Four coronavirus (COVID-19) vaccines have reached the final stage of testing, and one of the frontrunners is making progress toward the goal of proving to be safe and effective.
Pfizer has indicated it is likely to be the first manufacturer ready to apply for an emergency use authorization for its vaccine, and that could happen as early as next month.
In an open letter from its CEO, Pfizer said it expects to be ready to apply for public use of its COVID-19 vaccine candidate in the third week of November, if everything goes according to plan.
The company said it’s “operating at the speed of science,” with safety as its No. 1 priority.
Pfizer launched its phase three trial July 27.
It includes nearly 40,000 volunteers so far, with another 4,000 still being enrolled. Last week, Pfizer received permission from the Food and Drug Administration to enroll volunteers as young as 12 years old.
The trial also includes volunteers with chronic conditions such as HIV, Hepatitis C and Hepatitis B.
The vaccine is given in two doses, 28 days apart.
Some trial participants receive the actual vaccine, while the rest receive a placebo. Neither the researchers nor the participants know which group has received the vaccine or the placebo.
Researchers must then wait until a certain number of participants become infected with COVID-19.
Ultimately, they’ll compare the groups to see if fewer of the participants who received the actual vaccine got infected.
Stricter guidelines recently issued by the FDA require vaccine developers to follow participants for a median of two months after their final dose, before submitting any data.
The data will eventually be reviewed by FDA scientists and an independent panel of experts.
Of the other three vaccine makers, Moderna is most likely to finish its phase three trial next. Those results are expected toward the end of the year.
The other two trials -- AstraZeneca and Johnson and Johnson -- are currently paused while the FDA investigates an illness in a participant.
Once a vaccine maker applies for an emergency use authorization, how quickly can it be granted? That depends on many factors. All of the companies are working closely with the FDA throughout the process to make sure they’re gathering everything the agency wants as they go.
There will be a lot of scrutiny on this data, and realistically, it would likely take a few weeks, at a minimum, for an emergency use authorization to be granted after application.