Health Minister Issues Caution as New COVID Strain Detected Across Australia
A new branch of the COVID-19 Omicron variant has been detected in several Australian states, driving an increase in diagnoses of the disease.
The discovery has prompted Health Minister Mark Butler to call for Australians to take up the COVID-19 vaccine or boosters, while saying there was no evidence the variant would need to be handled any differently to those before it.
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New York Post
4 hours ago
- New York Post
FDA approves Moderna's next-generation COVID vaccine for adults 65 or older
The US Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the regulator tightened requirements. The vaccine has also been approved for people aged 12 to 64 with at least one or more underlying risk factors defined by the Centers for Disease Control and Prevention, Moderna said in a statement. The company said it expects to have the vaccine, called mNEXSPIKE, available for the 2025-2026 respiratory virus season. Advertisement 4 The FDA has approved Moderna's next-generation COVID-19 vaccine for people older than 65. REUTERS 'The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,' CEO Stephane Bancel said in the statement. The Department of Health and Human Services, under the leadership of long-time vaccine skeptic Robert F. Kennedy Jr., is tightening regulatory scrutiny on vaccines. Advertisement The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval, effectively limiting them to older adults and those at risk of developing severe illness. The Moderna vaccine can be stored in refrigerators rather than freezers, to offer longer shelf life and make distribution easier, especially in developing countries where supply-chain issues could hamper vaccination drives. The Centers for Disease Control and Prevention, which Kennedy also oversees, said on Thursday that COVID vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Kennedy's announcement days earlier that the agency would remove the shots from its immunization schedule. The CDC announcement eases investor concern to some extent, analysts say, as it keeps the existing framework for older adults and at-risk people who generally seek out the shots. Advertisement 4 The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval. REUTERS FDA leaders have said 100 million to 200 million Americans would still be eligible for annual shots. Moderna is betting on its newer messenger RNA vaccines as it grapples with waning demand for its original COVID vaccine Spikevax and lower-than-expected uptake of its respiratory syncytial virus vaccine. The approval for mNEXSPIKE was based on late-stage trial data, which showed the shot was not inferior in efficacy compared to Spikevax in individuals aged 12 years and older. Advertisement 4 Department of Health and Human Services secretary Robert F. Kennedy Jr. is tightening regulatory scrutiny on vaccines. Getty Images The shot also showed superior efficacy compared to Spikevax in adults 18 years of age and older in the study. Kennedy has kickstarted a major overhaul of health departments, laying off thousands of employees to align with President Donald Trump's goal of dramatically shrinking the federal government. This has further ignited worries about potential disruptions to the regulatory review of treatments and vaccines. 4 Moderna's COVID-19 shots are mRNA-based. dpa/picture alliance via Getty Images The CDC's outside panel of vaccine experts in April discussed recommending the booster shots only for populations at risk of severe COVID-19 for the upcoming immunization campaign. The FDA approved Novavax's COVID vaccine Nuvaxovid this month, limiting its use to older adults and people over the age of 12 with conditions that put them at risk due to the illness. Conditions that constitute additional risk range from illnesses such as diabetes and heart disease to behaviors like physical inactivity and substance abuse, according to the CDC. Advertisement While Moderna's shots, as well as Pfizer-BioNTech's Comirnaty, are mRNA-based, Novavax's vaccine is protein-based and takes longer to manufacture. Moderna this month withdrew an application seeking approval for its flu-and-COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot.
Yahoo
10 hours ago
- Yahoo
Charges dropped against Spokane dermatologist accused of COVID fraud
May 30—Charges of fraud related to federal COVID relief were dropped Friday against Spokane dermatologist Dr. William "Phil" Werschler. Between 2020 and 2022, Werschler's businesses received more than $2.9 million in federal CARES Act loans meant for struggling small businesses. The 23-count indictment filed last year alleged Werschler used $1.5 million of those dollars to purchase luxury vehicles and other items. On Friday, the charges were dropped with prejudice — meaning they cannot be filed again. Werschler also agreed to pay a $1.4 million settlement with the federal government as part of the deal to avoid a civil penalty. The Spokane dermatologist admitted to no wrongdoing as part of the settlement agreement. Lawyer Ronald Van Wert said the dismissal of such federal charges is "extraordinarily rare" and evidence of his innocence. Van Wert said the problems were the fault of an employee in Werschler's office who pleaded guilty to embezzlement in 2023. "The nature of this dismissal is highly unusual and uncommon. And between our defense team, I don't think any one of us has seen a dismissal with prejudice of criminal charges brought by a federal indictment," he said. In a statement, U.S. Attorney's Office spokesperson Rob Curry said the case's resolution was "just and in the best interest of the public." "Today's settlement restores public funds that were misused during the course of the Covid-19 pandemic, while also recognizing mistakes made by Dr. Werschler and his companies. This global resolution balances a just outcome and need to protect public funds with the unique facts of this matter," he said. According to Van Wert, federal prosecutors were misled Carol Castilla, Werschler's former bookkeeper who pleaded guilty to embezzling more than $715,000 from Werschler's Spokane Dermatology Clinic. As part of that case, Castilla provided testimony and evidence Werschler embezzled COVID relief funds. Weschler's lawyers argue they proved Castilla's testimony was fraudulent, which ultimately led to criminal charges being dropped. "This bookkeeper had a number of texts and communications between her and the Werschlers. She took that information and manipulated and misrepresented those texts, and also the financial records and the timing of various types of transactions. From our perspective, we were able to demonstrate, through our own financial analysis and our own experts, where that was inconsistent," Van Wert said. While Werschler was not aware or participated in the improper use of COVID funds, he could have been found civilly liable as the employer of Casilla, Van Wert added. Spokane Dermatology Clinic has remained open since Werschler's indictment, and the dermatologist plans to continue his practice now. "This ordeal has been emotionally and professionally devastating for me, my wife, and our employees. We are extremely pleased to put it behind us, and grateful for the support of our friends and colleagues," Werschler said in a statement. "Our greatest concern remains for our valued patients as we have tried to reassure them this case has nothing to do with the healthcare they receive at Spokane Dermatology Clinic, and that justice would prevail. We are moving forward, continuing to provide excellent care to those who trust us with their healthcare needs."
