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A PATH TO PROTECTION
As worldwide health care experts work to develop a vaccine for the coronavirus, one health care company in The Woodlands continues work on its own vaccine.
PRODUCING A VACCINE
Dr. Bottazzi described the steps in vaccine production from the fi rst stage of research to mass production. From start to fi nish, the process can take about 18 months or more.
Dr. Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Texas Children’s Hospital Center for Vaccine Development, spoke with Community Impact Newspaper about vaccine development and the medical community’s response to the coronavirus outbreak. This interview has been edited for length and clarity. DR. MARIA ELENABOTTAZZI Q&A WITH
The entity researching the vaccine must fi rst secure funding to proceed.
The researchers determine which part of a virus the vaccine should target and build a vaccine around the relevant protein.
The product is sent into preclinical toxicology evaluations by a clinical research organization. They ensure the material is safe through animal models before obtaining approval to move trials to humans. Human studies on healthy adult volunteers begin to ensure safety and e ff ectiveness. Regulatory approval includes a review of procedures, reproducibility and trial results.
WHAT IS THE OUTLOOK ON THE PRODUCTIONOF A COVID - 19 VACCINE?
INSIDE THE BODY
I think it’s clear that there are many vaccines that are hopefully going to be evaluated soon. ... It’s good to have a robust pipeline, meaning we’re not just assuming that one [vaccine] is going to be the only one that’s going to be a solution for all. Vaccines certainly have a high rate of failure due to the nature of how you de- velop them and what the expectation of a vaccine [is], which of course is a preventative measure.
A vaccine creates immunity by preparing the body to attack a protein similar in structure to that of the virus.
Vaccines include a manufactured protein that mimics the viral protein.
The immune system builds defenses to attack the protein in the vaccine.
HOWMUCH IS THE TESTING PHASE EXPECTED TO BE SPED UP NOW?
Because it’s not business as usual, the regulatory bodies are evaluating how they can allow certain things to maybe be done in parallel rather than sequentially. ... It’s going to be very di ffi cult to skip a step. I don’t think that’s really going to be able to be done, but at least steps can be shortened by sharing the information just in time even though there are risks.
The body then has an immune response ready for that same type of protein if encountered in the virus.
Dr. Bottazzi said researchers are considering the coronavirus’ “spike” protein as the vaccine target to block the virus from interfering with a human cell.
WHAT ARE SOME RISKS ASSOCIATEDWITH ACCELERATED VACCINE DEVELOPMENT?
Industrial entities start mass production.
You are pressuring those who have to evaluate to make decisions. In a normal way of business you wouldn’t be- cause you have more time. I trust 100% [in] our regula- tory bodies. The people who conform the teams within the [U.S. Food and Drug Administration] are teams that operate with their mission to ensure their decisions are based on robust and strong scienti fi c evidence.
To read the full Q&A visit communityimpact.com. SOURCES: DR. MARIA ELENA BOTTAZZI, VGXI INC. / COMMUNITY IMPACT NEWSPAPER
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