FDA prepares for clinical trials on six COVID-19 vaccine candidates

Marje Pelayo   •   July 30, 2020   •   383

MANILA, Philippines – The Food and Drug Administration (FDA) is set to launch the clinical trials on six drugs that are candidates for the treatment of coronavirus disease (COVID-19).

According to FDA Director General Eric Domingo, the selected drugs are based on the updates from the Department of Science and Technology (DOST), the agency that has been helping the FDA in searching for a potential vaccine for COVID-19.

The FDA, however, has not disclosed the details on the six candidate vaccines.

In addition to these, Domingo said the Philippines is now preparing to join the Phase 3 Clinical Trials together with other participating countries.

“Posibleng mag-apply at magsasagawa ng Phase 3 Clinical Trials on candidate COVID-19 vaccines sa bansa [We may apply and conduct a Phase 3 Clinical trials on candidate COVID-19 vaccines here in the country],” Domingo said. 

“Pinag-uusapan na rin ang pakikilahok ng Pilipinas sa gagawing Solidarity Vaccine Trials ng World Health Organization [There are also discussions on the participation of the Philippines in the upcoming Solidarity Vaccine Trials by the World Health Organization],” he added. 

Five of the 166 COVID-19 candidate vaccines that are already in the Phase 3 Clinical Trials include:

  • Sinovac
  • Sinopharm- Wuhan Institute of Biological Products
  • Sinopharm- Beijing Institute of Biological Products 
  • Astrazeneca- University of Oxford 
  • Moderna/ NIAD

The FDA clarified that though the agency is not involved in the clinical trials, it is the one that regulates the clinical products such as vaccines for public use.

Kapag napatunayan na ligtas at epektibo ang mga produktong ito, puwede na silang mag-apply for registration sa FDA upang maging available ang mga ito sa merkado,” Domingo explained.

[Once a product is proven safe and effective, the owner may apply for registration to the FDA so it may be available to the market.]

In his state of the nation address, President Rodrigo Duterte mentioned that a vaccine for COVID-19 may soon be out specifically by September this year. 

The FDA clarified, however, that developing a vaccine may take months to years, not to mention the strong scientific evidence from clinical trials and the effectiveness and safety of the product for human consumption. 

Nonetheless, the FDA is prioritizing the review of a number of applicants for potential vaccine and treatment for COVID-19.

The agency stressed, however, that there is no vaccine or drugs that have been approved yet to be taken by COVID-19 patients.

All drugs that have been selected for trial are still on trial stage and undergoing experts’ evaluation.

“Wala pa pong bakuna kontra COVID-19, kahit saang bansa [There is no vaccine yet for COVID-19 anywhere in the world],” he added.

The official advised the public to report to the agency any anti-COVID product that is being sold online through its email covidresponse@fda.gov.ph or at ereport@fda.gov.ph.

“Ipakita ninyo po sa amin. Ipadala ninyo po sa amin ang mga detalye at bahala po ang mga ahente namin na manghuhuli dahil mga manloloko po iyan [Show us the product. Send the details to us and our agents will track them and process their arrest because those are fraudulent],” Domingo stressed. –MNP (with reports from Aiko Miguel)

Tourism Dept., may paalala sa mga magbabakasyon sa Boracay

Robie de Guzman   •   October 1, 2020

MANILA, Philippines – Muli nang binuksan ngayong araw ang isla ng Boracay para sa mga turista matapos ang mahigit anim na buwang pagsasara bunsod ng coronavirus disease (COVID-19) pandemic.

Ibig sabihin, maaari nang bumisita sa isla ang mga nais mag-bakasyon. Ngunit paalala ng Department of Tourism (DOT), may mga requirement na kailangang sundin.

Batay sa ibinabang panuntunan ng DOT, ang mga magbabakasyon sa Boracay ay obligadong sumailalim sa RT-PCR test para sa COVID-19, at ipakita ang dokumentong nagpapatunay na negatibo sila sa virus dalawa hanggang tatlong araw bago ang petsa ng kanilang biyahe.

Habang hinihintay ang resulta ng test, dapat ding sumailalim sa quarantine ang pasahero hanggang sa araw ng kanilang biyahe.

Sinabi rin ni Tourism Secretary Bernadette Romulo-Puyat na kailangang may kumpirmadong booking ang pasahero sa alinman sa 200 accredited hotels sa Boracay.

