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AstraZeneca deal off it vaccine fails to get FDA okay — Duque

HEALTH Secretary Francisco T. Duque III yesterday said the COVID-19 vaccine deal among the government, the private sector, and AstraZeneca may be voided if the British drugmaker’s vaccine fails to get regulatory approval in the Philippines.

Duque stressed that the tripartite agreement requires the candidate vaccine to undergo evaluation by vaccine experts and the Food and Drug Administration.

“Mahihirapan pong makalusot ‘yan kung meron pong makikita sila na hindi magandang resulta at puwedeng makaapekto po sa tinatawag natin na pagiging ligtas, dekalidad at epektibo ang bakuna,” he said.

The health chief said there is a possibility that the agreement will be voided if the vaccine fails FDA standards because it could mean that there are violations in the agreement.

The Department of Health earlier said the vaccine will not be given to Filipinos without regulatory approval.

For her part, Health Undersecretary Maria Rosario Vergeire said the supply deal, secured by the private sector, was an “advanced commitment” to ensure the Philippines will get 2.6 million shots of the vaccine.

AstraZeneca’s vaccine, which is reportedly 70% effective against COVID-19 at its first half dose and 90% after the second full dose, is up for evaluation by the Philippine Vaccine Experts Panel and the Ethics Review Board.

After that, the vaccine would have to get FDA approval before clinical trials in the Philippines could proceed.

National Task Force Against COVID-19 chief implementer Carlito Galvez Jr. has said AstraZeneca offered the cheapest potential COVID-19 vaccine at $5 per dose.

Publication Source :    People's Journal
Lee Ann P. Ducusin
B.A. Journalism