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While "none of the COVID-19 vaccines in use are actually 'approved,'" Pfizer formally submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) May 7, racing to become the first China virus jab approved by the U.S. health regulator.
"Through an emergency access mechanism known as Emergency Use Authorization (EUA), the products being rolled out still technically remain 'investigational,'" the British Medical Journal (BMJ) cautioned earlier this month.
The journal asked if more data was needed, pointing to the lack of randomized controlled trials (RCT) for vaccine safety or duration of protection.
RCT assigns subjects randomly to an experimental group receiving the treatment being tested and to a control group receiving a placebo. The results assess the treatment's effectiveness, which is the extent to which it does patients more good than harm.
"All COVID-19 vaccines currently in use in the U.S. are available under emergency access only," the BMJ noted. "The situation is similar in Europe, where four COVID-19 vaccines have been granted 'conditional marketing authorizations,' a fast-track mechanism that can be used in emergencies."
These can be converted into standard "marketing authorizations," if positive data becomes available, but this hasn't yet happened for any shot being administered, Dr. Peter Doshi, BMJ senior editor, explained, citing FDA fact sheets distributed to jab recipients, which state: "There is no FDA approved vaccine to prevent COVID-19."
The FDA also said it would want placebo-controlled efficacy trials using at least 3,000 participants to demonstrate that a vaccine was at least 50% effective against preventing the China virus infection or disease of any severity.
For full approval, it also asked for safety assessments to include "serious and other medically attended adverse events in all study participants for at least 6 months after completion of all study vaccinations" and longer safety monitoring for new vaccine mRNA platforms.
Doshi expressed concern over applications for approval based only on six months of data — "the fastest for a novel vaccine in FDA history" compared to other vaccines approved by the FDA since 2006, which went through trials over a median of 23 months.
"On paper, the phase III studies by Pfizer, Moderna and Janssen are all of two years' duration," the BMJ confirmed.
Doshi also questioned the benefit of seeking a BLA when millions of doses of the jabs were already being administered across the globe. None of the vaccine manufacturers gave the BMJ an answer.
Cody Meissner, professor of pediatrics at Tufts University and member of the FDA's advisory committee, told Doshi that an approval would increase trust in the jab, particularly among those hesitating to take the shot.
More importantly, it could affect the potential for making vaccines compulsory. "It is unlikely these vaccines will be mandated while an EUA is in place. Remember that currently these vaccines are still considered experimental," Dr. Meissner added.
So far, at least one federal lawsuit has been filed challenging an employer's COVID-19 vaccine mandate on the grounds that vaccines are still under emergency use authorization. Questions on the legality of such actions hang on distinguishing authorized from approved.
The Federal Food, Drug and Cosmetic Act (Title 21) requires experimental vaccine recipients to be informed "of the option to accept or refuse administration of the product." Under the Nuremberg Code, no one may be coerced to participate in a medical experiment.
Meanwhile, Britain's best-known medical journal, The Lancet, is claiming that the absolute risk reduction (ARR) of the best known COVID-19 jabs is only 1·3% for the AstraZeneca, 1·2% for the Moderna, 1·2% for the Johnson & Johnson, and 0·84% for the Pfizer vaccines.
In an article titled "COVID-19 vaccine efficacy and effectiveness — the elephant (not) in the room," the journal criticizes the media and governments for hyping vaccine efficiency based on figures reporting Relative Risk Reduction (RRR) rather than ARR.
RRR considers only participants who could benefit from the vaccine, while ARR — which is the difference between attack rates with and without a vaccine — considers the whole population, the journal explains.
Data from the Vaccine Adverse Event Reporting System (VAERS) released Friday showed 227,805 reports of adverse events in the U.S. following the China virus jabs, including 4,201 deaths and 18,528 serious injuries between Dec. 14, 2020 and May 14, 2021.
In Britain, Medicines and Healthcare Products Regulatory Agency (MHRA) data from Dec. 9, 2020 to May 12, 2021, showed 226,158 reports of adverse events, including 1,178 deaths.
Dr. Joseph Mercola, author of The Truth About COVID-19: Exposing The Great Reset, Lockdowns, Vaccine Passports, and the New Normal, told Steve Bannon that the China virus jabs had killed "more people than any vaccine combined in deaths for the last 15 years." The death toll continues to increase.
The vaccine "gold rush" has spawned nine new billionaires with a combined net wealth of $19.3 billion since the China virus crisis. Eight existing billionaires who invested in COVID-19 vaccine pharma companies have seen their combined wealth increase by $32.2 billion.