New federal guidance surrounding COVID vaccine authorization could make it more difficult for many people to be inoculated against the circulating \u2014 and, now, seasonally spiking \u2014 coronavirus. <\/p>\n
Under the approval for the updated COVID-19 vaccines that was issued Wednesday by the Food and Drug Administration, adults younger than 65 who are otherwise healthy would need to consult with a healthcare provider before getting the shot.<\/p>\n
Such a step is notably not required for annual flu shots, which are widely available and administered everywhere from pop-up clinics to grocery stores. <\/p>\n
It\u2019s the latest move by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., a vaccine skeptic<\/a>, and his allies aimed specifically at COVID vaccines, which were developed during President Trump\u2019s first term in an effort dubbed \u201cOperation Warp Speed.\u201d<\/a><\/p>\n The move also comes as COVID activity has increased this summer both in California and nationwide, with waning immunity from earlier vaccinations and previous infections cited as one factor.<\/p>\n In a post on X<\/a>, Kennedy said the guidance would \u201ckeep vaccines available to people who want them, especially the vulnerable,\u201d while demanding additional research.<\/p>\n \u201cThe American people demanded science, safety, and common sense,\u201d he wrote. \u201cThis framework delivers all three.\u201d<\/p>\n Some public health experts, however, criticized the move \u2014 saying it does not make sense to change the authorization guidelines this way. <\/p>\n \u201cThe nightmare continues,\u201d said Dr. Peter Chin-Hong, an infectious disease expert at UC San Francisco. He said that requiring people to speak with a healthcare provider before getting a COVID-19 vaccine is \u201ccompletely wrong\u201d and a \u201cbarrier,\u201d and he expects it\u2019ll make it harder for those who don\u2019t have a regular healthcare provider to get vaccinated. <\/p>\n The Infectious Diseases Society of America on Wednesday said <\/a>the FDA\u2019s decision \u201ccompletely contradicts the evidence base, severely undermines trust in science-driven policy and dangerously limits vaccine access, removing millions of Americans\u2019 choice to be protected and increasing the risk of severe outcomes from COVID.\u201d<\/p>\n The U.S. Centers for Disease Control and Prevention, which also fall under Kennedy\u2019s purview, earlier this year began requiring<\/a> parents of healthy children to talk with a healthcare provider before getting the COVID vaccine for their youngsters. <\/p>\n Chin-Hong said he had heard that this policy had led some pharmacists to stop vaccinating those children. <\/p>\n \u201cThey don\u2019t want to do it,\u201d Chin-Hong said, \u201cbecause they don\u2019t know, in this environment, if they would be considered a \u2018healthcare provider.\u2019\u201d <\/p>\n In a rebuke to the CDC\u2019s guidance, the American Academy of Pediatrics last week said it recommends<\/a> infants and children ages 6 months to 23 months get the updated COVID vaccine, since they are at high risk of severe illness. The vaccine should also be offered to children age 2 and older if their parent wishes, according to the organization.<\/p>\n Wednesday\u2019s announcement came hours before additional drama gripped the CDC, as the Trump administration moved to oust Director Susan Monarez, who was just confirmed to the post by the U.S. Senate 29 days earlier. <\/p>\n The Washington Post on Wednesday reported<\/a> that Monarez was being forced to leave after Kennedy and other officials asked her if she was aligned with efforts to change vaccine policy, and she declined to agree without consulting her advisors.<\/p>\n Lawyers for Monarez later said the director had neither been fired nor quit, and had no plans to resign. News reports later in the evening stated the White House had formally fired<\/a> Monarez.<\/p>\n \u201cSecretary Kennedy and HHS have set their sights on weaponizing public health for political gain and putting millions of American lives at risk,\u201d attorneys Mark S. Zaid and Abbe David Lowell said in a statement<\/a> posted on social media. \u201cWhen CDC Director Susan Monarez refused to rubber-stamp unscientific, reckless directives and fire dedicated health experts, she chose protecting the public over serving a political agenda.