The Coronavirus is spreading fast in the U.S. and the world. A vaccine is desperately needed in order to stop the COVID-19 pandemic. To help develop, produce and distribute a vaccine faster, Operation Warp Speed was initiated.
What is Operation Warp Speed?
Operation Warp Speed was launched by the U.S. government in March 2020, in order to speed up the process of developing, producing and delivering a COVID-19 vaccine. It is a partnership between various state institutions and private companies.
The main idea is to avoid bureaucratic hurdles and to also run different phases of the development simultaneously, thus being able to provide the vaccine many months earlier than normal.
- Goals: The program’s goal is to to develop and distribute 300 million doses of an effective and safe vaccine for COVID-19 by January 2021. Another goal is to provide the vaccine for free to U.S. citizens.
- State institutions that are involved: The U.S. Department of Defense (DOD) and the U.S. Department of Health & Human Services (HHS). The latter includes the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority (BARDA), the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH).
- Budget: Through the Coronavirus Aid, Relief, and Economic Security (CARES) Act from March 2020, U.S. Congress directed nearly $10 billion to the OWS. BARDA got $6.5 billion of this sum, for countermeasure development. The rest was designated for NIH research.
- Companies that received reaserch funding: Janssen Pharmaceutical (Johnson & Johnson), Moderna, AstraZeneca and the University of Oxford, Novavax, Sanofi and GlaxoSmithKline, Merck and IAVI.
- The Pfizer and BioNTech partnership was the first to announce an effective vaccine candidate. These companies did not receive any research funding from OWS, but there is a $2 billion contract to manufacture 100 million doses of vaccine to be used in the U.S.
- Non-vaccine investments (manufacturing, vials, syringes): Emergent BioSolutions, Regeneron Pharmaceuticals, Texas A&M University and Fujifilm, Corning, SiO2 Materials Science, ApiJect, Grand River Aseptic Manufacturing, Ology Bioservices, Cytiva,Eli Lilly and Company, McKesson Corporation.
- OWS leaders: The supervisors of this program are Acting Defense Secretary Christopher Miller and HHS Secretary Alex Azar. General Gustave F. Perna serves as the chief operating officer of OWS and Dr. Moncef Slaoui (former head of GlaxoSmithKline’s vaccines department) is the chief advisor.
Timeline: What happened so far
Here is a timeline of the OWS milestones so far.
- March 2020: U.S. Congress allocated nearly $10 billion for OWS. Johnson & Johnson got $456 million for its candidate vaccine. The agreement was extended by $1 billion in August 2020, to fund the large-scale manufacturing and delivery of the vaccine.
- April 2020: $483 million for Moderna’s candidate vaccine. The agreement was extended by $1.5 billion in August 2020 as well to account for the large-scale manufacturing and delivery of the vaccine.
- May 2020: $1.2 billion for AstraZeneca’s candidate vaccine (and the agreement was extended by $486 million in October). $138 million contract with ApiJect for more than 100 million syringes.
- June 2020: Partnership with Emergent BioSolutions, Corning and SiO2 Materials Science (manufacturing, containers).
- July 2020: Agreements with Pfizer and Novavax for the large-scale manufacturing and nationwide distribution of their vaccine candidates. Moderna and Pfizer began Phase 3 clinical trials. Partnership with Texas A&M University and Fujifilm (manufacturing). Agreement with Sanofi and GlaxoSmithKline for developing and manufacturing a vaccine candidate.
- August 2020: Partnership with Grand River Aseptic Manufacturing, McKesson Corporation and Ology Bioservices for production and distribution of the vaccine. The FDA issued an Emergency Use Authorization for convalescent plasma. AstraZeneca began Phase 3 clinical trials.
- September 2020: The DOD published its Strategy for Distributing a COVID-19 Vaccine. It also identified five medical treatment facilities for Phase 3 vaccine trials. AstraZeneca had to pause its clinical trials. Meanwhile, Johnson & Johnson began Phase 3 clinical trials.
- October 2020: Agreements with Cytiva, Eli Lilly and Company, CVS and Walgreens. AstraZeneca resumed its Phase 3 vaccine clinical trials.
- November 2020: Pfizer-BioNTech and Moderna announced that their vaccine candidates are more than 90% effective in preventing COVID-19. Eli Lilly’s COVID-19 investigational antibody therapeutic received an Emergency Use Authorization from the FDA. The U.S. government announced a partnership with large chain pharmacies and networks to maximize access to vaccines.
The distribution plan
As of November 2020, Pfizer was testing delivery methods for its vaccines. But there was no concrete date scheduled for starting the distribution. Although the OWS accelerates the entire process, there are still certain steps that can’t be skipped. This is the distribution plan:
- While companies like Pfizer and Moderna are still running the clinical trials (Phase 3), manufacturers are already mass-producing vaccines. This way, the doses will be ready as soon as a vaccine is authorized.
- The FDA reviews data from clinical trials and issues Emergency Use Authorizations (EUA) or Biologics License Applications (BLA).
- The CDC defines prioritization models: initial doses will be distributed to certain groups (like first responders).
- A Central Distributor will oversee the distribution operations. Vaccines, syringes, needles, and alcohol swabs will be shipped to depots.
- Only after a vaccine was authorized, the doses will be delivered from the debots to hospitals, pharmacies, clinics, nursing homes and military treatment facilities.
- The FDA and CDC will monitor the results for adverse effects, for a period of 24 months.