In this new series, Alfabank-Adres’s pharmaceuticals analyst Dan Spitzer tracks the development of Operation Warp Speed, a partnership among the US government and pharmaceutical companies to develop a COVID-19 vaccine by January 2021.
The need to develop a cure
While masks and social distancing have shown to slow the spread of the novel COVID-19 (coronavirus), a vaccine is seen as the only way to eradicate the disease. In several months, the damage ensued from both a health and economic standpoint has only heightened the need to develop a cure. In conjunction with legislators, researchers from both public and private institutions are working together in order to develop a vaccine in record time. The fastest approval time previously for a vaccine took more than four years from start to finish, however experts estimate a vaccine can be available in 12-18 months.
How do you create a vaccine?
Broadly speaking, a vaccine works by training the immune system to recognize and attack specific pathogens, such as a virus. Vaccines typically contain a weakened or killed pathogen, in order to stimulate the immune system without causing the disease itself. However, a new generation of vaccines aims to improve on older methods through new DNA technologies. These methods increase the specificity of a vaccine towards a virus and are also easier to modify as viruses tend to mutate as they spread from person to person. Many of these vaccines use part of the COVID-19’s own genetic code to provoke an immune response, though several different delivery strategies are being tested.
Drug trials and FDA approval
Like all drugs designed for human use, vaccines must be approved by the Food and Drug Administration (FDA). In general, for a drug to be approved it must first pass preclinical studies demonstrating a proof of concept in animal models, before entering human trials. Drug trials are typically divided into three phases with the first involving healthy volunteers to determine the drug’s side effects and how it is metabolized. Phase two is a small scale, controlled study involving target patients and a control group that typically receives a placebo or different drug. Phase three is the largest and most costly study, expanding on the second phase and involving over 1,000 volunteers in order to gather more information about safety and effectiveness, as well as studying different populations and dosages.
New initiatives and high hopes
Over 140 vaccines are currently being developed, many of which involve both public and private partnerships with the hopes of having a cure ready by early 2021. Operation Warp Speed (OWS) is the most notable initiative due to its partnership among several government agencies, such as FDA, CDC, National Institutes of Health, the Department of Defense and others. In order to achieve its goal of delivering over 300 million doses of a safe and effective vaccine, OWS announced it would help fund several private companies in the Brand Name Pharmaceutical industry in the United States. Major players Pfizer, Johnson and Johnson and Merck among two others have been chosen due to their expertise in the field. Most drug candidates are in phase two of testing but several companies are planning to start phase three this summer as the FDA and other agencies help expedite the process.
