Although restrictions have been lifted in many parts of the country, there are those holdouts who refuse to leave their homes till a vaccine for COVID-19 (whose correct name is SARS-CoV-2) is discovered. There is no doubt that an effective and safe vaccine will put an end to this devastating pandemic, which has already caused the deaths of over 100,000 Americans.
There is also a considerable number of people in America who are negative on currently available IgG antibody to SARS-CoV-2 blood testing. Based upon New York City statistics, only approximately 25% of the population here is antibody-positive (higher than other parts of the United States). That leaves at least 75% vulnerable. If extrapolated across America, that would mean that a minimum of 225 million Americans will require a vaccine to be protected from COVID-19.
To this end, the President has created “Operation Warp Speed” to mass-produce a vaccine as soon as possible. His detractors and critics have already accused him of an “October Surprise” vaccine before the election. For the sake of America and the world, I hope and pray that he can pull it off. It would take a miracle.
Dr. Anthony Fauci has predicted that a vaccine will be available by January 2021 at the earliest. If any administration in the history of the United States could pull it off, it will be the Trump administration. He has risen to every challenge. He accomplished what very few other presidents could have done with the lightning speed manufacture of ventilators and PPEs. He deserves our thanks and praise in fighting an unprecedented deadly virus. As a physician, I can truly say that he has done an extraordinary job against a relentless and implacable foe. History will be a lot kinder to the President than the militarized media of today.
A vaccine is a very tall order. The polio vaccine is nearly 100 percent effective after three doses, but the annual flu vaccine is only around 45 percent effective (statistics from 2019-2020 data). Effective vaccines against HIV, SARS 1, and MERS have not been able to be made – not for lack of trying.
There are now over a hundred vaccines currently being developed against SARS-CoV-2. The Administration announced this past week that they had selected five companies as the most likely candidates to produce a vaccine. They are Moderna in Massachusetts, AstraZeneca in combination with Oxford University, Johnson and Johnson, Merck, and Pfizer.
Moderna is beginning Phase Three trials in July. They were able to show that eight patients who were given their vaccine developed antibodies. This does not mean yet that their vaccine will be effective in preventing COVID-19, but it is a start. All of the selected companies, listed above, will be using technology that has not been used much in the development of a vaccine. Merck has produced an Ebola vaccine using some of the methodologies. The tried-and-true method of making a vaccine is to use a whole inactivated virus. A Chinese firm is currently testing an inactivated SARS-CoV-2 in clinical trials. There are safety concerns around proving that the virus is totally inactivated. If not fully inactivated, it can cause the disease it is trying to prevent. Hence, many companies, including the five selected, went to gene-based vaccines. These methods deliver part of the DNA or RNA of the virus into the human cell and, by so doing, allow the body to develop its own antibodies. Currently, there are no FDA-approved DNA or RNA vaccines for any pathogen.
Besides the difficulty of actually finding an effective and safe vaccine, there is the problem of making enough doses fast enough to inoculate close to 300 million Americans, as well as the rest of the world.
The latter problem can be resolved by the use of the C1 Gene Expression platform developed by Dyadic using a fungal medium. The C1 platform can make any protein, including monoclonal antibodies against SARS-CoV-2, insulin, generic drugs, and vaccines faster and cheaper than anyone else. The platform was discovered 40 years ago by Mark Emalfarb, its CEO. Once an effective and safe vaccine is found against COVID-19, Dyadic can produce 300 million doses within one month. This is a true game-changer. Last week, the Frederick National Laboratory agreed. It selected Dyadic’s C1 cell lines to produce a number of COVID-19 vaccine candidates, which will be used by the National Institute of Allergy and Infectious Diseases and the National Institutes of Health (NIH). This technology is a must in a world where infectious disease and future pandemics are unfortunately looming.
I have no vested interest in this company. As a physician, I believe that the C1 platform is the only way you are going to save the most people more quickly and less expensively than any other method. If there is going to be an “October Surprise,” Dyadic will have to be in the mix. Let us all pray that we come up with an effective and safe vaccine against this dreaded virus quickly.
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Joseph M. Frager is a physician and lifelong activist.