Sitting in a hospital bed surrounded by cameras, Dr. Ihor Sawczuk became the first volunteer to receive a COVID-19 vaccine as part of a clinical trial at Hackensack University Medical Center.
“There’s no other way of knowing whether a vaccine will work or not without participating in a clinical trial,” he said.
The clinical trial is called COVE and the vaccines are made from the genetic code of the virus copied from SARS-CoV-2 rather than the whole virus.
“We will know the efficacy of the vaccine is. Simultaneously, that particular data is going to be forwarded to the FDA on a very timely matter,” said clinical trial principal investigator Dr. Bindu Balani.
Balani says the patients will receive two doses of the vaccine.
“One month later they will be back again for the second shot,” Balani said. “In person, the subject has to come seven times in all for the 2-year period, but there will be phone calls that we will be giving to the patient pretty much on a daily basis after the vaccine has been given for a week or so.”
So far they’ve had close to 500 people show interest in participating in the trial, but are looking for thousands of others, especially those at high risk for COVID-19.
“This particular vaccine trial is a phase 2 trial that is going to have 30,000 patients. The people who can actually apply for this particular vaccine could be anywhere from age 18 and above. Amongst the patients who are going to be coming here, the adults are going to be certified based on the risk of having severity of illness. If they are teachers, or if they are grocery store workers, or environmental people, or essential workers, firefighters, etc., anyone who is going to be exposed to patients who have COVID are definitely a particular population we are looking for,” Balani said.
The clinical trial is also being offered at Rutgers New Jersey Medical School and University Hospital.
Dr. Shobha Swaminathan, the principle investigator of the Rutgers trial, says they are all working their hardest to find a successful vaccine, but cautions it will take time.
“We never want to compromise the integrity of the research process. We’re all working our hardest to get it out as soon as possibly because we want to have it out there, we want to help the people, but it could be a few months or a little longer. I don’t want to speculate on that,” said Swaminathan. “That being said, I’m certainly not going to say that this will be effective. I think the purpose of a trial is clearly to establish that. We are hopeful and optimistic that it will be. Vaccines, I think, will ultimately be the best strategy to help address the global COVID-19 pandemic that we are currently in.”
“What I want to make sure of, what I would want to be convinced of, is that the real data has the time to mature for the FDA to make a decision that is not based on politics or based on any other type of science. I will tell you, it would be the most damaging thing for the FDA to prematurely approve a vaccine without being convinced of efficacy because all that does is undermine trust, undermine already prevalent skepticism in the community about vaccines. It would be the thing that arms the anti-vaccination movement more than anything else,” Dr. Shereef Elnahal, president and CEO of University Hospital.