The COVID-19 Pandemic
The global COVID-19 pandemic has led to millions of people being infected with COVID-19 and hundreds of thousands of deaths worldwide. In response to this crisis, and in an attempt to slow its spread, political leaders have restricted movement and enforced precautions to maintain public safety. These measures have unfortunately taken their toll on economies around the world.
The severity of this pandemic and the disruption to daily life has made finding potential cures or preventions a top priority for pharmaceutical companies. The highest priority in many countries has been the development of a vaccine.
Vaccines allow the body to fight against a small and harmless amount of a potential virus or bacteria, allowing the body to develop the ability to fight against that infection in the future. This process creates immunity - a condition where the body will be able to fight against an infectious agent before an infection really begins, making it impossible for the body to get the disease.
An effective vaccine against SARS-CoV-2 (the virus that causes COVID-19) would protect those who got the vaccine from developing an infection or spreading the infection to others. The only way to truly stop the spread of COVID-19 will be to have a large percentage of the population immune from being infected (called herd immunity) or to have a large percentage of the population immune from having had a vaccine.
The US Food and Drug Administration (FDA) has provided guidance for vaccine developers, outlining the requirements that have to be met for a vaccine against COVID-19 to be eligible for use by the public. To be authorized for use, a vaccine would have to prove that it is at least 50% effective against COVID-19.
There are at least 41 potential vaccine candidates that are currently under investigation for potentially immunizing patients against COVID-19. Three of these candidates are still in the early stages of research, 19 of them are in pre-clinical trials, meaning that they are not yet being tested on humans, but that testing has started, and 19 of these vaccines are in various stages of human clinical trials.
The United States Government announced a framework and leadership for Operation Warp Speed (OWS) on May 15, 2020. OWS is a “national program to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics,” according to a press release by the US Department of Health and Human Services (HHS). OWS involves a coordinated response by the public and private sectors to respond to the needs caused by COVID-19.
The US government has chosen three vaccines to fund for Phase 3 clinical trials through OWS. Phase 3 clinical trials are the final stage of testing for vaccines before they are approved for use and sale to the general public. While the fact that three vaccines are being funded for this final step of clinical trials is exciting, these clinical trials are quite involved, and it may still be some time before the results of these trials are final. Also, there is no guarantee that these higher-level clinical trials will show that any of the vaccine candidates are successful. While some caution may be warranted, it does seem that there is a decent probability that at least one of the three vaccines will show positive results.
Experts have estimated that, given the overwhelming dedication of global resources to the task, development of a COVID-19 vaccine may happen more quickly than is typical for normal vaccine development. The timeframe provided by experts for a best-case scenario tends to be about 12 months from initial vaccine conception to the actual approval of the vaccine.
While 12 months may seem like a relatively long time, we are already several months into the process of vaccine development. The first Phase 1 clinical trials were started on March 16, 2020, meaning that the process of researching began earlier than that. The idea that a vaccine could be available by the end of the year is not unrealistic.
While vaccine development is the ultimate goal, it will only be the first step in vaccinating the public and stopping the spread of COVID-19. The day that the vaccine is approved, there will not be nearly enough vaccines to meet the demand that will occur. The public will likely have spent close to a year taking precautions to stop the spread of COVID-19, with the pandemic being a major consideration for many.
The high demand for an approved vaccine, coupled with specialized production requirements that will make rapid mass production slow, will lead to a situation where the supply is not adequate to meet the demand for several months. Individual healthcare entities will find that sourcing vaccines will initially be quite challenging and that entities that have the ability to provide the vaccine will have competitive edge, especially in the early days.
One area of preparation that will be vital for healthcare providers and entities anticipating the authorization of a vaccine will be having the ability to store COVID-19 vaccines that they are able to source. Storage of the vaccine is already a consideration for developers. The FDA requirements state, “For vaccine licensure, the stability and expiry date of the vaccine in its final container, when maintained at the recommended storage temperature, should be demonstrated using final containers from at least three final lots made from different vaccine bulks.”
Storage will be a significant consideration, particularly given that the limited supply of vaccines will make it necessary for providers and organizations to purchase as many of the vaccines as they can as soon as they are available. There will likely be organizations in the early days of vaccine availability that will be limited by their storage capabilities. Preparing now, especially before the demand for cold storage makes it difficult to obtain, is wise for providers and organizations to consider as they plan for the eventual release of a vaccine.
We are here as a resource for you and your patients during this difficult crisis. Call us today at 1.800.218.7613 or contact us using our contact form to learn more about our storage solutions for the COVID-19 vaccines that your practice or pharmacy may need to accommodate soon.
Disclaimer: K2 Scientific does not provide medical advice and our content is intended for informational purposes only. Our content is not a substitute for professional medical advice, diagnosis or treatment of any disease or disorder. Specific medical questions should be directed to licensed healthcare providers or to an appropriate healthcare agency or entity and clinical practice or medical decisions should only be made using the advice of licensed healthcare professionals or sources recognized as medical authorities.