.

According to Post reporters, White House officials have never had a tight relationship with Becerra and his role in the pandemic response was never fully delineated.

“It is sometimes unclear who makes final decisions or is in charge of carrying out initiatives, with [White House COVID coordinator Jeff] Zients absorbing much of the portfolio that would have gone to an HHS secretary in previous administrations,” they write.

White House support for Becerra has reportedly diminished. Despite these criticisms, Biden is reportedly unlikely to fire anyone.

Meanwhile, Biden’s nominee to head the FDA, Dr. Robert Califf, has hit stumbling blocks in Congress. Senators have questions about his past record on abortion drugs, the opioid crisis, and his financial ties to the pharmaceutical industry.

Free COVID tests for Medicare beneficiaries coming soon

The Centers for Medicare and Medicaid Services announced last Thursday a promise to provide up to eight at-home rapid tests per month to people enrolled in Medicare.

The move closes an important gap because people with private insurance are already able to have the tests paid for or request reimbursement. The Medicare change is expected to come in spring.

Medicare doesn’t do reimbursement, but the upcoming plan will pay pharmacies directly for the tests, reports Joyce Frieden at MedPage Today.

Scientists deliberately exposed people to COVID

Researchers in the U.K. intentionally exposed 34 young, healthy adults to the coronavirus in an attempt to understand the course of disease from beginning to end.

Only half of the subjects got infected, and there was no serious illness.

The results, which have not yet been peer-reviewed, suggest that similar human-challenge trials can be done safely, perhaps to test vaccines and antiviral medicines, reports Ewen Callaway at Nature.

However, this trial did not test such interventions, leading some to question whether it was ethical to infect people just to learn about the disease process.

The study also found that people developed their first symptoms and tested positive by PCR within two days of exposure.

Subjects’ viral loads peaked around five days in, and antigen tests reliably identified when people were likely to be contagious, report Josephine Mason and Jennifer Rigby at Reuters.

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A couple of factors are at play, starting with the emergence of the highly contagious omicron variant. Omicron is more likely to infect people, even if it doesn’t make them very sick, and its surge coincided with the holiday travel season in many places.

People might mistakenly think the COVID-19 vaccines will completely block infection, but the shots are mainly designed to prevent severe illness, says Louis Mansky, a virus researcher at the University of Minnesota.

And the vaccines are still doing their job on that front, particularly for people who’ve gotten boosters.

Two doses of the Pfizer-BioNTech or Moderna vaccines or one dose of the Johnson & Johnson vaccine still offer strong protection against serious illness from omicron. While those initial doses aren’t very good at blocking omicron infection, boosters — particularly with the Pfizer and Moderna vaccines — rev up levels of the antibodies to help fend off infection.

Omicron appears to replicate much more efficiently than previous variants. And if infected people have high virus loads, there’s a greater likelihood they’ll pass it on to others, especially the unvaccinated. Vaccinated people who get the virus are more likely to have mild symptoms, if any, since the shots trigger multiple defenses in your immune system, making it much more difficult for omicron to slip past them all.

LAURA UNGAR | Contributed

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WASHINGTON (AP) — U.S. health regulators on Thursday authorized the second pill against COVID-19, providing another easy-to-use medication to battle the rising tide of omicron infections.

The Food and Drug Administration announcement on Merck’s molnupiravir comes one day after the agency cleared a competing drug from Pfizer.

Pfizer’s pill, Paxlovid, is likely to become the first-choice treatment against the virus, because of its superior benefits and milder side effects.

As a result, Merck’s pill is expected to have a lesser role against the pandemic than predicted just a few weeks ago. Its ability to head off severe COVID-19 is much smaller than initially announced and the drug label will warn of serious safety issues, including the potential for birth defects.

Both treatments will be free to patients in the U.S. after being purchased by the federal government.

The FDA authorized Merck’s drug for adults with a positive COVID-19 test, early symptoms and who face the highest risks of hospitalization, including older people and those with conditions like obesity and heart disease.

The agency said molnupiravir should be considered for patients “for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.” It did not include that restriction for Paxlovid, which was authorized for patients 12 and older.

Molnupiravir, made by Merck and Ridgeback Biotherapeutics, also will carry a warning against use during pregnancy. Women of childbearing age should use birth control during treatment and for a few days after while men should use birth control for at least three months after their final dose, the FDA said. The federal agency also said molnupiravir should not be used in patients under age 18 because it may affect bone growth.

Dr. Nick Kartsonis, Merck’s senior vice president of clinical research, said company scientists are still studying the drug and they hope to eventually get it approved for use in children.

The restrictions were expected after an FDA advisory panel only narrowly endorsed the drug last month, warning that its use would have to be strictly tailored to patients who can benefit the most.

Kartsonis said Merck researchers are “very comfortable” with their drug’s safety profile.

He also noted that molnupiravir has been studied in more than a thousand people, and researches saw side effects like diarrhea and nausea in only a small percentage of patients.

“The drug has actually looked very well tolerated,” he said.

Pfizer’s Paxlovid also comes with limitations. Regulators say doctors have to consider how it will interact with other medicines a patient may be taking, and they’ve noted it shouldn’t be prescribed to patients with severe liver or kidney problems.

Both treatments also should be started within five days of the beginning of symptoms, a deadline that puts pressure on patients to get tested and diagnosed quickly.

The two pills work differently and Pfizer’s doesn’t carry the same risks. Additionally, Pfizer’s drug was roughly three times more effective in testing, reducing hospitalization and death by nearly 90% among high-risk patients, compared with 30% for Merck’s.

Some experts question whether there will be much of a role for the Merck drug in the U.S.

“To the extent that there’s an ample supply of Pfizer’s pill, I think it won’t be used,” said Dr. Gregory Poland of the Mayo Clinic, referring to the Merck drug. “There would be no reason, given it has less efficacy and a higher risk of side effects.”

For now, the FDA decision provides another potential option against the virus that has killed more than 800,000 Americans, even as health officials brace for record-setting cases, hospitalizations and deaths driven by the omicron variant.

The seven-day rolling average for U.S. COVID-19 cases climbed past 160,000 Wednesday, according to data collected by Johns Hopkins University. That’s more than double the average in late November.

Antiviral pills like Merck’s and Pfizer’s are expected to be effective against omicron because they don’t target the spike protein where most of the variant’s worrisome mutations reside.

Researchers have warned that older COVID-19 treatments that are administered by IV are unlikely to work against the new strain.

The FDA based its Merck decision on results showing nearly 7% of patients taking the drug ended up in the hospital and one died at the end of 30 days. That compared with 10% of patients hospitalized who were taking the placebo and nine deaths.

Merck says several hundred thousand treatment courses will be available in the U.S. in the next several days and a million will be available over the next few weeks. The supply of Pfizer’s drug is more limited before ramping up in 2022.

The U.S. will pay about $700 for each course of Merck’s drug, which requires patients to take four pills twice a day for five days. A review by Harvard University and King’s College London estimated it costs about $18 to make each 40-pill course of treatment.

Merck’s drug inserts tiny errors into the coronavirus’ genetic code to slow its reproduction. That genetic effect has raised concerns that the drug could cause mutations in human fetuses and even spur more virulent strains of the virus. But FDA scientists said the variant risk is largely theoretical because people take the drug for such a short period of time.

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