Latest news with #LakshmiPanagiotakopoulos
Boston Globe
2 days ago
- Health
- Boston Globe
Why young children may not get COVID shots this fall
In July, the FDA granted full approval to Moderna's COVID vaccine for children — but only for those who have health conditions that may put them at increased risk should they become infected. Novavax's COVID vaccine has never been available for children younger than 12. The upshot is that if the FDA does not renew Pfizer's authorization for children 6 months to 4 years, or fully approve the vaccine, healthy children in that age group will have no officially sanctioned options — although doctors may still choose to provide the vaccine 'off label.' Advertisement That the FDA might rescind the authorization was first reported by The Guardian. 'Unfortunately, this leaves one of the vulnerable groups, specifically healthy children less than 2 years old, without access to a safe vaccine that's known to prevent hospitalization and death,' said Dr. Lakshmi Panagiotakopoulos, who oversaw the CDC's work group on the COVID vaccine before she resigned in June. Advertisement The risk of severe illness and hospitalization among children younger than 1 who are infected with the coronavirus is comparable to that among adults 65 and older. That's why experts have said that a child's first exposure should be through a vaccine, rather than infection. A late-summer COVID wave is moving across the nation, even as children are preparing to return to school. Fortunately, hospitalization rates remain low. In May, Health Security Robert F. Kennedy Jr. announced that COVID vaccines would no longer be offered to healthy children or pregnant women. Kennedy has called the Pfizer and Moderna vaccines dangerous. In May 2021, in the thick of the pandemic, he filed a petition with the FDA demanding that the agency revoke authorization for the shots. The CDC, which typically makes such recommendations, later walked back the secretary's statement, saying that healthy children could get the shot if a doctor agreed that it was needed. Moderna told the CDC it was ramping up supplies of its vaccine for the fall, according to the agency's email. But it is not approved for healthy children, and if the FDA rescinds authorization for children younger than 5, parents of healthy children will find themselves with no options. Andrew Nixon, a spokesperson for the Department of Health and Human Services, declined to comment on potential regulatory changes and said any reports before an official statement should be treated as 'speculation.' 'The COVID-19 pandemic ended with the expiration of the federal public health emergency in May 2023,' Nixon said. But public health experts noted that the coronavirus is still a threat, even for otherwise healthy children younger than 2. Among children ages 6 months to 2 years who were hospitalized with COVID from October 2022 to April 2024, more than half had no underlying medical conditions, according to data from the CDC. Advertisement The vaccines have also been shown to offer modest protection against long COVID in some children. The effects are already becoming apparent. Providers have stopped ordering last year's shot, as they often do at this time of the year. Normally by this point, there would be a clear plan for the 2025-26 season. Leanne Cronic-Powell, 36, a lawyer for a software company in Medford, Massachusetts, called four clinics but could not find one that could offer the COVID vaccine to her daughter later this month. Anticipating that the shots might be difficult to find in the fall, Cronic-Powell had opted to have her 8-month-old daughter, Ripley, immunized in June, soon after she was eligible. Ripley has received two of the three Pfizer doses in the primary series but cannot receive the third, which is due Aug. 22. 'I'm really frustrated,' she said. 'It feels like we're being thwarted at every turn.' The Massachusetts Department of Public Health, when Cronic-Powell turned to it for guidance, was not any wiser. 'At this time, sadly, there is not much more we can do to help as we do not have any further information from the CDC/FDA,' a representative told her in an email Monday viewed by the Times. The path to a COVID vaccine may not be much smoother even for children at high risk. About half of American children receive their shots through the Vaccines for Children program, which provides them free of cost. But providers who are enrolled in the program are not required to carry COVID vaccines. Advertisement 'Providers already don't order a lot of COVID vaccine, so this is going to very much complicate things,' said Claire Hannan, executive director of the Association of Immunization Managers, which represents state and local officials. If providers decide not to carry the COVID shots, 'it's going to be hard to find even if you're high risk,' Hannan said. This article originally appeared in .
