FDA logs 76,837 adverse events following immunization

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A total of 76,837 or 0.1 percent of Covid-19 vaccinees have experienced Adverse Event Following Immunization (AEFI), Food and Drug Administration director general Eric Domingo said on Thursday.

This number of AEFIs, Domingo said was based on the 59,316, 764 administered doses as of November 21.

“Only 0.005 percent are serious adverse reactions,” Domingo said in a webinar, adding that 94.96 percent or 76,837 are non-serious events.

Domingo said that effective spontaneous reporting of adverse events following immunization is important in making sure that the vaccine products are safe and being safely administered.

He said that the most common AEFIs reported are the increase in blood pressure before and after the vaccine was administered, fever, headaches, fatigue, chills, muscle pain, and pain on the part where the vaccine was injected.

The FDA official, however, stressed that “all vaccines used in national immunization programs are safe and effective.”

“However, no vaccine is completely risk-free and adverse events can occasionally occur after immunization,” he said stressing that other vaccines (i.e. vaccines inducing protective immunity) may produce some undesirable side effects which are mostly mild and clear up quickly.

He also said that it is not possible to predict every individual who might have a mild or serious reaction to a vaccine, adding that by following contraindications, the risk of serious adverse effects can be minimized.

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