AstraZeneca readies EUA application; FDA provides requirements to Sinovac, Gamaleya

MANILA, Philippines — British drugmaker AstraZeneca is preparing its application for an emergency use authorization (EUA) of its COVID-19 vaccines in the Philippines, the Food and Drug Administration (FDA) said Wednesday.

“AstraZeneca is also preparing for their submission because they already got their EUA from the United Kingdom and India and I believe they will be submitting very soon. We are anticipating that one,” FDA director-general Eric Domingo said over ABS-CBN News Channel.

Meanwhile, the FDA has also provided the list of requirements for EUA to China’s Sinovac and Russia’s Gamaleya Institute for their respective COVID-19 vaccines.

“Sinovac has an EUA from China and has been asking around. We have given them already the requirements and the process. Also Gamaleya or Sputnik from Russia has asked and we have given them the requirements,” Domingo said.

He added that the FDA has not had any contact with China’s Sinopharm, and Moderna from the United States regarding their vaccines.

According to Domingo, companies that have secured EUA from their respective countries or other jurisdictions are eligible to apply for an EUA in the Philippines.

“There are several companies that are eligible to apply [for an EUA]. These are companies with a vaccine that already has an EUA in their country or in any other jurisdiction. There are about six of them who have that now,” he said.

American drugmaker Pfizer earlier submitted its application for an EUA in the country. Domingo said the application is currently being evaluated by the FDA.

Securing an EUA from the FDA will allow a new vaccine to be administered in the country.

EDV