UPDATE: (6:00 PM)– Cities across the country were chosen to participate in a COVID-19 vaccine trial.
With Monroe being one of those cities, some locals are already making history and a difference in our health system.
It’s almost been a month since more than 70 volunteers started the COVID-19 vaccine trial right here in Monroe. So far, Dr. Jeb Andrews says it’s been successful and he’s excited to see what this vaccine can do, not only for our community but nationwide.
“I will say this, we have not seen anyone with COVID. Again that could just be luck at this point, but no one has had COVID and we have sent a number of specimen to the lab,” said Dr. Jeb Andrews, CEO of Clinical Trials of America.
Dr. Andrews says back in August, the first week of the vaccine trial went just as planned. However, that weekend, enrollment for the trial was put on hold due to an incident in the UK where a lady fell during a run. Doctors were concerned about it being related to the vaccine trial. It was later researched and determined there wasn’t a link between the two incidents. Enrollment has started back everywhere but the US, as the FDA wants to go over the data to make sure it’s safe.
“The FDA is very concerned about doing a good job so they have looked at all the data and continue to go over the data. We’ve been told we may get to start back enrolling new patients this coming week,” said Andrews.
All different walks of life, from physicians to mayors, are part of the COVID vaccine trial. Including co-owner of Flying Tiger Brewery.
“Everything has gone well so far, I had an injection two weeks ago. I have had no side effects at all, no irritations or anything. I’ll go back in two weeks and have another injection and I’ll have to play it by ear after that,” said David Johnson, co-owner of Flying Tiger Brewery.
And for everyone else, the symptoms have been minimal.
“We have had no significant adverse events what so ever. Some of the people have had some reaction like with the flu vaccine, feel a little achy the next day. But to a person, by day two, they are back to their old self and feeling great,” said Andrews.
Johnson says he feels positive about the vaccine and encourages others who might have been scared to think about joining.
“I think that if anyone else could do this, I think they should. You’re not just helping this generation but future generations,” said Johnson.
Now, it’s not too late to join the COVID-19 vaccine trial as Dr. Andrews says they still have room.
Once the FDA approves for new enrollment, they’ll start taking applicants again.
MONROE, LA (7/22/20)– “In five months the whole country has changed, so who knows maybe this will help us get back to a good normal again,” said David Johnson, co-owner of The Flying Tiger Brewery.
Over 200 local people are dedicated to making history and saving thousands of lives across the country as they have already signed up for the COVID-19 vaccine trials right here in Monroe. One of those volunteers, co-owner of The Flying Tiger Brewery. He’s leading by example and following his business mission.
“One of the main things we wanted to do with Flying Tiger was give back to the community, but with this coronavirus, we have been very limited. I just figured it’s the right thing for everyone, if they can, to do it,” said Johnson.
While he says he doesn’t know what to expect, he’s just happy to be making a difference.
“I kind of really just went in blind, I don’t have any expectations. I hope it doesn’t make me sick, but I hope that if it does, it helps with a cure for whatever the problem with COVID is,” said Johnson.
Though being a guinea pig for a vaccine trial never crossed Johnson’s mind, he says he hopes these next two years will make a difference for those who had COVID, those who lost someone to the virus, and for the future generations to come.
“I hope it’s going to be beneficial not to just our area but to our country and possibly the world. Who knows, this could be the wonder drug of the world like the polio vaccine,” said Johnson.
And it could be just that. CEO of Clinical Trials of America, the local business hosting the trial, says he is optimistic about the vaccine as phase 1 results show promise.
“Phase one results came out for the trial and the safety profile looks amazing. It looks good and safe and hopefully efficacious. Which means hopefully it’s going to work,” said Jeb Andrews, CEO of Clinical Trials of America.
Crossing their fingers that Monroe and 1500 patients can make a medical difference across the world.
“I just hope that whatever the end result is, it is positive and it is a cure or a vaccine for sure,” said Johnson.
Clinical Trials of America say they hope to start the trial on August 10th, but that depends on when the drug supply comes in. They are looking for 1500 participants. If you would like to join the trial or see more information you call the hotline at 318-267-4111 or text COVID Nela to 319-96.
MONROE, LA (07/18/20)– If you’re looking to make history and a difference in our health system, you may just have your chance. The city of Monroe was chosen to participate in AstraZeneca’s COVID-19 vaccine trial.
