Latest news with #CovidVaccines
The Guardian
3 hours ago
- General
- The Guardian
A ‘war on children': as US changes Covid vaccine rules, parents of trial volunteers push back
As the Trump administration contemplates new clinical trials for Covid boosters and moves to restrict Covid vaccines for children and others, parents whose children participated in the clinical trials expressed anger and dismay. 'It's really devastating to see this evidence base officially ignored and discarded,' said Sophia Bessias, a parent in North Carolina whose two- and four-year-old kids were part of the Pfizer pediatric vaccine trial. 'It's infuriating. My kids contributed literal blood and tears to help demonstrate the safety of these vaccines,' Bessias said. 'As a parent and also a pediatrician, I think it's devastating that we might no longer have the option to protect kids against Covid,' said Katherine Matthias, a pediatrician in South Carolina and a cofounder of Protect Their Future, a children's health organization. Robert F Kennedy Jr, head of the US Department of Health and Human Services (HHS), has called for new trials using saline placebos for each of the routine childhood vaccines recommended by the Centers of Disease Control and Prevention (CDC), even though these vaccines have already been tested against placebos or against vaccines that were themselves tested against placebos. Marty Makary, the head of the US Food and Drug Administration (FDA), and Vinay Prasad, the FDA's vaccines chief, outlined a plan in a recent editorial to restrict Covid boosters for anyone under the age of 65 without certain health conditions. For everyone else between the ages of six months and 64 years old, each updated Covid vaccine would need to undergo another randomized controlled clinical trial, Makary and Prasad said. It's not clear when, how or whether this plan will be implemented officially. On Tuesday, top US health officials said on the social media site X that they would remove the recommendation for Covid vaccination from the childhood immunization schedule, and would also cease recommending it for pregnant people, who have much higher risks of illness, death and pregnancy complications with Covid. On Friday, the CDC appeared to contradict that announcement by keeping Covid vaccines as a routine immunization for children – though the agency now says health providers 'may' recommend the vaccine, instead of saying they 'should' recommend it. Changing recommendations could affect doctors' and parents' understanding of the safety and effectiveness of the vaccines. Vaccines recommended by the CDC are also covered by the federal Vaccines for Children program, and health insurers are required to cover the costs of routine vaccines. It's not clear if the wording change from 'should' to 'may' will affect that coverage. If insurance no longer covers the vaccines, pediatricians are less likely to keep many of the shots in stock, Matthias said, and pharmacies are limited by different state laws on which ages they may vaccinate – which means families who want the vaccines may not be able to find them. Matthias drove her children, then aged 15 months and 14 years old, two hours each way to a Moderna pediatric trial. They did six or seven visits, plus two visits to receive the actual vaccines after they learned they had received placebos. Child participants spent hours on each visit and endured blood draws, Covid swabs, regular symptom and temperature monitoring, and, of course, several shots. Each shot was followed by a week of daily journaling and side-effect reporting. Participants who got Covid, even months later, had blood draws to check their antibody responses. 'It was a pretty big commitment of our time and energy. But I did it because I wanted to be sure that my kids and all kids had access to vaccines,' Matthias said. Laura Labarre, a parent in Oregon, said the trials involved 'committing to something that felt important but larger than ourselves, because it ended up being a lot of work and a lot of logistics and a lot of effort'. She drove her two kids, then aged one and three, an hour and a half each way to a Pfizer trial, and searched for ways to keep them occupied for hours on end. When most people hear about new developments in pediatric medicine, such as new vaccines, they don't often consider the hard work of volunteers, some only a few months old, who made the trials possible, Labarre said. 'I don't think people consider the toll on the families who are the ones who bravely and nervously put their children up to be the first to try it out,' she said. When Nick Giglia got the call asking if he still wanted to enroll his one-year-old daughter in the Pfizer pediatric vaccine trial, he immediately said yes. For eight visits, extending over nearly a year, he would drive an hour each way to a trial in New Jersey. In all, his daughter received seven shots – three saline placebos, three vaccines and a booster. Sign up to This Week in Trumpland A deep dive into the policies, controversies and oddities surrounding the Trump administration after newsletter promotion 'It was very rigorous,' Giglia said of the study design. Now, he said, 'it's really difficult to hear people harping on the thoughts of there not being the placebo group. Well, it's news to me. My kid was in the placebo group,' he said. Parents who were eager to enroll in the original trials now wonder whether families would want to endure another round of placebo-controlled trials for updated vaccines. 'Finding the number of participants that they would need would be extremely difficult,' Matthias said. 'To think that they would subject anyone, let alone children, to potentially getting the placebo in a trial where we know that the control is already so beneficial for health, just seems highly unethical and really disturbing,' Labarre said. 'A new trial today would not add anything we don't already know,' Bessias said. 'It would feel like actually participating in a project of undermining the existing evidence, rather than contributing new evidence.' And the whole point of updating the vaccines is to counter new strains, Matthias said. Those vaccines would be out of date by the conclusion of a new study, which could take years. 'People should have the option' to get Covid vaccines, Matthias said. 'The people who don't want it don't have to get it.' When Matthias enrolled her kids in 2021, she felt as though they were in a limbo, and 'we were all just desperate to get our kids protected', she said. 'To kind of have that feeling coming back now – we worked so hard and we advocated so much to get our kids access and now it might just be taken away – is really upsetting.' While Covid mortality rates are highest among people over the age of 65, Covid is still the eighth leading cause of all deaths among children. Any child dying a preventable death is a tragedy, Bessias said. 'We have to take a step back and realize that absolute numbers matter, too. And we can really avoid a lot of hospitalizations and deaths and transmission and horrible experiences for families by reaching those younger children. It's baffling because that seems to be completely left out of these discussions.' Labarre feels 'profoundly enraged and betrayed' by the Trump administration's actions. Limiting access to the vaccine, especially while proposing cuts to Snap and Medicaid, feels like 'an additional audacious battlefront they've opened up in this sort of war on children', she said. 'It is destabilizing, frustrating and enraging to feel like my daughter, who wasn't even 18 months old, has done more for public health than some people who are now currently in charge of it,' Giglia said. 'It is very frustrating to hear that sacrifice that we volunteered to make for the country, and frankly, the world, belittled.' At the end of the trial, Giglia's daughter was given a stuffed teddy bear in a sweater that said 'Covid-19 vaccine study hero'. 'I don't care what anybody says. That's what she is,' Giglia said. 'I look forward to one day being able to tell my little girl all about how she helped save the world. And it's hard to hear that many people think that we did the exact opposite.'
