Latest news with #boosterShots
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.
The Verge
21-05-2025
- Health
- The Verge
The FDA is making it more difficult for Americans to get vaccinated for covid
The Trump administration is working to limit access to covid booster shots by creating more regulatory hoops for companies developing vaccines for 'healthy persons.' The Food and Drug Administration (FDA) says it's only prioritizing covid vaccine approvals for adults older than 65 and others over the age of 6 months who have at least one 'risk factor' for a severe case of covid-19. 'The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,' FDA officials write in commentary laying out their plans in the New England Journal of Medicine (NEJM). The move comes as notorious antivax crusader Robert F. Kennedy reshapes the US Department of Health and Human Services, recently pushing out the FDA's top vaccine official and thousands of other federal health workers. Some public health experts are already voicing skepticism over whether the FDA's new guidance for covid boosters will reap any benefits. 'This is overly restrictive and will deny many people who want to be vaccinated a vaccine.' 'This is overly restrictive and will deny many people who want to be vaccinated a vaccine,' Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University, said in an email to the New York Times. 'The only thing that can come of this will make vaccines less insurable and less available,' Paul Offit, a vaccine scientist, virologist, and professor of pediatrics at the Children's Hospital of Philadelphia, told The Associated Press. The FDA says it will require more data from additional clinical trials before approvals can be granted for covid-19 vaccines being developed for people not considered to be at heightened risk from severe sickness. It says 100 to 200 million Americans will still have annual access to covid vaccines after its policy change. That would be less than 60 percent of the US population. Last week, the agency approved the Novavax covid-19 vaccine for only older adults and people at higher risk from the disease. '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 NEJM commentary says. But previous CDC studies have shown that getting a booster can help prevent mild to moderate cases of covid up to six months after getting the shot regardless of whether a person is at higher risk or not, Offit tells The Associated Press. And even if someone does get sick, being vaccinated can make the illness shorter and less severe and reduce the risk of developing long covid, according to the Centers for Disease Control and Prevention. The rate of covid-19-associated hospitalizations was 71.2 per 100,000 people during the 2024–25 season, according to the CDC — although hospitals haven't been required to report covid-related hospital admissions to HHS since May of last year. Vaccines are an important safeguard for people with a weakened immune system. The FDA's new directive raises questions about whether people considered healthy will be able to get vaccinated if they want to protect someone close to them who's at greater risk. In the NEJM article, the FDA notes that covid booster uptake has been low in the US, with less than a quarter of people getting the shot each year. 'There may even be a ripple effect: public trust in vaccination in general has declined,' it says. 'It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,' Peter Marks, former director of the FDA's Center for Biologics Evaluation and Research (CBER) that regulates vaccines, wrote in a resignation letter in March.
The Verge
20-05-2025
- Health
- The Verge
The FDA is making it more difficult for many Americans to get vaccinated for covid
The Trump administration is working to limit access to covid booster shots by creating more regulatory hoops for companies developing vaccines for 'healthy persons.' The Food and Drug Administration (FDA) says it's only prioritizing covid vaccine approvals for adults older than 65 and others over the age of 6 months who have at least one 'risk factor' for a severe case of covid-19. 'The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,' FDA officials write in commentary laying out their plans in the New England Journal of Medicine (NEJM). The move comes as notorious antivax crusader Robert F. Kennedy reshapes the US Department of Health and Human Services, recently pushing out the FDA's top vaccine official and thousands of other federal health workers. Some public health experts are already voicing skepticism over whether the FDA's new guidance for covid boosters will reap any benefits. ''This is overly restrictive and will deny many people who want to be vaccinated a vaccine.' 'This is overly restrictive and will deny many people who want to be vaccinated a vaccine,' Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University, said in an email to the New York Times. 'The only thing that can come of this will make vaccines less insurable and less available,' Paul Offit, a vaccine scientist, virologist, and professor of pediatrics at the Children's Hospital of Philadelphia, told The Associated Press. The FDA says it will require more data from additional clinical trials before approvals can be granted for covid-19 vaccines being developed for people not considered to be at heightened risk from severe sickness. It says 100 to 200 million Americans will still have annual access to covid vaccines after its policy change. That would be less than 60 percent of the US population. Last week, the agency approved the Novavax covid-19 vaccine for only older adults and people at higher risk from the disease. '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 NEJM commentary says. But previous CDC studies have shown that getting a booster can help prevent mild to moderate cases of covid up to six months after getting the shot regardless of whether a person is at higher risk or not, Offit tells The Associated Press. And even if someone does get sick, being vaccinated can make the illness shorter and less severe and reduce the risk of developing long covid, according to the Centers for Disease Control and Prevention. The rate of covid-19-associated hospitalizations was 71.2 per 100,000 people during the 2024–25 season, according to the CDC — although hospitals haven't been required to report covid-related hospital admissions to HHS since May of last year. Vaccines are an important safeguard for people with a weakened immune system. The FDA's new directive raises questions about whether people considered healthy will be able to get vaccinated if they want to protect someone close to them who's at greater risk. In the NEJM article, the FDA notes that covid booster uptake has been low in the US, with less than a quarter of people getting the shot each year. 'There may even be a ripple effect: public trust in vaccination in general has declined,' it says. 'It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,' Peter Marks, former director of the FDA's Center for Biologics Evaluation and Research (CBER) that regulates vaccines, wrote in a resignation letter in March.
Bloomberg
20-05-2025
- Health
- Bloomberg
FDA Requires Studies of Covid Boosters for Healthy Kids, Adults
US regulators will no longer approve booster shots to prevent Covid infections for healthy adults and children without new clinical trials showing they are still safe and effective, adding a costly new requirement that could ultimately limit who gets the vaccines. Food and Drug Administration Commissioner Marty Makary and Vinay Prasad, who leads the agency's vaccine division, outlined the approach the agency intends to take with the Covid shots in an article published Tuesday in the New England Journal of Medicine.