“We don’t get a lot of cool things in our area but they chose us to do the trial. I think because there are so many cases here and we have really good medical infrastructure,” said Jeb Andrews, CEO Clinical Trials of America
Clinical Trials of America in Monroe will be receiving 1,500 of the 30,000 doses distributed throughout the United States and they will arrive the first week of August.
“The scope of this is five times larger than the biggest thing we’ve ever done. Why? Because it’s important,” said Andrews.
Andrews says this trial will be different from others because two-thirds of the people will get an active vaccine instead of a placebo, where it’s usually a 50-50 split. The focus of this trial, “Does this vaccine offer immunity and how long will the immunity last”
“There will be 8 visits over the course of 2 years as we follow the people. You come in on the day and if you meet the criteria to participate, which most people will, you will get your first dose of vaccine that day,” said Andrews.
After the first vaccine, patients will come back four weeks later for a booster vaccine.
- be 18 or older,
- not be pregnant or breastfeeding;
- have no history of Guillain Barre syndrome;
- not have a previously confirmed SARS-CoV-2 infection;
- not have had cancer in the past two years;
- Must be in good health.
“If it works, which we are in high hopes that it does, it has already been through phase 1 and phase 2 clinical trials. It appears to be efficacious, it appears to work,” said Andrews.
This is a chance for locals to help make a difference on a larger scale, saving thousands of people across The United States.
“They need to get these drugs out there to protect our people and our communities. Get people back to school, work, church, and everything that comes with,” said Andrews.
AstraZeneca, the largest pharmaceutical company in Great Britain, will offer this vaccine at no cost worldwide. If you would like to become part of this trial you can text COVID Nela to 319-96.
Monroe will get 1,500 doses as part of trials for AstraZeneca’s COVID-19 vaccine, starting in August.
Jeb Andrews, president and CEO of Clinical Trials of America, said this trial will allow about 67% of participants to get the live vaccine instead of a placebo. Often, studies have a 50-50 placebo rate.
He said he’s honored to have been granted the contract and, looking at other places that will be testing the vaccine, it likely was awarded in Monroe because of the region’s climbing infection rates.
Nationally, 30,000 have participated in Phase III of human trials. Phase I results have not yet been published, but news reports this week imply positive immune system responses.
Andrews said this vaccine, originally designed for SARS, was among about 50 being developed by Oxford University. It fit the protocol and was being worked on well in advance of the coronavirus breakout last fall. It was not hastily developed.
Andrews said he plans to use local media to reach people who want to participate, and he expects the first trials here to start in mid-August. Participants will get some compensation for time and travel.
The vaccine has two parts, and the injections will be made a month apart.
- be 18 or older,
- not be pregnant or breastfeeding;
- have no history of Guillian Barre syndrome;
- not have a previously confirmed SARS-CoV-2 infection;
- not have had cancer in the past two years.
There is no age cap on the study, and candidates will be stratified by an 18-65 age group and those 65 and older.
Andrews said the trial will be on a first-come, first-served basis. Participants will be scheduled in blocks of four per hour, and Andrews is prepared to schedule on Saturdays as needed.
Clinical Trials of America will have to closely monitor participants over the course of a year.
If a participant gets COVID symptoms, they’re to report immediately for testing and will be issued a wearable device to track biometrics.
On Monday, AstraZeneca announced it will provide up to 400 million doses of the vaccine in Europe at no profit.
Experts estimate how long it will take to get a vaccine for COVID-19. (Photo: Javier Zarracina)
About the vaccine
The following information is from an AstraZeneca news release:
“ChAdOx1 nCoV-19, now known as AZD1222, was developed by Oxford University’s Jenner Institute, working with the Oxford Vaccine Group. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold (adenovirus) virus that causes infections in chimpanzees and contains the genetic material of SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack COVID-19 if it later infects the body.
“The recombinant adenovirus vector (ChAdOx1) was chosen to generate a strong immune response from a single dose and it is not replicating, so cannot cause an ongoing infection in the vaccinated individual. Vaccines made from the ChAdOx1 virus have been given to more than 320 people to date and have been shown to be well tolerated, although they can cause temporary side effects such as a temperature, influenza-like symptoms, headache or a sore arm.”
Want to participate?
Clinical Trials of America, 2509 Broadmoor Blvd., Suite B (second floor), Monroe
Call (318) 267-4111 to schedule an appointment.
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