More than 400 Austinites have been participating in the coronavirus vaccine Phase 3 trial from Moderna, which on Monday announced a preliminary 94.5% efficacy rate. Moderna has 30,000 people enrolled in the study. In Austin, it is enrolling people through Benchmark Research.
It’s the second vaccine study to announce preliminary efficacy results. Last week, Pfizer Inc. announced its vaccine was showing a 90% efficacy rate. That vaccine is also being studied in Austin, with 200 adults enrolled through Austin Regional Clinic’s research clinic and teens ages 12-17 now being enrolled. That study has 45,000 participants.
In both vaccine studies, half of the participants have been getting the vaccine and half have been getting a placebo. Participants receive two injections weeks apart and then are studied for two years for side effects and symptoms of the coronavirus.
Moderna on Monday announced that in its preliminary research it had 95 cases of the virus among study participants. Ninety of those were in the placebo group and five were in the vaccine group. A secondary study found another 11 cases of the virus, all in the placebo group.
Benchmark Research CEO Mark Lacy explained in October that November was going to be a key month for the trial. It's the month Moderna believed it would get to 150 cases of the virus among participants, which would be a significant number to show efficacy, and it would mark at least two months since study participants had received the second dose of the vaccine or placebo.
Pfizer is trying to get to 164 cases to confirm its efficacy.
Moderna also released some safety data on Monday. Participants reported some pain at the injection site following the first injection and some fatigue, muscle pain and joint pain following the second injection.
Now Moderna is submitting its information to be peer reviewed before applying for emergency use status with the FDA. That application is expected to happen within weeks.
By the end of 2020, Moderna expects to have 20 million doses ready and 500 million to 1 billion by the end of 2021.
Pfizer estimates it can produce 50 million vaccine doses this year and 1.3 billion doses in 2021.
Both Pfizer and Moderna’s vaccines are working with messenger RNA in creating a nonlive virus vaccine and both are using technology already developed for other vaccines for other viruses.
"Most of these drugs have been studied for many, many years already," Lacy said. "... It's not rushed in the way people have been led to believe it has been rushed."
What is different about these studies from previous vaccine trials Benchmark Research has conducted is the size of them. Instead of 6,000 people enrolled, it’s 30,000, he said.