Author: Mr. Z. Contributors: Brain Sanitizer; Rica Reviewer: Rica
The FDA issued an emergency approval of two COVID vaccines from Pfizer and Moderna in mid-December. Bloomberg reported that more than 29 million doses of the vaccines were distributed in 43 countries. Since the week of January 4th, many people in the U.S. started to receive the second dose, despite uncertainties of their actual efficacy and safety.
Five weeks ago, our report raised several safety questions about COVID-19 vaccines (https://gnews.org/634036) based on the limited information on Pfizer’s and Moderna’s phase 3 trial results. Recently, two journal publications in the New England Journal of Medicine and FDA reports became available with more details on clinical results. Peter Doshi, the associate editor of the British Medical Journal (BMJ), expressed his concerns on the actual efficacy of Pfizer’s and Moderna’s COVID vaccines on his BMJ blog last week based on the clinical data.
Peter first questioned about the “suspected COVID-19 cases.”
Pfizer’s phase 3 trial enrolled 43,538 participants. Pfizer claimed 95% efficacy because, among 170 symptomatic and PCR-confirmed COVID cases, 8 were in a vaccine group, and 162 were in the placebo group. Peter said in his article, “these numbers were dwarfed by a category of the disease called ‘suspected COVID-19’ —those with symptomatic COVID-19 that were not PCR confirmed.” The FDA report on Pfizer’s vaccine showed there were 3,410 “suspected” COVID-19 cases in the overall study population, 1,594 in the vaccine group, and 1,816 in the placebo group. Assuming, in the worst scenario, that all suspected cases are positive, the actual efficiency of Pfizer’s vaccine may be as low as 29%, which is far below the 50% threshold set by the regulators.
Although we still do not ascertain whether these 3,410 suspected cases are positive or negative COVID cases, the fact that Pfizer’s 92-page report doesn’t even mention the 3,410 “suspected covid-19” cases seem very suspicious.
371 individuals were excluded from Pfizer’s efficacy analysis.
They claimed that these participants had other significant protocol deviations on or before seven days after the second dose. However, nobody has mentioned any of these protocol deviations to the vaccine group and placebo group, containing 311 and 60 participants, respectively. Peter wondered why there were five times more participants excluded in the vaccine group. Neither the FDA report nor the Pfizer report said anything about it.
Masking effect from fever and pain medications.
It is known that the Pfizer vaccine can lead to severe side effects, especially after the second dose. Under these circumstances, doctors would recommend participants take medicines, such as Ibuprofen and Tylenol, to treat the symptoms following vaccination. This may lead to ignorance of COVID cases, more likely in people who received the vaccine and tried to prevent or treat adverse side effects.
Peter emphasized that we need raw data.
He said, “Addressing the many open questions about these trials requires access to the raw trial data. But no company seems to have shared data with any third party at this point.” Reports showed that Pfizer would start sharing data 24 months after the study completion, and Moderna plans to share their data in mid-to-late 2022. It would be a dangerous step to promote the COVID vaccine without knowing its real effectiveness and safety.
Since the beginning of the COVID vaccine development, there have been a few cases reporting unexplained illness and death that might be related to COVID vaccines.
– Associated Press reported that Dr. Gregory Michael (Miami, FL) died 16 days after getting the first dose of Pfizer’s COVID vaccine. Three days after he received the vaccine, he was diagnosed with immune thrombocytopenia, a condition situation that can prevent blood from clotting and cause internal bleeding. The CDC and Pfizer are currently evaluating the case.
– In September 2020, AstraZeneca suspended the clinical trial of its COVID vaccine because a healthy 37-year-old woman “experienced confirmed transverse myelitis ” after receiving her second dose.
– Jerusalem Post and ZeroHedge reported two participants who died in Pfizer’s COVID vaccine trial. Pfizer denied their deaths were possibly related to its vaccine.
– The CDC warned at least 29 people who have received shots and suffered the rare but potentially life-threatening allergic reactions that can constrict the airways and send the body into shock.
Besides the concerns about the safety of the COVID vaccine, scientists and doctors are also worrying about the new strands of the mutated CCP virus. Although recent research suggests Pfizer’s COVID-19 vaccine can protect against the mutation found in Britain, it is of the question of whether it can protect people from future mutations due to the high mutation rate of the CCP virus. It is necessary to conduct an independent investigation on the Wuhan Institute of Virology, to uncover the truth of the CCP virus.
The CCP virus has caused tremendous chaos in the world during 2020. Hopefully, the uncertain safety and efficacy of the COVID vaccine will not bring more secondary disasters in 2021.