Advisory on use of Pfizer COVID-19 vaccine among elderly eyed
MANILA, Philippines — The country’s Food and Drug Administration said an advisory on the use of Pfizer-BioNTech’s COVID-19 vaccine on the elderly may be issued following the post-vaccination deaths of frail and sick elderly patients in Norway.
Pfizer is the only drugmaker that has so far secured an emergency use authorization from the local FDA for its vaccine, which has an efficacy rate of 95% in preventing COVID-19.
During the Laging Handa briefing Tuesday, FDA Director General Eric Domingo said that the agency may not include elderly people with serious illnesses in the list of individuals who can receive Pfizer's COVID-19 shots.
“This is the direction we’re seeing that possibly, we’ll have guidelines that will limit the use of the vaccine in very old, very sickly and very frail individuals,” Domingo said.
Norway sought to allay safety concerns Monday, saying no link had been established between Pfizer-BioNTech’s COVID-19 jab and post-inoculation deaths in the country. Of the cases analyzed so far, Norwegian public health authorities said “they are people of advanced age, are frail and have serious illnesses.”
Norway nonetheless recommended doctors to consider whether patients who are frail or terminally ill should receive the vaccine.
The authorization given by the FDA last week cleared the Pfizer vaccine for use in people aged 16 and above. It can only be administered by health professionals who are trained to recognize and manage severe allergic reactions.
The Department of Health earlier said the emergency use authorization granted by the country’s FDA to Pfizer’s COVID-19 vaccine stays as authorities wait for a report from the firm.
Domingo said the regulatory agency is coordinating with Pfizer so it can update the protocol once it receives relevant information.
Revocation of emergency use
Domingo said the FDA can revoke an EUA issued to a COVID-19 vaccine in case serious adverse incidents arise from vaccination.
“Once we see safety concern abroad or here, the FDA can revoke the EUA at any time,” he said.
British-Swedish firm AstraZeneca, Chinese drugmaker Sinovac Biotech and Russia's Gamaleya submitted applications for EUA to the country's FDA.
President Rodrigo Duterte brought up the post-vaccination deaths in defending the government's controversial deal with Chinese drugmaker Sinovac.
"If you want to follow the experience of Norway, go ahead, nobody would stop you," he said in a speech Monday evening.
Pfizer’s COVID-19 vaccine uses messenger RNA, which teaches cells how to make a protein that triggers an immune response. The Norwegian Medicines Agency said last week that normal side effects from messenger RNA vaccines such as fever and nausea “may have contributed to a fatal outcome in some frail patients.”
Denmark, Finland, Iceland and Sweden also reported post-vaccination deaths, but no direct links to the vaccine have been established.
The Philippines aims to vaccinate 50 to 70 million Filipinos against COVID-19 in 2021 alone, but it depends on the global supply, which had been mostly procured by wealthy nations.
Vaccines from Pfizer, which will be obtained through the COVAX facility, are expected to arrive in the country as early as February. — Gaea Katreena Cabico with report from Agence France-Presse
The national government has so far secured two official deals for COVID-19 vaccine supplies in the Philippines, one with Chinese pharmaceutical company Sinovac and another with the Serum Institute of India.
Watch this space for bite-sized developments on the vaccines in the Philippines. (Main image by Markus Spiske via Unsplash)
Health Officer-in-Charge Maria Rosario Vergeire says the general population may now get their second booster jab.
"We're just waiting for the release of implementing guidelines, then we'll start rolling out our second booster for the general population," she says. — Gaea Katreena Cabico
Amid questions on vaccines being administered, the Department of Health assures the public all doses are safe and effective as the “process of extending shelf life goes through thorough stability studies.”
“The government ensures that every vaccine that is injected with an extended shelf life has gone through studies, and is still safe and effective against COVID-19,” it adds.
Government must increase vaccination capacity across the Philippines in anticipation of a surge of COVID-19 cases caused by the Omicron variant of the corona virus, Sen. Risa Hontiveros says.
She says local government units and the private sector can work together to put up more vaccination centers and deploy more vaccination teams to get more people inoculated against COVID-19.
"The active COVID cases have nearly doubled in three days. The positivity rate is almost four times the ceiling set by the World Health Organization. Huwag na nating hintayin na sobrang lumala pa ang sitwasyon bago tayo gumawa ng paraan para mapabilis ang ating pagbabakuna."
FDA chief Eric Domingo says that its agency has given emergency approval for the use of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11.
The United States immunized around 900,000 children aged five-to-11 against Covid in the first week the Pfizer vaccine was authorized for them, a White House official says Wednesday.
Roughly 700,000 more have made appointments at pharmacies, White House Covid coordinator Jeff Zients tells reporters.
"The program is just getting up to full strength," he says, adding most of the shots were given in the last couple of days alone. — AFP
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