FDA reiterates COVID-19 vaccine that has been registered and has been evaluated according to criteria in terms of safety, quality, and effectiveness from a committee of experts Vaccine quality is controlled both before registration and after registration. Including closely monitoring and evaluating risks. Asking people to be confident in the 19-19 vaccine that are permitted will help reduce losses from COVID-19 infection. Dr. Narong Aphikulwanich, Secretary-General of the Food and Drug Administration (FDA), revealed that according to observations from a group of people regarding the authorization of the COVID-19 vaccine. which is a conditional registration in that emergency situation The Food and Drug Administration (FDA) would like to clarify that during the COVID-19 outbreak There is still no vaccine to prevent the spread and reduce the severity of the disease. But in order for people to have vaccines to use quickly and in a timely manner, the FDA has required conditional drug registration in emergency si tuations where there is urgent need. It sets guidelines for companies wishing to register to provide sufficient information to support the quality, effectiveness, and safety of vaccines. Including the need to closely monitor safety, therefore, even with a shorter evaluation time, the FDA still pays attention to evidence indicating the safety, quality, and effectiveness of vaccines. On the issue of authorizing the use of the COVID-19 vaccine among the elderly and children It has been considered by a committee of experts from both the FDA and external experts. that is based on the World Health Organization guidelines for safety, quality, and effectiveness Consider animal studies and safety in humans. This includes tracking side effects and managing potential risks. The information at that time was sufficient to allow the use of the vaccine in the elderly and children. For pregnant or breastfeeding women Due to research ethics issues Therefore, reference data from animal studies is used as information in decidi ng to use medicine. In terms of the risk of myocarditis and pericarditis The incidence of myocarditis in vaccinated children is approximately 1.25 cases per million doses, which is lower than in the normal population of children. and lower than those with COVID-19 Therefore, it is not different from what is generally found. The Secretary-General of the FDA added that the FDA has control over the quality of vaccines in Thailand. Before registering, information on the quality, safety, and effectiveness of the vaccine has been evaluated. After registration, there will still be an analysis to certify the production version before releasing every lot of vaccines. To control the quality of the vaccine before it reaches consumers. Including monitoring of adverse reactions and safety after use of the vaccine. Therefore, we would like the public to be confident that the vaccines that the FDA has approved are safe, quality, and effective that will help reduce losses from COVID-19 infection. Yes. Source: Thai News Ag ency