EUA on Pfizer vaccine won’t be revoked yet despite Norway deaths, DOH says

Robie de Guzman   •   January 18, 2021   •   887

MANILA, Philippines — The emergency use authorization (EUA) issued last week by the Food and Drug Administration (FDA) to drug-maker Pfizer-BioNTech for its COVID-19 vaccine will not be revoked yet pending an investigation into claims that it caused the death of some elderly people in Norway, the Department of Health (DOH) said Monday.

Health Undersecretary Maria Rosario Vergeire said Norwegian authorities are still looking into reports that 23 individuals aged 75 to 80 with underlying health conditions died after getting inoculated with COVID-19 vaccine developed by Pfizer-BioNTech.

Vergeire also said that studies need to be done on the matter.

“Pfizer has to submit a report to the Philippine Food And Drug Administration regarding this matter. Once we evaluate the report, base sa kanilang conclusion, that’s the time FDA can decide on the EUA of Pfizer. For now,” Vergeire said.

“Hanggang wala pang sufficient evidence that it was caused by vaccines, status quo tayo on this EUA given to Pfizer,” she added.

The FDA granted EUA to Pfizer last January 14, the first out of four applications it received so far. Other applications are AstraZeneca, China’s Sinovac, and Russia’s Gamaleya Institute.

FDA Director-General Eric Domingo said they are still awaiting a report from Norwegian authorities and that they will “revise the conditions of the EUA as needed,” before starting vaccinations as part of the agency’s protocols on the use of vaccines.

Health authorities also reiterated that COVID-19 vaccines will go through stringent evaluation before it can be approved for use in the country.

“Aside from the safety, and the efficacy na meron ang mga bakuna na papasok, titingnan din nila iyon pong social impact nito, titingnan nila ang affordability and titingnan nila sa response ng equity,” Vergeire said.

“They will be evaluating and then they give their recommendation to the Secretary. Kapag positive ang recommendation, we can procure the specific vaccine,” she added. – RRD (with details from Correspondent Aiko Miguel)

PH records 3 more deaths among patients with COVID-19 Omicron variant

Robie de Guzman   •   January 26, 2022

 

MANILA, Philippines – Three more deaths among patients who contracted the COVID-19 Omicron variant  were recorded in the country, the Department of Health (DOH) said Wednesday.

In a message to reporters, Health Undersecretary Maria Rosario Vergeire said the additional fatalities were elderly and all had underlying medical conditions.

The new fatalities raised the number of deaths from the Omicron variant to five.

“Three are seniors and all have comorbidities. One partially vaccinated, one unvaccinated, and the remaining three are still for verification,” Vergeire said.

The DOH earlier said that the highly transmissible Omicron variant is now predominant in Metro Manila and other areas, with its sub-variants BA.1 and BA.2 detected in the country.

The agency also stressed that while the Omicron variant mostly presents with asymptomatic and mild disease, data showed that the elderly, those with comorbidities, and unvaccinated are still most at risk for fatalities.

The first two deaths linked to the Omicron variant were also senior citizens with co-morbidities and unvaccinated against COVID-19.

The DOH said there are 535 confirmed Omicron variant cases in the country.

Self-test kits na aprubado ng FDA, mabibili lang sa mga otorisadong drug outlets – DOH

Robie de Guzman   •   January 25, 2022

MANILA, Philippines – Maaari nang mabili sa mga lisensiyado at aprubadong drug outlets ang dalawang brand ng COVID-19 Antigen Self-test kits, ayon sa Department of Health (DOH).

Ito ay matapos aprubahan ng Food and Drug Administration (FDA) ang aplikasyon ng special certification ng dalawang kumpanya para sa self-test kits na tinatawag na Abbot’s Panbio at Labnovation Technologies SARS-CoV2 Antigen rapid test.

Una nang iniulat ni FDA officer in charge Oscar Gutierrez na nabigyan na ng sertipikasyon ang dalawang brand at maaari nang gamitin sa bansa.

“Ang Panbio COVID-19 antigen self-test kit ng Abbot available po siya sa 1, 4, 10, and 20 tests per box. At yung SARS-CoV-2- antigen rapid test ng Labnovation Technologies Incorporated ito po ay self-test for home use din. Available po siya ng 2,5, and 20 tests per box,” ani Gutierrez.

Pero paalala ng Department of Health na may tamang proseso at panahon ang paggamit ng self-test kits upang masegurong tama ang ilalabas nitong resulta.

Ayon kay Health Undersecretary Maria Rosario Vergeire, mas mainam gamitin ang self-test kits kung may sintomas ang isang tao upang matiyak na accurate ang resulta ng kit.

