California health officials are asking vaccine providers to stop administering a batch of Moderna’s Covid-19 jab, after an unusually high number of adverse reactions were linked to the drug.
Doses from Moderna Lot 041L20A are suspected of causing a “higher-than-usual number of adverse events” and should be shelved until a proper investigation can be conducted, the California Department of Public Health said on Sunday.
- December 9 – UK authorities confirmed 2 cases of anaphylaxis after vaccination
- December 18*, 2020 – CDC has identified 6 case reports of anaphylaxis following Pfizer-BioNTech vaccine meeting Brighton Collaboration criteria for anaphylaxis
- Persons with anaphylaxis following COVID-19 vaccination should not receive additional doses of COVID-19 vaccine
Most people will escape “severe” side effects, defined as those that prevent daily activity. Fewer than 2% of recipients of the Pfizer and Moderna vaccines developed severe fevers of 39°C to 40°C. But if the companies win regulatory approvals, they’re aiming to supply vaccine to 35 million people worldwide by the end of December. If 2% experienced severe fever, that would be 700,000 people.
Other transient side effects would likely affect even more people. The independent board that conducted the interim analysis of Moderna’s huge trial found that severe side effects included fatigue in 9.7% of participants, muscle pain in 8.9%, joint pain in 5.2%, and headache in 4.5%. In the Pfizer/BioNTech vaccine trial, the numbers were lower: Severe side effects included fatigue (3.8%) and headache (2%).
But that’s a higher rate of severe reactions than people may be accustomed to. “This is higher reactogenicity than is ordinarily seen with most flu vaccines, even the high-dose ones,” says Arnold Monto, an epidemiologist at the University of Michigan School of Public Health.
- Vaccine produced by a partnership between a University of Oxford research institute, Vaccitech, and AstraZeneca, does not need to be stored at freezing temperatures.
- Cheaper and easier to produce than the high-efficacy vaccines produced by BioNTech-Pfizer and Moderna.
- The price of AstraZeneca’s shares dropped on the news, and an analysis from an investment bank concluded, “We believe that this product will never be licensed in the US.”
- A closer look at the the Oxford-AstraZeneca trials reveals some very shaky science.
- Cherry-picked the data
- Dosing issues
- Opaque planning and data analysis procedures
- Age group selection
Two major U.S. pharmaceutical companies racing to develop novel coronavirus vaccines have announced that their vaccines have been confirmed to be over 90% effective. But Masayuki Miyasaka, a leading immunologist at Osaka University, told the Mainichi Shimbun in a recent interview that even after these vaccines become available, he does not plan to receive them for the time being.
At a meeting of the Committee on Health, Labor and Welfare of Japan’s House of Representatives on Nov. 17, Miyasaka stated, “There’s no doubt that their effectiveness is quite high, but their safety is not guaranteed at all,” sounding a word of caution about expectations for the vaccines.
- Phase I clinical trials simply test the safety of a drug or vaccine in a small number of healthy volunteers — usually brave and naïve college students.
- Phase II trials are responsible for testing its effectiveness in a larger number of subjects.
- A hyped-up and exuberant response to a Phase I trial as seen with Moderna press release is rare and nearly unheard of.
- Little information is gleaned from an investigational drug in Phase I that has many more hurdles to overcome before it successfully gets to market
- 77 percent of vaccines for infectious diseases make it through Phase I, but only 33 percent make it through the entire process overall.
Moderna’s RNA vaccine
- Upon examining Moderna’s non-peer reviewed press release, the actual data on the vaccine’s success is even more flimsy.
- When it comes to finding out whether the vaccine elicits an antibody response that could potentially fight the coronavirus, they only had data on eight patients out of the 45 patients who received the vaccine.
- The only data Moderna mentioned when it comes to determining whether the vaccine was clinically effective against the coronavirus were from mice.
- History also proves that success in animal models is often not replicated in human studies.
- Moderna’s messenger RNA vaccine is completely new and revolutionary. Messenger RNA vaccines have never before been brought to market for human patients
- It uses a sequence of genetic RNA material produced in a lab that, when injected into your body, must invade your cells and hijack your cells’ protein-making machinery called ribosomes to produce the viral components that subsequently train your immune system to fight the virus.
- Some messenger RNA vaccines are self-amplifying. That means they can force the cell to replicate more copies of itself.
- There are unique and unknown risks to messenger RNA vaccines, including the possibility that they generate strong type I interferon responses that could lead to inflammation and autoimmune conditions.
Oxford Vaccine Group’s vaccine:
- Oxford Vaccine Group has a competing vaccine that does not need to invade and hijack our cells’ own machinery.
- From a medical and clinical perspective, there is less risk of generating a type I interferon response and autoimmunity because there is no messenger RNA floating around our blood, invading our cells.