More than 300 of your friends and neighbors have already been vaccinated against the novel coronavirus.
They are volunteers in vaccine trials taking place in a DeLand lab, one of only two sites in the country testing vaccines from multiple drug companies.
The work ongoing at Accel Clinical Research has put DeLand on the map in the fight against COVID-19.
“Both companies, Moderna and Pfizer, picked 90 sites. We ended up being chosen by both,” Accel Medical Director Dr. Bruce Rankin told The Beacon.
Two groups of volunteers are now taking part in the vaccine trials.
“We’ve done vaccine trials for over 20 years. I was surprised to get two companies,” Rankin said.
A third biotech firm, Novavax, is also eyeing Accel for possible trials of its COVID-19 vaccine, and Rankin said other companies have contacted him about trying their vaccines at the DeLand research site.
“We’re going to be busy for several months,” Rankin said.
In conversations with The Beacon, Rankin described his role in the research.
The Beacon: Dr. Rankin, as we near the end of summer 2020, what is the status of the Accel clinical trials of a COVID-19 vaccine?
Dr. Bruce Rankin: We already have over 300 participants vaccinated to date. We started in the last two days of July. We are choosing over 2,000 participants all over Central Florida.
We are looking for high-risk participants, and they will include people over 65. We’re looking for people with health conditions such as COPD or asthma, and the essential workers, like the first responders and health care workers. We also have those related to the essential workers. We’re having mothers. I have a mom whose husband is an ER doctor, and she thinks she may get it.
We’re looking for minorities, ethnic groups, especially Blacks and Hispanics. The trials are geared for having a certain number of Blacks and Hispanics.
We need about 3,000 volunteers from all over Central Florida for the vaccine trials.
There are over 14 vaccine trials now going on in this country.
For more information, contact Accel Clinical Research:
Beacon: How does the vaccine research work?
Rankin: It’s a blinded randomization study, like flipping a coin. Half get the vaccine, and half get a placebo. We do not know. We do not want any bias in the studies.
There is a computer program that randomizes people. Everything is kept separate. None of the study staff knows who is getting what. That keeps the bias out of the studies. There is a very strict protocol that we have to follow on who is getting the vaccine.
Those who come in get a first shot. The second shot comes about three weeks after.
Beacon: What sort of commitment are the volunteers making?
Rankin: People are signing up and committing to be followed for 24 months. We’re going to be following them to see if they come down with the virus. If they have COVID-like symptoms, they will be tested for the virus.
They have an app on their smartphones, and they have to inform us if they have any reaction to the first dose or the second dose, and that’s uploaded to us.
Beacon: Do the study volunteers receive any compensation?
Rankin: It’s around $1,000 compensation for time and travel. People interested in participating in the vaccine trials may go to www.covidorlando.com for more information. They may also call Accel at 386-785-2400.
Each participant must read and sign an informed consent explaining the entire study process prior to beginning the study.
Beacon: Can you say if there will be any side effects?
Rankin: There may be mild to moderate symptoms, like muscle soreness and low-grade fever.
There is no way you can catch the coronavirus virus from the new vaccine. We don’t use attenuated viruses.
Beacon: What is in the vaccine, and how is it made?
Rankin: It’s called mRNA — little m — RNA. The m stands for “messenger,”
RNA, ribonucleic acid, produces the proteins that are identical to the proteins in the coronavirus. That is called an antigen. We’re injecting mRNA. It’s in the protein chain that is produced in the lab from basic amino acid, the basic building block of protein.
It goes into the cells, and the body sees those spikelike projections, and it produces antibodies against the virus. The virus needs those spikes, because that is how it attaches itself to cells in the body. The antibodies are in the bloodstream.
The early studies are showing it takes 14 days to produce the antibodies.
We’re doing the booster shot at three weeks, and antibody levels are higher than for those who have had the infection.
Beacon: Some people are concerned about reports they have heard or read that say the vaccines are developed from aborted human fetuses, and this poses a moral dilemma. Are fetal tissue or stem cells used to make these vaccines?
Rankin: No. There is nothing in this that came from aborted fetuses. It is an amino acid that is produced in the lab. There is no fetal tissue.
Beacon: Do we know if the vaccines give lifetime immunity against the coronavirus?
Rankin: We don’t know how long the antibodies last. How long are you protected? We don’t know. We may have to get booster shots in the future.
Beacon: Meanwhile, are masks really effective in combating the spread of the disease?
Rankin: Even if they’re 30 percent effective, it will help stop the spread. Masks help the asymptomatic patients from spreading the particles. Masks have been effective in slowing the transmission and the spread of the disease.
Beacon: If a coronavirus vaccine is determined to be effective and receives the endorsement of the U.S. Food and Drug Administration, do you foresee mass-vaccination events similar to those in the 1950s when polio was rampant?
Rankin: I think there will be strategically set-up vaccination centers. I see vaccination sites being set up, with people coming in for vaccinations.
If it is something effective, we want to vaccinate the public.