COVID-19: Latest 'Booster' to Be Released Before Human Testing is Complete, Report Says
The shots are aimed at preventing the spread of the Omicron variant
Once again, the U.S. is set to release a COVID-19 vaccine that will have lingering questions about safety and effectiveness, a report said.
The Wall Street Journal reported that the Food and Drug Administration is expected to OK the booster later this week “without a staple of its normal decision-making process: data from a study showing whether the shots were safe and worked in humans.” The new jab will not have finished testing in humans when the agency makes its decision.
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This is not the first time that the U.S. rushed the delivery of these unproven vaccines.
GARY NULL: FAILURES IN THE COVID NARRATIVE
In September 2021, Dr. Rochelle Walensky, the head of the Centers for Disease Control and Prevention, took a rare step and overruled agency advisers who did not recommend COVID-19 booster shots for younger, at-risk workers like teachers and nurses.
"As CDC Director, it is my job to recognize where our actions can have the greatest impact," Walensky said in a statement at the time. "At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good."
Dr. Yvonne Maldonado, an infectious disease expert at Stanford and the American Academy of Pediatrics liaison to the committee, told The New York Times at the time that she was “surprised that Dr. Walensky overturned one of the four ACIP [Advisory Committee on Immunization Practices] votes today, and I believe others will be as well.”
Dr. William Schaffner, a nonvoting member of the CDC’s vaccine advisory panel and chairman of the department of preventive medicine at Vanderbilt University School of Medicine, told The Times that the process has “not been done according to the rules.”
“It started in Washington with the president’s announcement,” he said, pointing out that the steps usually work their way from the Food and Drug Administration to the CDC. “This has been confusing all along.”
In this recent example, the FDA is expected to asses the shots “using data from other sources such as research in mice.”
Robert Califf, the FDA Commissioner, tweeted, “Real world evidence from the current mRNA Covid-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe.”
REVOLVING DOOR: Califf was one of seven different FDA commissioners since 2015. Dr. Califf succeeded fellow Obama appointee Margaret Hamburg and headed the agency for 11 months, in the last year of the Obama administration.
Dr. Califf is not President Biden's first nominee for the post; previous nominees were dropped in response to complaints of them being too close to the pharmaceutical industry. But Dr. Califf is hardly different in that regard; his biography from Duke University (where he ran a research center funded by the drug industry) indicates he is a member of the drug lord mobs while acting as a consultant to Merck, Amgen, Biogen, Genentech, Eli Lilly and Boehringer Ingelheim.
In addition, he's on the corporate board of the biopharmaceutical company Cytokinetics, and has been a senior advisor to Verily Life Sciences and its sister company Google Health.
TRENDPOST: It has been widely reported that vaccines are becoming less effective and for a shorter period of time when preventing infection from variants like Omicron, and the now-dominant Omicron sub variant called BA.2.
"By this fall, we may be on to a new variant. It could be sigma. It may be tau. There may be something new that may be circulating that we'll have to deal with," Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, told NPR in an interview. "We're going to have to make a good guess at what may be most effective.”
Nature magazine pointed out that researchers have been aware that the BA.1 subvariant “evades much of the protection that mRNA vaccines offer against mild-to-moderate disease.”
One researcher said BA.2 could be even more challenging for scientists with its ability to evade the vaccines.
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