Written By Michelle Botello
A program to get Coronavirus vaccines to the public has been brought out into the open. Operation Warp Speed is a strategy to accelerate the development, manufacturing, and distribution of Covid-19 vaccines, therapeutics, and diagnostics. According to Donald J. Trump, his push to have the vaccines developed are being made in just one year. The doses may be out in two to three weeks just before the end of the year.
According to the Trump Administration, the first citizens to receive this dose would be high risk individuals like:
- covid patients
- first responders
- health workers.
The OWS’s goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, stated in hhs.gov: Fact Sheet: Explaining Operation Warp Speed. By April, the vaccine should be eligible to the public, according to Trump, completely free of cost to patients.
The doses, aka OWS, is a partnership of the Department of Health and Human Services, the Centers for Disease Control and Prevention, the National Institutes of Health, the Biomedical Advanced Research and Development Authority and Department of Defense.
The engagement includes federal agencies such as the Department of Agriculture, the Department of Energy, and Department of Veterans Affairs.
The federal government will be overseeing the clinical trials of the vaccination and steps to further the process will follow for the demonstration of the vaccine's efficacy and safety. This may cost more financially, but will not cost product risk.
Announced on May 15, the vaccine development plan is the following: Fourteen candidates have been chosen from the 100+, to be narrowed down to seven with options of nucleic acid viral vector, and protein subunit, which will go through further testing in early-stage trials.
Second, large-scale random trials for demonstration of safety and efficacy will come next for most promising candidates.
The federal government is investing in firms giving them confidence that they can invest in the development and allow faster distribution of the vaccine. The manufacturing capacity for the candidates is to be advanced while in development, and not scaled up after approval or authorization.
Manufacturing capacity developed is to be used for the vaccine to be successful, whatever the successful product is, regardless of which firms have developed the capacity.