Learn more about the process for FDA approval. Pfizers paediatric formulation of the monovalent Omicron XBB.1.5 vaccine. No other systemic grade 4 reactions were reported. Infographic displaying COVID-19 primary vaccine course recommendations from ATAGI. One grade 4 fever (>40.0C) was reported in the vaccine group. These vaccines were found to meet the high standards for safety, effectiveness, and manufacturing quality FDA requires of an approved product. Overall, the median onset of systemic adverse events in the vaccine group in general was 1 to 3 days after either dose and lasted a median duration of 1 to 2 days. inspections of the sites where the vaccine is made.vaccine testing results to ensure vaccine quality, and.as well as details of the manufacturing process,.preclinical and clinical trial data and information,.Before granting approval, FDA reviewed evidence that built on the data and information submitted to support the EUA. Learn more in this video about EUAs.įDA has granted full approval for some COVID-19 vaccines. The EUAs allowed the vaccines to be quickly distributed for use while maintaining the same high safety standards required for all vaccines. Initially, they determined that COVID-19 vaccines met FDA’s safety and effectiveness standards and granted those vaccines Emergency Use Authorizations (EUAs). Any side effects from getting the vaccine are normal signs the body is building protection.īefore vaccines are made available to people in real-world settings, FDA assesses the findings from clinical trials. The benefit is that people get this protection from a vaccine, without ever having to risk the potentially serious consequences of getting sick with COVID-19. At the end of the process, our bodies have learned how to help protect against future infection with the virus that causes COVID-19.This is what your body might do if you got sick with COVID-19. This triggers our immune system to produce antibodies and activate other immune cells to fight off what it thinks is an infection. Our immune system recognizes that the protein does not belong there. ![]()
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