\u201d<\/p>\n Some CDC officials did resign Wednesday, including Dr. Demetre Daskalakis, director of the National Center for Immunization and Respiratory Diseases. He criticized recent changes in the CDC immunization schedule for children, as well as pregnant women. <\/p>\n \u201cAll of these moves are chilling, but they all are consistent in one thing, which is really increasing doubts and confusion about vaccines in general and public health,\u201d Chin-Hong said. <\/p>\n The CDC had long urged pregnant women to stay up-to-date on COVID-19 vaccines but, earlier this year, began saying it offers \u201cno guidance\u201d as to whether healthy pregnant women should get the vaccine. The American College of Obstetricians and Gynecologists last week recommended<\/a> that people receive the updated COVID-19 vaccine at any point during their pregnancy. <\/p>\n The new CDC policy, critics contend, has made it more difficult for pregnant women to get vaccinated. <\/p>\n In a resignation message posted on X, Daskalakis wrote<\/a> that recent changes in the CDC immunization schedule for adults and children \u201cthreaten the lives of the youngest Americans and pregnant people.\u201d <\/p>\n \u201cI have never experienced such radical non-transparency, nor have I seen such unskilled manipulation of data to achieve a political end rather than the good of the American people,\u201d Daskalakis said of efforts to support Kennedy\u2019s directives regarding vaccine policy. <\/p>\n \u201cThe intentional eroding of trust in low-risk vaccines favoring natural infection and unproven remedies will bring us to a pre-vaccine era where only the strong will survive and many if not all will suffer,\u201d he wrote. <\/p>\n California health officials and medical organizations criticized the new COVID-19 vaccine policy, which marks a significant departure from the CDC\u2019s previous recommendation that everyone age 6 months and older get an updated COVID-19 vaccination every autumn. <\/p>\n \u201cDoctors and patients need clear science-based vaccine recommendations. Unfortunately, changes in federal immunization policy have created uncertainty about who should take certain vaccines, and on what schedule they should be administered,\u201d the California Department of Public Health said in a statement to The Times. <\/p>\n \u201cVaccination is considered one of public health\u2019s greatest achievements, preventing the spread of serious illnesses, reducing hospitalizations and saving lives,\u201d the department said. <\/p>\n Doctors were already concerned that the federal changes would promote confusion and uncertainty \u2014 especially if the messaging is inconsistent. <\/p>\n \u201cA patient may hear one message in the national news, another one from their insurance provider, and a third from their local pharmacy or their public health clinic, and that patchwork of information can create real confusion,\u201d Dr. Jen Brull, president of the American Academy of Family Physicians, said in a webinar Wednesday. \u201cConfusion often translates into hesitation, which results in missed opportunities for protection. … The path to vaccination can feel unnecessarily complicated.\u201d <\/p>\n Here\u2019s what you need to know: <\/p>\n How can healthy, younger adults get a COVID vaccine, if they want?<\/p>\n Wednesday\u2019s change in COVID vaccine policy means that healthy people under age 65 will need to consult with their healthcare provider before getting the 2025-26 COVID vaccination, according to HHS.<\/p>\n The Infectious Diseases Society of America said<\/a> that physicians \u201ccan still provide COVID vaccines off-label, and IDSA strongly urges doctors to continue recommending and administering vaccination to their patients based on the best available science.\u201d <\/p>\n But that option isn\u2019t necessarily universally available. IDSA noted that \u201cpharmacists\u2019 ability to provide off-label vaccines may be severely constrained, underscoring the vital role of physicians and other clinicians in maintaining access.\u201d<\/p>\n Why did the FDA do this?<\/p>\n On social media Wednesday, Kennedy said the guidance rescinds the emergency-use authorizations for the COVID vaccines that allowed them to be broadly and quickly administered during the height of the pandemic.<\/p>\n One of his goals is \u201cto demand placebo-controlled trials from companies,\u201d he wrote. <\/p>\n Kennedy, who in his role oversees both the FDA and CDC, has long disparaged vaccines in general and the COVID shots in particular. <\/p>\n Other health experts have said seeking additional testing for COVID vaccines is unnecessary, given the extensive testing done before they were first distributed, and their track record since.<\/p>\n Kennedy has also canceled contracts and pulled funding from efforts to develop vaccines using mRNA technology \u2014 the same technology used to develop most of the COVID vaccinations administered in the U.S., and that has been credited with saving millions of lives.