Over 3% of COVID-19 vaccine recipients in PH reported adverse events - FDA

Kristine Sabillo, ABS-CBN News

Posted at Mar 18 2021 04:47 PM | Updated as of Mar 19 2021 12:21 AM

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MANILA (UPDATE)— Suspected adverse reactions were recorded among 3.11 percent of those inoculated so far in the Philippines against COVID-19, using the vaccine candidates of Sinovac and AstraZeneca, a rate that falls within the expected range, the country's drug regulator said Thursday.

According to the Food and Drug Administration, 2.21 percent of those who received Sinovac's CoronaVac experienced suspected side effects, and it was 5.19 percent for those inoculated with AstraZeneca's product.

FDA Director General Eric Domingo showed a breakdown of the reported “adverse events following immunization” (AEFI) in a media briefing, 18 days into the country's COVID-19 vaccine rollout.

CORONAVAC

Out of the 167,798 people vaccinated with CoronaVac, as of 6 p.m. of March 17, there were 3,700 who reported having suspected side effects.

Of those, 83 are considered serious while one fatality was reported, referring to the death of a 47-year-old female health worker which has already been deemed unrelated to vaccination.

There were also 46 recipients who reported respiratory symptoms such as cough and nasal congestion; 32 had allergic reactions; 31 had headache or other neurological symptoms; and 28 had such usual vaccination symptoms as pain, chills and fatigue.

Other reported AEFIs were increased heart rate, abdominal pain, and body pain.

Dr. Rommel Lobo, vice chair of the National Adverse Events Following Immunization Committee (NAEFIC), said that not all AEFIs are related to vaccines.

Some may not have a connection at all, but will have to be reported, he said.

ASTRAZENECA

For the AstraZeneca vaccine, 3,715 of the 72,499 who have since received it reported suspected adverse events.

Of those, 54 were considered serious. Most of the symptoms reported were pain, chills, fatigue, dizziness, headache, cough, nasal congestion and other common vaccination reactions.

“So far, wala naman tayong nakita na anything unusual,” Domingo said, adding that the death reported was already investigated on with a conclusion it was due to COVID-19 infection.

Domingo said the 3.11 percent AEFI rate among the country's vaccine recipients so far is within the accepted range because, according to him, in clinical trials where AEFI monitoring is more pro-active, 20% to 30% of vaccine recipients report side effects.

Below is the regional breakdown of the suspected adverse reactions, as reported:

Domingo said AstraZeneca assured the FDA during a meeting that the reported blood clot cases in Europe are unrelated to its vaccine candidate.

The World Health Organization said that while it noted the temporary suspension on the use of the AstraZeneca COVID-19 vaccine in some countries in the European Union as a precautionary measure based on reports of rare blood coagulation disorders in persons who had received it, the international body still recommends that vaccinations continue as it considers that the benefits of the product outweigh its risks.

Domingo said the FDA receives reports of suspected side effects daily.

Minor side effects must be reported within a week, while the serious ones must be relayed to them or the AEFI committee within 24 hours, he said.

Both Domingo and Lobo reminded the public that even after vaccination, those inoculated should still follow health protocols since vaccine protection is not 100% and it takes time for the body to produce antibodies.

"'Pag po kayo nabakunahan, 'di ka pa magkakaroon ng protection at immunity from COVID-19. For the first three or four weeks, ang possibility mo na magkaroon ng COVID ay kapareho ng mga 'di nabakunahan. Kaya kailangan magiingat pa rin po tayo," Domingo said in an interview with ABS-CBN's TeleRadyo.

The Philippines has received 525,600 doses from AstraZeneca and 600,000 doses from Sinovac.