FDA to allow use of Pfizer COVID-19 vaccines for 12 to 15 age group

Maris Federez   •   May 27, 2021   •   348

MANILA, Philippines — The Food and Drug Administration (FDA) said it is looking into the possibility of using American-made Pfizer-BioNTech COVID-19 vaccine on children aged 12 to 15, FDA director-general Eric Domingo said on Wednesday.

In the pre-recorded briefing with President Rodrigo Duterte, Domingo said that on May 20, the FDA received an application for amendment from Pfizer to include children aged 12 to 15 in the emergency use authorization for its COVID-19 vaccine.

He said that Pfizer had sought and received the approval of the US FDA of the said amendment and has started using the vaccine for the said age group.

“Ang atin pong mga experts, in-evaluate. In fact, early this evening, I already got the recommendations of our experts and it’s very favorable,” Domingo said.

“Within the week po we will be issuing an amendment to the emergency use authorization (EUA) of Pfizer and we will be able to use it in children of 12 to 15 years old,” he added.

Domingo also reported that, worldwide, there are 16 vaccines that have already secured emergency use authorization, including two new COVID-19 vaccines from China and Kazakhstan.

In the Philippines, he said, seven vaccines are currently being used under the EUA.

Domingo assured that experts are strictly monitoring the development of all the vaccines worldwide, saying that the real-world data that they receive are very encouraging.

“So ang ginagawa po natin. Binabantayan po natin yan nang masusi, ng DOH at FDA to make sure that every time we get any new information, we check all the adverse events and we make sure that the benefit definitely outweighs the known and potential risk of any vaccine,” he said. —/mbmf

Philippines grants emergency use for antiviral pill molnupiravir

Robie de Guzman   •   December 23, 2021

MANILA, Philippines – The Philippine Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Molnarz, a brand of the antiviral pill molnupiravir.

FDA director-general Eric Domingo said the EUA will allow the drug to be administered to patients with mild to moderate COVID-19 symptoms.

“Ito po ay pinapayagan nating ibigay sa mga with mild to moderate COVID disease, so hindi po ito pwede sa mga severe o sa mga nangangailangan ng mga oxygen,” Domingo said.

“Ito po pwedeng ibigay sa mga adult 18 years old and above na positive for COVID-19 and meron pong risk factors for developing severe illness katulad po ng mga senior citizens o mga may comorbidities,” he added.

Domingo said the pill is not recommended to be given to pregnant and lactating women.

“Hindi po siya pwedeng gamitin sa mga buntis o sa mga maaaring mabuntis na hindi gumagamit ng contraception at sa mga lactating women, dahil kulang pa ang datos natin para masabi na safe siya sa grupong ito,” he said.

Domingo said the guidelines on the use and distribution of molnupiravir based on the administrative order on drugs granted EUA in the Philippines will be issued by the Department of Health.

Following the approval of the antiviral pill, the FDA said it will stop issuing compassionate special permits but hospitals with remaining stocks of molnupiravir may still use them. (with details from Correspondent Aiko Miguel)

EUA ng Pfizer COVID-19 vaccine para sa mga batang may edad 5-11, aprubado na ng FDA

Robie de Guzman   •   December 23, 2021

MANILA, Philippines – Inaprubahan na ng Food and Drug Administration (FDA) ang emergency use authorization (EUA) ng Pfizer COVID-19 vaccines para sa mga batang may edad lima hanggang 11.

Naghain ng aplikasyon noong Nobyembre ang Pfizer para sa EUA nito upang magamit ang kanilang bakuna sa mas nakababatang populasyon.

Ang Pfizer COVID-19 vaccines ay ginagamit na para sa mga batang may edad 5 hanggang 11 sa Estados Unidos, Canada at sa Europa.

Ayon kay FDA director general Eric Domingo, mataas ang lumabas na efficacy rate ng Pfizer vaccine batay sa isinagawang clinical trials para sa mga bata.

“Above 90 percent sa mga batang five to 11 years old and at the same time ayun pong nakitang adverse events doon sa clinical trial ay very mild lang po katulad ng ibang bakuna na natatanggap ng mga bata — so konting, siguro — may sinisinat, konting pananakit sa area ng injection pero wala pong nakitang any unusual or important safety signals para hindi natin ibigay itong EUA,” ani Domingo.

Paliwanag pa ng opisyal, kailangan ng bagong EUA upang makabili ng bagong supply dahil iba ang ibibigay na bakuna para sa mga bata kumpara sa mga matatanda.

Inaasahang masisimulan ang rollout nito sa bansa pagpasok ng taong 2022.

“Hindi po siya kapareho nung dosage na binibigay sa adult. Ito po ay mas mababang dosage at hindi lang iyon, yung concentration ng vaccine ay mas mababa din po kesa doon sa ginagamit sa adults ngayon,” ani Domingo.

Pagtitiyak ng FDA, dumaan sa mabusising pag-aaral ang mga bakuna kaya ligtas itong gamitin para sa mga bata.

Hinimok din ng ahensya ang mga magulang na pabakunahan ang kanilang mga anak upang mabigyan sila ng proteksyon laban sa COVID-19 infection. (mula sa ulat ni Correspondent Aiko Miguel)

FDA OKs Covovax COVID-19 vaccine for emergency use

Robie de Guzman   •   November 17, 2021

MANILA, Philippines – The Food and Drug Administration (FDA) on Wednesday said it has approved the emergency use authorization (EUA) application of the Covovax COVID-19 vaccine.

In a public briefing, FDA director general Eric Domingo said the vaccine brand has been approved for the active immunization of individuals aged 18 years old and above.

The vaccine will be given in two doses with an interval of at least three to four weeks. It was made by Serum Institute of India Private Limited.

Domingo said that clinical trials showed that the vaccine showed “very mild” adverse effects and has an efficacy rate of about 89.7% in preventing COVID-19.

The FDA chief said Covovax is a new kind of vaccine that makes use of the protein subunit platform. This means that the vaccine replicates the pure antigenic part of the virus to elicit immune response.

The vaccine may possibly be used in the country toward the end of the year to 2022, he added.

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