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FDA chief wary of federal recommendations for Covid-19 vaccines
FDA chief wary of federal recommendations for Covid-19 vaccines

Yahoo

timea day ago

  • General
  • Yahoo

FDA chief wary of federal recommendations for Covid-19 vaccines

Dr. Marty Makary, commissioner of the FDA, on Sunday made it clear he was dubious of previous federal recommendations on Covid-19 vaccinations and the agencies who made them. In an interview with host Margaret Brennan of CBS' "Face the Nation," Makary responded to repeated requests from Brennan to clarify federal guidance (or the lack thereof) with variations on the same answer. "We believe the recommendation should be with a patient and their doctor," he said at one point, declining to give specific advice — or specifying how doctors might be able to offer guidance in the absence from direction from the federal government. Brennan was seeking clarity from Makary in the aftermath of Health and Human Services Secretary Robert F. Kennedy Jr.'s announcement that Covid-19 vaccines would no longer be recommended for healthy children and pregnant women. The CDC subsequently offered updated advice that somewhat countered what Kennedy said but also left room for interpretation. Makary there needed to be more controlled studies, so that decisions to approve vaccines would be more authoritative. The CBS host tried to get Makary to say what was lacking in the current data for such vaccines, and when that information might be available to the agency, as well as the general public. In his answers Sunday, Makary was not supportive of past guidance, criticizing the methodology of the CDC. "We know the CDC data is contaminated with a lot of false positives from incidental positive Covid tests with routine testing of every kid that walks in the hospital," he told Brennan. Makary also cast doubt on the CDC's Advisory Committee on Immunization Practices. "That panel has been a kangaroo court where they just rubber-stamp every single vaccine put in front of them," he said. At the time he was nominated in November, Makary was a Johns Hopkins surgeon who was best known for his criticism of the Biden administration's response to Covid, something for which Kennedy was also known. Trump said Makary was needed because "the FDA has lost the trust of Americans." Makary, he said, would "course-correct" the agency. On Sunday, when it came to discussing the shots and pregnant women, Makary was a model of consistency in his contention that the decision was a personal matter between a patient and her doctor. Brennan and Makary had this exchange: Brennan: "It is still unclear what pregnant women now should do until they get the data that you say." Makary: "I'd say talk to their doctor." Brennan: "When do they get the data you're promising? All these controlled studies." Makary: "In the absence of data, they should talk to their doctor ..." Brennan: "So no date?" Makary: "... and their doctor will use their best wisdom and judgment."

Caitlin Clark's quads, Trump-Musk bromance and 'Duck Dynasty': Your week in review
Caitlin Clark's quads, Trump-Musk bromance and 'Duck Dynasty': Your week in review

Yahoo

time3 days ago

  • Entertainment
  • Yahoo

Caitlin Clark's quads, Trump-Musk bromance and 'Duck Dynasty': Your week in review

COVID-19 vaccines will no longer be part of the Centers for Disease Control and Prevention's recommended immunization schedule for healthy children and pregnant women, Health and Human Services Secretary Robert F. Kennedy Jr. announced. National Institutes of Health Director Jay Bhattacharya, joining Kennedy for the announcement posted in a video on X, called the change 'common sense and good science." Traditionally, immunization guidance is voted on by a CDC advisory committee; then the CDC director makes the final call. The CDC panel has not voted on Kennedy's change. COVID-19 protocols: Changes are happening. Here's what to know Could there be some cooling in the Trump-Musk bromance? The president's crusade to pass his "big, beautiful" tax and spending bill through Congress took some flak from his former right-hand man, who said he was "disappointed" with the cost of the bill and complained that it "undermines the work the DOGE team is doing." (Musk has also criticized Trump's tariffs.) Asked about Musk's remarks on the spending bill, Trump cited politics: "I'm not happy about certain aspects of it, but I'm thrilled by other aspects of it. … It's got a way to go." At least one break is official, however: Musk's turbulent 130-day run as a "special government employee" is now over. It's the end of the line for free checked bags on Southwest. For the first time, the airline is now charging for the service: $35 for a first checked bag and $45 for a second bag (overweight and oversized baggage costs more). Tickets booked or changed on or before May 28 don't apply, and for some customers, new fare categories and membership perks will still earn them free checked bags. The new fees are the latest major change for Dallas-based Southwest, including a farewell to its open seating policy of more than 50 years. In a news release, the airline acknowledged that "preferences have evolved." Phil Robertson, the bushy-bearded and plainspoken patriarch of the colorful Louisiana family featured on A&E Network's 'Duck Dynasty," has died. He was 79 and had battled Alzheimer's disease and other health problems, his family said. His family-run hunting products business, Duck Commander, was the epicenter of "Duck Dynasty," which ran from 2012 to 2017 on the back of the clan's three core tenets: "faith, family and ducks.' The duck call will not go silent, however; a spinoff, "Duck Dynasty: The Revival," premieres June 1. Call it the Caitlin Clark effect − in reverse. The Indiana Fever's star guard is out for at least two weeks after she strained her left quad in a loss to the New York Liberty, which meant she would be sidelined for at least the next four games. The WNBA is feeling the pain, too: Ticket prices have plunged since news of Clark's injury. It's especially disappointing for the Fever's road game June 7 against the Chicago Sky − the latest Clark vs. Angel Reese clash − which had been moved to the 23,000-plus-seat United Center to meet demand for tickets. − Compiled by Robert Abitbol, USA TODAY copy chief This article originally appeared on USA TODAY: Caitlin Clark's quads, Trump-Musk and 'Duck Dynasty': Week in review