“Pwede ngang galing sa NCR at saka no age restrictions. Of course, ang importante pala, kailangan naka-book ka sa isang hotel. Lahat ng hotel doon dapat DOT-accredited hotel kasi ‘yon ay pumasa sa health and safety protocols ng DOT,” ang wika ni Romulo-Puyat.

Payo ng kalihim sa mga biyahero, alamin sa website ng DOT ang iba pang requirement bago sila magbiyahe upang maiwasan ang aberya.

Kasabay ng pagbubukas ng turismo sa isla ay ibinalik na rin ang biyahe ng mga eroplano patungong Boracay.

Dalawa hanggang tatlong flight schedules kada linggo ang inilaan ng Philippine Airlines, Cebu Pacific at Air Asia.

Ayon kay Michelle Lim, ang Corporate Communications Specialist ng Cebu Pacific Air, kakaunti lang ang bumiyahe pa-Boracay ngayong araw ngunit inaasahan na nila ito lalo’t marami ang nangangamba sa kanilang kaligtasan sa gitna ng pandemiya.

“The flight was about, it had about 10 percent of the seats occupied. The load kasi are building pa at the moment. In the next few weeks or months, as more people are inspired to travel as well and are assured that everything is safe and everything is all set for them, then it would encourage them to go out and travel,” ang pahayag ni Lim.

Paalala rin ng mga otoridad na mahigpit pa ring ipinatutupad ang health protocols gaya ng pagsusuot ng face mask at face shield, physical distancing at minimum contact upang maiwasan ang pagkalat ng COVID-19.

Nanawagan rin ang airline companies sa mga pasahero na alamin ang updated travel restrictions at regulations na inilalatag ng pamahalaan sa gitna ng nararanasang krisis. – RRD (mula sa ulat ni Correspondent Asher Cadapan Jr.)

QC requires helmets for bike-riding public

Aileen Cerrudo   •   October 1, 2020

Under the new normal, the Quezon City government is requiring bicycle riders to wear helmets while traversing roads in the city.

Mayor Joy Belmonte approved Ordinance No. SP-2942 to further encourage bike-riders to wear helmets as protection, especially with more people traveling by bicycle.

“Ngayong bahagi na ng new normal ang pagbibisikleta, nais nating gawing mas ligtas ang aktibidad na ito para sa mga dumadaan sa ating lungsod, (Since biking is part of the new normal, we want this activity to be safe for everyone travelling in our city),” she said.

The ordinance sets penalties imposing fines of P1,000, P3,000 and P5,000 for the first, second and third offense, respectively.

Belmonte recently initiated the implementation of a Bike Lane Project to provide a safe place for people who have shifted to biking as an alternative means of transportation amid the community quarantine. AAC

Cavite gov’t to allow visits to cemeteries until Oct. 27

Robie de Guzman   •   October 1, 2020

The provincial government of Cavite on Thursday announced that it will allow visits to cemeteries from October 1 to 27 but laid down some rules for those planning to do so to prevent the spread of novel coronavirus disease (COVID-19)

In a Facebook post, Cavite Governor Jonvic Remulla said the cemeteries in the province are open during said period from 9 a.m. to 7 p.m. but will be closed from October 28 to November 2 as agreed by local authorities.

He also warned visitors that eating meals and drinking alcoholic beverages inside the cemeteries are prohibited. Videokes and selling of food are also not allowed.

“Bawal po ang kainan kahit sa mga pribado at sosyal na libingan. Mga alta, matutong makisama. Kung bawal ang kainan, lalong bawal ang inuman at lasingan,” Remulla said.

“Bawal maglako ng mga pagkain at inumin sa sementeryo,” he added.

The governor said the municipal and city government will also issue regulations on the number of persons allowed to enter the cemeteries in their respective areas.

He stressed that visitors should strictly observe health protocols including the wearing of face mask and face shield.

“Kailangan naka-face mask at face shield. Mag-ingat lamang sa mga aksidente lalo na sa pagsindi ng kandila dahil ang face shield ay gawa sa plastic,” Remulla said.

He likewise emphasized that those below 18 years of age are not allowed to go to cemeteries.

“Ang mga bata below 18 years old ay bawal pumunta sa sementeryo. Alam ko na mahirap ito pero mas malakas mahawa at magkalat ng sakit ang mga kabataan kaysa matatanda,” Remulla explained.

“Dahil sa pandemya, ay kailangan pa rin nating paulit-ulit na ipaalala ang social distancing rules. Lagpas 10,000 na ang positibo sa COVID dito sa Cavite at malakas ang kutob ko na baka lalong kumalat ang sakit na ito ngayong papalapit na undas,” he added.

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