In the six months since the program began to develop a COVID-19 vaccine, Operation Warp Speed (OWS) has made significant progress in areas such as development, manufacturing and distribution. The White House has made substantial investments in each of these areas, spending more than $10.0 billion to support accelerated growth. However, this growth has not been without controversy, since increased concerns of how the historic funding is being used have arisen. Additionally, politics have also become a point of concern due to recent talks of accelerating safety trials as well as emergency approvals, eroding trust in the overall safety of a vaccine.
COVID-19 Vaccine Development
Logistics and Distribution
While most funding has been directed towards the development of various vaccines, additional logistical factors have also been used to support the distribution of an eventual vaccine. By shouldering the investment costs necessary for manufacturing capacity of not only the vaccine itself, but also the packaging and its components, the pharmaceutical and biotechnology companies involved have been able to allocate greater resources towards drug development. Still, the distribution of a vaccine will likely be a major challenge due to high demand. To address this, the Centers for Disease Control and Prevention (CDC), the Department of Defense and the Department of Health and Human Services announced that McKesson Corporation will be a central distributor of future COVID-19 vaccines and related supplies needed to administer the vaccinations.
Continuing from the previous article, three companies participating in OWS have recently begun phase three drug trials for their COVID-19 vaccine candidate. Biotechnology company Moderna was the first to begin, with Pfizer and its collaboration with BioNTech following shortly after, and now AstraZeneca, in partnership with Oxford University, has also begun its phase three trial in the United States. Each of these trials involves over 30,000 healthy adults to determine the safety and efficacy of the vaccine for the greater population.
Concerns and Challenges
OWS has experienced increased criticism due to the level of funding and recipients. One notable example was the $1.6 billion award to Novavax, a small biotechnology company that has never before brought a vaccine to market in its 33-year history. Due to the extraordinary circumstances and efforts being put towards the development of a COVID-19 vaccine, if one is developed, it would be the fastest a drug has been brought to market. This fact alone has caused mistrust in the final approved product to waver, especially since the vaccine will be distributed to healthy adults and children, further increasing the associated risk.
On top of these factors, the upcoming election in November and calls for accelerated approvals have begun to influence trust in the process for determining the overall safety of the vaccine. To address these concerns, nine drug makers pledged in September to promise to not file for regulatory approval or authorization of their experimental COVID-19 vaccines until the shots have been shown to work safely through late-stage clinical testing. While the three companies have shown the most promise in bringing a product to market, many challenges remain due to the novelty regarding this historic event.
