The deal to purchase at least 2.6 million doses of the coronavirus disease 2019 (Covid-19) vaccine developed by AstraZeneca will not push through if the drug firm fails to get local regulatory approval, Deparment of Health Secretary Francisco Duque 3rd said on Monday.
Duque said the tripartite agreement signed by the government with AstraZeneca and the private sector requires that the candidate Covid-19 vaccine of the UK-based drug firm undergo evaluation by vaccine experts and the Food and Drug Administration (FDA).
“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 (The vaccine will have a hard time getting approval if regulators will see something not good over the results and this will affect what we call its safety, quality and effectiveness),” Duque said at the Laging Handa briefing.
When asked if the agreement will be voided if the vaccine fails the standards of FDA, the DOH secretary replied “Posible ‘yan, syempre dahil ibig sabihin may violation ng agreement (That is possible, of course, because that will mean violation of the agreement).”
It was the private sector that will fund the purchase of Covid-19 vaccines from AstraZeneca, valued at P626 million. However, the drug firm has been criticized for admitting an error in its testing data, but earlier claimed its vaccine was 90-percent effective. SOVEREIGNPH