MANILA, Philippines — The Food and Drug Administration (FDA) issued a statement on Wednesday (January 21) clarifying that donated COVID-19 vaccines still require FDA authorization in the form of Emergency Use Authorization (EUA) prior to use.
The statement came after some senators in a recent Senate hearing, raised concerns on the issue of donated vaccines from China.
The FDA said, “Entities which intend to donate vaccines to the government are required to coordinate with the Department of Health (DOH) which will facilitate the acceptance and processing of the donation.”
The agency further noted that the proposed donations will be evaluated by the DOH in consideration to the need of beneficiaries, reliability of the source shelf life and other relevant criteria.
“Only after authorization of the FDA may the DOH distribute the products to the intended beneficiaries,” FDA said.
FDA stressed that “the approval of the donated product does not mean free use thereof. FDA’s authorization is limited to the donated lot and carries conditions for use depending on the nature of the donated product.”
The DOH is also mandated to take full responsibility for the use of the donated vaccines, given that the product has been granted EUA by the FDA which ensures its safety, quality and efficacy. MNP/Raymund David
Manila, Philippines — Senator Richard Gordon has filed a bill seeking to expand the country’s pool of vaccinators for the immunization program of the government.
Gordon, in a statement, said Senate Bill No. 1987 will allow training for other members in the medical field, as well as, non-medical practitioners.
“Since we have a limited number of doctors, nurses, and midwives that will aid in the COVID-19 vaccination program, we filed a bill that expands the pool of vaccinators of the DOH by training other professionals such as dentists, veterinarians, medical technologists, and even those without a medical background to be vaccinators,” he said.
Section 1 of Senate Bill No. 1987 states that non-medical practitioners that will be part of the training will be allowed provided that they will be given the appropriate training, certification and authority by the Department of Health (DOH), and that they will perform their duties under the supervision of a duly registered physician and for a limited period only contingent upon the existence of the national health emergency for which it is called.
Non-medical practitioners will be given appropriate training, certification, and authority by the Department of Health (DOH).
The filed bill also states that the trained individuals will perform their duties under the supervision of a duly registered physician and for a limited period only, subject to the existence of a national health emergency.
“If we expand the manpower for the vaccination program, the government’s target of inoculating 50 to 70 million Filipinos to be able to achieve herd immunity or population immunity can be attained,” Gordon added.
According to the DOH, only 617,239 health care workers from both public and private health institutions will be able to help in administering the COVID-19 vaccines. -AAC
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