Yahoo
12 hours ago
- Yahoo
CDC says healthy children may get COVID vaccine, contradicting RFK Jr.
May 30 (UPI) -- The Centers for Disease Control and Prevention now says children without underlying health conditions "may receive" a COVID-19 vaccine, contradicting a directive by Health and Human Services Secretary Robert F. Kennedy Jr. earlier in the week. The CDC updated the childhood immunization schedule published late Thursday. Kennedy, who said the agency would stop recommending the shots for healthy children, said the guidelines would be changed. Instead, the agency recommends vaccines based on "shared clinical decision-making," meaning children can get vaccinated if their parents and doctors agree. This will also require health insurance companies, Medicare and Medicaid plans to continue to cover the vaccines for children. "Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances," the new language said. HHS spokesman Andrew Nixon told The Washington Post in an email Friday: "The CDC and HHS encourage individuals to talk with their healthcare provider on any medical decisions. Under the leadership of Secretary Kennedy, HHS is restoring the doctor-patient relationship. If a parent desires their healthy child to be vaccinated or if a pregnant woman desires to be vaccinated, their decision should be based on informed consent through the clinical judgment of their healthcare provider." Kennedy didn't advise patients to consult doctors about the decision. The pediatrics association and the American College of Obstetricians and Gynecologists said Kennedy's Tuesday announcement undermined public trust in vaccination policy and understated COVID-19 dangers. The CDC didn't receive a directive to alter its recommendations until after Kennedy's video posted. "At least how some clinicians perceive it is, 'You guys are the experts, and if you don't know what the right thing to do is, how are we supposed to have that conversation in a 10-minute office visit?'" Sean O'Leary, chairman of the American Academy of Pediatrics' committee on infectious diseases, told The Washington Post. The shared clinical decision-making recommends COVID-19 vaccines for moderately or severely immunocompromised children, as well as most adults for now. COVID-19 vaccines during pregnancy are listed as "No Guidance/Not Applicable," where they were previously recommended for all pregnant adults. Kennedy said in his video announcement that healthy pregnant women were being removed from the immunization schedule for the COVID-19 vaccine. This contradicts what is on the CDC website. "Studies including hundreds of thousands of people around the world show that COVID-19 vaccination before and during pregnancy is safe, effective, and beneficial to both the pregnant woman and the baby," one CDC webpage still reads. "The benefits of receiving a COVID-19 vaccine outweigh any potential risks of vaccination during pregnancy." The CDC advisory committee at its last meeting in April said it didn't plan to lift the recommendation for pregnant women to get vaccinated. Citing "a review of the recommendations" of the Food and Drug Administration and National Institutes of Health, Kennedy's memo said that the risks of the COVID-19 vaccine for healthy children "do not outweigh the purported benefits of the vaccine." The directive also cited "the lack of high-quality data demonstrating safety of the mRNA vaccines during pregnancy combined with the uncertainty of the benefits" for pregnant women and their baby. Agency officials overseeing shot recommendations said they were surprised by Kennedy's move, CBS News reported. "As you might be aware, the HHS Secretary issued a directive to CDC to update COVID-19 vaccine recommendations on the child and adult immunization schedules. In accordance with that instruction, CDC last night posted updated versions," agency officials wrote in an email to staff Friday. Richard Hughes IV, who teaches vaccine law at George Washington University Law School, told The Washington Post the directives raise questions about federal health officials' approach. "They are running roughshod over processes when they are doing all this. They're just sort of trying to implement the biased positions that they came in with," Hughes, a former vice president of public policy at Moderna. "I don't think they thought it through a lot." This week, HHS notified Moderna that it was canceling contracts worth $766 million to develop, test and license vaccines for flu subtypes that could trigger future pandemics, including the dangerous H5N1 bird flu virus. Pfizer was the first COVID-19 vaccine to receive emergency approval in December 2020 and Moderna was followed one week later. The FDA first granted Pfizer-BioNTech full COVID-19 approval for those 12 and older in August 2021 and Moderna in January 2022. They remain available under emergency use authorization for children as young as 6 months. Earlier this month, the U.S. Food and Drug Administration approved Novavax's COVID-19 vaccine with age restrictions after a six-week delay. The agency approved the vaccine only for people 65 and older and those 12 and older with at least one underlying condition in which they are at a higher risk of severe illness. Novavax uses more traditional protein-based technology than the mRNA vaccines of Pfizer and Moderna. The first COVID-19 case was reported in the United States on Jan. 20, 2020. About 23% of U.S. adults are estimated to be up to date with the vaccine, according to the CDC through April. For children 6 months and up to 18, it is an estimated 13.% the CDC reported.
