Pfizer's Full FDA Approval Can Be a Game Changer, Says Entrepreneurship Adviser

Local FDA approval would mean the private sector can directly procure vaccines.

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PHOTO BY Jerome Ascano

(SPOT.ph) The U.S. Food and Drug Administration fully approved the use of the Pfizer-BioNTech COVID-19 vaccine, which used to be under Emergency Use Authorization, on August 23. This means that it can now be marketed like any other medicine in pharmacies under the brand name Comirnaty. Presidential adviser for entrepreneurship Joey Concepcion said that if the Food and Drug Administration (FDA) of the Philippines would follow suit, it could make it easier for the private sector to procure their own COVID-19 shots.

Also read: Your Comprehensive Guide to Metro Manila's Vaccination Programs

Since all available vaccines in the Philippines are still under Emergency Use Authorization (EUA), local private companies are in a tripartite agreement with the national government and vaccine manufacturers for procurement. This is necessary, according to the Department of Health, since vaccine manufacturers require that indemnifcation be covered by the national government, the cost of adverse effects is supposed to be covered by Malacañang, and the vaccines still don't have a Certificate of Product Registration that allows products to be bought directly from the market.

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Part of the agreement is that companies donate COVID-19 vaccines to the government, at least until it was announced by Concepcion on June 8 that they no longer need to do so if they're getting AstraZeneca. This was after COVID-19 vaccine czar Secretary Carlito Galvez Jr. said that the country has an ample supply of the brand. Around 17 million doses of AstraZeneca COVID-19 vaccines have been secured through tripartite agreements.

These deals, however, are experiencing some delay since some manufacturers like Sinovac and Gamelaya prefer to deal only with the national government, according to Galvez. Moderna and AstraZeneca, meanwhile, stopped accepting new orders, while Johnson and Johnson and Pfizer are not open for multi-party agreements.

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But if the Philippine FDA gives full approval to Pfizer, as the U.S. FDA did, then it can be a game changer for vaccine procurement in the country, according to Concepcion.

“The private sector, once the FDA grants full approval here in the Philippines, we can now import directly from Pfizer and we don’t need to form this tripartite already because they have FDA approval. That changes the game because when you have full approval, it’s already sold in commercial [establishments], you can buy it in Mercury and other drug stores,” he said.

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