Answers to FAQ of the The Institute's COVID-19 Vaccine Research
Question 1: Will the Institute's vaccine use aborted fetal cells in the design, manufacturing or testing of its vaccine?
Question 2: When will the Institute's vaccine be available?
Answer: The Institute's vaccine is currently at a preclinical stage. There are two phases to the preclinical stages before the vaccine can be tested in a clinical trial. Phase 1 involves the development of the vaccine product, which requires $325,000 and 6-9 months to development. Phase 2 involves 12-18 months and 1.5-2 million dollars to cover the cost of animal testing to evaluate vaccine safety and efficacy. The timeline to accomplish these milestones is dependent on achieving those fundraising objectives. This information is available in a published video.
Question 3: What type of vaccines are the Institute developing?
Answer: We are working on 2 different COVID-19 vaccine approaches. The first is a recombinant protein vaccine that will contain 2 COVID-19 proteins. The second vaccine platform will be designed to produce either a traditional killed virus vaccine or an attenuated live virus.
Question 4: What are the advantages of the Institute's recombinant protein vaccine over mRNA vaccines?
Answer: mRNA vaccines represent new generation methods but have not been approved for any infectious disease prior to COVID-19. Thus, there is no historic clinical information on the efficacy and safety of mRNA vaccines prior to COVID-19. Second, the mRNA vaccine delivers a viral gene (typically the spike protein) that is injected into muscle tissue, and the muscle tissue, in turn, produces that viral spike protein or antigen. The body's immune system then produces antibodies to the antigen, which, in turn, would theoretically neutralize the whole virus.
Yet, there are several shortcomings of mRNA vaccines not withstanding a lack of historic clinical data. First, the dose of spike protein that is produced is not standardized. The muscle tissue produces spike protein for an unknown period and in unknown quantities. Thus, every person produces different amounts of spike protein. Second, the glycosylation process (a process in which cells add sugar molecules on a protein, which defines the pharmacology of the vaccine) is also not standardized. In fact, patients with chronic diseases produce abnormal glycosylation processes that have been associated with the promotion of cancer and autoimmune diseases. Third, mRNA vaccines are very temperature unstable. mRNA vaccines require storage at ultra-cold temperatures.
The Institute's recombinant protein vaccine offer several advantages over mRNA vaccines. First, there is a clinical track record of recombinant protein vaccines such as with the hepatitis B vaccine. Second, the dose of the viral antigen is standardized. Third, the glycosylated process of the viral antigen is standardized. Fourth, the glycosylated viral protein is fully human which should reduce the risk of adverse immune reactions. Fifth, the recombinant protein can be transported and stored at room temperature, which can be easily distributed and administered to poor countries around the world. Sixth, the peptide sequence of an important super antigen found in the spike protein that is known to cause toxic shock from bacterial infections has been eliminated to improve vaccine safety. Lastly, the vaccine offers other viral targets other than the spike protein as the virus mutates.
Question 5: Why is the Institute pursuing an attenuated live vaccine and what are the scientific advantages when some experts claim that attenuated live vaccines take longer to develop?
Answer: An attenuated live vaccine offers the best chance of longer immune protection. Attenuated live vaccines do not require boosters like mRNA vaccines or gene-based vaccines. Attenuated live vaccines can elicit cell-mediated immunity, which is required to produce longer immunity. Pharmaceutical companies are only evaluating the initial humoral immunity which is typically brief and last for a few months. The humoral immunity from current COVID-19 mRNA vaccines decreases between 50 to 75 percent after 3 months in patients over the age of 55. It is not clear whether mRNA vaccines offer cell-mediated immunity. Previous research to develop subunit vaccines for SARS based on only expressing the spike protein failed to offer cell mediate immunity, which was one of the reasons why SARS vaccines failed. Attenuated live vaccines are traditional vaccines that have a track record of success for several infectious diseases in offering longer immunity. Attenuated live vaccines have better crossover protection against divergent viral strains, which may offer protection against future novel coronaviruses. However, attenuated live vaccines historically take longer to develop- the principal reason why "Operation Warp Speed" did not support this approach. Yet, the Institute is creating a platform to develop an attenuated live vaccine that will be quicker to modify and manufacture in response to future novel coronaviruses that evolve in nature or are manmade.
Question: Is the Institute's COVID-19 research restricted to only COVID-19 vaccines?
Answer: No. The Institute is conducting research in developing therapies and diagnostics to better diagnose and treat COVID-19 infections.