EUA may be revised in case vaccine shows safety issues, FDA says

The conditions in emergency use authorization (EUA) may be revised in case a vaccine product shows safety issues, Food and Drug Administration (FDA) director general Eric Domingo said on Sunday.

Interviewed on Dobol B sa News TV, Domingo made the statement after 23 senior citizens who were inoculated with Pfizer-BioNTech’s vaccine died in Norway.

“Ang EUA naman po laging subject to conditions po 'yan na puwede natin siyang i-revise,” he said.

Domingo noted that investigation into the deaths of the senior citizens in Norway is still ongoing.

He said the FDA will rely on the report of its counterpart in Norway as well as the report of Pfizer-BioNTech.

“Ang sabi nila before magkaroon ng bakuna is every day 400 ang namamatay doon sa senior citizen. So pinagbabakunahan lahat,” Domingo said.

“Talagang elderly, mga mahigit 90 anyos po yata. Tapos, meron pa rin namatay. Pero iniimbestigahan po nila ‘yan ngayon,” he added.

Assuming that the vaccine has adverse effects in this case, Domingo said that the FDA can indicate in the EUA that the product could not be used in the elderly and people with severe allergies.

"Bago natin magamit ang bakuna na 'yan, madadagdag po natin ngayon 'yan doon sa ating mga contraindications na huwag siyang gamitin sa mga merong severe allergies at siguro possibly mga sobrang matatandang-matatanda,” he added.

The FDA has granted EUA to the COVID-19 vaccine manufactured by Pfizer-BioNTech, Domingo announced on Thursday.

Vaccine czar Carlito Galvez Jr. on Sunday said the Philippines will be more cautious

Galvez said they would make sure that an incident similar to what happened in Norway will not happen in the Philippines once the government's COVID-19 vaccination program begins.

"Ang ating goal is zero casualty and as much as possible, very close watch," he said.

Galvez said that upon hearing the news, he reached out to Health Secretary Francisco Duque III about their plan for administering the vaccine to senior citizens in the Philippines.

"Sinabi namin na mas maganda 'yung original plan namin na 18 hanggang 59 [years old] lang muna at hahanap tayo ng bakuna na pang-matanda talaga," he said.

"Based sa initial report ng Norway, talagang delikado 'yung 80 and above. So 'yun ang talagang titignan natin lalo na 'yung talagang may komplikasyon at talagang nakikita natin 'yung mga frail. Kasi titignan natin din 'yung risk and benefit ng bakuna natin," he added.

The Philippines targets to inoculate 50 to 70 million individuals within the year, and an estimated 50,000 Filipinos are expected to be vaccinated in February.

For its part, the Norwegian Medicines Agency (NOMA) said vaccinations will continue while investigations are ongoing, but with extra evaluation for the sick and elderly.

"It may be a coincidence, but we aren't sure. There is no certain connection between these deaths and the vaccine," NOMA medical director Steinar Madsen was quoted as saying in a report of the British Medical Journal cited on GMA's "24 Oras Weekend" on Sunday.

"There is a possibility that these common adverse reactions, that are not dangerous in fitter, younger patients are not unusual with vaccines, may aggravate disease in the elderly," said Madsen.

"We are not alarmed or worried about this, because these are very rare occurrences and they occurred in the very frail patients with very serious disease."

For its part, the vaccine manufacturer said it is working with NOMA to look further into the matter.

"Pfizer and BioNTech are aware of reported deaths following administration of NBT162b2. We are working with NOMA to gather all the relevant information," it said. —KG/BM, GMA News