SILVER SPRING, Maryland (LifeSiteNews) – The Food and Drug Administration (FDA) is expected to approve requests for approval from Pfizer and Moderna for their new COVID boosters after the companies asked the agency for approval last week despite not being tested on humans, The Wall Street Journal reported.
The Journal noted that the FDA would usually look at a study showing that the vaccine in question would be both safe and effective, something that studies have shown the mRNA vaccines are not, and that the agency would instead be relying on data from trials conducted on mice, as well as data from current jabs and previous boosters.
In a Twitter thread released by FDA chair Dr. Robert Califf, he stated that “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.”
Bivalent and multivalent vaccines are very common and modifying a vaccine to include different virus strains often does not require a change in other ingredients. FDA has extensive experience with reviewing strain changes in vaccines, as is done with the annual flu vaccine.
— Dr. Robert M. Califf (@DrCaliff_FDA) August 25, 2022
“As we know from prior experience, strain changes can be made without affecting safety,” he said. Califf added that modifying pre-existing jabs to include protection against other strains of the same disease did not require a change in ingredients and is normal practice while producing annual flu vaccines.
Califf also noted that the FDA would not call a meeting to discuss the new boosters as the “agency feels confident in the extensive discussion that was held in June.” He also noted that the Vaccines and Related Biological Products Advisory Committee (VTBPAC) “voted overwhelmingly to include an Omicron component in COVID-19 boosters,” and that the FDA “has no new questions to warrant committee input.”
The WHO Pandemic Treaty looks set to be one of the biggest power-grabs in living memory, with unelected globalists seeking the power to declare pandemics, and then control your country's response.
But it's not too late to do something about it.
SIGN and SHARE this special petition telling Director General Tedros Adhanom Ghebreyesus that the WHO will never usurp your nation's sovereignty.
The past two years have been rife with infringements on personal liberties and civil rights by national governments, but now the World Health Organization is seeking to appropriate those same abusive powers to itself at a global level.
194 member states representing 99% of the world's population are expected to sign pandemic treaties with the WHO that would allow Tedros, or any future Director General, to dictate exactly how your nation would respond to a new disease outbreak which they consider a pandemic.
This attack on national sovereignty will come as no surprise to those who for years have listened to elites like Klaus Schwab and Bill Gates discussing their vision for the centralization of power into globalist organizations like the World Economic Forum (WEF), the WHO and the rest of the United Nations.
SIGN this petition against the WHO's Pandemic Treaty, before it's too late.
Ludicrously, 20 world leaders calling for the treaty, including Tedros, Boris Johnson and Emmanuel Macron, compared the post-Covid world to the post-WWII period, saying similar co-operation is now needed to "dispel the temptations of isolationism and nationalism, and to address the challenges that could only be achieved together in the spirit of solidarity and co-operation - namely peace, prosperity, health and security."
Australian PM Scott Morrison is the latest leader to express support for a “pandemic treaty”.
The stated intention of the WHO is to “kickstart a global process to draft and negotiate a convention, agreement or other international instrument under the Constitution of the World Health Organization to strengthen pandemic prevention, preparedness and response.”
The wheels are already in motion, with the Biden administration officially proposing the initial steps towards handing global pandemic control to the WHO.
Biden's representatives have submitted amendments to the WHO's International Health Regulations (IHR), which would give the Director General the right to declare health emergencies in any nation, even when disputed by the country in question.
These amendments, which would be legally binding under international law, will be voted on by the World Health Assembly (the governing body of the WHO) at a special convention running from May 22-28 and set the stage for a fully-fledged pandemic treaty to be passed.
SIGN and SHARE the petition telling the WHO that you won't accept any pandemic treaty
The ball has been rolling since the last World Health Assembly meeting in December, where the United States launched negotiations "on a new international health instrument on pandemic prevention, preparedness, and response," a U.S. statement read.
"This momentous step represents our collective responsibility to work together to advance health security and to make the global health system stronger and more responsive.
"We look forward to broad and deep negotiations using a whole-of-society and whole-of-government approach that will strengthen the international legal framework for public health/pandemic prevention, preparedness, and response and enable us to address issues of equity, accountability, and multisectoral collaboration evident in the COVID-19 pandemic.
"We know it will take all of us working together across governments, private sector, philanthropy, academia, and civil society to make rapid progress towards a long-term solution for these complex problems," the U.S. statement added.
SIGN the petition today to show the WHO that you won't accept this attack on national sovereignty.
These are precarious times in which freedom and self-determination must be defended from those who would ride rough-shod over your civil rights.
We do not want to go back to global lockdowns, vaccine mandates and propoganda.
Sign the petition - speak up now!
For More Information:
Pandemic Treaty is a backdoor to global governance - LifeSiteNews
Dr. Robert Malone on the WHO's power-grab - LifeSiteNews
**Photo: YouTube Screenshot**
Reacting to the potential approval, Dr. Paul Offit, an adviser to the FDA and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, voiced his concern. Speaking to the Journal, Offit stated that “I’m uncomfortable that we would move forward — that we would give millions or tens of millions of doses to people — based on mouse data.”
In June, Offit and Dr. John P. Moore, a virologist and microbiology and immunology professor at Weill Cornell Medicine, released an op-ed that urged the FDA not to approve vaccines without proper research. “A decision of this magnitude should be based on as much expertise and analysis as is reasonably practical,” they wrote.
Moderna has already begun human trials for its new booster, and Pfizer is expected to at some point this month. However, human trials are not expected to be completed until sometime in the spring. If approved, the new boosters would be available within the next three weeks.
The FDA has approved of COVID boosters without any clinical information in the past. In January, the FDA previously approved COVID boosters without any clinical data, allowing for Pfizer’s jab authorization to be extended to children as young as age 12. The agency authorized boosters for all adults in November.
In June, the FDA authorized use of Pfizer and Moderna’s jabs for children as young as six months old. Days before the agency granted the authorization, an analysis of reports submitted to the U.S. government’s Vaccine Adverse Event Reporting System (VAERS) stated that at least 58 infants under age three have suffered life-threatening adverse events after receiving the mRNA coronavirus injections.
The list of FDA-recognized adverse events to the jab includes severe anaphylactic reactions to include fatal thrombotic events, the inflammatory heart condition myocarditis, and neurologically disabling disease like Guillain Barré Syndrome.
In 2021, the FDA added a warning to patient and provider fact sheets for both Pfizer and Moderna COVID vaccines suggesting an increased risk of myocarditis and pericarditis — particularly following the second dose and with onset of symptoms within a few days after vaccination. The FDA’s update followed a June 23 meeting that concluded the benefits of receiving a COVID vaccine still outweigh any risks.