Latest news with #Pfizer-BioNTech
Epoch Times
28-05-2025
- Health
- Epoch Times
CDC Narrows Its COVID-19 Vaccine Recommendations: What to Know
The Centers for Disease Control and Prevention has removed COVID-19 vaccines from immunization schedules for healthy children and pregnant women, according to Health Secretary Robert F. Kennedy Jr. Kennedy Here's what to know. Child Recommendation Was Universal The CDC in 2023 COVID-19 vaccines were recommended for children aged 6 months and up under the universal recommendation. The recommendation advised doctors and parents that unvaccinated children under 5 should receive two doses of Moderna's vaccine or three doses of the Pfizer-BioNTech shot, unvaccinated children aged 5 to 11 should receive one dose of either shot, and unvaccinated children aged 12 to 18 should receive one dose of Moderna's vaccine, one dose of Pfizer's vaccine, or two doses of Novavax's shot. Vaccinated children were recommended to receive at least one dose, depending on how many doses and which vaccines they'd received before. Related Stories 5/27/2025 5/22/2025 According to the CDC, just 13 percent of youth and 14 percent of pregnant women have received one of the newest vaccines, which were The CDC also Recommendations Haven't Been Updated Kennedy said in a video statement that 'as of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule.' As of May 28, the CDC The schedule was last updated on Nov. 21, 2024, according to the CDC's website. The CDC Both were last changed in June 2024, according to the site. The CDC did not respond when asked when the schedules would be updated. 'As part of the Trump administration's commitment to common sense, the COVID-19 vaccine will be removed from the CDC's recommended immunization schedule,' a spokesperson for the Department of Health and Human Services, the CDC's parent agency, told The Epoch Times in an email. Change Came Without Formal Advice The CDC's vaccine advisers, the Advisory Committee on Immunization Practices, discussed COVID-19 vaccines during a meeting in April. A subgroup of the panel that studied the matter The advisers had been slated to vote on the topic during their next meeting, in June, according to the CDC. The CDC is not bound by the committee's advice but often adopts it. The panel in 2022 A dose of the COVID-19 vaccines available from 2023 to 2024 conferred an additional 52 percent protection for young children and 64 percent protection for those aged 5 to 17 against emergency department and urgent care encounters through August 2024, the CDC said in a The American Academy of Pediatrics said the removal of the COVID-19 vaccines from the childhood schedule was concerning. 'By removing the recommendation, the decision could strip families of choice,' Dr. Sean O'Leary, chair of the academy's Committee on Infectious Diseases, The American College of Obstetricians and Gynecologists (ACOG) also 'We are concerned about access implications and what this recommendation will mean for insurance coverage of the COVID-19 vaccine for those who do choose to get vaccinated during pregnancy,' ACOG said. CDC's Involvement Unclear It's not clear whether the CDC was involved in the decision to narrow the CDC's vaccine recommendations. Kennedy's announcement was made alongside National Institutes of Health Director Dr. Jay Bhattacharya and Food and Drug Administration Commissioner Dr. Marty Makary. The CDC currently has an acting director, a lawyer named Matthew Buzzelli, according to the health secretary. Buzzelli does not have a medical degree or public health experience, according to President Donald Trump has named Susan Monarez, a CDC official with a doctorate in immunology and microbiology, as CDC director, but the Senate has not yet confirmed her. Kennedy and the Department of Health and Human Services (HHS) have also not cited any studies in support of the change. 'As Commissioner Makary said, 'There's no evidence healthy kids need it today, and most countries stopped recommending it for children.' With the COVID-19 pandemic behind us, it is time to move forward,' a spokesperson for the department told The Epoch Times in an email. 'HHS and the CDC remain committed to gold standard science and to ensuring the health and well-being of all Americans—especially our nation's children—using common sense.' COVID-19 cases and hospitalizations have fallen sharply since the Omicron variant sent them soaring in early 2022. The World Health Organization declared the pandemic over in the spring of 2023. The removal came after FDA officials The officials noted the low uptake of COVID-19 vaccines and said that they did not know, based on the available evidence, whether healthy people who previously had COVID-19 and were vaccinated would benefit from additional doses.
