www.FDA.gov/COVID19vaccines

#FDAVaccineFacts

The Path for a COVID-19 Vaccine from Research 

to Emergency Use Authorization

A vaccine manufacturer conducts 

laboratory research to develop a 

vaccine candidate.

The manufacturer compiles the 

results of laboratory research and 

testing in animals and information 

about the manufacturing technology 

and the quality of the vaccine and 

must submit an Investigational New 

Drug (IND) application to FDA before 

beginning human clinical trials.

Such a clinical trial in humans is not 

permitted to proceed without the 

prior written authorization from FDA.

Clinical trials are conducted to 

generate data on safety and 

effectiveness of the vaccine.

A Data Safety Monitoring Board 

evaluates data from the Phase 3 

clinical trial and advises the vaccine 

manufacturer regarding whether 

criteria for the pre-specified clinical 

endpoint, as discussed and agreed 

to in advance with FDA, has been 

met for their COVID-19 vaccine.

Company reviews data to 

determine whether the company’s 

scientists and technical experts 

believe that the vaccine meets 

FDA’s outlined expectations for 

safety and effectiveness.

Taking into consideration input 

from FDA, a company decides 

whether and when to submit 

a request for Emergency Use 

Authorization (EUA) to FDA.

Once submitted, career scientists 

and physicians in the FDA’s Center 

for Biologics Evaluation and 

Research (CBER) will evaluate an 

EUA request taking into account the 

totality of scientific evidence about 

the vaccine that is available to FDA.1

1 Part of FDA’s evaluation of an 

EUA request for a COVID-19 

vaccine includes evaluation of 

the chemistry, manufacturing, 

and controls information for the 

vaccine. Sufficient data should be 

submitted to ensure the quality and 

consistency of the vaccine product. 

FDA will use all available tools 

and information, including records 

reviews, site visits, and previous 

compliance history, to assess 

compliance with current good 

manufacturing practices.

FDA convenes a public meeting of 

its Vaccines and Related Biological 

Products Advisory Committee 

(VRBPAC) to discuss the data from 

the clinical trials.

Following the advisory committee 

meeting, CBER’s career professional 

staff will consider the input of the 

advisory committee members 

and continue their evaluation 

to determine whether the 

available safety, effectiveness, 

and manufacturing data support 

authorization for use of the particular 

COVID-19 vaccine in the U.S.

If FDA determines that the criteria 

for an EUA are met, including that 

the known and potential benefits 

outweigh the known and potential 

risks of the vaccine and that the 

manufacturing information is 

adequate to ensure its quality and 

consistency, FDA may authorize the 

vaccine for emergency use.2

2 FDA has made clear in its October 

2020 guidance entitled Emergency 

Use Authorization for Vaccines 

to Prevent COVID-19, that, for 

a COVID-19 vaccine for which 

there is adequate manufacturing 

information to ensure its quality 

and consistency, issuance of an 

EUA would require a determination 

by FDA that the vaccine’s 

benefits outweigh its risks based 

on data from at least one welldesigned Phase 3 clinical trial 

that demonstrates the vaccine’s 

safety and efficacy in a clear and 

compelling manner.

FDA informs the company that its 

EUA has been authorized.