Daily Mail
3 days ago
- Business
- Daily Mail
CDC defies RFK Jr and Trump with bombshell vaccine maneuver
Covid vaccines are still being recommended for children despite Robert F Kennedy Jr 's push to remove them, according to new CDC guidance. Revisions to the CDC's vaccine schedules published late Thursday show the Pfizer and Moderna Covid vaccines are still recommended for healthy children over six months old. The Novavax shot is on the schedule for children 12 years and older. The guidance comes after Kennedy's announcement earlier this week that the shots would no longer be routinely offered to healthy children and pregnant women. RFK Jr said he 'couldn't be more pleased' to make the announcement, adding that it was 'common sense' and 'good science.' However, the revisions also state the shot is no longer advised for pregnant women, adding to the confusion surrounding the Trump administration's influence on CDC guidance. The CDC recommends the Covid vaccines for children based on 'shared clinical decision-making,' meaning children can get the shot if their parents and doctors agree. The new language states: '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.' Andrew Nixon, spokesman for the Department of Health and Human Services (HHS), told the Washington Post 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 claimed during his initial announcement that there was a 'lack of any clinical data to support the repeat booster strategy in children.' The FDA is also reportedly re-analyzing whether the evidence supports boosting healthy people under 65 against Covid. Normally, changes to the vaccine schedule would go through a consultation period and the CDC's vaccines advisory body — the Advisory Committee on Immunization Practices — before being made by the HHS Secretary. However, the CDC currently doesn't have an acting director. revealed in February how several members of Trump's administration were pushing for tighter restrictions on the Covid vaccine. The Make America Healthy Again (MAHA) Commission's first report published earlier this month also criticized the 'overmedicalization' of children and suggested paring down the vaccine schedule as a whole. Uptake of Covid booster shots has dropped in the US, with data showing that just 23 percent of those eligible for the booster, aged six months and over, came forward for last year's shot. Experts say this is linked to America's health insurance scheme, with the wide eligibility aiming to ensure that everyone is covered for accessing the shots. Kennedy has a history of opposition to the Covid vaccines, saying in 2021 that the shots were the 'deadliest vaccine ever made'. That same year, he also filed a petition with the FDA requesting the authorization of the Covid vaccines be revoked. Covid vaccines are thought to have saved millions of lives in the US, and the risk of adverse effects like heart inflammation is rare, occurring in just one in 200,000 cases.
New York Times
3 days ago
- General
- New York Times
C.D.C. Contradicts Kennedy and Keeps Advice That Children May Get Covid Shots
Days after Health Secretary Robert F. Kennedy Jr. announced that Covid shots would be removed from the federal immunization schedule for children, the Centers for Disease Control and Prevention issued updated advice that largely counters Mr. Kennedy's new policy. The agency kept Covid shots on the schedule for children 6 months to 17 years old with a new condition. Children and their caregivers will be able to get the vaccines in consultation with a doctor or provider, which the agency calls 'shared decision-making.' The shots will also continue to be available under those terms to about 38 million low-income children who rely on the Vaccines for Children program, according to an emailed update from the C.D.C. on Friday. However, the picture is less certain now for pregnant women, a group the C.D.C. had considered to be at high risk for a bad outcome from the virus. The official C.D.C. position for pregnant women is 'no guidance,' according to a communication released from the agency Friday. Mr. Kennedy's pronouncement on Tuesday had included a decision to drop the recommendation for pregnant women to receive Covid shots. The C.D.C.'s new guidance on pregnant women is a troubling turn of events for experts familiar with research showing that their risk of stillbirth, hospitalization and death rises if they have Covid. Dr. Michelle Fiscus, a pediatrician and chief medical officer with the Association of Immunization Managers, said that based on federal health officials' statements in recent days, she had expected to see a recommendation for pregnant women to get the vaccine if they had an additional condition putting them at high risk.
The Independent
5 days ago
- Health
- The Independent
New Covid variant may spread more easily than others
A new Omicron subvariant, NB.1.8.1, is spreading in the U.S. after a surge in China, though LP.8.1 remains the dominant strain nationally. The World Health Organization has designated NB.1.8.1 a variant under monitoring, noting its spread to 22 countries, including the U.S., and a rise in prevalence from late March to April. The WHO states that current data suggests NB.1.8.1 does not cause more severe illness than other variants, but it may spread more easily due to its ability to bind more tightly to human cells. Experts believe current Covid vaccines should remain effective against NB.1.8.1 in preventing severe disease. The Trump administration's plan to limit access to Covid vaccines is raising concerns among experts about potential impacts on vaccine availability and insurance coverage.
The Guardian
22-05-2025
- Health
- The Guardian
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 advisors 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 going forward 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 long-time 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 May 10. 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 is still causing a significant number of deaths mortality 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 to earlier seasons. Last season had a lower overall rate of Covid hospitalization among children – though the youngest children notably had the worst hospitalization rates.
