The Philippines Food and Drug Administration said on Tuesday 19 January 2021 that it may exclude elderly people with critical illnesses from the list of people who could receive Pfizer’s COVID-19 vaccine. This possibility was raised after 23 elderly patients in Norway reportedly died days after receiving the US pharmaceutical giant’s COVID-19 vaccine.
FDA Director General Rolando Domingo said in a briefing, “Possibly, we could have guidelines that will limit the use of the vaccine in very old, very sickly or very frail individuals,”
Domingo said they have reached out to Pfizer regarding the reported deaths in a nursing home in Norway. Doctors in the European country are looking into the possibility that the adverse reactions to the Pfizer’s vaccine “may have contributed to a fatal outcome in some frail patients,” According to CNN reported on the same day.
Pfizer’s vaccine’s side-effects are rare and usually mild similar to common vaccine reactions. But Domingo said it is possible that the “weak bodies” of very old, sick patients could not handle “mild adverse reactions” from the Pfizer vaccine.
Domingo said once they confirm that Pfizer’s jab contributed to the deaths of some individuals in Norway, they will revise the conditions for its use in the Philippines. Current guidance from the FDA states that Pfizer’s vaccine cannot be administered to those under 16 years old and individuals with a history of allergies.
“Any time that we get new data … we can always incorporate it in the EUA and revise the conditions for use.” he said.
The FDA chief also said a manufacturer can lose its Emergency Use Authorization (EUA) once safety concerns are identified.
“Kapag mayroon tayong safety concern na makikita sa ibang bansa or dito rin sa atin, the FDA can revoke the EUA at any time,”[Translation: Once we see safety concern abroad or here, the FDA can revoke the EUA at any time.]
Pfizer is the only manufacturer that has so far received FDA’s EUA for its anti-coronavirus shot. The company said use of its vaccine been authorized in over 40 countries, including the United States and the European Union. Its phase 3 clinical trial showed that it was 95% effective in preventing infection after a person received two anti-coronavirus shots.
According to CNN Philippines, the EUA applications of British firm AstraZeneca, Russian company Gamaleya Research Institute and Chinese drug maker Sinovac Biotech are pending at the agency.
Domingo said US-based Moderna, India-based Bharat Biotech, and Serum Institute of India have also expressed interest to apply for emergency use of their COVID-19 vaccines in the Philippines.