Yahoo
05-06-2025
- Health
- Yahoo
CDC official who oversaw COVID-19 vaccine recommendations has resigned following HHS rollback
An official who oversaw the recommendations for COVID-19 vaccinations at the Atlanta-based Centers for Disease Control has resigned. Dr. Lakshmi Panagiotakopoulos resigned on Friday. 'My career in public health and vaccinology started with a deep-seated desire to help the most vulnerable members of our population, and that is not something I am able to continue doing in this role,' she wrote in her resignation letter obtained by Channel 2 Action News. Panagiotakopoulos co-led a part of the CDC's independent panel of vaccine advisers to review evidence for recommendations on COVID vaccines. Last Week, U.S. Health Secretary Robert F. Kennedy Jr. announced that COVID-19 vaccines will no longer be recommended for healthy children and pregnant women. In mid-April, advisers had discussed the possibility of narrowing the recommendations for who should receive an annual COVID vaccine -- prioritizing those at higher risk, such as adults over 65 or those with an underlying condition, ABC News reported on Wednesday. Last Thursday, the CDC updated its website. The agency said that shots may be given to children ages 6 months to 17 years who do not have moderate or severe problems with their immune systems. Instead of recommending the shots, the CDC now says parents may decide to get their children vaccinated in consultation with a doctor. TRENDING STORIES: Driver hospitalized after car flips, split in half during crash on GA highway Man tries to carjack 2 victims, police say. Then a good Samaritan jumped in to help Trump threatens to cut Musk's government contracts as their public feud escalates 'The old COVID-19 vaccine recommendations for healthy children under 18 and for pregnant women have been removed from the CDC vaccine schedule,' an HHS spokesperson said in a statement. 'The CDC and HHS encourage individuals to talk with their healthcare provider about any personal medical decision.' Childhood vaccination rates for COVID-19 are already low — just 13% of children and 23% of adults have received the 2024-25 COVID-19 vaccine, according to CDC data. Talk of changing the recommendations has been brewing. As the COVID-19 pandemic has waned, experts have discussed the possibility of focusing vaccination efforts on people 65 and older — who are among those most as risk for death and hospitalization. A CDC advisory panel is set to meet in this month to make recommendations about the fall shots. Among its options are suggesting shots for high-risk groups but still giving lower-risk people the choice to get vaccinated. A committee work group has endorsed the idea. But Kennedy, a leading anti-vaccine advocate before becoming health secretary, decided not to wait for the scientific panel's review. The new vaccine recommendation changes, their timing and the way there were announced have created confusion that can be 'incredibly harmful to the success of vaccination programs,' Schwartz said. 'It would be understandable if the public is completely baffled in terms of what the federal government thinks and what the science suggests ... about the evidence for the safety and value of these vaccines,' he added. American Academy of Pediatrics President Dr. Susan Kressly said the organization is relieved that families wanting COVID-19 shots for their children will still be able to get them. 'However,' she added, '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.' The Associated Press and ABC News contributed to this article.
05-06-2025
- Health
CDC official who oversaw COVID vaccine recommendations resigns
An official at the Centers for Disease Control and Prevention who oversaw the agency's recommendations for COVID-19 vaccines has resigned, following a week of mixed messaging from federal health officials over who would be eligible for the shots. "My career in public health and vaccinology started with a deep-seated desire to help the most vulnerable members of our population, and that is not something I am able to continue doing in this role," Dr. Lakshmi Panagiotakopoulos wrote in her resignation letter obtained by ABC News. In her letter, Panagiotakopoulos said she resigned last Friday. Reuters first reported her resignation. Panagiotakopoulos co-led a part of the CDC's independent panel of vaccine advisers to review evidence for recommendations on COVID vaccines. In mid-April, the advisers had discussed the possibility of narrowing the recommendations for who should receive an annual COVID vaccine -- prioritizing those at higher risk such as adults over 65 or those with an underlying condition. Last week, Health and Human Services Secretary Robert F. Kennedy Jr. announced the removal of COVID vaccines from the immunization schedule for healthy children and healthy pregnant women. Later on Friday, the CDC updated the immunization schedule allowing all children to be eligible to receive COVID vaccines, now under a shared clinical decision-making model, which means parents can choose to get their children vaccinated with the advice of a doctor. The mixed messages prompted concern from some medical organizations. "American families deserve better," the American Academy of Pediatrics (AAP) said, in part, in a statement. "They deserve clear messages from all involved in their health, that are based on facts so they can continue to benefit from the success story of vaccines." The statement went on to say: "While the shared clinical decision-making model in the updated immunization schedule preserves families' choice, this model has consistently proven challenging to implement because it lacks clear guidance for the conversations between a doctor and a family. Doctors and families need straightforward, evidence-based guidance, not vague, impractical frameworks," the AAP statement added. Pregnant women were left without a recommendation on the CDC's immunization schedule as to whether or not to receive the COVID vaccine. Despite the change in recommendations from HHS, "the science has not changed," the American College of Obstetricians and Gynecologists (ACOG) said in part of a statement. "It is very clear that COVID-19 infection during pregnancy