Why You Shouldn’t Compare the FDA Approval Process for Cannabis and COVID Vaccines

To get vaccinated or not to get vaccinated? This question has caused quite the debate between those in support of vaccinations and those opposing them. When the U.S. Food and Drug Administration (FDA) quickly moved to approve Pfizer’s COVID-19 vaccine, those opposing vaccination were quick to point out that the very organization approving the Pfizer shot also claimed that cannabis has no medical value—which we all know is not the case.

Every person is entitled to their own opinions regarding the vaccine. However, comparing the approval process of a vaccine for a virus that caused a pandemic to that of cannabis by the same authority is quite nonsensical. While it’s true that the FDA claims cannabis has no medical value, the process to prove otherwise is quite lengthy.

Comparing Apples to Oranges

National Organization for the Reform of Marijuana Laws (NORML) Deputy Director Paul Armentano told L.A. Weekly that comparing “the pace the Pfizer vaccine made it through the FDA process to cannabis is like comparing apples to oranges.” Though the situations are both subject to the same process, the context and situation make all the difference.

Armentano stated, “The existing FDA approval system is designed for the assessment of privately produced compounds that go through conventional P1, P2, and P3 trials—so the Pfizer vaccine comports with the existing regulatory model. Cannabis does not. It is an illicit botanic product.” He continues by explaining that “under the existing regulatory and legal environment, there is no process for which the FDA could review or approve herbal cannabis—as acknowledged by the DEA and others who are familiar with the process.”

L.A. Weekly asked Armentano if expanding research in cannabis could lead to changes at the FDA regarding cannabis, to which he replied that the FDA system was established in 1968 and has remained the same since then. He states that “the system was established to promote limited federal research” and that it “was never established with the intent of potentially bringing any sort of whole-plant cannabis drug to market.” Unfortunately, it can be nearly impossible to accomplish something a federal system is geared against.

FDA Approval of the Pfizer Vaccine

According to Johns Hopkins Medicine, the FDA initially granted Pfizer an emergency use authorization (EUA) for the vaccine and fully approved it on Aug. 23, 2021. The Pfizer vaccine is the only one to have received full approval, but two others have EUA. The reason Pfizer was able to obtain full approval so quickly is that more than 165 million people received its vaccine, which serves as enough data to demonstrate that the vaccine is effective against serious disease or death as a result of COVID-19.

Not every vaccine receives EUA, and those coronavirus vaccines which did were able to due to the fact that the disease caused a public health emergency. Johns Hopkins Medicine goes on to explain that the FDA worked with “vaccine manufacturers, independent laboratories, academic research centers, and nonprofit organizations to quickly gather and interpret large amounts of data on the vaccines.”

The data was collected from people who got the vaccine all around the world and were instructed to report any adverse side effects. The COVID-19 vaccines, like many other fully approved vaccines, can cause temporary aches, pains, and fever in some people. Some vaccine recipients reported serious side effects, but the number of those individuals is extremely low in comparison to the millions of people who only experienced the minor, expected symptoms.

In order to get full approval, vaccines need to pass the review process, which consists of clinical trials, assessment of risks and benefits, continuous monitoring for adverse effects, and compliance with strict manufacturing guidelines. This is an oversimplified explanation of the approval process; due to the length of the process and the number of lives at risk with COVID-19 circulating, it was necessary for the FDA to grant EUA for the vaccines—and full approval followed within the year.

The FDA and Cannabis

Despite the many unveiled healing powers of cannabis, it’s unlikely we’ll ever see a situation comparable to the COVID-19 pandemic that requires quick FDA approval of cannabis. However, there is a glimmer of hope with the DEA having already issued licenses that legally permit the growth of cannabis in order to get clinical research data. According to Armentano, the purpose of these licenses is to establish the safety and efficacy of various cannabis products.

Hypothetically, those who have been granted one of these licenses by the DEA have the best chance of bringing an FDA-approved product to the market. Armentano concluded his discussion with L.A. Weekly by explaining that cannabis has a long way to go before getting the FDA’s approval since the research would need to “include a lot more people and be longer in duration.” And of course, the federally illegal status of cannabis makes all of this 10 times harder.

Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies, explains that “the FDA does want to regulate botanical medicine” and that “they are trying to find ways to make that happen,” but that “the FDA does want to try to regulate chemical medicines and botanical medicines that aren’t necessarily as controversial as marijuana.” Nonetheless, the FDA has already approved one cannabis-derived drug product (Epidiolex) and three synthetic cannabis-related drug products (Marinol, Syndros, and Cesamet).

It’s clear that the circumstances surrounding the COVID-19 vaccines and cannabis are vastly different. In spite of the historical controversy surrounding cannabis, increasing use is normalizing the plant slowly but surely. However, it’s meaningless to compare the FDA approval process for the vaccines to that of cannabis. Many impatiently await the day that cannabis gets its very own shiny stamp of approval from the FDA, but only research can speed that up.