Coronavirus outbreak: Everything to know about the vaccine being tested
Oxford University researchers have initiated a multi-site, Phase III clinical trial on an investigational COVID-19 vaccine called “AZD1222” in the United States (US), a huge step forward to combat the coronavirus pandemic.
Why is it a huge step forward? Aren’t we at least a year out from a potential vaccine?
The researchers are collaborating with the drug company AstraZeneca, and the biopharmaceutical company is leading the trial as the regulatory sponsor.
Additionally, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, are providing funding support for the trial.
As for the vaccine itself, it relies on a non-replicating chimpanzee adenovirus to deliver a SARS-CoV-2 spike protein to encourage immune response. Since SARS-CoV-2 is the virus responsible for COVID-19, previous preclinical study results indicate the candidate vaccine quickly induced immune responses against SARS-CoV-2 in mice and rhesus macaques.
Well, that’s a lot of government support. How big is this trial?
AZD1222 has begun its final round of testing, and the trial is expected to enroll approximately 30,000 adult volunteers at 80 sites within the country to determine if the candidate vaccine can prevent COVID-19.
The vaccine created by the collaboration is considered a frontrunner in successfully combating the virus. To date, there are eight additional COVID-19 vaccines undergoing large-scale trials globally, while 24 have started smaller trials to determine product safety.
The Phase III trial is part of Operation Warp Speed, a multi-agency effort led by the U.S. Department of Health and Human Services (HHS) with the goal to accelerate the development, manufacturing, and distribution of COVID-19 medical countermeasures.
Similar trials are already underway in the United Kingdom and Brazil, with the aim to determine if the vaccine is successful before the end of 2020.
Oxford researchers started dosing volunteers at Headlands Research in Florida this past Friday, and CBS News reported that 31 Americans were the recipient of either the vaccine or a placebo.
One volunteer, 23-year-old Jacob Serrano, already lost seven family members to COVID-19.
“Look at the amount of lives that we lost,” Serrano told CBS News. “I just don’t want that to keep occurring . . . I know there was a risk because it’s like – it’s a trial, but I’d rather have us one step closer, no matter what it takes.”
Headlands Research added their goal is to enroll members of the Black and Latinx communities who have been disproportionately impacted by the COVID-19 pandemic.
According to Johns Hopkins University, COVID-19 has infected over 25 million people across the world to date, while the US has an infection rate of more than 6 million cases.