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5 hours ago
Leading pediatrician group recommends COVID vaccine for infants, toddlers in contrast with RFK Jr.
The American Academy of Pediatrics (AAP) said on Tuesday that children ages 6 months to 23 months should receive a COVID-19 vaccine, in contrast with federal health officials. The recommendations are part of the AAP's annual childhood immunization schedule, which includes guidance for COVID, flu and RSV vaccines for those aged 18 and younger. The AAP has been releasing its own recommendations since the 1930s, but in a rare occurrence, the recommendations differ from those put out by the Centers for Disease Control and Prevention (CDC). The group also recommended Americans age 18 and under receive a COVID vaccine if they are at high risk of severe COVID, live in a long-term care facility or congregate setting, if they have never been vaccinated against COVID or if they live with someone at high risk for severe COVID. It comes after Health and Human Services secretary Robert F. Kennedy Jr. announced in late May that the CDC would no longer recommend the COVID vaccine for healthy children. The CDC, which is under Kennedy's purview, later updated the guidance to a " shared clinical decision making" model -- leaving the decision to vaccinate children to parents alongside advice from a doctor. The prior recommendations were that everyone aged 6 months and older get vaccinated against COVID with the most up-to-date shot. The contrasting vaccine recommendations highlight the growing rift between federal health officials and medical organizations on vaccine policy. "The academy has been making pediatric immunization recommendations since the 1930s, that has not changed," Dr. Susan J. Kressly, president of the AAP, told ABC News. "But what has changed is that this year, we're doing it in the environment of misinformation, which makes it more important than ever that we provide clear and confident guidance, because the majority of American families really depend on us for this guidance." Children between 6 months old and 23 months old are at the highest risk of severe COVID-19, and the vaccine can protect against serious illness, according to the AAP. "We know that this age group, that's the highest risk for severe disease," Kressly said. "And so we want to make sure that those children who are at highest risk and did not live through the pandemic -- they were not exposed to COVID viruses during the pandemic -- we want to make sure that they are protected as best as possible." Although medical organizations may differ in their vaccine recommendations, insurers often rely on the CDC's vaccine panel, known as the Advisory Committee on Immunization Practices (ACIP), recommendations to determine what they will and won't cover. If certain vaccines aren't recommended by the ACIP, it may lead to parents or guardians facing out-of-pocket costs if their children receive the shot. It could also mean the shots aren't covered by the Vaccines for Children (VFC) program, a federally funded program that provides no-cost vaccines to eligible children. "We need to work with our like-minded policy makers who understand the importance of keeping VFC vaccines available in every community for those children who depend on them," Kressly said. "At the same time, there are children in this country whose vaccines are paid for through commercial insurance, and we are having continuing conversations with major payers to make sure that those can be vaccines are available as well. Vaccination is part of high-quality preventive care, and we are confident that we can work with the payers to make sure that translated into policy."
Scientific American
7 hours ago
- Scientific American
More Teens Are Getting Vaccines
U.S. teenagers are rebelling. More teens got recommended vaccinations in 2024 than did so in 2023. This trend is the opposite of what's happening in younger children: vaccine rates in the U.S. continue to fall among kids who are entering kindergarten. The numbers come from the most recent report on childhood vaccinations from the Centers for Disease Control and Prevention. The uptick among teens is a win for public health as the vaccine framework in the U.S. is under attack. Robert F. Kennedy, Jr., head of the Department of Health and Human Services, has placed antivaccine advocates on the CDC's advisory committee that makes vaccine recommendations. The federal government has ended grants for the development of mRNA vaccines despite the safety and success of COVID shots. Since January there have been 32 measles outbreaks, largely among children and teens that did not get measles shots. On supporting science journalism If you're enjoying this article, consider supporting our award-winning journalism by subscribing. By purchasing a subscription you are helping to ensure the future of impactful stories about the discoveries and ideas shaping our world today. But the new findings suggest that communication between providers and parents can lead to higher vaccine uptake. In 2024 the percentage of teens aged 13 to 17 who got two or more doses of the combination measles, mumps and rubella (MMR) shot increased from the portion in 2023, from 91.3 percent to 92.6 percent. The percentage of teens who got the combination tetanus, diphtheria and pertussis (Tdap) vaccine rose from 89 percent in 2023 to 91.3 percent last year. And the number of teens who got at least one dose of the four-pronged meningococcal ACWY (MenACWY) shot increased from 88.4 percent in 2023 to 90.1 percent in 2024. (The MenACWY vaccine spurs an immune response to four versions of a bacteria that causes meningitis.) The results were published last Friday in the CDC's Morbidity and Mortality Weekly Report. The authors analyzed data collected from the 2024 National Immunization Survey–Teen, a two-phase survey that asked parents and their children's providers about vaccine use. But not all of the trends were upward. In 2024, for the third year in a row, teens' uptake of the HPV vaccine—which protects against