<\/p>\n In announcing and explaining that decision, Kennedy said federal health officials were prioritizing the development of \u201csafer, broader vaccine strategies.\u201d<\/p>\n Who can get updated COVID vaccines without first talking to a healthcare provider?<\/p>\n The FDA approved the 2025-26 COVID vaccines for seniors age 65 and up, and younger people with at least one health condition that puts them that at high risk for severe COVID should they get infected, according to the Department of Health and Human Services. <\/p>\n Such factors include obesity, diabetes, heart conditions, chronic lung disease, kidney disease and immunocompromising conditions. <\/p>\n What about the CDC?<\/p>\n Wednesday\u2019s announcement of the FDA\u2019s vaccine approvals for the 2025-26 formula was issued by the three manufacturers of COVID vaccines in the United States: Moderna<\/a>, Pfizer<\/a> and Novavax<\/a>. <\/p>\n Officially, the FDA \u201capproved\u201d the updated 2025-26 vaccine for only certain groups of people. The Department of Health and Human Services said the FDA was making these changes as hospitalizations and deaths from COVID-19 had declined dramatically. <\/p>\n Pharmacies and health systems sometimes don\u2019t start administering the updated COVID vaccine until after the CDC\u2019s Advisory Committee on Immunization Practices meets and makes a recommendation, typically around the beginning of fall. That recommendation is then considered by the CDC director, who typically endorses it or, rarely, makes her or his own recommendation.<\/p>\n It\u2019s unclear when the CDC immunization committee will render a recommendation. Its online<\/a> schedule notes two upcoming meetings, one for August\/September, with dates to be determined, and another on Oct. 22\u201323. <\/p>\n Kennedy fired all 17<\/a> members of the CDC\u2019s immunization committee earlier this year, and his replacement picks included some people who have criticized vaccines and spread misinformation, according to the Associated Press<\/a>.<\/p>\n So what does this mean for me?<\/p>\n Local health officials and healthcare organizations are still scrambling to understand the implications. <\/p>\n Among organizations that responded to requests for comment, CVS said it expected to receive the updated 2025-26 COVID-19 vaccines in the coming days. <\/p>\n \u201cWe\u2019ll administer FDA-authorized COVID-19 vaccines in states where legally permitted at CVS Pharmacy and\/or MinuteClinic to meet our patients\u2019 needs,\u201d said spokesperson Amy Thibault.<\/p>\n Kaiser Permanente was still reviewing the details of the FDA\u2019s approval. <\/p>\n \u201cWe will also review the CDC\u2019s clinical guidance when it is released and evaluate other sources of clinical recommendations, including relevant medical societies, to ensure safe and effective administration of the COVID vaccine,\u201d according to a statement from Kaiser spokesperson Terry Kanakri. \u201cVaccination continues to be one of the safest and most effective ways to protect against illness and reduce the severity of illness from COVID.\u201d<\/p>\n Kaiser, Kanakri added, \u201cis committed to making the 2025-26 COVID vaccine available at no cost to children and adults for protection from severe illness from COVID.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"New federal guidance surrounding COVID vaccine authorization could make it more difficult for many people to be inoculated…\n","protected":false},"author":3,"featured_media":182614,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[102771,64,16460,21062,33522,102770,64889,151,62396,6752,10999,3546,881,16776,67,132,68,2040,15613],"class_list":{"0":"post-182613","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-business","8":"tag-american-life","9":"tag-business","10":"tag-cdc","11":"tag-child-age","12":"tag-confusion","13":"tag-covid-vaccine-guidance","14":"tag-covid-19-vaccine","15":"tag-fda","16":"tag-healthcare-provider","17":"tag-kennedy","18":"tag-million","19":"tag-people","20":"tag-public-health","21":"tag-risk","22":"tag-united-states","23":"tag-unitedstates","24":"tag-us","25":"tag-vaccination","26":"tag-wednesday"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/115107122556240627","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/182613","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=182613"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/182613\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/182614"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=182613"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=182613"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=182613"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}