The FDA's lead regulators are supporting the World Health Organization based on insufficient data. Two prominent vaccine regulators, who previously announced their resignations from the Food and Drug Administration, are now opposing the Biden government's plan to provide a COVID-19 booster dose.
In an article published Monday in The Lancet, Marion Gruber, external director of the Food and Drug Administration's Office of Vaccine Research (OVRR) and Phil Krause, deputy director of OVRR, argued against the current boost. a program. They write that even if there are benefits to boosters, there are still risks, and any benefits "will not outweigh the benefits of primary protection for unvaccinated people." 16 international collaborators, including many of the WHO's leading experts. Krause is mentioned as the first author of the article and the corresponding author.
The two's public opposition to the boosters comes just weeks after announcing their resignations from the Food and Drug Administration. They leave October 31 and November, respectively. Announcement
Anger and Frustration
They were reported to resign at the end of August out of frustration and anger at the Biden administration's decision in mid-August to begin increasing doses as soon as the week of September. According to FDA sources, Gruber, Krause, and others at the agency felt the decision was premature and bypassed the FDA's role in using green enhancers. At the time, Politico called the FDA's case a "potential rebellion."
The Lancet article appears to confirm these internal differences within the organization. Gruber and Cross coordinated with the World Health Organization rather than support the Biden bolster plan, which has also condemned the supporting images and called for their use to be banned until at least the end of the year.
A WHO contributor to the Lancet article is Dr. Mike Ryan, Executive Director of the WHO Health Emergencies Programme. He has previously criticized the booster programs, describing them as "giving [extra] life jackets to those who already have life jackets." One of the WHO's arguments against offering boosters now. The biggest argument is the fact that the data shows that Covid-19 vaccines are resistant to the time and type of delta coronavirus. Vaccines still provide excellent protection against serious illness and death - the main purpose of vaccines. The US Centers for Disease Control and Prevention released data last Friday that strongly supports this issue.
Although there appears to be some evidence that protection from vaccines decreases over time, it is not yet clear whether overall protection against serious illness and death will decrease in near future or not. As the authors of The Lancet pointed out, the data was all about weakening the impact of a noisy vaccine. For example, data from outside Israel shows that people vaccinated in January or April were less effective than those vaccinated in February or March. Also, those who received the highest number of vaccinations now include those with compromised immune systems, and it becomes difficult to interpret whether any reduction in protection is associated with the general population. The Lancet authors argue that the current supply of the vaccine is limited. Each dose used for the vaccinated population is doses not given to vaccinated frontline workers and other at-risk groups in low-income countries. More current lives could be saved if current vaccines were used, if they were used in previously unvaccinated populations, the authors wrote. They add: "If vaccines are used where they are most profitable, they could hasten the end of the epidemic by preventing the further development of different species."
Gruber, Krause, and other authors point out that amplifiers may be needed in some cases in the future - should protection be severely reduced and/or more severe variants developed. She lacks it now. p>
This situation is only likely to create tensions this week before the launch of Biden's government boost program. To inject the Pfizer/BioNTech vaccine.
Top FDA regulators criticize US booster program after resigning
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