FDA during COVID-19

Question 1

What does the FDA not regulate

Answer 1

meat and veterinary vaccines (USDA)

Question 2

Emergency Use Authorization was established by ________ that allows for unapproved/off-label use of medical products in a declared public health emergency by ______

Answer 2

Bioshield Act of 2004
HHS secretary

Question 3

an EUA may be issued by FDA commissioner if…

Answer 3

• benefit outweighs risk
• reasonable to believe the product may help
• serious/life threatening condition
• no adequate or approved medication available

Question 4

EUA expires ______ unless renewed

Answer 4

after one year

Question 5

What was issue with original diagnostic test (EUA 4/1/2020)

Answer 5

contamination of N1 probe
poor design of N3 probe
poor quality control

Question 6

What diagnostic EUAs were used through Nov 2023?

Answer 6

276 molecular and 65 antigen
1 breath and 2 genotyping

Question 7

hydroxychloroquine EUA

Answer 7

EUA granted in March 2020
revoked in June 2020
second most cited study to be withdrawn

Question 8

Ivermectin EUA

Answer 8

never granted

Question 9

Remdesivir EUA

Answer 9

EUA issued in May 2020 and fully approved in December of 2020

Question 10

Remdesivir randomized control trials

Answer 10

shown to decrease recovery time and mortality

Question 11

Vaccine EUAs

Answer 11

Pfizer was authorized in Dec 2020 and fully approved in August 2021
Moderna was authorized in Dec 2020 and fully approved in January 2022
J&J was authorized in Feb 2021 and withdrawn May 2023
Novavax was authorized in July 2022

Question 12

What guidance existed from the FDA for COVID vaccine?

Answer 12

given in June 2020
- all requests to external advisory committee
- at least 50% efficacy with lower Ci >30%
- suggested inclusion/exclusion criteria (pregnancy)
- at least 5 cases of severe disease
- minimum 2 months of safety cohort for at least half of the cohort

Question 13

Pfizer and Moderna vaccine trials

Answer 13

summer and fall of 2020
with 30-40,000 participants
94-95% efficacy
severe disease:
p = vaccine 1, placebo 9
m = vaccine 0, placebo 30

Question 14

Oral antivirals

Answer 14

paxlovid EUA Dec2021, approved May 2023
- 89% efficacy against hospitalization/death
Molnupirivir EUA Dec 2021
- 30% efficacy

both had 1000+ enrollees in high risk, unvaccinated individuals, after 5 days of onset

Question 15

What happened to foodborne infections during COVID?

Answer 15

huge decrease! 23-35%

Question 16

what are potential reasons for decrease in foodborne illnesses?

Answer 16

• surveillance artifact - less public health personnel diverted here
• fewer people seeking health care = fewer diagnoses
• better hygienic practices = less illness
• changed eating patterns (eating and preparing food at home)
• reduced travel