Pfizer to get green light for emergency use application soon

THE PHILIPPINES is expected to grant the emergency use authorization for the coronavirus vaccine developed by Pfizer, according to the chief of the local Food and Drug Administration (FDA).

The vaccine made by the US drugmaker and its German partner BioNTech SE may get the green light by Jan. 14, FDA Director-General FDA Rolando Enrique D. Domingo told an online news briefing on Wednesday.

The review had been expedited because Pfizer has obtained emergency use listing from the World Health Organization (WHO) and authorization from several countries including the US, United Kingdom, Switzerland and Singapore, he said.

“The process is fast but we are going through each step to ensure the quality, safety and efficacy of the vaccines before we give approval,” Mr. Domingo said.

Results from a late-stage vaccine trial showed that the Pfizer vaccine is 95% effective after two shots.

AstraZeneca Plc has also applied for emergency use authorization of its COVID-19 vaccine in the Philippines, Mr. Domingo.

He said the British drugmaker has a tripartite supply deal with the private sector and Philippine government. It is in talks with local governments seeking to order vaccines, he added.

“The vaccine from Oxford and AstraZeneca was already approved in the United Kingdom and India,” Mr. Domingo said. “We anticipate that they will also apply in the Philippines.”

AstraZeneca’s vaccine, which was found to be 70% effective on average after two shots, is reportedly cheaper than the Pfizer/BioNTech vaccine and does not require super cold temperatures.

Mr. Domingo said the Pfizer vaccine, “the most in-demand brand,” would most likely become available locally in the third or fourth quarter.

Meanwhile, biotechnology companies in the Philippines will seek approval for emergency use authorization for a coronavirus vaccine made by Bharat Biotech India this month, IP Biotech, Inc. said in a statement.

The FDA will get the application from IP-Biotech, Family Vaccine & Specialty Clinics and Ambica International Corp., IP Biotech said after India’s drug regulator approved the vaccine.

Bharat Biotech India’s Covaxin was developed with the Indian Council of Medical Research-National Institute of Virology.

“The indigenous, inactivated, whole virus vaccine has a standard cold chain temperature of 2-8 degrees Celsius, making it ideal for tropical countries,” IP Biotech said in the statement. — Kyle Aristophere T. Atienza