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Gov't setting up monitoring teams for COVID-19 vaccine users —FDA chief

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The government will put in place a strong surveillance mechanism for those who will receive COVID-19 vaccines in the country after the Food and Drug Administration (FDA) was given the power to issue emergency use authorization (EUA) for vaccines and medicines against the novel coronavirus disease, an official said on Thursday.

FDA director general Eric Domingo told reporters in an online briefing that the team for the post-authorization monitoring is being set up with the Department of Health's Epidemiology Bureau.

He said there would be regional teams that would monitor adverse effects of the COVID-19 vaccines which would be issued an EUA.

"If there's any possible serious adverse events, if something happens within 24 hours of vaccination, whether or not sigurado tayo na connected 'yan sa bakuna, kailangan i-report agad 'yan," Domingo said.

The teams would relay the information to the central office and prompt the DOH and the FDA to conduct an investigation and necessary consultations with the World Health Organization and other counterparts abroad who would be using similar vaccines.

"We will make a decision whether to pause, stop, or continue the vaccination. It's a very active process and it will start at the day na mag-umpisa tayong magbakuna," Domingo said after stressing that the issuance of EUA would be risk-based.

The benefits of potential COVID-19 vaccines and medicines should outweigh the possible risks before these can secure EUA in the Philippines, he added.

On Tuesday, President Rodrigo Duterte signed Executive Order 121 which allowed the FDA to issue an EUA for COVID-19 drugs and vaccines.

This will reduce the processing time for the approval of the vaccines for local use from six months to 21 days.

Domingo said with the "accelerated" approval of some vaccines abroad, the FDA in the Philippines may expect applications for EUAs from vaccine developers soon.

"Kung mag-aapply po sila sa atin within the month, then its possible that we will be able to issue also the EUA within another three to four weeks. So, sa January," he said.

"Pag ganoon po, maaari na po siguro mag-umpisa ang proseso ng pag-procure ng pamahalaan ng bakuna para makakuha sila ng allotment at supply at madala sa Pilipinas," he added.

At a Palace briefing, Domingo projected that COVID-19 vaccines may be ready for distribution in the Philippines by March 2021.

While the FDA was authorized to issue the EUA, the prioritization of who will get vaccinated first would depend on the implementers of the immunization program.

"We will authorize its use for the public health program and of course the Department of Health and the program implementers, sila 'yung magse-set ng prioritization nila kung sino ang una nilang babakunahan at 'yung scheduling," Domingo said.

No one will be forced to be vaccinated against COVID-19, according to the FDA official.

"Hindi po kayo pwedeng pilitin at hindi puwedeng sapilitan. Kapag tayo ay nagpabakuna kailangan naiintindihan natin kumpleto kung ano ang benepisyo nito at ano ang posibleng adverse events, side effects, or risks nito," he said.

The DOH is preparing an education campaign about the risk and benefits of COVID-19 vaccines to help the public make an informed decision, he added.—AOL, GMA News

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