DOH awaits AstraZeneca to apply for vaccine emergency use after trial request withdrawal

Kristine Sabillo, ABS-CBN News

Posted at Dec 14 2020 02:24 PM

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MANILA — The Department of Health on Monday said it is waiting for vaccine developer AstraZeneca to apply for emergency use distribution in the Philippines after it withdrew its application for COVID-19 vaccine clinical trials.

“Nalaman natin last week na nag-withdraw na ang Astrazeneca because apparently they were able to meet the sufficient number required from them para matapos yung clinical trial nila,” Health Undersecretary Maria Rosario Vergeire said during a virtual briefing. 

(We learned last week that AstraZeneca withdrew its application because apparently they were able to meet the sufficient number required from them to finish their clinical trial.)

“We are already having negotiations with AstraZeneca. So, the next step would be an application for an emergency use authorization here in the country, if ever,” she said.

Last Friday, the Food and Drug Administration of the Philippines told ABS-CBN News about AstraZeneca’s decision.

The UK-based vaccine developer is the only company, so far, that has a supply deal with the Philippines. It was signed in November by the government and the private sector.

Vergeire said AstraZeneca can now apply for regulatory approval for the distribution of their COVID-19 clinical trials with the FDA and the Health Technology Assessment Council.

Joey Concepcion, Presidential Adviser on Entrepreneurship, said Monday that the business sector is set to buy a second batch of vaccines from AstraZeneca.

Vergeire said vaccine czar Carlito Galvez Jr. is in close coordination with the business sector for additional support.

The health official said the purchase of vaccines by private companies for the priority sectors and their employees is important, especially since workers are at risk of contracting COVID-19 because of their daily exposure. 

International media recently reported that AstraZeneca is working with Russia’s Gamaleya Institute to create a combination vaccine.

Gamaleya is another vaccine developer applying for clinical trials in the Philippines. However, its application has not yet moved forward because of incomplete documents.

Vergeire said there should not be any problem with the new development. She said it will not affect Gamaleya’s existing application since it refers only to Sputnik V.

“Also, if they are going to go through this partnership and come in the country, then we need to have it undergo the regulatory process,” she said.

The Philippines has logged 449,400 confirmed COVID-19 cases, as of Dec. 13, of which, 21,980 are active infections, 8,733 resulted in deaths, and 418,687 have recovered.