Health experts still question Dengvaxia-mass vaccination

UNTV News   •   February 7, 2018   •   3753


MANILA, Philippines – The Senate Blue Ribbon Committee once again questioned the process of procurement of the controversial Dengvaxia vaccines.

For Senate Blue Ribbon Committee chairman, Senator Richard Gordon, there seems to be a manipulation on the procurement of the said vaccines.

The Food and Drug Administration (FDA) and former Health Secretary Janette Garin refuted the allegations.

“I would say that it follows the process po,” FDA Deputy Dir. Gen. for Field regulatory Operations Office Ma. Lourdes Santiago said.

“Because if no CPR (Certificate of Product Registration) is forthcoming, then I will directly inform the president na imposible po ang dengue vaccine (that a dengue vaccine is impossible).” Garin said.

But for some health experts, the mass vaccination of more than 800,000 children is still questionable, as the conduct of such undertaking entails long and thorough preparation.

“I will not take any risk . . . especially on a massive scale,” UP-PGH Dr. Juliet Sio-Aguilar said.

“The patient has the right to know. Hindi nalaman ng tao ‘yan (The public did not know). Prescription based ka, bakit ka magma-mass vaccination (It’s prescription-based, why would you conduct a mass vaccination?),” said health reform advocate, Dr. Anthony Leachon.

On the other hand, health experts believe there is no need to worry for now regarding the effects of Dengavaxia.

“Sa daming kanilang na bakunahan ng Dengvaxia, talagang mayroon at mayroon doon na mga normal diseases that will happen with or without Dengvaxia,” Aguilar said.

( Translation: With the number of people vaccinated with Dengvaxia, there will inevitably be normal diseases that will happen with or without Dengvaxia.)

“Results from the clinical trials . . . in general safe ho,” infectious diseases specialist, Dr. Mary Ann Lansang said.

They said it is premature for them to come up with any conclusion until they have seen the result of the probe conducted by the Dengue Investigative Task Force.

Meanwhile, DOH Secretary Francisco Duque said, the Dengvaxia issue has greatly affected the other government’s Immunization Program.

“And to date, I think it’s down to 57% it’s substantial 30% reduction, that’s truly a cause of concern,” Duque said.

As the hearing rolled on, the Blue Ribbon Committee has issued subpoenas to Public Attorney Office (PAO) Chief Persida Acosta and PAO Forensic Laboratory Director Dr. Erwin Erfe who conducted a separate investigation on the issue.

Some senators are calling for unity on handling the issue to establish an airtight case against the persons involved in the controversy.

“Eh di ba dapat tayo ay magsama-sama, magtulong-tulong? Ang hindi ko maintindihan bakit ayaw nilang makipagtulungan, ano ba ang meron?” said Senate Committee on Health & Demography chairman, Sen. Joseph Victor Ejercito.

(Are we not supposed to work together? I don’t understand why they refuse to cooperate. What’s the reason?)

“Ang ayaw ko lang sa kanila, sinasabi nila Dengvaxia. Hihina ang kaso ng gobyerno kapag sinasabi niyo Dengvaxia tapos wala namang napapatunayan,” Gordon said.

(What I don’t like about them is they keep saying it’s Dengvaxia. The government’s case will weaken if you keep saying Dengvaxia without any proof.)

The Blue Ribbon Committee will set another hearing on the Dengvaxia controversy. – Nel Maribojoc | UNTV News & Rescue

FDA warns against consumption of unregistered Kirkland Signature Vitamin C 1000mg tablet

Marje Pelayo   •   July 15, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) released a warning regarding the consumption of unregistered Kirkland Signature Vitamin C 1000mg tablet.

In an advisory on Facebook, the FDA cited a result of its Post-Marketing Surveillance (PMS) which revealed that the product did not go through the agency’s registration process.

The FDA Philippines said it cannot assure the product’s quality and safety.

The agency also asked for assistance from local government units and law enforcement agencies in ensuring that the product is not being used or sold in the market.

The advisory is addressed to all healthcare professionals and the general public.

Mga doktor, importer at distributor ng ‘di rehistradong bakuna o gamot maaaring maharap sa parusa — FDA

Robie de Guzman   •   July 14, 2021

MANILA, Philippines — Walang anumang pananagutan sa batas ang isang indibidwal na naka-inom o nabigyan ng hindi rehistradong gamot at bakuna, ayon sa Food and Drug Administration (FDA).

Sinabi ni FDA director-general Eric Domingo na tanging ang mga doktor na nagbakuna o nagreseta ng gamot ang maaaring maharap sa reklamo alinsunod sa batas.

“Sa atin po kasing batas, wala pong pananagutan ang mga nakabili ng mga counterfeit na gamot, mga substandard na gamit or nakainom nito, nainiksyunan nito. Sa FDA po, ang meron pong kinakasuhan natin iyong nagbebenta ng unregistered, illegal, falsified, or mga poor quality drugs,” ani Domingo.

