FDA: Less than 1% of vaccine recipients experienced side effects after COVID-19 vaccination


(UNSPLASH / MANILA BULLETIN)

Less than one percent of individuals who have already received their coronavirus disease (COVID-19) vaccine have experienced side effects, the Food and Drug Administration (FDA) said on Wednesday, July 14.

“As of now...yung ating adverse events reporting system, ang captured na adverse events is less than one percent (As of now... based on our adverse events reporting system, the captured adverse events is less than one percent),” said FDA Director-General Rolando Enrique Domingo during a televised press briefing.

Domingo also noted that the majority of the side effects experienced by the vaccinated individuals are non-serious.

“Karamihan ay very mild ang mga adverse events or reactions na kino-complain (Most of the adverse events or reactions complained of are very mild),” he added.

In a separate online forum, DOH Technical Advisory Group (TAG) member Dr. Anna Ong-Lim said “to date, no fatal case reports are found to have causal relationship with the vaccines,” she said.

Based on the FDA data presented by Ong-Lim, a total of 47,897 adverse events (0.41 percent) were reported out of the 11,708,029 individuals who received their COVID-19 vaccine as of July 4.

Of the total adverse events reported, there were 46,826 considered as non-serious (97.76 percent), and 1,071 were tagged as serious (2.23 percent).

Common side effects experienced by vaccine recipients include headache, injection site pain, fever, dizziness, and increase in blood pressure, said Ong-Lim.

Janssen

Meanwhile, the FDA is still recommending the use of COVID-19 vaccine developed by Johnson & Johnson.

Recently, the US FDA has added neurological condition Guillain–Barré syndrome (GBS) on the list of potential side effects associated with the said vaccine brand.

Domingo said that the risk of GBS is “very rare.”

“It was seen in one for every 100,000 vaccinated individuals. Among the unvaccinated, chances of GBS is also one for every 100,000. But in the Philippines, five in every 100,000 are infected by COVID-19 on a daily basis,” he said.

“It is so rare that all regulatory agencies continue to believe that the benefits still outweigh the risks,” he added.