can be catastrophic and lead to major disability, and it can cause devastating consequences for families. The COVID-19 vaccine is safe during pregnancy, and vaccination can protect our patients and their infants after birth," the ACOG statement added. Federal officials had made the changes to the vaccine recommendations without the input of the CDC's independent panel of vaccine advisers and before their meeting set for late June, according to the public calendar. In the meeting, advisers were set to discuss their recommendation for who should be eligible for COVID vaccines including a vote on whether to narrow the recommendations. "Governmental guidance about vaccines is an important foundation that enables insurance coverage of—and therefore access to—vaccines, so changing government recommendations about which specific and limited populations should receive COVID-19 vaccines has far-reaching consequences," the Infectious Disease Society of America (IDSA) said in part of a statement. Some medical and public health organizations had expressed concerns at the officials' change to vaccine recommendations without the input of independent advisers. "Federal vaccine recommendations have traditionally been developed by medical and public health experts who gather openly to review evidence and receive public input before recommending what vaccines are needed and who should be eligible for them. Conclusions are based on the best available science, and recommendations are communicated with precision and clarity, providing guidance to clinicians to make the best decisions with their patients," part of the IDSA statement read.
Yahoo
05-06-2025
- Health
- Yahoo
CDC official who oversaw COVID vaccine recommendations resigns
An official at the Centers for Disease Control and Prevention who oversaw the agency's recommendations for COVID-19 vaccines has resigned, following a week of mixed messaging from federal health officials over who would be eligible for the shots. "My career in public health and vaccinology started with a deep-seated desire to help the most vulnerable members of our population, and that is not something I am able to continue doing in this role," Dr. Lakshmi Panagiotakopoulos wrote in her resignation letter obtained by ABC News. In her letter, Panagiotakopoulos said she resigned last Friday. Reuters first reported her resignation. MORE: RFK Jr. cuts COVID vaccine recommendation for healthy kids, pregnant women -- and why it matters Panagiotakopoulos co-led a part of the CDC's independent panel of vaccine advisers to review evidence for recommendations on COVID vaccines. In mid-April, the advisers had discussed the possibility of narrowing the recommendations for who should receive an annual COVID vaccine -- prioritizing those at higher risk such as adults over 65 or those with an underlying condition. Last week, Health and Human Services Secretary Robert F. Kennedy Jr. announced the removal of COVID vaccines from the immunization schedule for healthy children and healthy pregnant women. Later on Friday, the CDC updated the immunization schedule allowing all children to be eligible to receive COVID vaccines, now under a shared clinical decision-making model, which means parents can choose to get their children vaccinated with the advice of a doctor. MORE: Why healthy children may need vaccination as RFK Jr. cuts COVID shot recommendation for some kids The mixed messages prompted concern from some medical organizations. "American families deserve better," the American Academy of Pediatrics (AAP) said, in part, in a statement. "They deserve clear messages from all involved in their health, that are based on facts so they can continue to benefit from the success story of vaccines." The statement went on to say: "While the shared clinical decision-making model in the updated immunization schedule preserves families' choice, this model has consistently proven challenging to implement because it lacks clear guidance for the conversations between a doctor and a family. Doctors and families need straightforward, evidence-based guidance, not vague, impractical frameworks," the AAP statement added. Pregnant women were left without a recommendation on the CDC's immunization schedule as to whether or not to receive the COVID vaccine. Despite the change in recommendations from HHS, "the science has not changed," the American College of Obstetricians and Gynecologists (ACOG) said in part of a statement. "It is very clear that COVID-19 infection during pregnancy can be catastrophic and lead to major disability, and it can cause devastating consequences for families. The COVID-19 vaccine is safe during pregnancy, and vaccination can protect our patients and their infants after birth," the ACOG statement added. MORE: Why are more than 300 people in the US still dying from COVID every week? Federal officials had made the changes to the vaccine recommendations without the input of the CDC's independent panel of vaccine advisers and before their meeting set for late June, according to the public calendar. In the meeting, advisers were set to discuss their recommendation for who should be eligible for COVID vaccines including a vote on whether to narrow the recommendations. "Governmental guidance about vaccines is an important foundation that enables insurance coverage of—and therefore access to—vaccines, so changing government recommendations about which specific and limited populations should receive COVID-19 vaccines has far-reaching consequences," the Infectious Disease Society of America (IDSA) said in part of a statement. Some medical and public health organizations had expressed concerns at the officials' change to vaccine recommendations without the input of independent advisers. "Federal vaccine recommendations have traditionally been developed by medical and public health experts who gather openly to review evidence and receive public input before recommending what vaccines are needed and who should be eligible for them. Conclusions are based on the best available science, and recommendations are communicated with precision and clarity, providing guidance to clinicians to make the best decisions with their patients," part of the IDSA statement read.
