What are the COVID-19 vaccines?
1.2.1.1. Pfizer- BioNTech. The Pfizer-BioNTech COVID-19 vaccine (BNT162b2) is a mRNA vaccine designed to be taken in two separate shots to the upper arm, separated by 21 days (with a third shot 28 days after the second shot authorized for certain immunocompromised people), according to the CDC. According to the Republic Journal, Pfizer’s clinical trials were a failure. Regardless, Prizer-BioNTech was granted Emergency Use Authorization (EUA) in the U.S. for ages 16 and older on 11 Dec 20. On 10 May 21, Pfizer-BioNTech was granted EUA in the U.S. for ages 12-15. According to the FDA, it is an “Investigational New Drug” (see Item G of FDA’s 9/22/21 letter to Pfizer), which means this vaccine is legally considered to be an experimental drug and requires the effective legal consent of participants prior to its administration. On 23 Aug 21, the FDA directed Pfizer to place the following on their printed materials: “This product has not been approved or licensed by the FDA” (see item Y of FDA’s 9/22/21 letter to Pfizer).
1.2.1.2. COMIRNATY. Pfizer renamed their Pfizer-BioNTech vaccine to COMIRNATY (“CO” from COVID-19, “MIRNA” from “mRNA,” and “TY” to emphasize “community” and “immunity”) in Europe on 28 Dec 20. According to the FDA, the COMIRNATY and Pfizer-BioNTech vaccines have the same formula, but are “legally distinct with certain differences.” On 23 Aug 21, the FDA approved COMIRNATY, and on 22 Sep 21, approved a single booster dose of COMIRNATY at least 6 months after initial vaccine for ages 65 and older and 18-64 at high risk of severe COVID-19. Of note, the FDA approved COMIRNATY, not the Pfizer-BioNTech vaccine, which is still under EUA. Since the FDA notes these two vaccines are “legally distinct,” there is technically no FDA-approved COVID-19 vaccine available in the U.S. Every COVID shot in America currently remains under the EUA law and thus people have the “option to accept or refuse” them.
1.2.1.3. Moderna. The Moderna COVID-19 vaccine (mRNA-1273) is a mRNA vaccine designed to be taken in two separate shots to the upper arm, 28 days apart. It was granted EUA in the U.S. for ages 18 and older on 18 Dec 20. The FDA released information on increased risk of myocarditis and pericarditis n 25 Jun 21. The FDA authorized a third dose for certain immunocompromised individuals on 12 Aug 21.
1.2.1.4. Johnson & Johnson. The Johnson & Johnson COVID-19 vaccine (JNJ-78436735) is a viral vector vaccine designed to be administered in a single shot to the upper arm. It received EUA for ages 18 and older on 27 Feb 2.
1.2.1.5. Novavax. The Novavax NVX-CoV2373 is a traditional vaccine against COVID-19. It does not use mRNA or viral vector, rather it “introduces a protein that prompts an antibody response, which blocks the ability of future coronavirus to bind to human cells and prevents infection.” It is currently undergoing late-stage clinical trials, and has thus far been shown to be safe and effective, according to NIH and the New England Journal of Medicine.
1.2.2. Timeline of FDA decisions on COVID-19 vaccines
11 Dec 20 – FDA granted Pfizer-BioNTech vaccine EUA in U.S. for ages 16 and older
18 Dec 20 – FDA granted Moderna vaccine EUA in U.S. for ages 18 and older
28 Dec 20 – Pfizer-BioNTech vaccine renamed to COMINARTY in Europe
27 Feb 21 – FDA granted Moderna vaccine EUA in U.S. for ages 18 and older
10 May 21 – FDA granted Pfizer-BioNTech vaccine EUA in the U.S. for ages 12-15
25 Jun 21 – FDA released information regarding myocarditis and pericarditis related to Moderna vaccine
12 Aug 21 – FDA authorized a third Moderna shot for certain immunocompromised individuals
23 Aug 21 – FDA granted Pfizer’s COMINARTY vaccine full approval in U.S. for ages 16 and older
22 Sep 21 – FDA issued EUA for single booster dose of COMIRNATY or Pfizer-BioNTech at least 6 months after initial vaccine for ages 65 and older and 18-64 at high risk of severe COVID-19.
1.2.3. What is a mRNA vaccine? A mRNA vaccine is a new type of vaccine in which messenger RNA, which is genetic material that codes for a protein, is injected into cells, causing them to create a spike protein. This spike protein is identical to a protein found on the surface of SARS-CoV-2 (the virus that causes COVID-19), eliciting an immune response from the body that protects you from the SARS-CoV-2 virus. See the Mayo Clinic’s explanation of how different types of COVID-19 vaccines work.
1.2.4. What is a viral vector vaccine? A viral vector vaccine is a vaccine that uses a modified version of a different virus (not COVID-19) to deliver the virus’s DNA to your cells to instruct them to make a spike protein. This spike protein is identical to a protein found on the surface of SARS-CoV-2 (the virus that causes COVID-19), eliciting an immune response from the body that protects you from the SARS-CoV-2 virus. See the Mayo Clinic’s explanation of how different types of COVID-19 vaccines work.
1.2.5. What is an Emergency Use Authorization (EUA)? An EUA allows the FDA to permit the use of “unapproved medical products or uses of approved medical products in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives,” per the FDA.
1.2.6. How many people have been vaccinated? The Mayo Clinic tracks how many people have been vaccinated by various categories.
