The FDA adopted a "future framework" scheme that will allow Big Pharma companies to reformulate and release updated Wuhan coronavirus (COVID-19) vaccines without conducting any additional clinical trials. The framework permits the rollout of reformulated and completely untested vaccines in the United States.
The framework is not only limited to COVID-19 vaccines. The elimination of clinical trial requirements may also be expanded to other drugs and vaccines over time.
While many examples of rigged vaccine trials had been recorded over the years, the future framework served as an extreme expansion and formalization of the scheme.
Such rigging involves improperly recording vaccine injuries, if not failing to record them altogether. The exclusion of parameters that turn out to be problematic, which could include injured trial participants, serves as another method.
This rigging has already occurred in Pfizer's pediatric clinical trials for its COVID-19 vaccine. During the trial, the vaccine maker excluded 3,000 of 4,526 children aged between six months and four years old who were enrolled as participants – a clear red flag. (Related: JAB ‘EM YOUNG: FDA approves Pfizer’s booster vaccine for children aged 5 to 11 without consulting vaccine advisory panel.)
Furthermore, the FDA's future framework also includes the component of a COVID-19 booster dose specific to the B11529 omicron variant, which 19 of the 21 members of the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of. The VRBPAC defended its decision, arguing that the modified vaccine would offer broader protection to match the circulating BA4 and BA5 omicron subvariants.
Dr. Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, said there will be a conversation going forward to determine who will need another booster, or what the booster will look like. He did note, however, that a bivalent vaccine targeting the BA4 and BA5 subvariants seem to be the preference for the committee.
During the VRBPAC's meeting in April, the committee members agreed on the necessity of developing a framework for how the country can keep up with the evolving virus with an appropriate vaccine strategy. The FDA also said in May that the new normal may include an annual COVID-19 and flu shot for people, as cases are expected to rise in the fall and winter.
Current COVID-19 vaccines are based on the original SARS-CoV-2 strain that emerged in late 2019, but Pfizer and its competitor Moderna have been working on updated versions as the current ones are not as effective against the omicron subvariants.
Following the VRBPAC vote, the FDA will decide on the updated vaccine with a panel of independent experts that advise the Centers for Disease Control and Prevention (CDC) to take a closer look at the available data and make recommendations. These recommendations would then head to CDC Director Dr. Rochelle Walensky, who will decide and sign off on them.
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Watch the video below for more information about the FDA's future framework.
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