Many COVID-19 vaccine trials are currently in the works around in the world. Residents of Imperial Beach will have an opportunity to be part of the San Diego based trials to help overcome the pandemic with an effective vaccine.
Dr. Susan Little is the UCSD principal investigator for the lead vaccine studies. She explained that there are at this time three vaccine studies being done in San Diego. The Moderna study is headed by her colleague Dr. Steven Specter while Little heads two trials - AstraZeneca and Johnson & Johnson/Janseen. All the vaccines are under the Operation Warp Speed in partnerships with the Department of Health and Human Services and Department of Defense to accelerate, develop and manufacture a vaccine. Little said there are close to 100 sites in the United States that are holding clinical trials through COVID-19 Prevention Network, which are academic research sites. “They are looking at sites with a lot for research experience. I’ve been doing HIV research for decades and we’ve been redeployed and doing COVID research,” said Little.
The AstraZeneca study started in the U.S. on Aug. 28 with 800 people, but a side effect in a patient in London caused a stop.
“We were about to start when the global pause occurred. We’re hopeful that after a review we’ll be allowed to reopen,” said Little. That vaccine is in Phase 2 and has reopened in South Africa, Brazil and the UK but not in the U.S.
Residents who sign up for the AstraZeneca trials will have the convenience of buses in three locations, Imperial Beach, Chula Vista and La Mesa, parked at set locations for 4 to 5 days.
Little said the group targeted for trials are individuals with underlying medical conditions, who work at jobs with greater risk of exposure, work in elder care, and are of specific racial groups most affected by COVID-19: African Americans, Latinos, Asian Pacific, Native Americans and Alaska Natives. Little explained the reasons for prioritizing those groups is to have a representation of a diverse population and to understand the response rate of the vaccine on people who have a greater risk of hospitalization and mortality rate and a higher rate of the disease.
“It’s critically important to raise awareness and make everyone understand. There is mistrust in those communities…we don’t expect to gain trust in the next 8 to 12 weeks…we’re not going to find a cure in 8 to 12 weeks but in the next couple of years. [We want to] build enough trust that when the vaccine is found people trust us [to be vaccinated],” she said.
Although the trial is paused right now, Little expects it will start soon so she encourages people to sign up now and they will be called as soon as they are given the go ahead. The goal number is to enroll 1,600 people. Enrollees will be compensated and expected to visit the research sites 10 or more times over two years. This study will be done with a 2 to 1 ratio with two people receiving the vaccine and the third a placebo. Some side effects can include pain at local injection site, headaches and fatigue.
Although this study will last up to two years it doesn’t mean a vaccine won’t be available until then. Little said there are eight different vaccines studies in the pipeline. “We hope to have multiple-effective to partially-effective vaccines…not a vaccine that prevents you from getting COVID but one that reduces the number of deaths…that’s why we have so many trials. If we found [only] one vaccine that works, it would be logistically, incredibly challenging. We need multiple ones to get to so many people and [with] multiple manufacturers. It’s important to see the difference between the vaccine and the placebo and who’ll develop COVID and determine if the vaccine is effective,” she explained.
Little said she expects outcomes of the trials in 6 to 8 months. “[The studies] have all good safety data in earlier studies with large enough numbers shown to be safe …with generally good immune response,” she said.
Last May the Department of Health and Human Services announced up to $1.2 billion in support for AstraZeneca’s candidate vaccine, developed in conjunction with the University of Oxford. The agreement will make 300 million doses of the vaccine available in the United States. The hope was that Phase 3 clinical studies would begin this summer with approximately 30,000 volunteers in the United States.
The Imperial Beach vaccine trial bus will be at the Imperial Beach Neighborhood Center, 455 Palm Avenue. Those people interested in taking part of the vaccine trials can log on
COVIDvaccinesd.com and fill out a short survey.