FDA: PH's number of reported adverse events following COVID-19 vaccination within 'acceptable' rate

Published November 25, 2021, 8:11 PM

by Analou de Vera

Food and Drug Administration

The Food and Drug Administration (FDA) said that the reported adverse events following immunization (AEFIs) involving vaccines against coronavirus disease (COVID-19) were within the acceptable rate.

“If you look at the clinical trials before we give the emergency use authorization for these vaccines, the AEFI would rate somewhere between 10 to 15 percent. That’s 10 to 15 percent of the people, who would really feel something after vaccination,” said FDA Director-General Rolando Enrique Domingo on Thursday, Nov. 25.

“Definitely, the data we’re getting at less than one percent is within the allowable limit, very well within the acceptable levels of AEFI— both for adults and children,” he added.

Based on FDA’s data, 76,837 AEFIs have been recorded so far. This figure is equivalent only to 0.10 percent of the 75.6 million COVID-19 vaccines administered as of Nov. 21.

Domingo said that most of the adverse reactions experienced by the vaccinees were mild.

“In our country, the most common things that are reported are an increase in blood pressure, especially before and right after vaccination. Of course, patients tend to be anxious on the day of vaccination,” said Domingo.

“Fever would be the second one, headaches, pain on the area of vaccination site, malaise, some get chills, muscle pain, cough, dizziness, and tiredness. These are the most common adverse events that we see,” he added.

The FDA chief said that all vaccines used in the vaccination program of the government are safe and effective.

“No vaccine is completely risk-free and adverse events can occasionally occur after an immunization. Effective vaccines may produce some undesirable side effects which are mostly mild and clear up quickly,” said Domingo.

“The majority of events thought to be related to the administration of a vaccine are actually not due to the vaccine itself–many are simply coincidental events,” he added.