the cancer-causing human papillomavirus—remained the same. The national average of teens who have had at least one dose of the HPV vaccine held steady at 78 percent, though there was broad variability from state to state. The researchers reported that, in 2024, less than 40 percent of teens in Mississippi got at least one shot, but close to 80 percent in Massachusetts did so. And communication was key: parents who reported talking about the vaccine with a provider were more likely to have teens who got it. In metropolitan statistical areas (which can include urban, suburban and rural communities), the percentage of teens who got the vaccine was about 18.8 percentage points higher on average when their provider recommended it than when the provider didn't. And in addition to variability among states, there were other differences. In general, urban areas had higher vaccination rates than rural areas and, in some cases, suburban ones. This sort of difference has long been the case in the U.S., where transportation, insurance coverage and provider availability have created wide rural-urban disparities in health care access. For some of the diseases targeted by the vaccines on the CDC's immunization schedule, even the increase in teens getting the shots doesn't mean the U.S. is at a herd immunity level, the point at which the population as a whole is more generally protected from an illness. For example, to achieve herd immunity for pertussis, 92 to 94 percent of the population needs to be vaccinated. The vaccination rate for kindergartners in 2024–2025 was 92.1 percent. Teens were at 91.3 percent, putting the U.S. just under the lower threshold for herd immunity. In 2024 there were more than 35,000 cases of whooping cough in the U.S. In 2023 there were approximately 7,000.
Yahoo
9 hours ago
- Yahoo
Invivyd Announces Continued Neutralizing Activity of PEMGARDA® (pemivibart) and VYD2311 Against Currently Dominant SARS-CoV-2 Variant XFG ('Stratus')
New in vitro neutralization data show continued, consistent neutralizing activity of PEMGARDA® (pemivibart) against XFG Centers for Disease Control data and wastewater surveillance data indicate XFG variant appears to be driving a growing wave of COVID-19 in America VYD2311 in vitro neutralization data demonstrate similarly consistent and highly potent results against XFG Similar new, positive in vitro neutralization data for pemivibart and VYD2311 against other SARS-CoV-2 viruses currently circulating in the U.S. (NB.1.8.1 ('Nimbus') and LF.7.9, as well as LP.8.1) affirm Invivyd's unique technology, reflect consistently stable target epitopes, and indicate ongoing, complete coverage of any tested, relevant SARS-CoV-2 variant by Invivyd's investigational monoclonal antibodies; no non-responsive viruses identified or anticipated Data to be provided to U.S. FDA imminently, with anticipated inclusion in PEMGARDA Fact Sheet for Healthcare Providers WALTHAM, Mass., Aug. 18, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced positive, continued, clinically meaningful in vitro neutralization data for PEMGARDA® (pemivibart) against the currently dominant and growing XFG variant of SARS-CoV-2. Notably, and consistent with all dominant variants for the past three years, XFG did not generate any meaningful change to the in vitro neutralization activity of pemivibart or VYD2311, the company's next generation COVID-19 monoclonal antibody (mAb) candidate, as the epitopes targeted by pemivibart and VYD2311 remain structurally intact. PEMGARDA (pemivibart) is authorized by the U.S. Food and Drug Administration (FDA) for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients. Currently, the level of COVID-19 viral activity detected in wastewater in 12 states is reported as high or very high levels as of early August, and the U.S. Centers for Disease Control and Prevention (CDC) estimates that COVID-19 infections are growing or likely growing in 34 states and declining in zero states, according to forecasting models. Further, the company estimates that every clinical variant reported in the CDC COVID Data Tracker since the Omicron BA.2 lineage has been susceptible to pemivibart, even if untested, due to the consistent structural integrity of the epitope targeted by pemivibart. Therefore, Invivyd anticipates continued meaningful clinical activity for pemivibart for the foreseeable future if the epitope pemivibart targets remains intact. 'COVID-19 activity is once again on the rise across much of the United States, with wastewater data and forecasting models pointing to sustained growth in infections. Against this backdrop, we are pleased but not surprised that pemivibart has continued to demonstrate neutralizing activity against the currently dominant XFG variant, and we look forward to rapidly advancing our next generation antibody VYD2311 which has shown similar in vitro neutralization results at much higher potency. The demonstrated stability of the epitopes our monoclonal antibodies target across SARS-CoV-2 evolution underscores the strength of our molecular design strategy and our capability in creating high-barrier-to-resistance medicines,' said Robert Allen, Ph.D., Chief Scientific Officer of Invivyd. 'For people whose immune systems may not get enough protection from vaccines such as those on immunosuppressive therapies and those undergoing cancer treatment, each new COVID-19 wave can create additional challenges and disrupt care,' commented Tim Lee, Chief Commercial Officer of Invivyd. 