Science

Should Moderna and Pfizer File for Full FDA Authorization at this Stage of the Pandemic?

READING TIME ~ 3 MINUTES

On Tuesday, June 1, 2021, Moderna became the most recent company to file for full FDA approval for people who are 18 and older. Their current approval is for emergency authorization in light of the COVID-19 pandemic. For context, Pfizer and BioNTech filed for full authorization in people who are 16 and older just last month, with no further steps taken as of the publication of this article. There are significant differences between emergency authorization and full authorization of vaccines, which will be addressed later in the article.  However, a question can and should be raised here: should companies like Moderna and Pfizer be filing this early in the first place?

Key Questions to Consider:

  1. What’s the difference between emergency authorization and full authorization?
  2. Should companies like Moderna and Pfizer be filing this early in the first place

1: What’s the difference between emergency authorization and full authorization?

A table delineating the differences between the requirements for emergency and full authorization (Aaron Badida/AgencyIQ)

In the current state of affairs, the Moderna and Pfizer-BioNTech two-dose vaccines have been listed under emergency authorization under the guidelines of the FDA. This was done around six months ago, in December of 2020. This has allowed for 151 million doses to be given in the months since the approval of the vaccines, translating to over 50% of the U.S. population having received at least one dose. With more age groups being authorized to take the vaccine, more skeptics are siding in favor of the vaccine. These numbers will continue to grow for the foreseeable future. So, in the event that the FDA grants full use authorization for these vaccines, what will be new? Firstly, it’s great news for the companies in question; they will be able to market their vaccines directly to the people, but it also allows for public areas and buildings to mandate and require vaccinations. This could in turn boost rates of vaccination, as the public would be more confident in taking these vaccines. Therefore, the difference in the two authorizations is quite significant, especially for the future of these authorized vaccines and for the future of the pandemic.

2: Should companies like Moderna and Pfizer be filing this early in the first place?

A diagram depicting the timeline for vaccination authorization before the COVID-19 pandemic and emergency use authorization under the COVID-19 pandemic (FDA, HHS, and PhRMA documentation/U.S. Government Accountability Office)

Both companies have filed for FDA approval on the grounds of rolling trials in well-conditioned areas and production of “substantial evidence” to the FDA of their continued effectiveness and safety. Keep in mind that full authorization lasts beyond the pandemic, while emergency authorization is only until the state of emergency is lifted. Therefore, this type of authorization will take months to decide upon, and is much more thorough than the emergency use authorization. Prior to the pandemic, vaccines took years and even decades to be authorized, so the discrepancy in this situation is considerably large. With all of these new rules and regulations on the path to full authorization by the FDA, as well as the large number of people already vaccinated worldwide, it is apparent that filing this early is fair and even beneficial, to both the companies and to the public.

TL;DR

  1. On Tuesday, June 1, 2021, Moderna became the most recent company to file for full FDA approval in people who are 18 and older, as their current approval is for emergency authorization in light of the COVID-19 pandemic.
  2. With full authorization, the use of the vaccines lasts beyond the pandemic, while emergency authorization is only until the state of emergency is lifted. Companies will be able to market their vaccines directly to the people, but it also allows for public areas and buildings to mandate and require vaccinations.
  3. With 151 million doses to be given in the months since the approval of the vaccines, translating to over 50% of the U.S. population having received at least one dose, as well as more extensive trials and checks on the effectiveness of these vaccines, it seems apparent that filing for full FDA approval is justified.

Sources

https://www.nytimes.com/2021/06/01/science/moderna-vaccine-fda-approval.html

https://www.usnews.com/news/health-news/articles/2021-05-07/pfizer-applies-for-full-fda-approval-of-coronavirus-vaccine

https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-starts-application-full-us-approval-covid-19-vaccine-2021-06-01/

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

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