Studies show that few older people are included in the COVID-19 vaccine trial

Currently, many COVID-19 vaccines and clinical trials in adults are underway worldwide.

The first human trial, called the Phase 1 trial, is a completed immunogenicity and safety trial in a small number of closely monitored individuals.

After this first step is successfully completed, the dose-ranging study enrolls hundreds of subjects in a phase II study to determine the safest and most effective dose that provides the best immunoprotection.

The final stage typically enrolls thousands of individuals and provides the validity and security data required for the final license.

Throughout all these stages of research, the Food and Drug Administration (FDA) may request additional information and research if the data raises concerns about efficacy or safety. You can even stop a clinical trial altogether.

According to the authors of the study, people over the age of 65 make up 9% of the world’s population, but make up 30-40% of all COVID-19 cases and 80% of all COVID-19 deaths.

For this study, researchers investigated the current COVID-19 study by examining all 847 COVID-19 clinical trials and 18 registered vaccine trials. ClinicalTrials.gov, The largest clinical trial database.

In a study enrolled between October 2019 and June 2020, they found that more than 50% of COVID-19 clinical trials and vaccine trials excluded people over the age of 65.

“When you start studying humans, you want to test in a group [that] There is no underlying condition and I am healthy. ” Dr. Paul Gepfeld, Director of the Alabama Vaccine Research Clinic and Professor of Medicine and Microbiology at the University of Alabama.

“Many elderly people [people] If there are underlying medical conditions, this excludes them from early studies. [they] It also doesn’t respond to vaccines, “Goepfert explained.

When vaccines are designed and tried, they are intended to be given to both children and adults. Vaccines are given to a much wider audience, unlike drugs that are usually given only to a specific subset of the population. This includes vulnerable people such as the elderly, children, pregnant people and people with chronic illnesses.

There are various reasons why older people are excluded from clinical trials. Some studies have age-based cutoffs, while others have indirect exclusion criteria, such as excluding participants with underlying illness. Other participants need access to their smartphone or other technology.

FDA “I strongly recommend itRegister the populations most affected by COVID-19, especially racial and ethnic minorities, the elderly, children and pregnant people. However, companies are not obliged to enforce this.

Exclusions are not uncommon and can be important to the health of research volunteers. Some individuals have severe or unstable risk factors that are known and should be ruled out.

However, as it may be more convenient to get FDA approval, companies may push to study only the healthiest people.

Older people often have more side effects from the vaccine than younger and healthier people. These complications and side effects can slow down the FDA approval process.

Not all seniors have smart devices, so there may be additional hurdles to registering seniors. This may be essential for participation in the exam. There may also be mobility issues that prevent you from seeing a doctor.

All populations need to be included in various studies, but we are hesitant to include more vulnerable populations such as the elderly, children, and pregnant people.

Some researchers have used common illnesses as exclusion criteria to ensure that only the healthiest people enroll in the early stages of the test.

“There is a general fear of including pregnant people in clinical trials, including drug therapies and vaccines, for fear of harming the developing fetus,” he said. Dr. David Aronov, Director of the Infectious Diseases Department of Vanderbilt School of Medicine in Nashville, Tennessee.

Excluding these people from the trial could put them at risk because there is little or no data on how they will be affected before the vaccine is released, Aronov said. It was.

“Before deciding to rule out pregnancy based solely on fear, more attention needs to be paid to including pregnant people in clinical trials,” Aronov told Healthline.

Excluding people with general health conditions, such as diabetes, from the study population means that only the healthiest individuals will be surveyed. This group is not necessarily a true representation of the general population.

Traditionally, vaccines are first tested in adults before being spread to children.

However, children do not appear to be at risk for particularly serious COVID-19 symptoms. Many people infected with the virus were asymptomatic or had mild symptoms. Therefore, those symptoms are rarely life-threatening or complicated.

Many pharmaceutical companies haven’t yet studied how safe and effective vaccines are in children, but that’s starting to change.This week, Pfizer Presentation Obtained permission from the FDA to include children up to the age of 12 in future vaccine trials.

Public vaccines will be an important measure against COVID-19. But for a successful vaccine, we need to ensure the safety of more people. Creating a vaccine for the open market requires many steps to be taken to secure vulnerable groups.

Make a vaccine like any other drug Requires step-by-step testing based on three evidences To prove its effectiveness and safety before it is released to the public.

Currently, there is no real prediction as to when the vaccine will be generally available, but by socially moving away, wearing masks and ensuring maximum hygiene, the general public is prevalent with COVID-19. Can be delayed.