Hospital chief discusses vaccine safety, approval process, importance of vaccination

Vaccine and syringe
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Medical Chief of Staff at the Joseph Nathaniel France General Hospital, Dr. Cameron Wilkinson.

BASSETERRE, St. Kitts — Awareness about the safety and effectiveness of the COVID-19 vaccine, the need for persons to get vaccinated, and testing measures to ensure medicine is safe before they can be clinically approved for human use were recently discussed by Medical Chief of Staff at the Joseph Nathaniel France General Hospital, Dr. Cameron Wilkinson.

“Vaccination is important,” said Dr. Wilkinson as he referenced the historical outbreak of the Smallpox virus in the 1760s and a subsequent high death rate. He noted the important role played by the cowpox vaccine at the time in reducing the spread and death of the smallpox virus adding that “Genna started to inoculate children with the cowpox vaccine stemming the tide of death.”

“The most commonly used vaccines have been around for decades with millions of people receiving them safely each year, and more than 3 million lives are saved each year from vaccines,” said Dr. Wilkinson. “Vaccines are safe and effective to prevent diseases and save lives, as it not only protects the individual who received the vaccine but those around them. Thus, if diseases are allowed to run rampant more lives will be lost, and society will suffer.

“Imagine a world where we’re fighting COVID-19 in addition to smallpox, polio, mumps, measles, and rubella,” he said, as he recalled the important step taken by the Government in its fight against Coronavirus. “The vaccination rollout was not only an effort to protect us from this deadly virus but to show you the confidence we have in the vaccine efficacy and safety.

“The success of vaccines in eliminating a number of diseases locally and worldwide, some that require over 90 percent population coverage to achieve herd immunity, speaks to the fact the majority of us do the right thing and get vaccinated.”

Dr. Wilkinson urged all residents to act responsibly and get vaccinated to help curb the far-reaching and detrimental effects of the Coronavirus.

Clinically approving vaccines

Vaccines, as with all medicines throughout the world, must go through extensive and rigorous testing to ensure that they are safe before they can be clinically approved for global human use.

“An experimental vaccine is first tested in animals to evaluate its safety and potential to prevent disease,” he said. “If positive results are achieved in a lab, a manufacturer can then apply for clinical trials meaning testing in human beings.”

“Many of the COVID-19 vaccine trials will never make it beyond the stage of animal testing,” said Dr. Wilkinson. “There are now more than 200 vaccine trials being conducted with only 60 at the clinical stage and just a handful have been given emergency use authorization for use in the public.

“This speaks to the rigorous safety hurdles that have to be crossed before a vaccine can make its way into your arm.

“These trials typically involve several thousand healthy participants on a voluntary basis whose safety is ensured by national regulatory authorities and may last many years.”

Dr. Wilkinson explained that the trials are governed by strict regulations and take place across four major clinical phases once reliable, safe data are received from animal studies.

“In phase one, the vaccine is given to a small number of volunteers usually between 20-50 to assess its safety, side effects; composition mode of administration confirms if it generates an immune response and determines the right dosage,” said Dr. Wilkinson. “If successful, it proceeds to phase two. In phase two, the vaccine is usually given to hundreds of volunteers who are closely monitored for any side effects and to further assess its ability to generate any new response.

“Participants in this phase have the same characteristics such as age and sex as the people for whom the vaccine is intended. In this phase, some volunteers receive the vaccine and others do not, which allows comparisons to be made and conclusions are drawn about the vaccine.

“Phase three is similar to phase two, but expanded to involve thousands of volunteers with a continued assessment of the safety and efficacy of the vaccine.

“When the results of phase three clinical trials are available, a number of steps are required including reviews by various regulatory boards before the vaccine can be introduced into a national immunization programme,” said Dr. Wilkinson. “Following the introduction of a vaccine, close monitoring continues to detect any unexpected adverse side effects and further assess its effectiveness in the general population.”

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