FDA OKs Covovax COVID-19 vaccine for emergency use

Robie de Guzman   •   November 17, 2021   •   194

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.

Aplikasyon para sa 2 brand ng COVID-19 self-test kits, pinoproseso na – FDA

Robie de Guzman   •   January 11, 2022

MANILA, Philippines – Sinisimulan na ng Food and Drug Administration (FDA) ang pagproseso sa aplikasyon ng dalawang brand ng COVID-19 self-test kits.

Ayon kay FDA director general Oscar Guiterrez, sinusuri na ng ahensiya ang mga aplikasyon para sa paglalabas ng special certification

“Dalawa po ang ini-evaluate ng FDA sa ngayon. Na-endorse na po ito kahapon sa RITM para sa technical validation. Once matapos po ng RITM, pwede na po mabigyan ng FDA ng special certification,” ani Gutierrez.

Habang wala pang aprubadong COVID-19 home test kits sa bansa, nagpaalala ang Department of Trade and Industry (DTI) sa publiko na mag-ingat sa mga ibinibentang COVID-19 home test kits online.

Ayon kay DTI Assistant Secretary Ann Claire Cabochan, hindi dapat tangkilikin ang mga ‘di rehistradong self-administered tesing kits dahil hindi tiyak kung ligtas itong gamitin o kung dumaan sa pagsusuri ng mga eksperto.

“Doon sa mga self-test kits na alam ko din na naging very in demand as of this time, of course, that has not been given the proper certification from the Food and Drug Administration to be sold here in the Philippines kaya hindi siya talaga dapat ibinebenta,” ani Cabochan.

Babala ng opisyal, maaaring maharap sa reklamo ang sinomang nagbebenta ng hindi rehistradong self-test kits sa bansa.

pwede nating habulin yung mga nagbebenta n’yan online for as long as this is not certified as legitimate to be sold in the Philippines,” ani Cabochan. (mula sa ulat ni Correspondent Joan Nano)

PH FDA says application for certification of self-administered COVID test kits now open

Robie de Guzman   •   January 7, 2022

MANILA, Philippines – The Food and Drug Administration (FDA) announced it has opened the applications for the certification of home test kits for COVID-19 amid the demand for testing due to the growing infection rate.

“I am calling po all the manufacturers and even the importers of self-administered COVID-19 test kits that — to register their product in a form of special certification,” Dr. Oscar Gutierrez Jr., FDA OIC director general, said during President Rodrigo Duterte’s Talk to the People on Thursday.

Gutierrez said they have already met with the Department of Health (DOH) for the issuance of the guidelines on the use of these self-administered kits and how people who use them can report the results.

 “We already met with the DOH and they will be coming out with an algorithm actually a guideline or policy on the use of these home test kits considering that these products need to be administered by the patient or the household themselves,” he said.

“Kailangan po natin ng guidelines on the use, reporting system, even disposal of the waste, interpretation of the test results, and what actions should the individual take when he finds out that he is positive,” he added.

Gutierrez said self-administered test kits will get samples from individuals orally or through the mouth, and nasally or through the nose.

All the antigen test kits currently approved by the FDA are only administered by laboratories and healthcare professionals.

The DOH earlier reiterated the proper use of antigen test kits at the right time for more accurate test results. The agency said antigen test is better used to check symptomatic persons for COVID-19 infection.

Limitasyon sa galaw ng ‘di bakunado vs COVID-19, isinusulong ipatupad sa buong bansa

Robie de Guzman   •   January 5, 2022

MANILA, Philippines – Inirerekomenda ni testing czar at presidential adviser for COVID-19 response Vince Dizon na ipatupad sa buong bansa ang pagbabawal sa mga hindi pa bakunado laban sa COVID-19 na pumunta sa mga pampublikong lugar.

Sa gitna ito ng bumibilis na namang pagtaas ng kaso sa bansa at local transmission ng Omicron variant.

“Mr. President, nag-usap na po kami ni Secretary Año, ni Secretary Duque, Secretary Galvez, Secretary Lorenzana na we are recommending that this policy in NCR also be adopted by the entire country even in areas po na hindi pa nagsu-surge dahil alam naman po natin it is really just a matter of time na itong Omicron ay kumalat na sa buong bansa,” ang wika ni Dizon sa pagpupulong ng mga opisyal ng Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF-MEID) kay Pangulong Rodrigo Duterte noong Martes.

Ang rekomedasyon ay batay aniya sa mga ginagawang paghihigpit sa mga bansang nakararanas na ng case surge ng Omicron variant.

“Kung titingnan po natin ang ibang bansa, countries all over the world are restricting the exposure of the unvaccinated. Sa France po, they are cracking down on unvaccinated; Germany, they are locking down unvaccinated people; and even in South Korea po they are now imposing new vaccine passes  para po ano  i-restrict ‘yung movement ng mga unvaccinated,” paliwanag ni Dizon.

Nakatakdang pag-usapan ng IATF ang panukalang ito sa kanilang pagpupulong sa Huwebes.

Ang paglilimita sa galaw ng mga hindi pa bakunado kontra COVID-19 ay una nang iminungkahi ng Metro Manila Council sa pamamagitan ng isang resolusyon.

Ang naturang resolusyon ay in-adopt na rin ng Regional Task Force against COVID-19 ng CALABARZON na naghihikayat sa lahat ng local task forces sa rehiyon na magpatupad na rin ng limitasyon sa paggalaw ng mga di pa bakunado sa nasasakupang probinsya.

Sa kasalukuyan, 65.63 percent na ng target population ang fully vaccinated at 79.42 percent ang nakatanggap ng at least isang dose ng bakuna. (mula sa ulat ni Correspondent Rosalie Coz)

 

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