Sunday, September 14, 2025

FDA: Vaccine side effects still under 0.1%

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ADVERSE effects following immunization (AEFIs) remain at a minimal rate nearly a year since government began rolling out COVID-19 vaccines.

In its latest report on AEFIs, the Food and Drug Administration (FDA) said the AEFI rate in the country is at 0.07 percent.

It said that as of February 13, about 131.6 million vaccine doses have been administered, and only “90,714 suspected adverse reaction reports were received, evaluated, and analyzed by the FDA.”

The FDA said majority of the AEFIs, or 85,150 incidents, are considered minor side effects like body pain, chills, fatigue, fever, headache, nausea, and pain at the injection site.

“Such reports are minor adverse reactions,. These usually appear on the first or second day of vaccination and may last for two to three days. Most people tolerate these adverse reactions while others experience greater discomfort,” the FDA said.

The report also showed 5,564 reports of serious side effects.

“One of the criteria for serious adverse reaction is hospitalization or extended hospital stay.

(However,) reports of adverse reaction that results in hospitalization does not necessarily mean that vaccine caused the reaction,” it said.

Also as of February 13, there were 1,847 fatal events involving vaccinees received by the FDA.

“Most of these events occurred in persons with multiple existing comorbidities. These include cardiovascular diseases, ischemic heart diseases, cerebrovascular diseases, cancer, diabetes, and infections including pneumonia. There were also cases of confirmed COVID-19 infections leading to severe cases with fatal outcomes,” said the FDA.

The FDA said AstraZeneca vaccinees had the most AEFIs reported with 34,827 out of the 19,557,660 doses administered followed by Sinovac (33,091 AEFIs from 44,115,728 shots), Pfizer (12,899 AEFIs from 43,427,241 shots), Moderna (4,794 AEFIs, 16,175,626 shots; Janssen (4,088 AEFIs out of 6,303,538 shots), Sputnik V (811 AEFIs from 1,051,019 shots), and Sinopharm (204 AEFIs out of 1,027,707 shots. No adverse effect was reported from 531 Sputnik Light shots administered.

The government started the COVID-19 vaccination drive in March 2021. There are now 61.4 million fully vaccinated individuals, 5.9 million partially vaccinated, and 9 million who have received booster shots.

The Department of Health appealed to almost 24 million fully vaccinated individuals to get booster shots as soon as possible.

“Booster doses are shown to have significant impact in preventing hospitalizations and severe disease,” said the DOH.

As of February 20, around 33.5 million individuals are already qualified to receive their booster shots.

“Of these, 9.7 million or 28.95 percent have gotten their boosters,” said the DOH.

Health Undersecretary Myrna Cabotaje said the low number of those who availed of booster shots can be attributed to the lack of the sense of urgency.

“They know the importance of getting booster shots. But they don’t know the urgency.

Some don’t want to miss their work so they they haven’t gotten their booster shots yet,” she said.

The government giving booster shots last November. By December 2021, the interval for the administration of booster doses was shortened to at least three months after the second dose of a two-dose vaccine, and at least two months for a single-dose vaccine.

BARMM RATE

Cabotaje said the DOH is looking at what Muslim countries like Malaysia, Indonesia, Saudi Arabia, and the United Arab Emirates did to convince their population to get vaccinated, to help improve the vaccination rate in the Bangsamoro Autonomous Region in Muslim Mindanao (BARMM).

“They are saying there is (vaccine) hesitancy due to religious beliefs. But Malaysia and Indonesia are Muslim countries and have high vaccination coverage… “Saudi Arabia and UAE also have high vaccine coverage. These are also Muslim countries. So it might not be religious beliefs. We may just have to do something else,” she said.

Cabotaje, head of the National Vaccine Operations Center (NVOC), also said they are coordinating with imams and BARMM officials on how to increase vaccine coverage in the region.

BARMM has the lowest vaccination rate in the country with only 28.02 percent of their population fully vaccinated against COVID-19.

On the other hand, vaccination rate in the UAE is at 97 percent, 70 percent fro Saudi Arabia, 18 percent for Malaysia, and 52 percent for Indonesia.

The NVOC is looking at increasing the jab rate among senior citizens. She said 2.4 million senior citizens have yet to be inoculated nationwide despite being the second priority population for COVID-19.

“Many of them are saying, if it is their time to die, then it is their time to die. What they don’t understand is if they get sick, their families are also affected,” she pointed.

Another factor in failing to jab the elderly sector are vaccination guidelines and the need to go to vaccination sites.

“We need to ease the process because our senior citizens don’t want that much requirements. They want their vaccination to be easy and swift,” she said.

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