Duque pushes issuance of EO for acquisition of Covid shots
THE Department of Health (DOH) is pushing for the issuance of an Executive Order (EO) that will fast-track the approval of novel coronavirus vaccine (Covid-19) to be used in the country.
Health Secretary Francisco Duque III appealed to President Duterte to come out with the issuance authorizing the Food and Drug Administration ( FDA) to grant emergency use authorization ( EUA) to the said vaccines “through the process of reliance and recognition.”
“It will cut down the processing time [for the approval of Covid-19 vaccines] from six months to just 21 days,” Duque told Duterte during his public address on Tuesday evening.
He explained the process of “reliance” wherein FDA will rely on the evaluations done by regulatory authorities of other government to vet the efficacy of vaccine.
As for “recognition,” he said it is the routine “acceptance” of FDA of the regulatory decision of other countries.
The health chief, however, clarified that the granting of EUA must comply with several conditions.
These include that there is a medical health emergency number; serious or life-threatening disease; there is proof that a product may be effective to prevent to diagnose, or treat the disease; there is positive risk-benefit balance; and there is no adequate or approved at available alternative for it.
“FDA will conduct a stringent post marketing surveillance activities and the EUA can be revised or revoked by FDA if necessary to protect public health,” Duque said.
Chief Implementer of the government’s national policy on Covid-19 and vaccine czar Carlito Galvez endorsed the said recommendation from DOH.
Higher target
GALVEZ said FDA was already able to rank the 17 possible sources of vaccines to be purchased by the government for its planned mass Covid-19 immunization drive next year.
He said if the government is able to finalize which vaccines it will buy and sign the necessary advance procurement agreement in the coming weeks, they may be able to secure the financing for the purchase before the end of the year.
“So our recommendation is we enter into advance market commitment through multilateral arrangement with the World Bank and ADB [Asian Development Bank] as our finance manager,” Galvez said.