Author: Mr. Z Contributor：Magnum 44
According to Jerusalem Post and ZeroHedge, two participants who died in Pfizer’s COVID vaccine trial. FDA plans to hold a meeting on December 10 to discuss Emergency Use Authorization of the Pfizer-BioNTech Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.
As of today, COVID-19 is still rapidly spreading all over the world and causing thousands of deaths as each day goes by. So far, there is no panacea for COVID-19. Even though clinical data show the safety and efficacy of hydroxychloroquine for both early treatment and prophylaxis, big pharmaceutical companies have been actively touting vaccines for COVID treatment, likely driven by the high profit.
Currently, the three most promising vaccines are close to be ready for FDA approval, i.e., Pfizer and BioNTech SE, Moderna, and AstraZeneca-Oxford. In mid-November, Pfizer announced over 90% efficacy of their COVID-19 vaccine and submitted an emergency use authorization request to U.S. FDA and other agencies. In late November, Moderna also announced over 90% efficacy of its vaccine and seek for immediate regulatory clearances in the U.S. and Europe. AstraZeneca said their COVID-19 vaccine trial results will be complete likely in late January.
However, several concerns about the safety of COVID vaccines are still not addressed:
Lack of efficacy study in all patient groups — Pfizer and Moderna phase 3 trials only showed their vaccines’ efficacy to prevent severe COVID symptoms. It’s unclear whether their vaccine can protect against asymptomatic infections because asymptomatic and mild-symptomatic patients were not included in their studies. Thus, the conclusion of the exceptionally high efficacy of their vaccines is flawed.
Unknown long-term immune response — It is not included in their phase 3 trials whether their vaccines can develop a long-term immune response. The efficacy of Pfizer’s vaccine was measured only within 7 days after the second shot, and Moderna’s vaccine was evaluated in 2 weeks after the second shot.
Side effects — Both Pfizer and Moderna reported Grade 3 or “severe” adverse events of their vaccine that can interfere with daily activity. Pfizer’s study showed adverse events of fatigue at 3.8% and headache at 2.0% of all participants following the second dose. Moderna’s trial also found severe side effects, including fatigue in 9.7% of all participants, muscle pain in 8.9%, joint pain in 5.2%, and headache in 4.5%.
Dr. Li-Meng Yan warned multiple times that the antibody dependence enhancement (ADE) effect could be a big hurdle for COVID vaccine development. As reported by Lee et. al. in Nature magazine in 2020, previous SARS vaccine studies have shown many failed vaccine trials due to safety risks related to the ADE effect. ADE effect is believed to be related to the Fc receptor, a protein found on the surface of quite a few types of cells in the human body. Normally, the function of the Fc receptor is to destroy pathogens or infected cells. However, studies have shown that some viruses, such as SARS and SARS-CoV-2 can use the Fc receptor to infect human cells.
If Pfizer and Moderna’s vaccines are as safe and effective as claimed, a good starting point is to have Pfizer and Moderna’s CEO and employees take their vaccines first.
On December 8th, a 90-year-old woman took the first Pfizer vaccine, according to ABC News. The UK was the first Western nation that authorized the emergency use of the Pfizer vaccine. Since there are still so many questions about the long-term efficacy and adverse side effects of the COVID vaccine, the world needs to take a very cautious step on giving COVID vaccine to its citizens.