Not what we voted for: Fed Commission advances questionable mRNA flu shot for 50+
The federal Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 9-0 last Thursday to approve Moderna’s mFlusiva (mRNA-1010) mRNA flu vaccine for people over 50, despite serious doubts about the safety and efficacy of the product. If approved mFlusiva would be the first mRNA seasonal flu shot licensed in the US.
VRBAC’s recommendations are advisory but are usually accepted. A final decision is expected by August 5.
This approval follows the rejection in February of mFlusiva by the FDA’s Center for Biologics Evaluation and Research (CBER). Since the rejection letter was issued both FDA Commissioner Marty Makary and CBER Director Vinay Prasad have left the administration.
In CBER’s rejection letter signed by Director Vinay Prasad, said:
“CBER does not consider the application to contain a trial ‘adequate and well-controlled’ and the application is therefore, on its’ face, inadequate for review. This is because your control arm does not reflect the best-available standard of care in the United States at the time of the study. I note that this determination is consistent with FDA’s advice given to you prior to your study.”
Since the rejection letter was issued, both FDA Commissioner Marty Makary and Prasad have left the administration.
The VRBPAC vote means further safety and efficacy studies will be delayed until after mFluvisa is on the market, rather than before, which would have been required if CBER’s denial was still in effect.
This is not what we voted for. We voted for drastically needed reform, not business as usual.
We voted for subjecting medical products, especially vaccines, to independent review using the highest standards. We voted for full independent investigations into the enormous safety and efficacy issues with MRNA technology, and the profound corruption that was essential to bringing COVID shots to market. We voted for informed consent as the basis for all medical care. We did not vote for the dismissal of regulators because they seek higher standards than applicants are willing to meet.
TAKE ACTION
Please use the panel to the right to send a message to President Trump and your members of Congress to let them know that this is not what we voted for and demand that these products must not come to market until we have transparent and independent safety and efficacy studies that meet the highest standards. Until then, these products must not receive licenses.
Look up your US Senator's contact information here:
https://www.senate.gov/senators/senators-contact.htm
Look up your Representative in the US House of Representatives:
https://www.congress.gov/members/find-your-member
COVID shots are the only mRNA licensed vaccines in the US, and they have an atrocious safety and efficacy record. According to a CDC Wonder search of the Vaccine Adverse Events Reporting System (VAERS) including 4.3 million reported adverse events, 19,694 deaths, 19,770 permanent disabilities, 91,951 hospitalizations and 121, 384 emergency room visits.
The body of evidence showing deliberate cover-ups of COVID shot side effects keeps growing. On April 29, Sen. Ron Johnson, Chairman of the Senate Permanent Subcommittee on Investigations, held a hearing and released a report titled "Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals" documenting the active cover-up of safety warning signals by HHS regulators in 2021.
As recently as June 3, the US Senate Permanent Subcommittee on Investigations held a committee meeting on “Plausible Mechanisms of COVID-19 Injections which presented evidence Causing Cancer and Attacks on Scientific Publications”
In the current study of mfluvisa, an inert placebo was not used in the control group. The control group was given a standard strength flu vaccine, not an inert placebo, the “gold standard” in vaccine safety studies, which would have shown a more accurate safety profile. Nor were they given an extra-strength flu shot, which is usually given to older people, that would have shown a more accurate efficacy profile, which was one of the criticisms made in the initial rejection letter from the FDA.
Total deaths in the combined test and control groups in Moderna’s trial were half of what would be expected from a group of similar size and age. Moderna reported that .2% of the test subjects, equally divided between the control and test groups, died during the test period. However, a random selection of people of similar demographics would probably have a death rate of about .4%, twice what was seen in the test subjects, which shows a clear bias toward selecting healthier test subjects.
Moderna’s own study showed that a serious adverse event is a more likely outcome from getting mFluvisa than avoiding a case of the flu. Moderna reported a 2.2% serious adverse events rate compared to an existing flu vaccine with 1.9%, or a 16% higher rate of “serious adverse events” with mFluvisa. A serious adverse event means either death, life-threatening condition, hospitalization (initial or prolonged), persistent or significant disability/incapacity, congenital anomaly/birth defect, or another medically important event that investigators judge could jeopardize the patient.
Moderna’s study also showed that the number of vaccines need to be given to avoid one infection is between 140 and 220, but at the cost of a reasonable expectation based on Moderna’s own data of 2 to 5 serious adverse events to prevent one infection.
Big money is on the line. Moderna received $750 million in private equity funding from Blackstone Life Sciences to conduct its mRNA-1010 clinical trial.
Moderna is marketing a combined COVID-flu shot in Europe that is not licensed in the US. Andrew Tsai, a financial analyst with the Jeffries Group, estimated the market for Moderna’s combined COVID-flu shot could be $750 million by 2030 in the US.
Until the profound concerns with both the safety and efficacy issues with mFluvisa and MRNA products can be resolved, there is no way mFluvisa or any other mRNA products should be licensed in the US.