The fastest rollout of a new vaccine in world history occurred the only way it could possibly occur — by bending the rules, creating a new regulatory playbook and failing to obtain any human data for the new vaccines.
- The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) cooperated to issue Emergency Use Authorizations (EUA) and roll out new, bivalent Pfizer and Moderna COVID-19 vaccines this week, without any human trials, which is unprecedented.
- There is international coordination regarding bivalent boosters, and a major effort will be undertaken to get them into arms, despite historically low levels of severe COVID-19. Why?
- These vaccines continue to enjoy extraordinary protection from liability, while the recipient has no access to the legal system in the case of injury.
- There is no evidence the new vaccines are safe, while there is limited evidence that they may be more harmful than earlier COVID-19 vaccines. However, in the absence of human testing, there is no way to truly predict their safety. Safety data are being concealed by federal health agencies. Messaging by them is misleading.
- There is no evidence the new bivalent vaccines will be more effective than the older vaccines, and existing evidence suggests that any efficacy they provide will persist no longer than one to several months.
- COVID-19 vaccines appear to increase susceptibility to COVID-19 infections, on average starting six months after inoculation.
- Perpetual boosters briefly stave off the negative efficacy that develops a few months after a COVID-19 vaccination. This may be why frequent boosters are being pushed. But frequent boosters may also weaken overall immunity and may even contribute to rising mortality rates in the U.S. and U.K.
The FDA on Aug. 31 issued EUA for new Pfizer and Moderna mRNA booster vaccines for COVID-19.
One day later, the CDC and its director, Dr. Rochelle Walensky, approved the immediate rollout of the new vaccines, which will be administered in the U.S. beginning this week.
Surprisingly, more than a month before either agency had given its okay to the entirely new formulation, the federal government ordered 105 million doses from Pfizer and 66 million doses from Moderna.
The desired composition of the vaccine had only been formally determined by the FDA after its advisory committee met on June 24.
The vaccines contain a mix of the old, original Wuhan strain vaccine mRNA (now also referred to as the ancestral vaccine) and a new Omicron BA.4/5 mRNA coding for the Omicron spike protein.
The total amount of mRNA for the Pfizer and Moderna booster vaccines is the same as before: 30 mcg for Pfizer and 50 mcg for Moderna. Each is composed of 50% Omicron mRNA and 50% ancestral mRNA, and thus they are termed bivalent vaccines.
The new vials and their boxes do not list the dose, hinting that the decision regarding how much to use was made very recently. Even the members of the CDC’s advisory committee did not know the dosage of...