'Pemivibart has shown extraordinary continuing in vitro neutralization activity against SARS-CoV-2 over now several years, and our next-generation antibody VYD2311 represents another hopeful step toward more scalable protection with a more patient-friendly route of administration.' Data showing continued in vitro neutralizing activity of PEMGARDA® (pemivibart) against XFG and other circulating viruses will be provided to the FDA imminently, with anticipated inclusion in the PEMGARDA Fact Sheet for Healthcare Providers. About PEMGARDA PEMGARDA® (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA was engineered from adintrevimab, Invivyd's investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1, XEC and LP.8.1. PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby inhibiting virus attachment to the human ACE2 receptor on host cells. PEMGARDA (pemivibart) injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2. PEMGARDA is not authorized for use for treatment of COVID-19, treatment of Long COVID, or post-exposure prophylaxis of COVID-19. Pre-exposure prophylaxis with PEMGARDA is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate-to-severe immune compromise who may derive benefit from COVID-19 vaccinations, should receive COVID-19 vaccination. In individuals who have recently received a COVID-19 vaccine, PEMGARDA should be administered at least 2 weeks after vaccination. Anaphylaxis has been observed with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis. The most common adverse reactions included systemic infusion-related reactions and hypersensitivity reactions, local infusion site reactions, and infusion site infiltration or extravasation. For additional information, please see the PEMGARDA full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning. To support the EUA for PEMGARDA, an immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA. There are limitations of the data supporting the benefits of PEMGARDA. Evidence of clinical efficacy for other neutralizing human mAbs against SARS-CoV-2 was based on different populations and SARS-CoV-2 variants that are no longer circulating. Further, the variability associated with cell-based EC50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges. Additionally, certain SARS-CoV-2 viral variants may emerge that have substantially reduced susceptibility to PEMGARDA, and PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants. The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner. PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to 90%, based on available information including variant susceptibility to PEMGARDA and national variant frequencies. About VYD2311 VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration. VYD2311 was engineered using Invivyd's proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd's investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd's investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. About Invivyd Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit to learn more. Trademarks are the property of their respective owners. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as 'anticipates,' 'believes,' 'could,' 'expects,' 'estimates,' 'hypothesizes,' 'intends,' 'potential,' 'predicts' 'projects,' and 'future' or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the company's ongoing research and development activities, as well as future potential research and development efforts; the ongoing in vitro neutralizing activity of PEMGARDA and VYD2311 against dominant SARS-CoV-2 variants; anticipated update to the PEMGARDA Fact Sheet for Healthcare Providers; expectations regarding the COVID-19 landscape and growing U.S. COVID-19 infections; expectations regarding the neutralization activity of pemivibart and VYD2311 for the foreseeable future, and beliefs about the stability of the epitope targeted by pemivibart and VYD2311; expectations about the strength of Invivyd's molecular design strategy and its capability in creating high-barrier-to-resistance medicines; the potential of PEMGARDA as a mAb for pre-exposure prophylaxis (prevention) of COVID-19 in certain immunocompromised persons; the potential of VYD2311 as a novel mAb candidate that may be able to deliver clinically meaningful titer levels through more patient-friendly means; the company's devotion to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company's forward-looking statements and you should not place undue reliance on the company's forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company's actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the timing, progress and results of the company's discovery, preclinical and clinical development activities; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of the company's product candidates based on neutralizing activity in nonclinical studies; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; the company's reliance on third parties with respect to virus assay creation and product candidate testing; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; whether the epitope that pemivibart and VYD2311 targets remains structurally intact; whether the company's product candidates are able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; whether U.S. COVID-19 infections grow as estimated by forecasting models; how long the EUA granted by the FDA for PEMGARDA will remain in effect and whether the EUA is revised or revoked by the FDA; the success of the company's in-house sales force, and the company's ability to maintain and expand sales, marketing and distribution capabilities to successfully commercialize PEMGARDA; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for authorization or approval of the company's product candidates; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of any product candidate following regulatory authorization or approval; changes in the regulatory environment; the outcome of the company's engagement with regulators; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways; changes in expected or existing competition; the complexities of manufacturing mAb therapies; the company's ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading 'Risk Factors' in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, each as filed with the Securities and Exchange Commission (SEC), and in the company's other filings with the SEC, and in its future reports to be filed with the SEC and available at Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law. This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release. 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