Deal with AstraZeneca may be canceled if vaccine fails to get FDA approval

Health Secretary Francisco Duque III said Monday the deal with may be canceled if the vaccine fails to get the approval of the Food and Drugs Administration ().

Duque emphasized that the agreement among the government, private sector, and AstraZeneca requires the potential vaccine to undergo FDA and vaccine experts evaluation.

“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,” Duque said at the Laging Handa briefing.

Asked whether the deal will be voided if AstraZeneca’s vaccine fails to meet FDA standards, Duque said: “Posible ‘yan, syempre dahil ibig sabihin may violation ng agreement.”

Previously, President Rodrigo Duterte, “in principle,” has approved the recommendation of the Department of Health (DOH) to issue an executive order for   in the country.

Palace spokesperson Harry Roque said the executive order would authorize Food and Drug Administration to issue emergency use authorization (EUA) for COVID-19 vaccines.

The EO would shorten the processing time from six months to 21 days.

Deal with AstraZeneca may be canceled if vaccine fails to get FDA approval

The EUA would allow the country to use medicines, vaccines, and other health technologies through reliance and recognition.

The EUA is a facilitated approval for public health emergencies like the COVID-19 pandemic, a serious or life-threatening disease, the product is proven effective to prevent, diagnose or treat the disease, there is a positive risk-benefit balance, and there is no adequate available alternative.

Last week, the Philippine government signed an agreement with British-Swedish pharmaceutical company  and the private sector to purchase 2 million doses of its .

AstraZeneca said its COVID-19 vaccine was 70% effective in crucial trials and could be up to 90% effective.

The drugmaker also said that it would manufacture as many as 200 million doses by the end of 2020. The number was 400 times higher than U.S. competitor Pfizer Inc. AstraZeneca said 700 million doses could be available worldwide by the end of the first quarter of 2021.

AstraZeneca has also submitted the necessary documents to Philippine health authorities to conduct clinical trials for its vaccine.