Ginawa ng FDA ang pahayag kasunod ng umano’y pagpapaturok ng tig-dalawang dose ng magkaibang brand ng bakuna si San Juan City Representative Ronaldo Zamora.

Una nang sinabi ni Zamora na nagpabakuna ito ng dalawang dose ng Sinopharm at dalawang dose ng Pfizer noong Disyembre.

Bagamat maituturing itong iligal dahil wala pang emergency use authorization mula sa FDA noon ang Sinopharm, ang medical professional na nagbigay o nagturok ng bakuna ang may malaking responsibilidad dito batay sa isinasaad ng batas.

“Ang doctor ay bawal magreseta, mag-ineksyon o magbigay ng gamot na hindi po rehistrado sa FDA. Pagkatapos iyong importer at distributor ay mayroon din pong kaso iyon dahil bawal din po magpasok at magbenta ng gamot na hindi rehistrado,” ani Domingo.

Ayon naman kay San Juan City Mayor Francis Zamora, handa si Cong Zamora na makipagtulungan sa imbestigasyon.

“I’m sure my father will be more than willing to cooperate,” ani Zamora.

“Ako po sa totoo lang nagulat din sa ikinwento niya because as far as I know ang bakunang nakuha niya lamang ay yung dalawang dose ng Pfizer mula sa San Juan. Kaya noong sinabi niya na nakapag-Sinopharm na siya previously, sa totoo lang, nag-aalala ako because as a son, I don’t know if that will affect my father’s health,” dagdag pa niya.

Samantala, muli namang nagpaalala ang Department of Health sa publiko na dalawang dose ng mga aprubadong bakuna at single-dose ng Johnson & Johnson vaccine lamang ang ginagamit sa Pilipinas.

Dapat ring sumunod ang publiko sa vaccination protocol na ipinatutupad ng pamahalaan upang masegurong magiging patas ito at ligtas para sa lahat. – RRD (mula sa ulat ni Correspondent Aiko Miguel)

FDA: Vaccines ‘still very useful’ despite drop in efficacy rate vs COVID-19 variants

Robie de Guzman   •   July 13, 2021

MANILA, Philippines ­– Available vaccines against novel coronavirus disease (COVID-19) are “still very useful’ in helping stem the spread of severe respiratory illness despite a decrease in their efficacy against coronavirus variants, the Food and Drug Administration (FDA) said.

In his report to President Rodrigo Duterte during the taped weekly briefing on Monday night, FDA director general Eric Domingo reiterated that COVID-19 vaccines remain effective despite a slight decrease in their efficacy, particularly against the Alpha and Delta variants.

Citing studies on the efficacy of the vaccines, the FDA chief said the data indicate that the US-made Pfizer vaccine has a high efficacy rate of about 95 percent against the original COVID-causing virus.

Against the Alpha variant, which was first detected in the United Kingdom, Pfizer’s vaccine efficacy rate decreased to somewhere less than 10 to 20 percent, Domingo said.

For the Beta variant, which was first reported in South Africa, Pfizer’s vaccine efficacy rate dropped by 20 to 30 percent.

Against the Delta variant, which first emerged in India, Pfizer’s vaccine efficacy rate declined to about 10 to 20 percent.

“Ibig sabihin po maganda pa rin naman po ang kanyang coverage,” Domingo said.

US-made Moderna vaccine has an efficacy rate of 94.1 percent against the original virus but is 10 to 20 percent less effective against Alpha and Delta variants, and 20 to 30 percent against Beta.

British-Swede-made AstraZeneca vaccine has an efficacy rate of 74 percent is less than 10 to 20 percent effective against Alpha and Delta variants, and 20 to 30 percent against Beta.

Russia-made Sputnik V has an efficacy rate of about 91 percent but is less than 10 percent effective against Alpha variant, and 20-30 percent against Beta variant. Its efficacy rate against Delta variant is still being studied.

Single dose US-made Janssen vaccine has an efficacy rate of 70.3 percent against the original virus but is less than 10-20 percent effective against Alpha, up to 30% less effective against Beta, and less than 10 percent against Delta variant.

China-made Sinovac has an efficacy rate of 83.5 percent against the original strain, based on recently concluded trial in Turkey. Against Alpha variant, it was found to be less than 10 percent effective, and 10-30 percent against Beta. No available data yet on its efficacy rate against the Delta variant.

Another China-made vaccine, Sinopharm has a 76.29 percent efficacy rate against the original coronavirus strain, but less than 10 percent effective against the Alpha variant and up to 20 percent less effective against Beta. Its efficacy against the Delta variant is still being studied.

“Ang mga variant po, nababawasan nang kaunti ‘yung efficacy ng vaccine pero hindi naman po siya nawawala ‘no, nagiging very useful pa rin naman po,” Domingo said.

The FDA chief then urged the public to get vaccinated as available jabs offer a certain degree of protection against COVID-19.

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