As coronavirus cases spike and the pandemic enters its second year, a DeLand medical-research firm is out front in perfecting the vaccines that promise to save lives and reduce the spread of the illness.
As part of the U.S. government’s multi-agency effort known as Operation Warp Speed, Accel Clinical Research in DeLand has already given coronavirus injections to hundreds of volunteers who signed up for the studies. Dr. Bruce Rankin, who heads up Accel Research, has provided an update on his team’s role in countering the coronavirus.
Operation Warp Speed’s goal is to test, develop and rush to all in need an adequate supply of the vaccines needed to halt the deadly disease in its fast-moving and mutating tracks.
Often, clinical trials of experimental treatments take many months or years before the U.S. Food and Drug Administration approves them for general use. Begun only months ago in response to the outbreak and spread of a virus in Wuhan, China, in the latter part of 2019, the U.S. Departments of Defense and Health and Human Services mobilized resources and support to accelerate the development of an effective vaccine or vaccines to safeguard people against the disease that has disrupted life as we know it around the world.
BEACON: It appears we are witnessing history in the making. Is this the first time in history that a vaccine has been made available to large numbers of people while the clinical trials are still underway?
DR. BRUCE RANKIN: “This is the first vaccine that has been rolled out while the trials are still going on, and in a pandemic.
“Obviously, in the last pandemic, the Spanish flu in 1918, they didn’t have the technology.”
BEACON: Describe the beginning of the vaccine trials.
RANKIN: “We began the vaccine trials in the late summer, the last week in July. We started with Pfizer at the end of July, and we started with Moderna on the 6th of August.
“We were vaccinating about 40 to 50 a day. We allowed people to decide which trial they wanted. If they didn’t have a preference, we would give them the opportunity to re-consent.
“We worked through August and September seven days a week — even on Labor Day. Moderna wanted 30,000 in the study. We enrolled 555 participants for Pfizer and 666 for Moderna.
“Pfizer and Moderna are both making arrangements now to get the participants who received the placebo to get the vaccination.”
BEACON: Is there a two-injection beginning of the trials?
RANKIN: “They came in and got their initial vaccination, and then they came back for the second.
“They got their second dose, and they followed up 30 days after the second dose. “There is a blood test for the antibodies. We are blinded. We do not know what we gave them, either the vaccine or a placebo.
“The study will continue to monitor the participants for 24 months for symptoms.
“If they report COVID-like symptoms, we will do PCR [polymerase chain reaction] COVID testing. We try to get it within the first 72 hours of the symptoms.
“Pfizer also has a self-test.”
BEACON: What can you say about the rate of effectiveness of the vaccines?
RANKIN: “Moderna and Pfizer are saying that they [vaccines] are 95-percent effective. That is, the vaccination is 95-percent effective for those who received a vaccine did not get COVID. None of the vaccine group that had gotten COVID had a severe illness.”
BEACON: So now the coronavirus vaccine is being distributed for those deemed at highest risk for contracting the disease?
RANKIN: “An advisory panel for the FDA on Dec. 10 endorsed the development of Pfizer’s coronavirus vaccine, and the FDA issued an emergency-use authorization.
“Gov. DeSantis said the priority will go first to long-term residential facilities staff and residents and to front-line health care workers with the most contact with COVID patients.
“We do not have any vaccine doses outside the trial vaccine to use for our research staff or my medical office staff. All early allocations have gone to the Florida Hospital systems to distribute to health care providers, long-term facilities, and soon Floridians over 65 years old.. Hopefully the supply chain will improve early next year. It will improve also when several more COVID vaccines are approved soon.”
BEACON: Who is monitoring the clinical trials and the vaccine development?
“The FDA oversees everything we do here. Pfizer and Moderna oversee everything we do here.”
BEACON: Will Accel Research perform any additional coronavirus vaccine trials?
RANKIN: “We’ve gotten new contracts from Johnson & Johnson and Novavax for clinical trials for their coronavirus vaccines.
“There are potentially six vaccines that have a great chance to be approved in the U.S. Accel Research will be working on five of the six COVID -19 vaccines here in DeLand. I doubt there is another research facility in the U.S. that will work on the development of that many different COVID vaccines. We are not working on the AstraZeneca COVID vaccine. We anticipate working on Sanofi/GSK Covid vaccine when their trials start in the spring as our site has already been selected for those research trials.
“We are enrolling for Janssen/(Johnson and Johnson) and Novavax vaccines now, and those interested in participating can go to COVIDORLANDO.com or call 386-785-2400.”
BEACON: There is word of a new and more virulent strain of the coronavirus spreading. Will the vaccines now being tested and given protect people against this virus variant, as well?
RANKIN: “I know there has been much recent discussion about coronavirus mutating. We do not know how mutations might affect the vaccine efficacy. The current mutated strains are reported to be more transmissible from person to person but are not causing more severe illness. I think we will see the current vaccines hold up to the current mutations due to the fact the vaccines target that spike protein on the coronavirus surface. That specific spike protein is what allows the virus to attach to our tissue and infect (invade) our cells. The hope is that the spike protein will not mutate much so the vaccine will remain very effective.”