AstraZeneca to cooperate with FDA regarding vaccine’s side effects

British-Swedish drugmaker on Friday expressed its commitment to work with the Philippine Food and Drug Administration (FDA) to address concerns regarding the adverse side effect of its .

The Food and Drug Administration (FDA) temporarily stopped giving the remaining AstraZeneca vaccines to individuals aged 59 and under.

This is due to reports that it allegedly causes a rare  clot in some vaccinated in Europe.

According to FDA Director General Eric Domingo, they are now just waiting for clearer evidence and guidance from the World Health Organization before re -using it.

“Nakita ng European Medicines Agency ay mayroong very, very rare ‘no, kasi out of 200 million na mga nabakunahan ng AstraZeneca, mayroon pong parang mga 16 cases na tinitingnan nila na possible connected nga po noong clotting saka iyong pagbaba po ng platelet,” said Domingo.

“Tsinek ko po sa ating National Adverse Events Following Immunization Committee, wala naman daw po tayong kaso nari-report na ganito, na pagbaba ng platelet at saka po thrombosis dito sa atin,” he added.

He said there has never been a similar incident in the country.

AstraZeneca to cooperate with FDA regarding vaccine’s side effects

The FDA insists this does not mean that AstraZeneca  is not safe or ineffective.

The vaccine manufacturer said, “Patient safety remains to be the highest priority for AstraZeneca.” “AstraZeneca will continue to work with the Philippine FDA to answer any questions they may have.”

According to an assessment, 86 blood clotting cases out of some 25 million people in Europe who received AstraZeneca vaccine found that  side effect is “very rare” and most common among women younger than 60.

According to World Health Organization (WHO), causal relationship between the AstraZeneca vaccine and the blood clots was “plausible but not confirmed.”

However, the United Kingdom Medicines and Healthcare Products Regulatory Agency as well as the European Medicines Agency asked that blood clots be listed as an “extremely rare potential side effect.”

“AstraZeneca has been actively collaborating with the regulators and is already working to understand the individual cases, epidemiology and possible mechanisms that could explain these extremely rare events,” it said.