CDC now says kids "may receive" COVID-19 vaccines, should talk to their doctors
CDC now says kids "may receive" COVID-19 vaccines, should talk to their doctors

CBS News

time3 days ago

  • General
  • CBS News

CDC now says kids "may receive" COVID-19 vaccines, should talk to their doctors

The Centers for Disease Control and Prevention now says that kids with no underlying health conditions "may receive" COVID-19 vaccines, dropping a broad recommendation for all children to get vaccinated against the virus. Updates to the CDC's childhood immunization schedule were published late Thursday, following an announcement earlier this week by Health and Human Services Secretary Robert F. Kennedy Jr. that the agency would stop recommending COVID-19 vaccines for healthy children and healthy pregnant women. "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 CDC says in its new guidance. Thursday's change to what the CDC calls "shared clinical decision-making" recommendations for children means that health insurance companies will continue to be required to broadly cover the shots for now in this age group. The agency still broadly recommends COVID-19 vaccines for moderately or severely immunocompromised children, in addition to most adults for now. COVID-19 vaccines during pregnancy are now listed as "No Guidance/Not Applicable," where they were previously recommended for all pregnant adults. While Kennedy said in his video announcement that healthy pregnant women were also being removed from the CDC's recommended immunization schedule for COVID-19 vaccines, several pages of agency guidance saying that pregnant women are recommended to get vaccinated because of their higher risk of severe disease remain on the CDC's website as of Friday. "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. The benefits of receiving a COVID-19 vaccine outweigh any potential risks of vaccination during pregnancy," one CDC webpage still reads. Health authorities and experts closely watch changes to the CDC's recommendations, usually updated through open meetings of the CDC's Advisory Committee on Immunization Practices, since they are tied to policies like liability protections and insurance coverage requirements. The CDC also deleted a statement previously on the childhood immunization schedule that the guidance had been recommended by the committee, approved by the CDC and backed by a number of outside medical groups. So far, the CDC's changes echo what the committee had already been considering voting on next month: narrowing COVID-19 vaccine recommendations to only older adults and younger ages with risk factors, but still allowing for permissive coverage of others getting vaccinated. The CDC has used "shared clinical decision-making" guidance in the past to allow for federal requirements guaranteeing insurance coverage and access to some vaccines, while stopping short of full-throated recommendations for everyone eligible to get a shot. At its last meeting in April, the committee had not signaled that they were planning to lift the recommendation for pregnant women to get vaccinated. Instead, pregnancy was listed during the meeting as among the underlying conditions that might warrant a continued recommendation for vaccination. RFK Jr.'s directive to CDC Multiple CDC officials said the change came after the agency received a directive signed by Kennedy, shortly after he posted his announcement to social media. Kennedy's memo cited "a review of the recommendations" of the Food and Drug Administration and National Institutes of Health, saying 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 moms and their baby. "Truly the death of expertise. This would be like the secretary of transportation directing that all planes must fly 5,000 feet higher than current. It's vibe-based decision making," one federal health official said of the directive. Agency officials overseeing immunization recommendations said they were surprised by Kennedy's move. The Washington Post previously reported news of the directive. "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. contributed to this report.

