FDA warns against purchase, use of AiDeLai face masks

Marje Pelayo   •   January 15, 2021   •   420

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

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Duterte ‘puzzled’ over FDA advice on Sinovac use for health workers – Palace

Robie de Guzman   •   February 24, 2021

MANILA, Philippines – President Rodrigo Duterte was perplexed by the recommendation of the Food and Drug Administration (FDA) not to use the Sinovac COVID-19 vaccine on health workers who are frequently exposed to patients with coronavirus disease (COVID-19), Malacañang said Wednesday.

Presidential Spokesperson Harry Roque said the president has asked FDA Director-General Eric Domingo to explain such recommendation after the agency’s issuance of an emergency use authorization (EUA) to Sinovac.

“Si president po mismo, nagtataka bakit nga ganuon nga ang naging EUA ng FDA at pinatawag po talaga si Dr. Domingo ng huling cabinet meeting… Naiparating ng president ang pagtataka kung bakit may ganitong colatilla,” Roque said.

Domingo explained that the vaccine’s efficacy rate on healthcare workers is 50.4% based on Sinovac’s clinical trials conducted in Brazil, making it not the best vaccine suited for healthcare workers treating coronavirus patients.

The FDA chief, however, stressed that this is only a recommendation and healthcare workers are not prohibited from receiving Sinovac if they chose to.

“Nirerespeto po ni president ang mga opinion ng mga experts kaya let the colatilla remain,” Roque said. – RRD (with details from Correspondent Rosalie Coz)

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

Philippines approves emergency use of Pfizer-BioNTech’s COVID-19 vaccine

Marje Pelayo   •   January 14, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) on Thursday (January 14) granted emergency use authorization (EUA) for the coronavirus disease (COVID-19) vaccine developed by US pharmaceutical giant Pfizer Inc. and its German partner BioNTech SE.

The approval followed issuance of Executive Order No. 121 s. 2020, which grants vaccines under development an EUA “where there is no adequate, approved and available alternative to a vaccine for preventing COVID-19 during this present public health emergency.” 

The FDA clarified, however, that the EUA does not mean that the vaccine would be available for use as the country has yet to settle an agreement for its supply.

“The granting of the EUA is not a marketing authorization or a Certificate of Product Registration, hence this cannot be used to market the vaccine commercially,” the FDA explained.

Pfizer-BioNTech’s COVID-19 vaccine, which boasts a 95% efficacy rate, is expected to arrive in the country by February according to vaccine czar Carlito Galvez Jr., in a meeting with President Rodrigo Duterte on Wednesday evening (January 13).

“After a thorough review of the currently available data by medical and regulatory experts, the FDA is granting Emergency Use Authorization to Pfizer-BioNTech COVID-19 vaccine,” Director General Eric Domingo said.

“The interim data from the ongoing phase 3 trial shows that the vaccine has an efficacy of 95% in the study population and at least 92% among all racial groups,” he added.

Domingo noted the adverse events that happened in other countries following the inoculation of the vaccine. 

Thus, he said, close monitoring of the COVID-19 immunization programs is necessary to ensure adverse reactions will be properly addressed.

“The roll out of the vaccine and use in more than five million people worldwide has identified severe allergic reaction in a few individuals,” Domingo said.

“Therefore, the vaccinations must be done by health professionals trained to recognize and manage adverse reactions and they should have resources at hand to adequately respond,” he added.

The FDA noted also that reporting of the patient’s response to the vaccine shall be through the pharmacovigilance system that will be activated once the vaccination program is implemented.

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