1.2.7. Are COVID-19 vaccines safe? This is the big question many people are asking, and is difficult to answer since long-term safety studies have yet to be accomplished. In the near-term, COVID-19 vaccines appear to be relatively safe, since adverse reactions seem to be relatively rare. The FDA claims they are “safe and effective,” but numerous drugs once deemed “safe and effective” by the FDA were later found to be dangerous after long-term studies were completed. Currently, the FDA “strongly believes that the known and potential benefits of COVID-19 vaccination greatly outweigh the known and potential risks of COVID-19.” However, this statement fails to consider the difference in risk levels in various ages and health statuses. What might be worth the risk for a 90 year old with comorbidities might not be worth the risk for healthy 19 year old (for example, University of California finds that teenage boys 6x more likely to suffere heart problems from COVID vaccine than be hospitalized by COVID). Although apparently rare, adverse reactions to COVID-19 vaccines include myocarditis, pericarditis, thrombosis, Guillain-Barre Syndrome, and death.
1.2.7.1. Myocarditis/pericarditis. Myocarditis is an inflammation of the heart muscle, and pericarditis is inflammation of the lining surrounding the heart. The CDC recognized “increased cases of mycarditis and pericarditis” in the U.S. after mRNA vaccinations.
1.2.7.1.1. In the U.S. Military. On 29 June 21, the Journal of American Medical Association (JAMA) released a study on military members getting myocarditis within 4 days of receipt of a COVID-19 vaccine.
1.2.7.1.2. In Israel. The Israeli Health Ministry reported that 1 in 100,000 (.001%) people who received the Pfizer COVID-19 vaccine suffered from myocarditis (heart muscle inflammation). Further studies are ongoing.
1.2.7.2. Thrombosis occurs when blood clots block blood vessels. On 13 Apr 21, the CDC issued a health alert regarding 6 cases of cerebral venous sinus thrombosis (CVST) seen in women aged 18-48 years after taking the J&J vaccine, and paused its use. On 23 Apr 21, use of the J&J vaccine was resumed, and CDC stated “the J&J/Janssen COVID-19 Vaccine’s known and potential benefits outweigh its known and potential risks.“
1.2.7.3. Guillain-Barre Syndrome (GBS). According to the FDA, GBS is a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness, or in the most severe cases, paralysis. Only about 100 cases of GBS following the J&J vaccine have been reported.* The FDA “continues to find the known and potential benefits clearly outweigh the known and potential risks.” *Current as of 13 Jul 21.
1.2.7.4. Death. Of note, “the total number of deaths associated with COVID-19 vaccines is greater than the number of deaths associated with all other vaccines combined since the year 1990.” For some reasons, autopsies on COVID-19 vaccine-associated deaths are apparently not required and are rarely being done. The way the CDC reports the death is interesting. For example: CDC reports 8,164 deaths of people who received COVID-19 vaccine out of 390 million doses, claiming a percentage of .0021%. Does anyone see a problem with this calculation?
1.2.8. How are adverse reactions to COVID-19 vaccines reported?
1.2.8.1. Vaccine Adverse Event Reporting System (VAERS). Established in 1990 and co-managed by the CDC and FDA, VAERS is a “national early warning system to detect possible safety problems in U.S.-licensed vaccines.” The official VAERS website can be difficult to navigate and analyze, so some sites devoted to its analysis have been created, such as “VAERS Analysis.”
1.2.8.1.1. According to HHS, “Adverse events from drugs and vaccines are common, but underreported.”
1.2.8.1.2. As part of a lawsuit filed against HHS, a whistleblower with inside access to VAERS alleges (under penalty of perjury) that the number of deaths from COVID-19 vaccines is closer to 45,000.
1.2.8.2. CDC’s 14-day threshold. According to the CDC, “a vaccine breakthrough infection is defined as the detection of SARS-CoV-2 RNA or antigen in a respiratory specimen collected from a person ≥14 days after they have completed all recommended doses of a U.S. Food and Drug Administration (FDA)-authorized COVID-19 vaccine.” In other words, if someone receives a COVID-19 vaccine and dies from it 10 days later, that person’s death is apparently counted as an unvaccinated death, since they died <14 days after receiving the shot. Therefore, this death would not be recorded in VAERS since the person who died was not considered vaccinated. This is significant, since the vast majority of people who die after receiving a COVID-19 vaccine do so within 14 days. There are various other questionable data reporting methods that the CDC is apparently engaging in.
1.2.9. Are COVID-19 vaccines effective? The NIH called them “highly effective,” but there is a pretty strong argument against the effectiveness of COVID mRNA vaccines.
1.2.9.1. From the source. According to Pfizer scientists, “your antibodies are probably better” than the COVID vaccination, “you’re protected for longer” if you have natural COVID antibodies, and they “work for an evil corporation.”
1.2.9.2. Waning effectivenes. Study shows Pfizer/BioNTech COVID-19 vaccine effectiveness drops after 6 months. According to another study published in The Lancet, Pfizer ‘vaccine’ effectiveness falls below 50% after 5 months… or is it 2 months? Compare that to 1 year for natural antibodies.
1.2.9.3. Opposite effect. Does COVID shot enhance Delta infectivity?
1.2.9.4. Breakthrough cases. A deadly COVID outbreak in 96% vaccinated Israel, which isn’t doing as well as Sweden. A California study showed that “Fully vaccinated were more likely than unvaccinated persons to be infected by variants.” In September 2021, 76% of deaths in Vermont were ‘vaccinated.’