“Please use it rationally, use it at the right time at tamang proseso. Ibig sabihin gagamit lang po kayo ng test kapag kayo ay nakakaramdam ng sintomas dahil ang antigen test po ay most accurate pa rin kapag kayo po ay nakakaranas ng sintomas dulot ng COVID-19,” ani Vergeire.

Ang panawagan naman ng Infectious Diseases expert na si Dr. Rontgene Solante, bigyang-prayoridad sa paggamit ng test kit ang mga may sintomas at nasa vulnerable population gaya ng mga matatanda upang agad malaman ang kanilang kondisyon at malapatan ng karampatang lunas.

“I-prioritize natin ang paggamit nitong antigen test doon sa mga may symptoms at vulnerable population. Bakit? Because these are the population that are kailangan na kung mag-positive meron tayong gamot na mga anti-viral or monoclonal antibodies para hindi po lalala ang mga infections nila to severe COVID at hindi sila maho-hospitalize,” ani Solante.

May pagkakaiba rin ang Antigen self-test kits sa rapid test kits na kalimitang ginagamit sa mga ospital at laboratory kaya payo ng DOH sa publiko na basahing mabuti ang instructional manual na nakapaloob sa bibilihing test kits.

“Ang kaibahan nito ay iyong pong specimen na kinokolekta. Ito pong mga self-administered test kits usually would have nasal specimens po ang kinukuha. Ibig sabihin kapag nasal specimen, di ganun kalalim sa inyong ilong ang pagkuha ng specimen for this test kits compared doon sa current na kailangan na guided siya ng health worker at mas malalim ang kinukuhang specimens para rito,” ang paliwanag ni Vergeire.

Paalala rin ng DOH na ang self-test kits ay available lamang sa mga otorisadong botika at hindi maaaring bilhin online.

“Bumili lamang ng self-administered test kits na aprubado nf FDA o galing po sa mga FDA-licensed drug outlets para lagi po tayong makakasiguro ana ito ay ligtas at lagi po tayong makakaseguro na makakapagbigya ng accurate na resulta,” ani Vergeire.

Paalala rin ng DOH sa publiko na i-check ang expiration date ng self-test kits at itago ang opisyal na resibo ng botikang pinagbilhan nito.

Sa ngayon ay isinasapinal na ng DOH ang guidelines, kaakibat ang evaluation ng Research Institute for Tropical Medicine at FDA hinggil sa COVID-19 self-test kits.

“Ang kagawaran namn po ng kalusugan are on our final stages dito po sa pagssusulat ng polisiya at guidelines kung paano natin gagamitin ito sa mercado,” ani Vergeire.

“Siguro po within the week makakapaglabas na tayo nitong guidelines natin,” dagdag pa niya.

FDA grants special certification to two self-antigen test kit brands

Maris Federez   •   January 25, 2022

MANILA, Philippines — The Food and Drug Administration (FDA) announced Monday (January 24) that it has given its nod to two brands of self-administered COVID-19 antigen test kits.

During President Rodrigo Duterte’s pre-recorded Talk to the Nation, FDA Officer-in-Charge Oscar Gutierrez said it has granted special certification to Panbio COVID-19 Antigen Self-Test by Abbot Laboratories, and to SARS-Cov-2 Antigen Rapid Test from Labnovation Technologies, Inc.

Panbio COVID-19 Antigen Self-Test kit will be available in 1, 4, 10, or 20 tests per box, while SARS-Cov-2 Antigen Rapid Test will be available in 2, 5, or 20 tests per box.

Gutierrez also confirmed Duterte’s earlier announcement that they have pulled out around 86 antigen test kits from the local market.

“Hindi nila na-meet ang RITM (Research Institute for Tropical Medicine) performance validation habang mayron silang special certification o ‘di kaya ‘di po sila rehistrado, authorized o kaya sinurender ng special certification holder ‘yong kanilang certification,” he said.

Gutierrez added that the agency was able to seize around 50,000 test kits and 70,000 boxes of fake medicine and antigen tests in Manila last week.

Gutierrez said the FDA continues to monitor a product, such as the self-test kit, that has been given special certification even after it reaches the market.

He said FDA operatives collect samples and send them back to the RITM to test them for actual use.

The Research Institute for Tropical Medicine is the office mandated to do performance validation of testing kits.

Gutierrez added that as of January 18, they have already received 11 applications from manufacturers.

He said the special certification will be issued for self-test kits to make them accessible and available to the public for home and individual use. —/mbmf (with details from UNTV Correspondent Nel Maribojoc)

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