Video courtesy of the Department of Health
MANILA — The Philippines has approved Pfizer’s COVID-19 vaccine for emergency use, the Food and Drug Administration announced Thursday, as the government aims to inoculate 100,000 to 200,000 Filipinos daily in a national vaccine rollout.
“After a thorough review of currently available data by medical and regulatory experts, the FDA today is granting emergency use authorization to Pfizer BioNTech COVID-19 vaccine,” FDA Director General Eric Domingo said during a virtual briefing.
He said that “the benefit of using the vaccine outweighs the known and potential risks.”
The approval comes 3 weeks since the US-based company applied for emergency use authorization (EUA) in the Philippines.
An EUA means a vaccine approved by the countries where they were developed can be used locally after 21 days, down from the current required 6-month verification, Presidential Spokesperson Harry Roque earlier said.
Pfizer’s vaccine is the only one that has been included in the World Health Organization’s emergency list. Among other vaccine frontrunners, it also has EUAs in the most number of countries.
An EUA allows Pfizer’s vaccine to be imported, distributed and administered in the Philippines through a national immunization program.
Domingo said the vaccine, based on interim data of Phase III trials, has an efficacy rate of 95%. The efficacy rate for all racial groups was at 92%.
“The adverse events were transient and mostly mild to moderate, similar to common vaccine reactions among other vaccines that are in use now,” he added.
While there were no safety concerns, Domingo noted that “more adverse effects may be observed” based on close monitoring of those already immunized.
“The roll out of the vaccine and its use in more than 5 million people worldwide has identified also severe allergic reaction in a few individuals. Therefore the vaccination must be done by health professionals trained to recognize and manage such adverse reactions and they should have resources at hand to adequately respond and manage such cases,” the official said.
Unlike other vaccines, Pfizer and BioNTech is a messenger RNA (mRNA) vaccine, which utilizes newer technology. While it has a high efficacy rate, it requires ultra cold storage, making it difficult for poor countries to import and store it.
Domingo said the vaccine requires storage with temperatures of -80 to -60 degrees Celsius and can only be used for people who are 16 years and older.
Vaccine czar Secretary Carlito Galvez said on Wednesday that Pfizer may be the first vaccine to enter the country through the help of the COVAX Facility, an international platform that aims for equitable access to COVID-19 vaccines. This means Pfizer may be the first vaccine to be used in the country, ahead of China’s vaccines from biopharmaceutical firm Sinovac.
Galvez earlier said that the Pfizer vaccine will most likely be used in Metro Manila and other areas near the vaccine hubs in Cebu and Davao because of its storage requirements.
Domingo reminded the public that the EUA is not a marketing authorization or a Certificate of Product Registration, which means the vaccine cannot be sold commercially. It cannot be sold by pharmaceutical stores or doctors.
Instead, “Pfizer Inc. (Philippines) shall supply Pfizer- BioNTech COVID-19 Vaccine only to emergency response stakeholders consistent with the terms and conditions of this EUA including Department of Health (DOH) or the National Task Force Against COVID-19 (NTF),” Domingo said.
He added that the DOH can also authorize public and private health facilities, local government units and other members of the private sector to procure the vaccine.
The EUA also requires Pfizer, if there is no agreement with the government, to provide appropriate cold storage requirements until the vaccine is delivered to the vaccination sites.
Domingo said the government will be monitoring adverse events after Pfizer is used for the national immunization program.
“Submission of serious and non-serious adverse reaction reports is mandatory,” he said.
Recipients of the vaccine will also receive fact sheets with information on the vaccine and when they will receive the second dose. They will also be asked to sign a written informed consent before being vaccinated.
Currently, the FDA is also evaluating the EUA applications of AstraZeneca, Gamaleya Institute of Russia and Sinovac from China.
Domingo said the companies still have pending documents and will be evaluated within the 21-day period they have set for EUA processing.