Yahoo
27-05-2025
- General
- Yahoo
CDC Stops Recommending COVID-19 Vaccines for Pregnant Women and Children
Credit - Getty Images The U.S. Centers for Disease Control and Prevention (CDC) is no longer recommending the COVID-19 vaccine for pregnant women and healthy children, the U.S. Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. announced in a video on his X account on May 27. 'We're now one step closer to realizing President Trump's promise to Make American Healthy Again," said Kennedy, who was flanked by Dr. Martin Makary, commissioner of the Food and Drug Administration (FDA), and Dr. Jay Bhattacharya, head of the National Institutes of Health. The announcement reverses previous CDC advice. At the time of the announcement, the CDC's webpage still contained its previous recommendation that everyone ages six months and older get vaccinated, and that 'getting the 2024-2025 COVID-19 vaccine is especially important if you are pregnant, breastfeeding, trying to get pregnant, or might become pregnant in the future.' Public-health experts immediately pushed back against the announcement. 'Despite the change in recommendations from HHS, the science has not changed," said Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, in a press statement. "It is very clear that COVID infection during pregnancy can be catastrophic and lead to major disability, and it can cause devastating consequences for families. The COVID vaccine is safe during pregnancy and vaccination can protect our patients and their infants.' The makers of the most-administered COVID-19 vaccines—Pfizer-BioNTech and Moderna—did not immediately respond to requests for comment. But in response to the FDA's other recent restriction of COVID-19 vaccine eligibility, Pfizer said it "[stood] by the science behind the Pfizer-BioNTech COVID-19 vaccine and continue to believe that broad vaccination programs are an essential tool for helping to prevent COVID-19 associated hospitalizations and severe disease, including death," while Moderna said it "remain[ed] committed to working with the Agency to provide the data they need to ensure access for Americans." Here's what to know about the unusual reversal in guidance. In the U.S., the FDA approves vaccines after reviewing studies on their safety and efficacy, and the CDC makes recommendations about who should be vaccinated and when, based on advice from an advisory committee of experts. It's not clear whether that committee was consulted before Kennedy made the change; TIME contacted several members, and one declined to comment while others did not immediately respond for comment. 'This decision bypasses a long-established, evidence-based process used to ensure vaccine safety and ignores the expertise of independent medical experts, including members of the CDC committees who are examining the evidence regarding the vaccine to make recommendations for the fall,' said Dr. Sean O'Leary, chair of the American Academy of Pediatrics Committee on Infectious Diseases in a statement to TIME. For the public, the decision could mean more obstacles to getting COVID-19 vaccines, and higher prices if they do manage to gain access. Insurers make decisions about which shots to cover based on CDC recommendations—in particular for children—and if the COVID-19 vaccine is no longer part of CDC's recommended immunizations, insurers could stop covering them, forcing parents who wish to vaccinate their children to pay out of pocket for the shots. Read More: What the New 'Make America Healthy Again' Report Says About Children's Health During the pandemic, when the COVID-19 vaccines were first authorized and then approved, federal health officials focused on using the shots to control severe disease and lower hospitalizations and deaths—not prevent infection. Kennedy, who has long been a skeptic of vaccines in general and continues to openly question their safety, and his health officials have publicly discussed whether the same recommendations for COVID-19 vaccines are still relevant today, when more people have developed immunity to the virus either from repeated vaccinations, infections, or both. A week before this announcement, the FDA said it would limit COVID-19 vaccine approvals to those at highest risk of severe disease, and require additional studies on healthier people to confirm the shots' safety and effectiveness. Still, some infectious diseases experts note that in the U.S., during the peak of the latest winter respiratory disease season, just over 400,000 people were hospitalized with COVID-19, and several hundred people died each week. Those most vulnerable to complications that send them to the hospital were older people, those with weakened immune systems, and those who were pregnant. Given the potential risk of Long COVID and some of the still unknown long-term effects of recovering from an infection, the CDC still advises that 'getting a COVID-19 vaccine is a safer, more reliable way to build protection than getting sick with COVID-19.' That's especially true for pregnant women, who may also pass on the protection they receive from getting vaccinated to their newborns in the first six months, before the infants can get immunized. 'By removing the recommendation, the decision could strip families of choice,' said O'Leary. 'What is clear is that pregnant women, infants and young children are at higher risk of hospitalization from COVID, and the safety of the COVID vaccine has been widely demonstrated.' Contact us at letters@
Time Magazine
