Dr. Narong Aphikulwanich, Secretary General of the Food and Drug Administration (FDA), revealed this based on comments 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) wants to clarify that during the COVID-19 epidemic There is not yet a vaccine to prevent the spread and reduce the severity of the disease. But in order for people to have vaccines for use quickly and in a timely manner, the FDA has required conditional registration of drugs in emergency situations where they are urgently needed. It establishes guidelines for companies wishing to register to provide sufficient information to support the quality, effectiveness and safety of vaccines. Including the need to carefully monitor safety, so even with a shorter evaluation time, the FDA still pays attention to evidence indicating the safety, quality and effectiveness of vaccines.
On the question of authorizing the use of the Covid-19 vaccine among the elderly and children It was considered by an expert committee of both the FDA and external experts. which is based on World Health Organization guidelines for safety, quality and effectiveness. Considers animal studies and safety in humans. This includes monitoring side effects and managing potential risks. The information at that time was sufficient to allow the vaccine to be used in older adults and children. For pregnant or breastfeeding women Due to research ethics issues Therefore, baseline data from animal studies are used as information in the decision to use the medicine. In terms of 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 no different from what is generally found.
The FDA secretary general added that the FDA has control over the quality of vaccines in Thailand. Information on the quality, safety and effectiveness of the vaccine was assessed before registration. After registration, there will still be an analysis to certify the production version before releasing each batch of vaccines. Check 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 have confidence that FDA-approved vaccines are safe, of quality, and effective in reducing losses from COVID-19 infection.
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