The FDA made a loud show of “approving” Pfizer’s Covid 19 shot on Monday. But the injection they actually approved is a formulation made by a German company in partnership with Pfizer, called Comirnaty.
The new injection is not yet available, but FDA says the old one can be used in its place. The old one is protected from liability lawsuits by an FDA Emergency Use Authorization (EUA).
“…providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses.” per FDA guidance released Monday.
Vaccines that are not fully approved, but only fall under EUA use can’t be mandated. Now that an identical version has been approved, but substitutable by the old, it appears a mandate has been slipped into place.
Senator Ron Johnson (R-WI) said the expedited approval appears to have been pushed to allow for vaccine mandates. He notes that safety concerns and reported health problems from the vaccines are mounting.
FDA’s approval letter HERE
Although the lack of current research information on reported health and safety problems with heart inflammation did not prevent approval, FDA is still requiring additional monitoring of health problems like myocarditis, pericarditis, pregnancy issues, and vaccine effectiveness.
Per the FDA’s adverse event reporting database, as of 23 August there are 611,945 adverse events reported for Covid 19 vaccines. That’s 43.41% of all adverse events reported to the FDA, ever. It includes at least 12,791 deaths. It’s unknown how many may not have been reported.
“Underreporting is a limitation common to passive surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS) that monitors the safety of U.S.-licensed vaccines. Nonetheless, previous reports demonstrate substantial case capture for clinically severe adverse events (AEs), including 47% of intussusception cases after rotavirus vaccine, and 68% of vaccine associated paralytic polio after oral polio vaccine.” per the federal National Institutes of Health.
The consortium of doctors who formed the group America’s Frontline Doctors have cautioned that the vaccine was rushed through production. They fear it may ultimately make recipients more susceptible to the virus.
During Moderna clinical trials, control group patients who had received a placebo were called back and offered the vaccine.
“It’s a loss from a scientific standpoint, but given the circumstances I think it’s the right thing to do,” study director Dr. Carlos Fierro is quoted in a February 19 NPR report titled “Long-Term Studies Of COVID-19 Vaccines Hurt By Placebo Recipients Getting Immunized.”
Without a control group, it would be impossible to gauge how well that vaccine performed in comparison to no vaccine.
Lytton, British Columbia Dr. Charles Hoffe was removed from duty at St. Bartholomew’s Health Centre after warning BC health officials of adverse health effects after vaccination, per a CBC report. Hoffe has reported vaccinated patients show evidence of microscopic blood clots at the capillary level. He says the clots are invisible to CT scans, but show up in D-dimer tests. His letter is HERE.
America’s Frontline Doctors makes video appointments with doctors who can prescribe hydroxychloriquine, Ivermectin and other treatments available on its website, americasfrontlinedoctors.org.