A number of pharmaceutical companies have entered the home stretch in the race to develop a COVID-19 vaccine: human trials.
One of those trials is being conducted at in Dallas, and Ashley Agura is the perfect candidate. As a Physician Assistant, she spends 12 hours a day taking care of COVID-19 patients. A typical day for Agura starts around 7 a.m.
鈥淲e kind of glue your mask on for the day 鈥� your N-95, plus a droplet mask over that, eye shield 鈥� and then go visit with those patients and see how they're doing," she said. "Check in with their oxygen, check in with their symptoms."
Before Agura received her first injection of the experimental vaccine, she watched a video about how the process would work and the risks involved. She gave her informed consent and went through a few tests. Then, she received the first dose of either the vaccine or a placebo. About three weeks later, she got the second dose.
No one, not even the doctors, knows which she received. The first dose didn鈥檛 bother her much; it just left her with a sore arm. But after the second injection, she experienced mild side effects.
鈥淚 definitely had much more arm soreness and I actually felt a little bit, not ill the next day, but I definitely had body aches and a low grade temperature, which was not bothersome," Agura said. "I worked the whole day and I just took some Advil."
That鈥檚 a good sign, said Dr. Mezgebe Berhe. He鈥檚 the lead researcher with the , the team working on this trial.
鈥淵ou are actually trying to simulate a natural infection. So if you had COVID-19 virus, you鈥檙e expected to develop chills, pain, maybe fever," Berhe said.
He said this trial vaccine is unique because it's using the body鈥檚 own RNA. Messenger RNA, or mRNA, tell the body which proteins to build. Scientists have found a way to code mRNA to produce proteins that fight COVID-19.
鈥淭he whole concept is how do I expose the body to a specific protein of interest, so the body can mobilize a more targeted immune response," he said.
This technology has been around for a few years, but it hasn鈥檛 been used in a vaccine before.
The pharmaceutical company is sponsoring this vaccine trial 鈥� Baylor is just one of the medical centers involved. Pfizer鈥檚 CEO Albert Bourla last week that enough data will be collected by the end of October to be ready for FDA approval.
鈥淏ut of course, that doesn鈥檛 mean that it works," Bourla said. "It means we will know if it works.鈥�
Substantial public skepticism could throw a wrench in things, though. About one in three Americans say they wouldn鈥檛 get a free COVID-19 vaccine approved by the FDA, according to a recent .
is the Dean of the National School of Tropical Medicine at in Houston. He said he understands people's concerns, especially because of . That鈥檚 the federal government鈥檚 effort to speed up the development of COVID-19 treatments and vaccines.
鈥淪o far, the communication out of Operation Warp Speed has been largely non-existent, and I鈥檓 not sure for something of this profile and magnitude and concern, whether that will be adequate," Hotez said. "So there's going to have to be a higher level of communication with the American people.鈥�
Bourla said that鈥檚 part of the reason he declined federal funding for his company鈥檚 vaccine. He wants to keep politics out of it.
鈥淲henever you get money from someone, that always comes with strings. They want to see how you are going to progress, what type of moves you are going to do, they want reports," Bourla said. "I didn鈥檛 want to have any of that. Basically I gave them an open checkbook, so they can worry about scientific challenges and not anything else.鈥�
Agura, the trial participant, said she trusts the science behind the Pfizer vaccine, but she is concerned about the long-term effectiveness.
"It's still too early to know, are you going to have antibodies going into next year?" she said. "Because that's just not enough time to test that.鈥�
In the meantime, Dr. Berhe 鈥� the lead researcher on the Baylor trial 鈥� says Pfizer wants to recruit 10,000 for its human trials, specifically minorities.
鈥淚f the minority are not enrolled in a study, it鈥檚 very difficult to understand the efficacy of this intervention in that sector of the population," Berhe said.
Even though FDA approval isn't guaranteed, Pfizer's already started manufacturing its vaccine so it can be ready to distribute it as soon as possible.
CDC director Dr. Robert Redfield recently told Congress that won鈥檛 be possible until next year, but Berhe鈥檚 optimistic it will happen before the end of the year, and he said he expects an accelerated FDA approval process. Berhe said that鈥檚 not unheard of if there鈥檚 overwhelming data that the vaccine is effective.
Got a tip? Email Rebekah Morr at rmorr@kera.org. You can follow her on Twitter .
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