PH authorizes Pfizer's COVID-19 vaccine for emergency use

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Metro Manila (CNN Philippines, January 14) — The Philippines has approved the use of Pfizer-BioNTech's COVID-19 vaccine, the first one to be granted emergency use authorization in the country.

The Food and Drug Administration granted the application of American pharmaceutical giant on Thursday, Director General Eric Domingo confirmed. An EUA issuance from the regulators is required for the vaccines to be legally rolled out in the country.

“The interim data from the ongoing phase 3 trial shows that the vaccine has an efficacy of 95% in the study population and at least 92% among all racial groups,” Domingo said in a briefing.

He added that the adverse events were transient and mostly mild to moderate similar to common vaccine reactions, and no specific safety concerns were identified. However, monitoring is still required after immunization for other possible side effects, he noted.

Pfizer has already secured EUA approval from United States and United Kingdom among other countries and emergency use listing from the World Health Organization after its phase 3 clinical trial showed that it was 95% effective in preventing infections after a person received two shots.

Under the terms of the EUA, the vaccine can only be administered by vaccination providers to individuals 16 years old and above. Also, Pfizer shall only supply the vaccine to emergency response stakeholders including the Department of Health, the National Task Force Against COVID-19, or other authorized designees like public and private hospitals, local government units, and the private sector.

The country has not yet formally secured doses of Pfizer's shots, but vaccine czar Carlito Galvez Jr. said the Philippines may receive more or less 40 million doses from the US biopharmaceutical company this year as they continue to finalize negotiations. Pfizer doses could also arrive this quarter if the Philippines' application for an early rollout under the World Health Organization's COVAX facility is granted.

Unlike other brands, Pfizer's vaccine needs to be stored in ultra-cold minus-70 degrees Celsius freezers, which are not yet widely available nationwide. Adhering to the temperature requirements during storage and distribution is crucial to ensure the efficacy of the vaccines.

Domingo said under the authorization, Pfizer shall provide the required cold chain requirements for storage, transport, and handling until vaccines are delivered to inoculation sites, unless a different agreement with the DOH or the task force is formulated.

He also said that government authorities will determine areas that will receive the Pfizer vaccine to ensure proper storage and cold chain management

Galvez earlier said distribution of Pfizer vaccines may be limited to Metro Manila, Cebu City, and Davao City for now as these urbanized areas can meet the storage requirements. The national government is also in talks with private firms to establish cold storage rooms and walk-in freezers.

The EUA application of AstraZeneca and Sputnik V made by Russia's Gamaleya Research Institute are pending at the FDA. Domingo told CNN Philippines on Thursday the agency may decide on AstraZeneca's application before the end of January. He pointed out that the British-Swedish drugmaker has already secured EUA from a stringent regulatory authority from the UK, which would "help (the FDA) evaluate a little faster."

The government aims to vaccinate 50 million to 70 million Filipinos this year.