27-05-2025
- Health
- Time Magazine
CDC Stops Recommending COVID-19 Vaccines for Pregnant Women and Children
The U.S. Centers for Disease Control and Prevention (CDC) is no longer recommending the COVID-19 vaccine for pregnant women and healthy children, the U.S. Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. announced in a video on his X account on May 27. 'We're now one step closer to realizing President Trump's promise to Make American Healthy Again," said Kennedy, who was flanked by Dr. Martin Makary, commissioner of the Food and Drug Administration (FDA), and Dr. Jay Bhattacharya, head of the National Institutes of Health. The announcement reverses previous CDC advice. At the time of the announcement, the CDC's webpage still contained its previous recommendation that everyone ages six months and older get vaccinated, and that 'getting the 2024-2025 COVID-19 vaccine is especially important if you are pregnant, breastfeeding, trying to get pregnant, or might become pregnant in the future.' Public-health experts immediately pushed back against the announcement. 'Despite the change in recommendations from HHS, the science has not changed," said Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, in a press statement. "It is very clear that COVID infection during pregnancy can be catastrophic and lead to major disability, and it can cause devastating consequences for families. The COVID vaccine is safe during pregnancy and vaccination can protect our patients and their infants.' The makers of the most-administered COVID-19 vaccines—Pfizer-BioNTech and Moderna—did not immediately respond to requests for comment. But in response to the FDA's other recent restriction of COVID-19 vaccine eligibility, Pfizer said it "[stood] by the science behind the Pfizer-BioNTech COVID-19 vaccine and continue to believe that broad vaccination programs are an essential tool for helping to prevent COVID-19 associated hospitalizations and severe disease, including death," while Moderna said it "remain[ed] committed to working with the Agency to provide the data they need to ensure access for Americans." Here's what to know about the unusual reversal in guidance. How do decisions like this typically get made? In the U.S., the FDA approves vaccines after reviewing studies on their safety and efficacy, and the CDC makes recommendations about who should be vaccinated and when, based on advice from an advisory committee of experts. It's not clear whether that committee was consulted before Kennedy made the change; TIME contacted several members, and one declined to comment while others did not immediately respond for comment. 'This decision bypasses a long-established, evidence-based process used to ensure vaccine safety and ignores the expertise of independent medical experts, including members of the CDC committees who are examining the evidence regarding the vaccine to make recommendations for the fall,' said Dr. Sean O'Leary, chair of the American Academy of Pediatrics Committee on Infectious Diseases in a statement to TIME. What the decision might mean for you For the public, the decision could mean more obstacles to getting COVID-19 vaccines, and higher prices if they do manage to gain access. Insurers make decisions about which shots to cover based on CDC recommendations—in particular for children—and if the COVID-19 vaccine is no longer part of CDC's recommended immunizations, insurers could stop covering them, forcing parents who wish to vaccinate their children to pay out of pocket for the shots. Do kids and pregnant women still need COVID-19 vaccines? During the pandemic, when the COVID-19 vaccines were first authorized and then approved, federal health officials focused on using the shots to control severe disease and lower hospitalizations and deaths—not prevent infection. Kennedy, who has long been a skeptic of vaccines in general and continues to openly question their safety, and his health officials have publicly discussed whether the same recommendations for COVID-19 vaccines are still relevant today, when more people have developed immunity to the virus either from repeated vaccinations, infections, or both. A week before this announcement, the FDA said it would limit COVID-19 vaccine approvals to those at highest risk of severe disease, and require additional studies on healthier people to confirm the shots' safety and effectiveness. Still, some infectious diseases experts note that in the U.S., during the peak of the latest winter respiratory disease season, just over 400,000 people were hospitalized with COVID-19, and several hundred people died each week. Those most vulnerable to complications that send them to the hospital were older people, those with weakened immune systems, and those who were pregnant. Given the potential risk of Long COVID and some of the still unknown long-term effects of recovering from an infection, the CDC still advises that 'getting a COVID-19 vaccine is a safer, more reliable way to build protection than getting sick with COVID-19.' That's especially true for pregnant women, who may also pass on the protection they receive from getting vaccinated to their newborns in the first six months, before the infants can get immunized. 'By removing the recommendation, the decision could strip families of choice,' said O'Leary. 'What is clear is that pregnant women, infants and young children are at higher risk of hospitalization from COVID, and the safety of the COVID vaccine has been widely demonstrated.'
