Health Secretary Francisco Duque III has proposed the emergency use of coronavirus vaccines once they arrive in the country to hasten the processing of their regulatory approval.
In a meeting on the government’s pandemic response Tuesday night, Duque asked President Duterte to allow the Food And Drug Administration (FDA) to issue the emergency use authorization (EUA) for vaccines, medicines, and technologies to fight the spread of the new coronavirus disease.
EUAs are applied to justify the use of certain medical products during a public health emergency to diagnose, treat, or prevent life-threatening disease or condition.
“We are respectfully requesting that you consider the issuance of an executive order for FDA to grant an Emergency Use Authorization for the various vaccines that will enter the country and for which applications are to be filed,” Duque said in a report to the President.
“Para mabilis po ito, it will cut the processing time from six months to about 21 days, Mr. President. So it will cut the red tape and, again, that is for your consideration,” he added.
Duque said the EUA will facilitate the approval of medical products and technologies during the pandemic through the process of “reliance and recognition.”
He said reliance refers to the FDA’s trust in the evaluation made by other national regulatory authorities abroad in deciding on a medical product’s application in the country. Recognition, on the other hand, is FDA’s routine acceptance of the regulatory decision of the other regulatory authorities or trusted institutions.
Duque explained that EUA is used when there is a medical health emergency, a serious or life-threatening disease, proof that the product may be effective to prevent, diagnose, or treat a disease, positive risk/benefit balance, and when there is no adequate or approved alternative available.
“Ang FDA ay mariin na magsasagawa po ng post-marketing surveillance activities at ang EUA maaaring i-revise or i-revoke ng FDA kung kinakailangan upang maprotektahan ang kalusugan (The FDA will conduct post-marketing surveillance activities and may revise or revoke the EUA if needed to protect public health),” he said.
In the same meeting with the President, vaccine czar Carlito Galvez Jr. backed Duque’s proposal for the issuance of the emergency use of coronavirus vaccines in the country.
Galvez, chief implementer of the government’s action plan to combat the pandemic, said the country could be assured of 30 million to 50 million doses by next year. “Pagka nag-roll out po ang ibang bansa (Once other countries roll out the vaccines), we can also have our rollout here,” he told the President.
He said the country has 17 possible sources of coronavirus vaccines abroad. Of the 17 potential vaccines, Galvez said nine products are undergoing phase three clinical trials. On the last stage of clinical studies, three potential vaccines will undergo trials in the country this December and January.
Galvez also recommended that the government should take the “advance market commitment” by the end of the year through the multilateral arrangement with the World Bank and Asian Development Bank as finance managers.
“At the same time, we also have to have various modes of financing including Private-Public Tripartite Agreement without the cost with the government,” he said.
Galvez said the private sector also intends to buy supplies directly from the vaccine company but subject to the regulation of the health department. “The DOH will be the one who will know, who will decide where the vaccine will be given,” he said.