AUSTIN (KXAN/AP) – On Thursday, the CEO of Pfizer announced it could have results from its late-stage COVID-19 vaccine trial as early as October.
This comes one day after a letter from the Centers for Disease Control and Prevention told states to prepare for a coronavirus vaccine to be ready to distribute by Nov. 1.
The Austin Regional Clinic (ARC) is part of the Pfizer vaccine trial that currently includes at least 23,000 participants across the country.
ARC says the recent announcement from Pfizer has not impacted its current COVID-19 vaccine trial.
“Our timeline is still the same, because we have to go through a very methodical process to ensure we have the right information, we are enrolling the right patient, and we are following all the safety [protocols],” said Dr. Anas Daghestani, CEO of ARC.
ARC is currently in the enrollment phase of the trial, which means staff is calling all interested people, confirming they are qualified for the study and booking an appointment for them to come in. The ARC says they are on track to complete this phase next week, which means they will have all 250 people needed to enroll in the trial.
A participant’s first visit includes: informed consent (where they learn about the study), evaluation for inclusion in the study (enrollment), exam and lab tests, study intervention (vaccine or placebo which is blinded), learning about their responsibilities for using a symptom diary and when to call if any problems arise. They’re in the office for about two hours and are free to decline participation at any point. From there, studies like this are part of a much longer process that could take years.
“There’s an ongoing process whether by phone or by follow up to see if you’ve gotten exposed to the infection, did you get an infection,” explained Dr. Daghestani.” And then we compare those who have had the vaccine to those who haven’t had the vaccine, so the study could continue for a long time.”
In the meantime, companies like Pfizer continue monitoring data from thousands of participants across the country.
“Because COVID is still active and still with us, I suspect within a month or two we could see early results of how effective it is,” said Dr. Daghestani.
Dr. Jaquelin Dudley, a professor of molecular biosciences at the University of Texas, says there is a new technology that is helping fast-track the development of COVID-19 vaccines.
“The new technology is they are giving a sub-component vaccine or sub-viral vaccine, where they are only giving you a portion of the virus information, and that technology, to my knowledge, has never been used,” said Dr. Dudley. “They have shown that at least its able to protect monkeys against a challenge inoculation, and the other good news, its easier to prepare and scale up.”
ARC says the have had over 3,500 people express interest in participating in their vaccine trials and 88% are both qualified to participate in the study.
Many experts say an early November vaccine is “ambitious.”