Class discussion: Covid-19 vaccine development, approval, and authorization
Learning objectives
 To learn the requirements for a vaccine EUA, as well as the similarities and differences
between an EUA and BLA approval.
 To learn the history and status of the three vaccines currently authorized in the US.
 To understand challenges with vaccine development, authorization, and distribution on a
global scale.
Please read the articles and be prepared to answer the questions below. With your Lehigh
account, you should be able to access all the articles below. If you attend class on Tues 9/28 or
Fri 10/1, you don’t need to hand in your answers. If you’re absent, please email me the answers
to the questions below before the next class.
Background. Read the following FDA links:
 https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-andpolicy-framework/mcm-emergency-use-authorities
 https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-andpolicy-framework/emergency-use-authorization
 https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorizationvaccines-explained
1.
2.
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4.
What is an MCM and when is it used?
What is an EUA? Who allows the EUA?
What safety and effectiveness data is required for the EUA?
What is the minimum number of vaccine recipients in a Phase 3 study? What is the
minimum number of months of follow-up in a Phase 3 study?
FDA Guidance for Industry, “EUA for vaccines to prevent COVID-19”:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-useauthorization-vaccines-prevent-covid-19
1. Is this document legally binding for industries developing/manufacturing covid-19
vaccines?
2. What are the four statutory requirements for an EUA (p.3)?
3. What are the FDA’s expectations about working toward a BLA?
4. What are your impressions/observations about Section IV of this guidance?
5. What are your impressions/observations about Section VI of this guidance in terms of
the amount of information needed in the EUA request in terms of chemistry,
manufacturing, and controls, as well as the clinical data?
Focus on the US: Development, EUA, and full-approval of Pfizer, Moderna, and J&J vaccines.
Reference: NY Times Coronavirus Vaccine Tracker:
https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
1. Pfizer vaccine
a. When did the FDA grant EUA for the vaccine in adults? For children ≥12 yrs?
b. When was the BLA approved (aka “full approval”) for people ≥16 yrs?
c. What are the storage conditions? Why is this a challenge?
d. What is the status of boosters?
e. What is the effectiveness against the delta variant?
2. Moderna vaccine
a. When did the FDA grant EUA for the vaccine in adults?
b. What is the status of the EUA in children? What is the status of the BLA?
c. What is the status of boosters?
d. What are the storage conditions? How does this compare to the Pfizer vaccine
and why is this important?
3. Johnson & Johnson vaccine
a. When did the FDA grant EUA for the vaccine in adults?
b. What issues has this vaccine faced with respect to distribution and side effects?
c. What are the storage conditions? How does this compare to the Pfizer vaccine
and why is this important?
4. What are your general impressions/observations about this website?
World-wide effort and challenges: Read “COVID-19 vaccine challenges: What have we learned
so far and what remains to be done?” by Forman et al.
https://doi.org/10.1016/j.healthpol.2021.03.013
1. What are the “three D’s” needed to achieve widespread global immunity via
vaccination?
2. Within each “D”, what are the challenges identified by the authors?
We’re not going to discuss all the challenges, but let’s discuss a few:
3. Running coordinated clinical trials. What are some examples of problems in the trial
methodologies, as described by the authors? What can be the results of such problems
among the many different clinical trials that were run? What are the authors’
recommendations, and do you think these are realistic?
4. Authorizing safe and effective vaccines efficiently and transparently. What are some
examples of how different countries have different authorization processes and
different recommendations for emergency use? What can happen if a country
authorizes a vaccine without sufficient safety and efficacy data? In what countries were
vaccines authorized without Phase 3 data? What are the authors’ recommendations,
and do you think these are realistic?
5. Ensuring equitable vaccine access globally. Define HIC and LMIC. According to the
authors, what is “vaccine nationalism” and what are its consequences? What are the
health, economic, and ethical implications of insufficient vaccine supply in LMIC’s? What
is your opinion on an HIC fulfilling its needs before donating supplies to lower-income
nations? What are potential solutions, according to the authors?
6. Manufacturing sufficient quantities and maintaining supply chain capacity. What are
examples of the challenges in manufacturing the quantity of vaccines needed? How
does this relate to Question 5? How do cold chain requirements present a challenge?
What are potential bottlenecks in the supply chain? How can manufacturing/supply
chain challenges be overcome, according to the authors?
7. Determining fair vaccine allocation. Which populations have generally been classified
as high priority for vaccine distribution? How has allocation to different populations
varied in each country, as described by the authors? How have vaccine storage
conditions, as well as equity within priority groups, played a role? How can unfair
allocations be minimized?
8. Encouraging the uptake of vaccines. What is vaccine hesitancy? What is the anti-vax
movement? What are the causes of these phenomena? What are strategies for
preventing/reversing these phenomena? In your opinion, what methods are effective at
overcoming anti-vaxxers and vaccine hesitancy?