How Does the U.S. Plan to Release an Eventual COVID-19 Vaccine?
By Aashvi Busa
This article was originally published on December 11th, 2020.
Ever since the beginning of the COVID-19 pandemic, there has been one question on everyone’s mind: when and how will a vaccine be released? As of now, companies around the world are working to develop a vaccine with a high success rate that is safe to use. However, we are yet to get a confirmed release date for any of them. Over 200 prototype vaccines, however, have been authorized by the World Health Organization to undergo stages of testing to prove effectiveness.
For a vaccine to be approved, it has to pass pre-clinical trials and three phases of testing in different sized groups. The pre-clinical trials are performed with animals to verify that the vaccine provokes an immune response. Then, Phase I testing is done with about 20–100 volunteers, and can help to determine how dosage correlates with possible side effects. If the vaccine is successful in Phase I, it progresses to Phase II where the vaccine is distributed between hundreds of people. Here, scientists look for common side effects and overall performance of the vaccine. If all evaluations are passed, the vaccine advances to Phase III, where it is taken by hundreds to thousands of people. It is analyzed with both a control group and a vaccinated group to compare results and ensure safety. Below is a table of the top ten vaccine candidates and the phase of testing they are presently in. Many of the companies listed are optimistic of a vaccine being approved by the end of the year as they are working through the final phase of testing.
After the pre-clinical and clinical trials, if the benefits of the test vaccine outweigh the potential risks it is granted a license by the FDA confirming that it is cleared to release to the public. Currently, the proposal for distribution of a COVID-19 vaccine is to deliver the first shipment to nursing homes where staff and patients are the most at risk for getting infected. After looking closely at data from the vaccine tests, the Advisory Committee on Immunization Practices has recommended that healthcare personnel, workers in essential industries, people with underlying medical conditions that put them at high risk, and people over the age of 65 get the vaccine first if there is a limited supply. These deductions were made to maintain a functional society and treat those most endangered of contracting the virus. The administration of the vaccine will be done by pharmaceutical companies and transportation will mostly be handled by private delivery services. This government-funded plan for the distribution of a possible vaccine is known as Operation Warp Speed and allows for rapid development and delivery while still following safety regulations.
While Operation Warp Speed has granted corporations the ability to quickly come up with a vaccine, there are still obstacles to overcome to ensure safety and effectiveness. One issue is storage as some probable vaccines such as Pfizer’s need to be kept in temperatures below 80 degrees Celsius to prevent it from degrading. To resolve this, Pfizer is planning to ship their vaccine in “Pizza boxes”, or insulated containers filled with dry ice. The company hopes that by doing so their vaccine and others required to be stored at lower temperatures will be usable. Another concern is the amount of staff available to administer the vaccines to the public. To keep up with the demand, many states are considering providing lower-level pharmacists the training to do so safely. Lastly, guaranteeing access to treatment for individuals at no-cost could pose as a challenge. To combat this the government has pre-ordered millions of doses of plausible vaccines along with clarifying legislative preconditions to allow insurance companies to provide them for free. While there are still some problems to be sorted out, the government and other corporations are working together to come up with solutions as the release of a vaccine nears.
Once a vaccine is released and distribution begins it is very likely that things won’t go back to normal right away. According to the Centers for Disease Control and Prevention, the country will reopen in three stages. Stage I will allow for businesses to open with strict social distancing guidelines, but schools and other organizations are recommended to continue online. Meetings will continue to be limited to ten people or less to ensure the prevention of a spike in cases. If there aren’t any, Stage II can commence in certain areas permitting non-essential travel to resume and gatherings of up to 50 people. In this stage schools and other businesses can properly open without strict measures in place. Finally, if everything goes to plan, the country can move to Stage III, where vulnerable individuals may stop sheltering in place and visits to nursing homes and senior centers can restart. As companies come closer to releasing a vaccine, many people are working hard to ensure the safety of the public and end the pause the pandemic has put on the world.