- The U.S. Food and Drug Administration (FDA) will now restrict COVID-19 vaccine approvals primarily to high-risk groups (65+, immunocompromised and those with underlying conditions). Manufacturers must prove effectiveness in preventing severe outcomes (hospitalization/death) for healthy individuals under 65.
- Fewer than 25 percent of Americans have taken the latest booster, with under 10 percent of children and less than one in six healthcare workers vaccinated. Officials acknowledge aggressive past policies may have eroded trust in routine immunizations.
- The Centers for Disease Control and Prevention (CDC) will no longer universally recommend COVID-19 vaccines for children, teens and pregnant women, citing minimal severe risks for these groups. Decisions will now be individualized (doctor-patient discussions).
- The FDA ended emergency use authorization (EUA) for original COVID-19 vaccines, replacing them with bivalent shots for ages 6 months and up. Some groups (65+, immunocompromised unvaccinated kids) can now get an additional booster after four months.
- While FDA officials discourage mandates for healthy kids, post-marketing studies on long-term effects remain unclear. Insurers may drop coverage and the CDC has not yet confirmed if COVID vaccines will be removed from the childhood immunization schedule.
The U.S. Food and Drug Administration (FDA) has announced that it will restrict future Wuhan coronavirus (COVID-19) vaccine approvals to individuals aged 65 and older and those at high risk due to underlying health conditions or occupational exposure.
On Tuesday, May 20, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad of the agency's Center for Biologics Evaluation and Research acknowledged that public confidence in COVID-19 vaccines has waned, with fewer than 25 percent of Americans receiving the latest booster. Uptake is particularly low among children (under 10 percent) and healthcare workers (less than one in six). The agency suggested that aggressive vaccination policies may have inadvertently eroded trust in other routine immunizations, including the measles-mumps-rubella (MMR) vaccine.
In line with this, Makary and Prasad outlined in an article published for the New England Journal of Medicine (NEJM) that the FDA now plans to limit updated vaccine authorizations primarily to high-risk groups, those over 65 and individuals with underlying health conditions, while requiring vaccine makers to conduct randomized clinical trials demonstrating effectiveness in preventing severe outcomes (symptomatic infection, hospitalization or death) before approving vaccines for healthy individuals aged six months to 64 years.
Under the new framework, vaccine manufacturers must demonstrate that their shots prevent symptomatic infection, hospitalization or death in healthy individuals before gaining full FDA approval. However, immunocompromised adults, seniors and those with conditions like obesity or depression, estimated at 100-200 million Americans, will remain eligible under existing emergency use authorizations. (Related: For anyone under 80, COVID "vaccines" are deadlier than COVID itself.)
The agency encourages post-marketing trials for healthy adults. Still, it has not yet clarified whether the Centers for Disease Control and Prevention (CDC) will adjust its recommendations or remove COVID-19 vaccines from the childhood immunization schedule.
HHS to drop routine COVID-19 vaccine recommendations for children, pregnant women
Aside from restricting future COVID-19 vaccine approvals for high-risk groups, the Department of Health and Human Services (HHS) also announced its plan to rescind long-standing CDC recommendations that children, teenagers and pregnant women receive COVID-19 vaccines as a matter of routine.
The move comes amid growing skepticism about the necessity of vaccinating low-risk populations, including young children, who face an exceedingly low likelihood of severe COVID-19 outcomes, and pregnant women. Critics argue that widespread natural immunity and the minimal threat to these groups make blanket recommendations unnecessary.
HHS Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic, has long criticized COVID-19 shots, particularly mRNA-based vaccines, and previously petitioned the FDA to revoke their emergency authorization. Sources indicate that the updated CDC guidance may shift from a blanket recommendation to advising individuals to consult physicians about risks and benefits.
The decision also marks a stark departure from Operation Warp Speed, the Trump-era program that fast-tracked COVID-19 vaccines. Critics warn the move could further reduce vaccination rates – already low among children (13 percent) and pregnant women (14 percent) – and potentially lead insurers to drop coverage.
But then, Makary frankly said on May 15, that he is "not encouraging or insisting young, healthy children to get a COVID shot."
"Separate from my role as a regulator at the FDA, I am not encouraging or insisting young, healthy children to get a COVID shot unless there is new evidence that emerges that suggests there is a clear benefit," the commissioner remarked.
Watch this episode of the "Health Ranger Report" as Mike Adams, the Health Ranger, sounds the alarm about the possibility of COVID-19 vaccine die-off.
This video is from the Health Ranger Report channel on Brighteon.com.
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