Yahoo
05-06-2025
- Health
- Yahoo
CDC official who oversaw COVID vaccine recommendations resigns
An official at the Centers for Disease Control and Prevention who oversaw the agency's recommendations for COVID-19 vaccines has resigned, following a week of mixed messaging from federal health officials over who would be eligible for the shots. "My career in public health and vaccinology started with a deep-seated desire to help the most vulnerable members of our population, and that is not something I am able to continue doing in this role," Dr. Lakshmi Panagiotakopoulos wrote in her resignation letter obtained by ABC News. In her letter, Panagiotakopoulos said she resigned last Friday. Reuters first reported her resignation. MORE: RFK Jr. cuts COVID vaccine recommendation for healthy kids, pregnant women -- and why it matters Panagiotakopoulos co-led a part of the CDC's independent panel of vaccine advisers to review evidence for recommendations on COVID vaccines. In mid-April, the advisers had discussed the possibility of narrowing the recommendations for who should receive an annual COVID vaccine -- prioritizing those at higher risk such as adults over 65 or those with an underlying condition. Last week, Health and Human Services Secretary Robert F. Kennedy Jr. announced the removal of COVID vaccines from the immunization schedule for healthy children and healthy pregnant women. Later on Friday, the CDC updated the immunization schedule allowing all children to be eligible to receive COVID vaccines, now under a shared clinical decision-making model, which means parents can choose to get their children vaccinated with the advice of a doctor. MORE: Why healthy children may need vaccination as RFK Jr. cuts COVID shot recommendation for some kids The mixed messages prompted concern from some medical organizations. "American families deserve better," the American Academy of Pediatrics (AAP) said, in part, in a statement. "They deserve clear messages from all involved in their health, that are based on facts so they can continue to benefit from the success story of vaccines." The statement went on to say: "While the shared clinical decision-making model in the updated immunization schedule preserves families' choice, this model has consistently proven challenging to implement because it lacks clear guidance for the conversations between a doctor and a family. Doctors and families need straightforward, evidence-based guidance, not vague, impractical frameworks," the AAP statement added. Pregnant women were left without a recommendation on the CDC's immunization schedule as to whether or not to receive the COVID vaccine. Despite the change in recommendations from HHS, "the science has not changed," the American College of Obstetricians and Gynecologists (ACOG) said in part of a statement. "It is very clear that COVID-19 infection during pregnancy can be catastrophic and lead to major disability, and it can cause devastating consequences for families. The COVID-19 vaccine is safe during pregnancy, and vaccination can protect our patients and their infants after birth," the ACOG statement added. MORE: Why are more than 300 people in the US still dying from COVID every week? Federal officials had made the changes to the vaccine recommendations without the input of the CDC's independent panel of vaccine advisers and before their meeting set for late June, according to the public calendar. In the meeting, advisers were set to discuss their recommendation for who should be eligible for COVID vaccines including a vote on whether to narrow the recommendations. "Governmental guidance about vaccines is an important foundation that enables insurance coverage of—and therefore access to—vaccines, so changing government recommendations about which specific and limited populations should receive COVID-19 vaccines has far-reaching consequences," the Infectious Disease Society of America (IDSA) said in part of a statement. Some medical and public health organizations had expressed concerns at the officials' change to vaccine recommendations without the input of independent advisers. "Federal vaccine recommendations have traditionally been developed by medical and public health experts who gather openly to review evidence and receive public input before recommending what vaccines are needed and who should be eligible for them. Conclusions are based on the best available science, and recommendations are communicated with precision and clarity, providing guidance to clinicians to make the best decisions with their patients," part of the IDSA statement read.
