DOH agrees with FDA decision to ban Dengvaxia in Phl

Maris Federez   •   August 22, 2019   •   1242

A Filipino nurse prepares to administer an anti-dengue vaccine during a nationwide vaccination at a school in the flood-prone city of Marikina, east of Manila, Philippines, 04 April 2016. (Photoville International / FILE)

The Department of Health (DOH) has rejected the request of Sanofi Pasteur to overturn the decision of the Food and Drug Administration (FDA) to ban the use of Dengvaxia vaccine in the Philippines.

With this, the DOH approved the ruling of the FDA to permanently revoke the certificate of product registration of Dengvaxia for Sanofi’s failure to submit the necessary post-approval requirements.

“The decision concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety,” DOH Secretary Francisco Duque III said in a statement.

Although Sanofi was able to submit the first two versions of its risk management plans (RMP), the pharmaceutical company failed to submit the third and final version of the plan.

The DOH said, however, that Sanofi may apply for a new certificate of product registration (CPR) for Dengvaxia but this must be in accordance with the FDA regulations.

“Given that Dengvaxia is an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety,” the statement added.

Meanwhile, the department has assured that it continues to address the increasing cases of dengue in the country. /mbmf

FDA clarifies donated vaccines require authorization, evaluation

Marje Pelayo   •   January 21, 2021

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

Gordon files bill to expand country’s pool of vaccinators

Aileen Cerrudo   •   January 21, 2021

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

FDA warns against purchase, use of AiDeLai face masks

Marje Pelayo   •   January 15, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) on Friday (January 15) warned against the purchase and use of AiDeLai face masks.

In an advisory dated January 8, the FDA said it cannot guarantee the safety and quality of the popular face mask brand because it has not gone through the agency’s evaluation process.

The regulator also warned establishments not to distribute, advertise, or sell the medical product until Product Notification Certificate is issued.

“Otherwise, regulatory actions and sanctions shall be strictly pursued,” the FDA mentioned.

The agency urges the public to always check certain products on their website www.fda.gov.ph before purchasing. MNP / Raymund David

No photo description available.

REACH US

The Philippine Broadcast Hub

UNTV, 915 Barangay Philam,

EDSA, Quezon City M.M. 1104

(+632) 8396-8688 (Tel)

info@untv-newsandrescue.com (General inquiries)

ABOUT UNTV

UNTV is a major TV broadcast network with 24-hour programming. An Ultra High Frequency station with strong brand content that appeal to everyone, UNTV is one of the most trusted and successful Philippine networks that guarantees wholesome and quality viewing experience.