The FDA reshaped the vaccine landscape last week, authorizing single boosters for Moderna and Janssen vaccines, and permitting boosters from all vaccine manufacturers regardless of the initial vaccine brand. Here is an updated vaccine chart, incorporating these changes.
The changes were discussed at the two-day Advisory Committee Meeting on Vaccines and Related Biological Products Advisory Committee, held October 14-15, 2021. EUA applications for single boosters of Moderna and Janssen vaccines were unanimously recommended (4:26:25). The committee heard a report on the NIH “Mix and Match” study (5:27:26), the basis for the booster interchangeability authorization, but did not vote. After this meeting, FDA approved booster interchangeability and updated Fact Sheets for Healthcare Providers Administering Pfizer, Moderna, and Janssen vaccines. These Fact Sheets still say there is “no information on the co-administration” of vaccines. The rules for interchangeability between primary and booster vaccines are based on the vaccine used for the primary series. By these rules, anyone over 18 years old can get a Moderna or Pfizer booster 2 months after an initial Janseen injection.
FDA Approval means that a drug, treatment, or medical device has been licensed by the FDA for a particular purpose. Contrary to what you may hear, approval is not a guarantee of safety and efficacy. Rather, it means that the item in question has been through FDA’s rigorous gauntlet designed to prevent worthless or harmful products coming to market in the United States. Approval is different from authorization. FDA Authorization means that a product is available by Emergency Use Authorization, also known as EUA. The EUA process is designed to speed availability of products in the U.S. during an emergency. “Off Label” is a term used to describe use of an approved drug or device for a purpose other than its express licensed intent. Off label use of drugs is common practice. “Not authorized” is a term used to describe use of a drug or device which has neither been approved by the FDA nor made available by EUA.
Two key criteria for EUA are that an emergency exists, and there are no approved products to address the needs of the emergency. The continued availability of COVID vaccines under EUA is problematic on both points. First, as COVID-19 returns to endemic levels in many parts of the country, it’s debatable whether an emergency still exists. Once an emergency passes, and all EUAs, including the authorizations for vaccines, should be withdrawn. Second, there is an approved COVID vaccine: COMIRNATY. By approving a product that is not available in the U.S., the FDA has twisted itself into a pretzel. If the product is unavailable, it should not be approved. If the product is approved, EUAs for the other vaccines should be withdrawn. The FDA changes its call from heads to tails depending on how you flip the coin.
Expect two additional significant changes in coming weeks. The first will be the push to vaccinate children. The second will be the definition of “fully vaccinated” to include boosters. This will be followed by authorization for multiple boosters, meaning that you will always be just months away from losing your “fully vaccinated” status. Vaccine passports will then be a reality in the United States. Maybe that was the endgame all along.
Who would have thought this is where we would be 21 months ago?
4 replies on “Vaccine Booster Update”
Two weeks to flatten the curve. The Big Lie.
As a layperson, it is bizarre the lengths to which the authorities have gone to justify the approach they set regarding vaccination and these vaccines. It seems to be done regardless of the facts. Of course that breeds suspicion on the part of thinking peoples. FYI, i am an Australian living in Singapore. I just received an email from the Australian national carrier happily advising me that they are re-opening flights to and from Singapore and Australia. However, check out this fine-print: “Passengers on a Qantas international flight are required to be fully vaccinated (with a TGA approved or recognised vaccine).” Essentially, as an Australian Citizen I am potentially stranded overseas unless i submit to have the vaccinations.
Vaccine passports equals the complete loss of privacy and freedom. This is the globalist’s Great Reset, NWO agenda. I’m sure many will scramble to get their boosters and passports so they can feel “free” again.
Unbelievable!
[…] for COMIRNATY’s approval—to provide a veneer of legitimacy to the authorizations for boosters and child vaccines that followed. The Fact Sheets are clear: Pfizer-BioNTech […]