Emergency use authorizations (EUAs) may be revised if a drug shows safety problems, the government said Sunday, even as the official in charge of procuring COVID-19 vaccines said authorities would be more cautious after Norway reported that 29 elderly people given the Pfizer vaccine died.
In the wake of the Norwegian reports, Food and Drug Administration (FDA) Director General Eric Domingo said an EUA is always subject to conditions that could be revised.
In a radio interview, Domingo noted that investigation into the deaths of the Norwegian senior citizens was still ongoing, and that his agency would rely on reports from its counterpart in Norway and Pfizer-BioNTech.
Assuming that the vaccine has adverse effects in this case, Domingo said that the FDA can indicate in the EUA that the product may not be used in the elderly and people with severe allergies.
The FDA granted an EUA to the COVID-19 vaccine manufactured by Pfizer-BioNTech on Thursday.
Vaccine czar Carlito Galvez Jr. said the Philippines will be more cautious in choosing the COVID-19 vaccine to be administered to the elderly.
Galvez said they would make sure what happened in Norway will not happen in the Philippines once the government’s COVID-19 vaccination program begins, adding that the goal is zero casualties.
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.
The government aims to inoculate 50 million to 70 million people this year, with priority given to health care workers and the elderly.
Norway on Saturday expressed concern about the safety of Pfizer’s coronavirus vaccine on elderly people with serious underlying medical conditions, after at least 29 of them died within days of receiving the shot, Bloomberg reported.
The vaccine produced by Pfizer and BioNTech was the only one available in Norway until Friday, and “all deaths are thus linked to this vaccine,” the Norwegian Medicines Agency said in a written response to Bloomberg.
“Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site, and worsening of their underlying condition,” the agency said.
The Canberra Times, meanwhile, said Australia is investigating reports Norwegian authorities are concerned about the safety of the Pfizer COVID-19 vaccine.
Federal Health Minister Greg Hunt is seeking additional information through the Therapeutic Goods Administration from the company and the Norwegian medical regulator.
Foreign Minister Marise Payne has also tasked the Department of Foreign Affairs and Trade to seek advice directly from the Norwegian government.
Earlier, Pfizer tried to ease concerns in Europe about the slow deliveries of its vaccine.
Several Nordic and Baltic countries described the situation as “unacceptable,” while Belgium’s vaccination strategy task force condemned a lack of consultation by Pfizer over the deliveries as “incomprehensible.” With AFP