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New FDA guidelines on use of AstraZeneca jab seen out this week

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New FDA guidelines on use of AstraZeneca jab seen out this week
A vial of AstraZeneca Covid-19 vaccine is pictured at a vaccination center in Pristina, Kosovo on April 13, 2021 as the government begins the country's vaccination rollout for people aged over 85 with the AstraZeneca vaccine.
AFP / Armend Nimani

MANILA, Philippines — New guidelines on the use of the COVID-19 vaccine developed by AstraZeneca will be issued this week, the country’s Food and Drug Administration said Wednesday.

FDA Director General Eric Domingo made the announcement nearly a week after the agency and the Department of Health temporarily suspended the use of the AstraZeneca jab for people aged below 60 years old to investigate reports of blood clots disorders from overseas.

According to Domingo, the World Health Organization, the National Adverse Events Following Immunization Committee and local vaccine experts said the vaccine’s benefits outweigh potential risks.

“We’re finishing the guidelines so we can release it this week,” Domingo said in Filipino during a briefing.

“We will release guidelines, especially for the vaccinators, so they can advise vaccine recipients which symptoms to watch out for and so they will know when they need to consult for this very rare possible occurrence of a blood clotting event,” he said.

Last week, the European Medicines Agency said that unusual blood clots should be listed as a very rare side effect of the AstraZeneca shot, while stressing that overall benefits in preventing COVID-19 outweighed the risks.

There were 222 cases of atypical thromboses out of 34 million AstraZeneca injected administered in parts of Europe. Most of the cases reported were in women under 60 years of age within two weeks of vaccination.

In the Philippines, there is no reported case of such side effect.

Some 525,600 AstraZeneca vaccine doses—donation from COVAX Facility—had been delivered to the country last month. But government officials said all of the doses were already utilized.

Authorities said the arrival of additional AstraZeneca jabs will be delayed. 

The single-dose vaccine of Johnson & Johnson has come under similar suspicion for the same issue, with health authorities in the United States recommending the rollout of the jab be paused while they investigate six cases of clotting.

The country aims to inoculate up to 70 million people this year. But only over a million shots have been administered since the immunization campaign began last month. — Gaea Katreena Cabico with report from Agence France-Presse

COVID-19 VACCINE

NOVEL CORONAVIRUS

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