|제목||[No. 221 Special] Vaccine booster shot, but US FDA opposes|
Vaccine booster shot, but US FDA opposes
Cheongdae Times Senior Reporter of Culture Affairs, Jin-Hyeong Jo
The dictionary meaning of booster shot is “to increase the effectiveness of the vaccine after a certain period of time has passed and then give a booster shot.” Originally, the number of vaccinations was determined in the initial clinical stage, but as various mutations of this corona virus appear, the vaccine is inevitably administered one more time without clinical trials to prevent it.
According to the Korea Institute of Health and Medical Sciences, if the additional dose of the COVID-19 vaccine (booster shot) is administered, the immunogenicity increases when the third dose is administered compared to the second dose, and serious adverse reactions will not occur.
In addition, for hemodialysis and organ transplant patients it was revealed that the immunogenicity was increased, and the neutralizing antibody response to mutant viruses such as alpha, beta, and delta also increased.
Korea's booster shots are also currently being introduced. It is expected that the first vaccination will be started in earnest after October, when the 18–49-year-old population, which is about 17.77 million people, completes the first vaccination.
Currently, Israel is a typical example of a booster shot abroad. Three million people, a third of the population, have already been vaccinated. Israel started the world's first third dose of vaccination for people whose immunity has been weakened due to immunosuppressive treatment after organ transplantation surgery since July 12.
Since then, the age group for the third dose has been gradually expanded to those 12 years of age or older who can receive the Pfizer vaccine. Israel’s next target is to vaccinate 4 million people, and the government will launch a new program in the coming weeks to achieve that goal. Israel’s Health Minister Nitzan Horowitz said: "Vaccines are the best way to block delta mutations and have already been proven in real life."
On August 18, the Centers for Disease Control and Prevention (CDC) in the United States announced plans for booster shots for Pfizer and Moderna vaccines. The AstraZeneca(AZ) vaccine will be announced separately when additional data are available.
Based on clinical data that has been reviewed for safety and effectiveness, it has announced that it will start the third dose, the vaccine booster shot, for people 8 months after completing the second dose from September 20th.
The booster shot recipients referred to here are residents of nursing facilities or medical staff who were initially vaccinated.
However, on September 19, an advisory committee of the US Food and Drug Administration (FDA) and the US Food and Drug Administration (FDA) opposed the Pfizer booster shot plan scheduled for the 20th. This was because there is a possibility of myocarditis in young men during the third dose, and the need for a booster shot is not sufficient because the existing second dose is effective enough.
In addition, Pfizer presented the Israeli research results as the main evidence, but the government decided to start broadly inoculating booster shots early and judged that the research results were biased.
“The problem is that most of the results of many studies that have been used and submitted for discussion have not been reviewed by experts, and the FDA has not reviewed them,” said the deputy director of FDA Vaccine Research Review.
Instead, it recommended booster vaccination only for occupational groups that are vulnerable to infection, such as the elderly 65 years of age or older and medical workers.
Although the advisory committee’s decision is a recommendation that is not legally binding, the FDA has traditionally followed the advisory committee's decision, so it followed the advisory committee’s decision this time as well. There was a setback in the booster shot vaccination plan for the general public, which was planned by the US government from the 20th.
Became the FDA’s final decision was to be announced early next week, and the Korea Centers for Disease Control and Prevention (KCDC) which secured a budget of 2.4 trillion won for an mRNA vaccine for next year's booster shot and new school-age first vaccination, decided to announce a specific plan once the target of vaccination is confirmed.