FDA: Most of 24 fatalities reported after COVID-19 vaccination ‘coincidental’

The Food and Drug Administration (FDA) on Friday, April 23, reported that 24 deaths have been recorded following vaccination in the country.

But the country’s food and drug regulatory agency noted that most of the fatalities were classified as “coincidental” and unrelated to the vaccination.

“Out of 1 million vaccinated, we have 24 reports involving fatalities,” FDA Director General Eric Domingo said in a virtual press briefing, noting that most of the cases of fatalities were people with existing comorbidities.

“Kung tiningnan yung kanilang mga records...19 were found to be coincidental. So hindi siya konektado doon sa pagbabakuna (If you look at their records...19 were found to be coincidental. So those are not connected with the vaccination),” he said.

Domingo said 11 fatalities were diagnosed with COVID-19, eight died due to cardiovascular or cerebrovascular diseases, three succumbed to infectious disease other than COVID-19, while two deaths were still under review.

The FDA chief noted that most of the deaths involved people with existing comorbidities, 19 of which were classified as “coincidental,” three were still indeterminate, while the other cases remained under investigation.

Domingo also noted that deaths following vaccination were also reported in Norway, Hong Kong and the United States.

Meanwhile, Domingo said there were 24,698 reports of adverse events following immunization (AEFIs) out of the 1,006,511 Filipinos vaccinated since the start of the country’s immunization program on March 1 to April 10 using China’s Sinovac vaccines and AstraZeneca shots.

Of the number, Domingo said 24,330 were reports of non-serious events, while 344 were serious events other than deaths.

“From the start of our vaccination period to April 10, only 1.5 percent of the total AEFIs were serious cases. This means that for every 1,000,000 vaccinated, less than 0.04 percent may experience serious AEFI cases,” Domingo said in a separate statement.

“But it does not necessarily mean that the vaccine causes the events. This risk is much lower than the fatality of the COVID-19 infection in our country which has a 1.69 percent fatality rate,” he added.

For those vaccinated with CoronaVac, Domingo reported that 7,044 have experienced adverse events out of the 497,837 people inoculated with the jab.

Of the number, 6,882 were non-serious events, 152 were serious events other than deaths, while 10 were reports involving deaths.

Most common adverse events found in those immunized with CoronaVac were transient increase in blood pressure, headache, pain in the injection site, rash and fever.

As for those vaccinated with AstraZeneca, Domingo reported that there were 17,654 reports of AEFIs out of the 508,674 people immunized.

Of the number, 17,448 were non-serious events, 192 were serious other than deaths, while 14 were reports involving deaths.

Most common adverse events found on those inoculated with AstraZeneca were fever, headache, pain in the injection site, chills and some body pains.

Despite this, the Department of Health and the FDA assured the public that vaccines are safe and effective in preventing hospitalization and deaths, and that the benefits of the vaccine outweigh its risks.