by Michael Nevradakis, Ph.D., Childrens Health Defense:
The U.S. Food and Drug Administration said the new vaccines are “formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death.” However, the vaccines target the XBB.1.5 variant, which “is declining in the U.S.,” according to CNBC.
The U.S. Food and Drug Administration (FDA) on Monday approved updated mRNA COVID-19 vaccines produced by Pfizer-BioNTech and Moderna, paving the way for their approval by the Centers for Disease Control and Prevention (CDC). TRUTH LIVES on at https://sgtreport.tv/
The CDC’s Advisory Committee on Immunization Practices (ACIP) is meeting today to vote on whether to recommend the two vaccines, CNBC reported. Following ACIP’s vote, CDC Director Mandy Cohen is “likely” to approve its recommendation, Endpoints News reported, opening the door for the vaccines’ public availability.
The vaccines received FDA approval for people ages 12 and up, and Emergency Use Authorization (EUA) for children from 6 months to 11 years. Ages 5 and over will be eligible to receive a single dose, previously vaccinated children between 6 months and 4 years of age will receive one or two doses, while unvaccinated children in the same age group will be eligible for two Moderna doses or three Pfizer-BioNTech doses.
According to the FDA, the new vaccines are “formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death.”
However, the vaccines target the XBB.1.5 variant, which “is declining in the U.S.,” according to CNBC, citing CDC data.
Linda Wastila, Ph.D., professor of geriatric pharmacotherapy at the University of Maryland School of Pharmacy and director of research for the Peter Lamy Center for Drug Therapy and Aging, accused the FDA of acting unethically.
Wastila told The Defender:
“It is unethical to continue to approve and authorize mRNA vaccines for COVID-19 when the pandemic has disappeared. It is unethical to promote these boosters as safe and effective when it is clear they are not, and the government is ignoring evidence that the vaccines can provide considerable harm.
“The fact that these vaccines were authorized for children when a public health emergency no longer exists is unconscionable.”
Dr. Pierre Kory, president and chief medical officer of the Front Line COVID-19 Critical Care Alliance (FLCCC), said, ”It is unconscionable that the government can recommend this booster for 6-month-olds when the FDA has no data on how children might be affected.”
In a separate statement, the FLCCC said, “By leveraging the unnecessary Emergency Use Authorization … the FDA is pushing forward with an experimental vaccine booster based on limited safety and efficacy data.”
“There is no need to vaccinate healthy children for COVID-19,” Kory said. “To give them an untested booster goes against everything we are trained to do as physicians.”
Canadian physician Dr. William Makis said, “There is no ‘COVID-19 emergency’ for children, therefore there is no legitimate scientific basis for an ‘emergency authorization’ of a new COVID-19 booster in this age group,” adding, “any doctor still administering COVID-19 mRNA vaccines to children of any age is engaging in medical malpractice.”
According to The New York Times, “Federal officials have been retreating from labeling the new formulation as boosters to previous shots, preferring to recast them as an annual immunization effort akin to the flu vaccine,” due to “the fatigue that some Americans have expressed about yet another round of shots against the virus.”
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said, “Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death.”
While ACIP, whose meeting was still in progress at the time of this writing, still needs to formally recommend the vaccines, approval appears to be all but certain.
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