The CDC Opposes RFK Jr.'s COVID Vaccine Guidance, Saying Children 'May Receive' Their Shots
The CDC Opposes RFK Jr.'s COVID Vaccine Guidance, Saying Children 'May Receive' Their Shots

CNET

time3 days ago

  • Business
  • CNET

The CDC Opposes RFK Jr.'s COVID Vaccine Guidance, Saying Children 'May Receive' Their Shots

On Tuesday, Health and Human Services Secretary Robert F. Kennedy Jr. stated that the CDC will no longer recommend COVID-19 vaccinations for pregnant people and healthy children. A mere two days later, the CDC seemingly contradicted that advice with its newly updated Child and Adolescent Immunization Schedule with what it calls "shared clinical decision-making" for children aged 6 months to 17 years who are not moderately or severely immunocompromised. "Shared clinical decision-making vaccinations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian," states the CDC. "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." This means that health insurance providers will still be required to cover the COVID-19 vaccinations for kids in this age group. According to the New York Times, this also means the shots will continue to be available to the 38 million low-income children under the Vaccines for Children program. But what about pregnant people? According to the NYT, the CDC's official position is "no guidance." This contradicts a still-live CDC web page updated Sept. 10, 2024, stating that pregnant people are at increased risk for COVID-19 and resulting complications such as preterm birth or stillbirth. That same web page also states that COVID-19 vaccination during pregnancy is safe and effective and that these vaccines are not associated with fertility problems in women or men. What RFK Jr. had to say In a shift to federal public health guidance, Health and Human Services Secretary Robert F. Kennedy Jr. announced on May 27 that the Centers for Disease Control and Prevention will no longer encourage COVID-19 vaccinations for pregnant people and healthy children. The pivot, shared by Kennedy in a 58-second video posted to X, formerly Twitter, marks a significant departure from the CDC's stance just two weeks ago, when it reiterated the importance of high-risk groups, which included expecting parents. "I couldn't be more pleased to announce that as of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule," Kennedy said, flanked by Jay Bhattacharya, director of the National Institutes of Health, and FDA Commissioner Marty Makary. The trio framed the decision as a return to evidence-based policymaking. Makary said "no evidence" supports healthy children benefit from routine COVID vaccination, while Bhattacharya called the update "common sense and good science." The update comes just after a similar policy announcement from the Trump administration, which last week stated it would no longer recommend annual COVID shots for younger adults and children. Instead, older adults (65 and up), and anyone over six months with underlying conditions like diabetes, obesity, chronic respiratory diseases or cancer will be prioritized in vaccination efforts. Meanwhile, pregnant people appear to have been reclassified under RFK Jr.'s guidance and are no longer encouraged to get COVID-19 vaccines. The CDC's Advisory Committee on Immunization Practices is scheduled to meet on June 25 to finalize COVID-19 vaccine recommendations for this fall. What does this new COVID-19 vaccine guidance mean for families? The new CDC versus RFK Jr. guidance may leave parents or pregnant people wondering how to move forward. While the change reflects a broader approach based on individual risk assessment, it also places more responsibility on families to navigate complex medical decisions without the same level of clear federal direction. The new CDC guidelines state that children 6 months and older may receive the COVID-19 vaccination as long as a healthcare provider and parent agree. The guidance is more unclear for pregnant people. This change reopens the debate about whether vaccination during pregnancy remains a protective measure or an unnecessary risk. What should you do now? Here are a few tips for navigating the latest vaccine guidance changes and making the most informed decisions for yourself and your family. Talk to your doctor Any medical decisions, especially during pregnancy and for young children, should be consulted with your primary care provider or OB-GYN. They can help you determine individual needs and risks. Assess your risk factors The COVID-19 vaccination guidelines state that it is "especially important to get your 2024-2025 COVID-19 vaccine if you're ages 65 and older, are at high risk for severe COVID-19 or have never received a COVID-19 vaccine." The same goes for children and adults who are moderately to severely immunocompromised, but guidelines vary based on age and vaccination history. You may also want to check COVID levels in your area to further assess your risk. Stay informed As federal health guidance evolves, it's important to monitor updates from reputable and trusted medical sources, including your state health department and professional medical associations.