Yahoo
23-05-2025
- Health
- Yahoo
FDA advisers recommend Covid vaccine updates to target new strains
The Food and Drug Administration's advisory committee unanimously recommended that newest vaccines for Covid should be updated to target a variant of strains currently on the rise, during a meeting on Thursday – the first since the Trump administration took office. The meeting focused on selecting a Covid strain to target in upcoming vaccines as well as formalizing new FDA rules that limit vaccine access to Americans. Though it was intended to help advisers recommend strains for the upcoming year's booster shots to the FDA, the meeting came in the context of upheaval at the federal health department. 'We have a very specific and important goal,' said Arnold Monto, professor of epidemiology at the University of Michigan School of Public Health and chair of the committee. 'We are asking for guidance to help the FDA decide what strain to select for going forward.' On Tuesday, Trump administration health officials announced they would take a less 'aggressive' approach to booster shots and require placebo-controlled trials for healthy individuals younger than 65. 'As many of you all know, this week in the New England Journal of Medicine the commissioner and I revealed a framework for Covid-19 policy,' said Vinay Prasad, the director of the Center for Biologics Evaluation and Research at the Food and Drug Administration, which oversees vaccines. He said the new framework would generate 'important and relevant information for the American people', referring to new trial requirements. The plan includes limiting access to Covid-19 vaccines to people 65 and older and others who are considered high-risk, as well as requiring manufacturers to conduct clinical trials to show whether the vaccines benefit healthy younger adults and children. The FDA's vaccines and related biological products advisory committee, a group of independent vaccine experts, concluded their all-day meeting by unanimously recommending that Covid vaccines for the 2025-2026 period target newer strains of the JN.1 variant. Although their decision is not binding, the FDA usually takes their advice. Currently, the US has three Covid-19 vaccines approved – Pfizer-BioNTech, Moderna and Novavax. Typically, the FDA advisory committee would recommend formulations for shots and whether they should be approved, with a separate advisory committee at the CDC creating recommendations for who should get the shots. Trump administration officials took the unusual step of announcing a policy change rather than seeking independent guidance from its own expert committees first. Prassad joined the FDA after the longtime vaccine head Peter Marks quit, citing Kennedy's refusal to accept information that did not comport with his long-held opinions questioning vaccine safety. According to the CDC, the LP.8.1 strain, a subvariant of the JN.1 strain, accounted for 70% of total cases in the US over a two-week period that ended on 10 May. Covid-19 evolved less than in previous years, CDC microbiologist and immunologist Natalie Thornburg told the advisory committee. Most viruses currently circulating are descendants of the JN.1 virus variant, she said, though there is potential for that to be replaced. Wastewater in South Africa detected a new variant dubbed BA.3.2, which could indicate a shift in the virus. However, very few sequences of that variant have been identified globally. Government experts presenting to the committee emphasized that Covid-19 was still causing a significant number of deaths in the US. Hospitalization rates have declined overall since 2021-2022 but are highest among people older than 65 and children younger than six months old. Since October of last year, an estimated 30,000 to 50,000 people have died from the virus and between 260,000 and 430,000 have been hospitalized, according to data from the CDC. 'When you add up those cumulative rates over a 12-month period, Covid-19 is still causing an enormous burden on the US health system,' said Ruth Link-Gelles, an epidemiologist with the CDC. Overall, almost all people in the US have experienced a Covid infection, meaning nearly everyone has some level of infection-induced immunity when vaccine efficacy was measured, but that immunity is believed to wane over time. Vaccine-induced immunity, in this context, should be viewed as an 'added benefit', according to a CDC epidemiologist presenting to the committee. Vaccine effectiveness could not be estimated for 2024-25 in children because of the low level of coverage and relatively low level of disease compared with earlier seasons. Last season had a lower overall rate of Covid hospitalization among children – though the youngest children notably had the worst hospitalization rates.
India Today
23-05-2025
- Health
- India Today
Covid-19 vaccine rules may change from 2025: What you should know
The US Food and Drug Administration (FDA) is planning to make big changes to COVID-19 vaccine recommendations. On May 20, FDA officials said that in the future, annual COVID-19 booster shots for healthy people under 65 would be approved only if drug companies carry out detailed clinical implemented, the updated vaccines might be available to older adults only and people who are at high risk of getting seriously sick from COVID-19, according to FDA also wants Pfizer and Moderna to add warnings to their vaccine labels to explain the small risk that males, aged 16 to 25, could develop heart inflammation after vaccination. According to previous studies by the Centres for Disease Control and Prevention (CDC), the new COVID-19 vaccines have reduced the risk of hospitalisation to around 33% in those with compromised immune systems. However, the benefits in healthy individuals are still not quite clear. Therefore, according to the FDA, more testing is OFFICIALS SAY BOOSTERS MAY NOT BE NEEDED FOR ALLFDA Commissioner Dr. Marty Makary and vaccine official Dr. Vinay Prasad wrote in the New England Journal of Medicine that while the original development of COVID-19 vaccines in 2020 was a huge achievement, it's not clear whether healthy people still need yearly explained that many countries have limited vaccine access to older adults or people with health problems. However, the US still lets nearly everyone over six months old get a shot."The US policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age-and-risk-based recommendations," they wrote. "We reject this view."Makary and Prasad proposed that the FDA would allow boosters without conducting full trials for adults above 65 and people with medical conditions like asthma, cancer, or cystic fibrosis."We simply don't know whether a healthy 52-year-old woman with a normal BMI who has had COVID-19 three times and has received six previous doses of a COVID-19 vaccine will benefit from the seventh dose,' the doctors wrote. 'This policy will compel much-needed evidence generation."PFIZER RESPONDS TO FDA'S PLANPfizer, one of the major vaccine makers, is still reviewing the FDA's proposal. "We stand by the science behind the Pfizer-BioNTech COVID-19 vaccine and continue to believe that broad vaccination programs are an essential tool for helping to prevent COVID-19-associated hospitalisations and severe disease, including death," Pfizer said in a statement to USA TODAY on May Watch
