« The Pfizer BioNTech SARS-CoV-2 Vaccine Receives an EUA | Main | The Moderna Vaccine Application for EUA »

What is Operation Warp Speed?

When the coronavirus SARS-CoV-2 was identified last year scientists knew that vaccines needed to be developed and many companies and research facilities began the process (more than 150).  The fastest a vaccine has ever been developed is 4 years - the mumps vaccine.  Suddenly a pandemic was declared and a worldwide catastrophe was imminent.  By early April Dr. Peter Marks, an oncologist who worked in academia and the drug industry and was currently the head of the FDA division that regulates vaccines, began laying the groundwork for what would become Operation Warp Speed.  Working with Robert Kadlec he wrote a proposal for the HHS Sec'y Alex Azar for a process that went from screening potential vaccine candidates to distributing the final product to 330 million Americans. Dr.Marks was a longtime Star Trek Fan and dubbed the proposal Operation Warp Speed.   

They wanted to find 8 vaccines that were promising in early testing, and select 2 for each method of vaccine development.  The first 5 companies that were selected were Moderna, Oxford-AstraZeneca, Johnson and Johnson, Merck, and Sanofi Glaxo Smith Kline.  Pfizer didn't accept government funds for vaccine development, but signed a contract with the government to buy 100 million doses of their vaccine if successful.  Novavax and Vaxart were accepted later.  Operation Warp Speed was announced on May 15th and vaccine development became a private-public partnership with gov't financial support. Government funding also allowed the companies to begin manufacturing, which is a financial risk if the vaccines aren't successful.    Read Below  


All drugs and vaccines go through preclinical, Phase 1, 2, and 3 Clinical Trials.  Phase 3 clinical trials randomize volunteers between vaccine and placebo to determine efficacy in preventing Covid-19 and safety.  In Operation Warp Speed, every company had to have 30,000-50,000 trial subjects to make sure that the results were statistically significant. Pfizer and Moderna had very successful Phase 3 Trials and both should have an Emergency Use Authorization within days.  Developing vaccines can be very frustrating and both Oxford-AstraZeneca and Sanofi-GSK have hit some problems.  Oxford-Astrazenca's trial inadvertently used half the amount of vaccine for the first dose in a portion of their trial participants (~3000), which actually showed higher efficacy than the 2 full dose vaccinations.  They now need to test these varying doses and add additional trial volunteers in order to determine if the efficacy continues to be 90%. Sanofi's vaccine was not as effective in older volunteers and the vaccine will be revised and retested in older subjects.  We should soon be hearing about clinical trials from the other 4, especially J and J and Merck.


Post a comment

(If you haven't left a comment here before, you may need to be approved by the site owner before your comment will appear. Until then, it won't appear on the entry. Thanks for waiting.)