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Experimental COVID-19 vaccine is being tested on volunteers

Pfizer and BioNTech began to test an experimental vaccine, BNT162, to prevent COVID-19 on a first batch of volunteers in the United States.

TAMPA, Fla. — The coronavirus pandemic has thrown almost every healthcare system around the world into a kerfuffle.

At the beginning of the pandemic, hospitals and healthcare professionals were overwhelmed. On a global level, there are more than 3 million confirmed cases of the coronavirus, and more than 254,000 deaths. To date, 1,184,625 people recovered from the disease. 

There weren’t enough hospital beds to take care of the sick, and hospital morgues had to resort to refrigerated trailers for the overflow of deaths. To protect the human race from the deadly virus, drug companies, researchers and scientists are putting their heads together to develop a vaccine.

The World Health Organization has a list of COVID-19 vaccines that are currently being developed. Out of hundreds, only eight have moved onto clinical trials. One of them sits in the laboratory of Pfizer, Inc.

On May 5, Pfizer and BioNTech SE started to test an experimental vaccine to prevent COVID-19 on an initial batch of volunteers in the United States.

The vaccine, BNT162, is in the Phase ½ study. In this phase, the drug company is determining the safety, the immune response in the human body and the ideal amount to use per dose.  

The BNT162 trial is part of a global development program, which started on April 23, 2020, in Germany. Twelve volunteers received a dose of the BNT162 experimental vaccine. 

The main ingredient for BNT162 is mRNA, which has been used in several cancer clinical trials. 

In total, Phizer and BioNTech plan to enroll up to 360 healthy volunteers.

Volunteers will be divided into two groups. The first group is between the ages of 18 to 55. The second will be between 65-85 years old.

The older adults, who have a higher risk of contracting the virus, will only be immunized once the younger group showed enough evidence that the dose administered is safe.

The first batch of volunteers in the United States signed up at the testing sites, NYU Grossman School of Medicine and the University of Maryland School of Medicine.

The University of Rochester Medical Center/Rochester Regional Health is also on the list of test sites. URMC is currently recruiting 90 volunteers between the ages of 18 to 85 who have not been infected with COVID-19. 

Cincinnati Children’s Hospital Medical Center is also looking for 90 volunteers for the vaccine. The hospital is expected to start administering the vaccine within the next two weeks. 

There's also a company right here in the Tampa Bay area that is trying to develop a COVID-19 vaccine.

On May 4, 2020, Oragenics, Inc. announced the acquisition of Noachis Terra Inc., with the plan to develop a “spike protein” based vaccine to prevent the coronavirus.

Scientists at the University of Georgia's Complex Carbohydrate Research Center explained that a spike protein is a carbohydrate that is found on the surface of a virus.

"This protein is how the virus gets into the human cells," said Dr. Parastoo Azadi.

"The carbohydrates have been one of the leads in the discovery," Dr. Robert Wood explained.

Oragenics' acquisition of Noachis is betting that they’ll find the answer.

“We're working with the FDA to try and accelerate when we can file the Investigational New Drug relative to their existing rules," said Oragenics CEO, Alan Joslyn.

"We're going to try and convince them that that very first batch of vaccine that we make out in our contract manufacturer is suitable for use in that very first clinical trial,” he explained.

To date, the Food and Drug Administration has yet to approve a vaccine for the prevention of COVID-19.

5 May 2020 Platform Type of Developer Coronavirus Current stage of clinical Same platform for candidate target evaluation/regulatory status- non-Coronavirus vaccine Coronavirus candidate candidates Non- Adenovirus Type CanSino Biological COVID-19 Phase 2 Ebola Replicating 5 Vector Inc./Beijing Institute of ChiCTR2000031781 Viral Vector Biotechnology Phase 1 ChiCTR2000030906 RNA LNP- Moderna/NIAID COVID-19


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