Clinical Trials & Coronavirus-Are We Ready For A Vaccine?
Sufficient supply, careful storage, and effective distribution of vaccines are important considerations.
The world has reached another grim milestone, with 1.5 million deaths from the coronavirus, an alarming 280,000 of those in the United States alone. As numbers of cases and deaths continue to climb following the predicted post-Thanksgiving surge, there may be a glimmer of hope on the horizon: a vaccine (or perhaps more accurately, ‘vaccines’ plural). Countries around the world are quickly bringing good news to the pandemic front.
Pfizer, Moderna, and AstraZeneca seem to be leading the proverbial ‘race’ to the vaccine finish line, but it is important to note that this process is not a race. The development of a vaccine, especially when one considers the process of drug discovery, is not something that should be rushed. The process requires proper study. From preclinical studies to clinical trials to drug approval, each step is essential and necessitates careful planning and consideration.
The average timeline for drug approval is 12 years; however, there are pathways for accelerated development, such as Emergency Use Authorization (EUA). The EUA allows the Food and Drug Administration (FDA) to facilitate the development of a drug outside of normal protocols, often shortening the time from drug discovery to approval significantly. While invoking EUA is not without its risks, a state of emergency such as the global pandemic necessitates extraordinary action.
The development of COVID-19 vaccines from Pfizer, Moderna, AstraZeneca has been impressively swift, to say the least. Existing studies show the efficacy of the vaccines range from 62% to 95% depending on the specific vaccine and the method of administration.
While this is exciting news, there may be challenges ahead.
Logistics and Adoption
The development of sufficient supply, careful storage, and effective distribution of the vaccines each present important considerations. Cold storage requirements present a real hurdle, given the current solutions by Pfizer and Moderna both require freezing cold storage, a nippy -70° C (-94°F) for Pfizer’s drug. This can present challenges to procurement, storage, and distribution, given temperatures must remain stable such that the drug retains its viability.
In addition to potential logistical hurdles, there is the concern of adoption. While it is safe to assume that everyone would like to see an end to this pandemic, the means by which this is achieved is not something everyone agrees on.
There are some who mistakenly support the idea of ‘herd immunity’, despite this being accepted in the medical community as tantamount to slaughter. There are still others who shun the idea of vaccination altogether, as the anti-vaccination movement continues to grow.
For those who choose to take a vaccine, there is the potential concern of patients returning for another dose. Given some recipients may experience side effects, those same individuals may feel wary about receiving a booster shot.
Logistics and adoption both present potential challenges, as well as the lack of study for certain populations, including pregnant women. Currently, pregnant women have not been included in coronavirus vaccine trials. As such, the vaccine is unlikely to be recommended until further study is completed. Continuing research, assessing potential drug interactions, and gathering longitudinal data along the way will be essential going forward.
Despite these concerns, there is a reason for celebration. There seems to be a resolution in our sight with the hope of viable vaccines. With the United Kingdom as the first sovereign country to approve a vaccine for COVID-19, there is the promise of further approval in the weeks to come.
In the meantime, we should continue to soldier on, masks up.
About James Goydos, M.D.
James Goydos is an expert in melanoma research and specialist in surgical oncology with an M.D. from Rutgers University. With over 20 years of experience as a Professor, Surgeon, and Clinical Trial Lead, he is a leading expert in his field.
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