AstraZeneca vows cooperation with FDA amid COVID-19 vaccine concerns

British-Swedish drugmaker AstraZeneca on Friday vowed to work with the Philippine Food and Drug Administration (FDA) to address concerns on the rare side effects of its coronavirus vaccine.

The Philippines temporarily suspended the use of the AstraZeneca jab on people younger than 60 upon the recommendation of the FDA following reports of rare blood clots with low platelet count in some vaccine recipients abroad.

“Patient safety remains to be the highest priority for AstraZeneca,” the company said in a statement. “AstraZeneca will continue to work with the Philippine FDA to answer any questions they may have.”

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

The World Health Organization also said a 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 requested 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,” the drugmaker said.

Health authorities in the Philippines have not monitored such side effects among people who got the AstraZeneca shot but vowed to continue monitoring recipients for possible adverse reactions.

Over 922,000 individuals have been vaccinated against COVID-19 as of April 6. Of this number, over 493,000 got the AstraZeneca jab. 

‘Exaggerated’

Meanwhile, presidential adviser for entrepreneurship Joey Concepcion on Friday lamented the suspension on the use of AstraZeneca’s COVID-19 vaccine for people under 60 years old, calling it "exaggerated."

Interviewed on Dobol B TV, Concepcion insisted that the benefits of the vaccine outweigh its risk.

“‘Yung UK, ang ginawa nila 30 years old and below. Sa atin dito, sobrang exaggerated. Buti ba kung marami tayong vaccine. Pakaunti-kaunti lang nga ang vaccine natin  ngayon,” he said.

(In the UK, they suspended the vaccination for people below 30 years old. Here, it was very exaggerated. That is okay if we have many vaccines, but  but we don't.)

Concepcion said that risk is very rare, noting that there were only four incidents of blood clot out of 1 million recipients.

“As of the moment, the Philippines has inoculated more than 500,000 individuals using the same vaccines. And if there are any extreme adverse effects, we should know them by now,” he said in a separate statement.

“Also, countries like Australia, Brazil, Mexico, Malaysia, Vietnam, Taiwan, Thailand, and many others have made no restrictions except for the UK, which restricts ages below 30,” he added. — RSJ, GMA News