2020 has been a year made tumultuous by a once-in-a-century pandemic. At the time of writing this post, there have been over 6.3 million confirmed cases and nearly 190,000 confirmed deaths caused by COVID-19. (1) To put those numbers into perspective, that is more than 3 times greater than the estimated death toll of the Vietnam War (58,220) and more than 63 times the attacks on September 11th, 2001. (2)  While social distancing and the use of masks has likely helped prevent these numbers from being much higher, COVID-19 has still managed to take a massive toll on our country and many others around the globe. After months of quarantine, conflicting information, unclear recommendations from our leaders, and sweating behind facemasks, Americans are asking questions such as, “When will this be over?”, “When will we have a vaccine?”, and, “Will the vaccine be safe?”. While we cannot answer these questions with objective truth due to the multitude of factors that remain unknown, we can tell you what we know.

On September 2nd, 2020, it was reported (first by The New York Times, then followed by several others) that the United States Centers for Disease Control (CDC) provided official documents to public health officials among all 50 states and in several large cities providing guidance for, and advising that they prepare to begin providing a Coronavirus vaccine to health care workers and high-risk groups as soon as late October or early November. (3) While it is universally agreed upon that rolling out the COVID-19 vaccine(s) for patients across the country will be a massively complex process requiring anticipatory preparation, the announcement has raised concern that the suggested time-frame may be too soon, especially considering that vaccines normally take several years to undergo development and clinical trials prior to becoming publicly available. It is not unusual for the pharmaceutical product development to be accelerated in times of urgency, but it is unheard of for a product to go from development to the public market in less than 12 months. It stands to reason, then, that there are justifiable concerns regarding the safety and efficacy of any vaccine released so soon.

There are two vaccine formulations described in the documents. While the manufacturers responsible for these products have not been identified by the CDC, the supplied information regarding shipping, storage, and administration align with vaccines currently in development by pharmaceutical manufacturers Pfizer and Moderna. (3) Interestingly, it was reported on September 8th, 2020, just six days after the CDC issued their aforementioned guidance, that Pfizer and Moderna, along with seven other companies, had made a joint pledge not to release submit a vaccine for Food & Drug Administration (FDA) approval until both safety and efficacy have demonstrated by a full Phase III trial. (4) To understand exactly what this means, let’s discuss the clinical trial process put in place by the FDA to ensure that pharmaceutical companies prove their drugs and vaccines are safe and effective prior to going on the market.

First, the drug or vaccine is tested in around 50 to 100 healthy volunteers to ensure safety and to determine the best dose or range of doses. These studies are called Phase I Clinical Trials and typically last approximately 6 months. Next, the drug or vaccine will undergo Phase II testing which includes several hundred healthy volunteers. The expansion to a larger study population helps researchers be more certain that the results of the study will be representative of how the drug or vaccine will work in the general population. Phase II studies test both the safety and effectiveness of the drug or vaccine. Lastly, the drug or vaccine will enter Phase III Clinical Trials which are the most rigorous and thorough step in the process. During Phase III, the drug or vaccine will be given to thousands of study participants, often including special populations in which the drug or vaccine will likely be used. Phase III trials expand upon Phases I and II by widening the treatment population beyond healthy volunteers, allowing for a more realistic simulation of what the outcomes of using the drug in the general population will be. These clinical trials are complex and typically take 1-3 years (in addition to the time needed for Phases I and II). (5) Generally, all three phases of clinical trials must be completed prior to the submission of a drug or vaccine for FDA approval. However, there is an accelerated approval process in place. Accelerated approval is sometimes granted to products that show overwhelmingly positive results in diseases in which treatment options are very limited, such as groundbreaking anticancer therapies. This pledge is a commitment to undergoing the full clinical trial process rather than pursuing accelerated FDA approval.

The announcement that not one, but two vaccines may be available as early as late October 2020 has come with heavy skepticism from many experts in the field, some going as far as to say the decision to release a vaccine this early may be influenced by the upcoming presidential election. This claim may be warranted considering President Trump stated on September 7th, “We’re going to have a vaccine very soon. Maybe even before a very special date. You know what date I’m talking about.” (4)  Politics aside, there are very real safety concerns involved in this situation. Any COVID-19 vaccine released will quickly be administered to hundreds of thousands of patients in the United States. An undetected safety concern could harm thousands of patients nationwide. In addition, if the vaccine doesn’t work, millions of dollars and hours of labor will be wasted administering a useless shot to the masses.

For these reasons, the previously mentioned pledge between pharmaceutical companies developing vaccines for COVID-19 is a very big deal. By committing to avoiding accelerated approval and, instead, opting for the standard Phase III trials to be completed, these companies are committing to providing a safe and effective vaccine instead of rushing to get to market first. While this likely means that the wait for a vaccine will be longer, it is a reassuring move in a time of uncertainty and skepticism that, in the end, will allow us to be more confident in the vaccines being safe and effective. Until then, we must continue to do what we can to reduce the spread and to protect ourselves and those around us.

Author: Stephen Vallely | PharmD Candidate 2021 | University of Michigan

References

1. Times TNY. Coronavirus in the U.S.: Latest Map and Case Count. The New York Times. https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html. Published July 20, 2020. Accessed September 3, 2020.

2. How the Coronavirus Death Toll Compares to Other Deadly Events From American History. Time. Accessed September 8, 2020. https://time.com/5815367/coronavirus-deaths-comparison/

3. Kaplan S, Wu KJ, Thomas K. C.D.C. Tells States How to Prepare for Covid-19 Vaccine by Early November. The New York Times. https://www.nytimes.com/2020/09/02/health/covid-19-vaccine-cdc-plans.html. Published September 2, 2020. Accessed September 8, 2020.

4. Sullivan P. Drug companies issue rare joint pledge on vaccine safety amid political fears. TheHill. Published September 8, 2020. Accessed September 8, 2020. https://thehill.com/policy/healthcare/515416-drug-companies-issue-rare-joint-pledge-on-vaccine-safety-amid-political

5. Washington D of C 1100 CANS 1300B, Dc 20036. PolitiFact - The race to create a coronavirus vaccine: A primer. @politifact. Accessed September 8, 2020. https://www.politifact.com/article/2020/apr/06/race-create-coronavirus-vaccine-primer/