As COVID-19 booster shots begin for those with compromised immune systems, researchers at the UC Davis School of Medicine continue to collect data from clinical trial participants. The goal is to help federal health authorities decide whether to expand vaccine booster shots to more people. 

 

UC Davis is one of only 150 sites taking part in the major clinical trial that led to the federal government’s Emergency Use Authorization (EUA) of the widely used Pfizer COVID-19 vaccine. 

In the latest phase of the trial, 60 participants at UC Davis Health recently received a third dose of either the vaccine or placebo to determine whether a booster is necessary, safe and effective against not only the original COVID-19 but the highly infectious Delta variant. 

School of Medicine researchers are excited that UC Davis was chosen as one of a limited number of sites for the follow-up booster trial. 

But they weren’t surprised the academic medical center was picked, given the success of the trial over the past year, which involves 225 participants. 

Angela Haczku, co-principal investigator, said Pfizer was impressed with the “efficiency of trial participant recruiting, quality of data collection, recording and timeliness of submission, and professionalism of our coordinators and physicians led by Dr. Tim Albertson,” who is the principal investigator. 

“Without subjects or data, we wouldn’t be able to have a vaccine. Without research subjects, we wouldn’t have been able to get something approved for emergency use in the beginning. So I’m willing to help with this."

— Nicholeth Santiago

“This all played a role in being selected for additional trials,” Haczku said. “I am very proud of our team and I am delighted UC Davis got selected for this important work.” 

The ongoing worldwide trial involves 40,000 participants. They were the first to receive COVID-19 vaccines, several months before the U.S. Food and Drug Administration approved the EUA for the vaccine developed by Pfizer Inc. and BioNTech in December 2020. 

Participants are excited to take part

Among those selected for the booster study is Eric Astacaan, a flight attendant who was eager to participate, calling it an honor and a privilege. 

“We’re in an unprecedented time, a global crisis that requires every person to be involved every way we can to stop the pandemic. We’ve lost millions of people and hundreds of millions more have gotten infected,” Astacaan said. 

“I volunteered for the first trial and now the booster trial because I wanted to give back to the country that has given me so much since I immigrated with my family 36 years ago,” added Astacaan, who is of Filipino origin. “America has been generous to me, my hubby, and our families. I’m simply paying it back by volunteering and making sure I help in the effort to stem the pandemic.” 

Nicholeth Santiago also accepted the call to participate, without hesitation.

She happens to know a lot about research – she works at the UC Davis Medical Center helping to recruit and coordinate participants for studies in the Department of Emergency Medicine. 

“We’re in an unprecedented time, a global crisis that requires every person to be involved every way we can to stop the pandemic. We’ve lost millions of people and hundreds of millions more have gotten infected.”

— Eric Astacaan

“Without subjects or data, we wouldn’t be able to have a vaccine. Without research subjects, we wouldn’t have been able to get something approved for emergency use in the beginning,” she said, “so I’m willing to help with this.” 

Astacaan and Santiago were not told whether they received the vaccine or the placebo. 

Haczku said the data collected by participants is processed by Pfizer, which then shares its results with the federal government. 

Timing is critical, to see if the booster can protect against the rapidly spreading Delta variant. 

“SARS-CoV-2 is a highly contagious, potentially lethal virus,” Haczku said, using the laboratory name for the coronavirus that has sickened more than 206 million people worldwide, and killed more than 4.3 million. 

“The longer it is harbored by humans through this prolonged pandemic, the greater capability it acquires to produce even more dangerous mutants. The only way of stemming this process is to acquire immunity against it,” Haczku said. 

“Vaccination is a safe and effective way to obtain anti-SARS-CoV-2 immunity,” she added. “We would like to urge everyone who hasn’t received their doses yet to get vaccinated.”