The label for COMIRNATY is a legal document updated on 12/20/21:
By Meryl Nass
1. CDC made the false claim on its website that anaphylactic reactions occur at rates approximately the same after COVID vaccines as other vaccines. I just looked for the citation and see the claim has recently been removed. Now, CDC informs us that “safeguards are in place” in case you do develop anaphylaxis after a COVID shot.
The Comirnaty label and CDC website make plain that administration of the vaccine is limited to only those facilities able to medically manage anaphylactic reactions. This is not the case for other vaccines.
A study from Harvard hospitals (where the CDC Director worked till Jan 2021) showed the rate of anaphylaxis, using standard criteria, in vaccinated employees, was about 50-100 times higher than the rate claimed by CDC, which happens to be the rate calculated by VAERS (in which underreporting by a factor of 10 to 100 is believed to occur). I wrote about this in the Defender in January 2021 and revealed how CDC used inappropriate and inadequate data to derive such a low rate.
2. While the CDC website suggests episodes of myocarditis are mild and resolve quickly, the label plainly states, “Information is not yet available about potential long-term sequelae.”
3. CDC encourages vaccination during pregnancy. What the label says is, “available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine associated risks in pregnancy.”
4. It has been claimed that COMIRNATY and other vaccines could not possibly cause or stimulate cancer or cause fertility problems. What does the label say? “COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.”
Around the time that FDA gave the Pfizer vaccine an EUA at warp speed, on December 11, 2020, an EUA review memorandum was written, which I discuss below
1. Although people who had already had COVID were encouraged and sometimes forced to be vaccinated, the document states, “very few cases of confirmed COVID-19 occurred among participants with evidence of infection prior to vaccination. Therefore, available data are insufficient to make conclusions about benefit in individuals with prior SARS-CoV-2 infection.”
2. Although FDA gave Pfizer an authorization to vaccinate everyone aged 16 and up on December 10, 2020, the document points out, “only one confirmed COVID-19 case was reported in this age group.” In other words, there were no data to support efficacy in the 16 and 17 year olds. No wonder 4 members of the FDA advisory committee voted no, and one abstained from supporting authorization. My suspicion is that 16 and 17 year olds were needed in order to put COVID vaccines on CDC’s recommended childhood schedule, despite lack of supporting data, so FDA pushed it through.
And sure enough, CDC had its Advisory Committee vote (13-1) to put the vaccine on the childhood schedule in August 2021. This will provide it a different form of liability protection, and opens the door to future mandates to attend school.
However, I just searched and failed to find evidence that the vaccine was actually added. Very interesting.
3. Even though the spectre of asymptomatic infections drove masks, social distancing, school closures, working from home, etc. etc., apparently FDA did not require Pfizer to test its vaccine to see if it prevented asymptomatic infection. The document states, “Data are limited to assess the effect of the vaccine against asymptomatic infection.”
4. The entire point of vaccinating to achieve herd immunity was allegedly to prevent spread from person to person. How is it possible that neither FDA nor Pfizer sought out evidence that the vaccine prevented transmission? The report states, “Data are limited to assess the effects of the vaccine against transmission of SARS-CoV-2 from individuals who are infected despite vaccination.”
5. The biggest concern of scientists everywhere, including Fauci, was the potential that the vaccine might cause enhanced coronavirus disease, a prooblem that had occurred occasionally with new vaccines and had occurred with a coronavirus vaccine prototype. LIsten to what the report says: one ‘could’ conduct such studies in future: “Available data do not indicate a risk of vaccine – enhanced disease, and conversely suggest effectiveness against severe disease within the available follow-up period. However, risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and in observational studies that could be conducted following authorization and or licensure.”