Comparing Steps Required for Regular FDA Vaccine Approval and the Steps the Currently Approved Vaccines Underwent
The launch of widespread vaccination for the coronavirus in Israel has been met with enthusiasm from the many dedicated healthcare professionals across the country and although this feeling has by-and-large been shared by the public, feelings of skepticism and concern are present as well. Under normal circumstances a vaccine can take more than 10 years to develop- from research, clinical development, to regulatory review and approval, and finally distribution. How then was a vaccine for COVID-19 developed in under a year? We know that the vaccine candidates of Pfizer and Moderna underwent a relatively shortened process to achieve an Emergency Use Authorization, but what exactly was skipped/shortened?
The vaccine was developed so quickly due to; years of previous research on related viruses, a shortened manufacturing process, drastically increased funding allowing for multiple trials running simultaneously and a speedy regulatory process. To find out more, let's examine the regular steps required to receive authorization from the FDA.
Authorization from the FDA begins with research and development of the vaccine based on a hypothesis that the candidate can work. Once the R&D is complete, it undergoes preclinical testing, which checks to see if the candidate can produce results and be safe in animals before it is tried on people. If the preclinical trials are found to be successful, the candidate can continue to Phase 1 Clinical Trials which tests the candidate's safety on a limited number of humans by giving increasing doses.
Early efficacy results may also be obtained during this phase. If Phase 1 is successful, Phase 2 will begin with hundreds of people, further testing the candidate's safety among different people with different health statuses, and the relationship between different doses and their immune responses. If successful, Phase 2 will be succeeded by Phase 3, in which there will be tens of thousands of participants, this will generally be conducted using one dose, and will check the candidate's safety and efficacy using that dose. The company will then seek approval from the FDA. If approval is granted, there will be follow-up conducted among the recipients of the newly-approved vaccine to reaffirm its safety or efficacy, in what is commonly called Phase 4 testing.
For the Coronavirus vaccine Pfizer's and Moderna's candidates generally underwent all 3 phases. The only shortened part of the process was that Phases 1 and 2 were combined. While this theoretically could have caused a concern regarding the safety or efficacy of the candidate, Phase 3 testing soundly removed the concerns that arose out of the shortening, as it was conducted on tens to hundreds of times the number of people then usually involved during this stage of the process.
In conclusion, the factors that are responsible for the shortened time span have no relevance to the safety and reliability of the vaccine. Increased spending and cooperation the individual stages were conducted faster and were the main contributing factors, however, the candidates underwent all the regular stages of vaccine development and approval and should not be considered unsafe because of their speedy process.
Thank you for the zoom (and all your updates). It was great. I wish the news was like that. Straight forward, factual, unemotional. Bravo to both of you ladies!!
My experience with Ema Care has been so positive that I wanted to share it in case it could help someone else. Eight days ago my daughter, a Shanah Bet student, called to say she wasn’t feeling well and had symptoms of Covid-19. I was put in touch with an Infectious Disease specialist who recommended Ema Care. I reached Dr. Eliana Aaron easily and signed my daughter up. The next morning, Ema Care gave my daughter a telehealth exam and provided her with prescriptions, as well as a list of...
I would like to also add my compliments, you exceeded my already very high expectations. You can certainly send other schools our way for a recommendation.
-Mr. E. Naiman
Dear Dr. Eliana words simply cannot express how much you have done for all of us and so many others in keeping us informed, calming anxieties, and being such a wonderful and patient resource through such a difficult time. Wishing you much bracha and hatzlacha in the merit of all the countless mitzvot u have done to help so many through these trying times; mikol halev, ein milim and thanks so so much .
Gap Year Program Staff
Hello Dr. Aaron. I cannot thank you enough for providing not only crucial information but a framework that gave us stability and allowed us to function (instead of descending into chaos, which undoubtedly would have happened, if not for you). At the risk of waxing dramatic, I will tell you that when I think of what you've done these past couple of months, what comes to mind is Rav Yohanan Ben Zakai asking Vespasian to give him Yavneh ve-Hakhameha, thus saving the entire enterprise of Talmud...
I just wanted to say I think Dr. Eliana is one of the most rationale people providing the public with current information. I have no idea how I came across your Facebook page but I love what you say, just heard the one about reopening shuls, and the way you present it. clear, concise and factual. I work in Toronto on COVID 19 and just wanted to let you know that you are doing a fantastic job. I think here there are community doctors putting out information and I have told them they are too...