Covid-19 shots for healthy children remain on CDC vaccine schedule despite Kennedy's pledge to remove them
Covid-19 shots for healthy children remain on CDC vaccine schedule despite Kennedy's pledge to remove them

CNN

time3 days ago

  • General
  • CNN

Covid-19 shots for healthy children remain on CDC vaccine schedule despite Kennedy's pledge to remove them

Vaccines Respiratory viruses Children's health Federal agenciesFacebookTweetLink Follow The US Centers for Disease Control and Prevention has updated its immunization schedule for children after US Health and Human Services Secretary Robert F. Kennedy Jr.'s announcement this week that Covid-19 vaccines would be removed from the list of recommended shots for healthy children and pregnant women. However, the vaccines remain on the schedule for kids, although with a slightly different designation. Instead of being listed as 'recommended' by the CDC, they are now listed as 'recommended vaccination based on shared clinical decision-making,' meaning healthy children – those who don't have an underlying condition that raises their risk of severe illness – can get the shots after consulting with a health care provider. According to the CDC, such a provider would be anyone who routinely administers vaccines, including doctors, nurse practitioners, nurses and pharmacists. A vaccine listed on the schedule in this category is required to be covered by insurance with no cost-sharing, meaning no co-pays for patients, according to the CDC. Many of the agency's information pages continue to recommend the Covid-19 vaccine for pregnant women, but the adult immunization schedule has been changed to specify that the recommendation applies only to adults who aren't pregnant. 'The old COVID-19 vaccine recommendations for healthy children under 18 and for pregnant women have been removed from the CDC vaccine schedule,' HHS press officer Emily Hilliard said in a statement Friday. 'The CDC and HHS encourage individuals to talk with their healthcare provider about any personal medical decision. Under the leadership of Secretary Kennedy, HHS is restoring the doctor-patient relationship. If a parent desires their healthy child to be vaccinated, their decision should be based on informed consent through the clinical [judgment] of their healthcare provider,' the statement said. The change to the vaccine schedule comes days after Kennedy posted a video on social media saying it had happened. 'As of today, the Covid vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule,' Kennedy said in the video Tuesday, standing beside FDA Commissioner Dr. Marty Makary and National Institutes of Health Director Dr. Jay Bhattacharya. 'Last year, the Biden administration urged healthy children to get yet another Covid shot, despite the lack of any clinical data to support the repeat booster strategy in children.' The announcement was met with dismay from parents and pediatricians who feared that kids and pregnant women might lose insurance coverage for the vaccines. 'It's been a bit disheartening, to be honest,' said Fatima Ka, co-founder of the nonprofit grassroots group Protect Their Future, which advocated for kids' access to Covid-19 vaccines throughout the pandemic. 'A lot of parents right now have been doing everything they can. They've been calling their representatives, their health departments, anyone who will listen, anyone who is accountable to the public. And it just felt like today we were heard even if it was in a small way,' Ka told CNN. Kids can become severely ill with Covid-19, especially if they're younger than 5. Data presented at the last meeting of the CDC's independent vaccine advisers showed that children 4 and under were hospitalized with Covid at roughly the same rate over the past two respiratory seasons as they were with the flu, and it was a severe influenza season. Fewer than 5% of children hospitalized with Covid-19 last season were up to date on their Covid-19 vaccinations. Dr. Susan Kressly, president of the American Academy of Pediatrics, said the updated recommendation – which preserves insurance coverage for the vaccines – was a relief. 'After confusing, mixed messages from leaders at Health and Human Services (HHS) earlier this week, we are relieved to see today that the U.S. Centers for Disease Control and Prevention (CDC) updated its schedules for child and adolescent immunizations to allow families to maintain the choice to immunize their children against Covid in consultation with their doctor,' Kressly said in a statement. 'However, the deeply flawed process to reach the recommendation raises serious concerns about the stability of the nation's immunization infrastructure and commitment by federal leaders to make sure families can access critical immunizations, whether for Covid or other infectious diseases,' she added. Pregnancy is a risk factor for severe Covid-19 infections. Early in the pandemic, CDC studies found that pregnant women with Covid were three times more likely to need ICU care and nearly twice as likely to die compared with those who weren't pregnant. Covid infections during pregnancy have also been linked to fetal complications such as stillbirth and preterm delivery. The Society for Maternal-Fetal Medicine said it would continue to recommend that people who are pregnant be vaccinated against Covid-19. 'Maternal immunization remains the best way to reduce maternal, fetal, and infant complications from COVID-19 infection, and is safe to be given at any point during pregnancy. Maternal immunization is also associated with improved infant outcomes and decreased complications, including maternal and infant hospitalizations,' the group said in a statement.

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