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

Robie de Guzman   •   July 13, 2021   •   295

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.

No nasal sprays yet against COVID-19, FDA says

Robie de Guzman   •   September 22, 2021

MANILA, Philippines — The Philippine Food and Drug Administration (FDA) on Wednesday said that nasal sprays have not been proven effective yet in preventing COVID-19 infection.

FDA director-general Eric Domingo said nasal sprays against COVID-19 are still being studied and undergoing clinical trials.

“Wala pa pong approved sa mga ito. Hinihintay pa nating matapos ang mga trial na ito para masabi talaga (na panggamot sa COVID-19),” he said in a televised briefing.

Domingo said the public would have to “wait for a little more” for the results of these trials before COVID-19 nasal spray vaccines become available in the market.

“Sa ngayon, ang available sa atin na nasal sprays, mga ano lang po ito, panlinis ng ilong, pambigay ng konting proteksyon pero sa panandaliang panahon lamang at hindi pa maaaring gamiting pamalit sa mga gamot at bakuna kontra COVID,” he said.

Domingo urged the public to immediately report to authorities anyone who is selling or offering products that claim to be COVID nasal spray.

“Wala pa pong COVID vaccine nasal spray na pinapayagan sa Pilipinas o kahit saang parte ng mundo,” he said.

“‘Pag merong nagbenta sa inyo ng spray na sinasabing COVID vaccine po ito, ito po ay either fake o hindi po natin alam kung ano ang laman nito. Huwag po ninyong gagamitin at paki-report po ninyo sa FDA para mahuli po namin,” he added.

The World Health Organization (WHO) earlier said that eight spray vaccines that aim to deliver immunity against COVID-19 through the nose are being evaluated.

FDA, may babala vs mga ospital na maniningil ng higit kaysa COVID-19 drug price cap

Robie de Guzman   •   September 17, 2021

MANILA, Philippines – Binalaan ng Philippine Food and Drug Administration (FDA) ang mga ospital na maniningil ng higit kaysa itinakdang price cap para sa mga gamot na ginagamit para sa mga pasyenteng may COVID-19.

Sa panayam sa programang Get it straight with Daniel Razon, sinabi ni FDA director general Eric Domingo na maaaring patawan ng parusang pagkakakulong at suspension ng lisensiya ang mga ospital gayundin ang mga botika na nagbebenta ng COVID-19 drugs na mas mahal kumpara sa price ceiling.

Ginawa ng FDA ang babala kasunod ng mga ulat ng overpricing sa mga gamot na ginagamit sa treatment ng COVID-19 patients tulad ng Remdesivir at Tocilizumab .

“Pag ospital po, kwestyonable ang presyo, at least yung quality sigurado tayo dahil yung ospital hindi naman yan bibili, bawal po silang bumili sa unlicensed distributor. Pero mayroon silang pananagutan dahil lumalagpas po sila sa retail price na pinapayagan po ng DOH,” ang paliwanag ni Domingo.

Alinsunod sa kautusan ng DOH, nasa P8,000 hanggang P28,000 ang suggested retail price ng Tocilizumab na ginagamit sa treatment ng critical hanggang severe COVID cases.

Nasa P1,500 hanggang P8,200 ang retail price ng bawat 100 milligram vial ng Remdesivir.

Samantala, kaugnay naman ng pagkakaloob ng compassionate special permit o CSP sa COVID-19 drugs, inihayag ni Domingo na halos lahat ng ospital sa bansa ay may special permit na para sa isa o dalawang gamot kontra COVID-19.

Dagdag pa nito, hindi masyadong istrikto ang FDA sa pagbibigay ng CSP basta lisensyado ang ospital at mga doktor na gagamit ng gamot para sa COVID-19 patients.

“Actually lahat ng ospital ngayon sa Pilipinas, may special permit na sila for one drug or another, para sa ating COVID dahil talagang puno ng COVID-19 cases. At tayo naman po, hindi tayo very strict,” ani Domingo.

Ayon sa FDA, nade-desisyunan naman agad sa loob ng 24 hanggang 48 oras ang aplikasyon para sa CSP ng isang ospital. Maaari ding mag-apply in advance ng CSP ang mga ospital para sa COVID-19 patients nito sa pamamagitan ng email address na odg@fda.gov.ph.

Kaugnay naman ng investigational drug na Leronlimab, sinabi ni Domingo na wala pang price ceiling na itinakda ang pamahalaan dito dahil kakaunti lamang ang nanghihingi ng special permit para sa suplay ng gamot na ito. – RRD (mula sa ulat ni Correspondent Rosalie Coz)

PH expects to receive 190K doses of Sputnik V vaccine this September – Galvez

Robie de Guzman   •   September 17, 2021

MANILA, Philippines – Around 190,000 doses of Sputnik V COVID-19 vaccine (component 2) manufactured by Russian firm Gamaleya Research Institute are expected to arrive in the country this month, vaccine czar Carlito Galvez Jr. said Friday.

Galvez said the additional vaccine supply may be delivered by the weekend or early next week.

“This shipment of Sputnik V vaccines shall be used for the second dose. After this, we will be receiving the single-shot Sputnik V Light as we move forward with our vaccine rollout,” he said.

Galvez, who is also the chief implementer of the National Task Force (NTF) against COVID-19, eased concerns among those who have already received their first dose of Sputnik V.

“As per our vaccine experts from the Department of Health, the gap between first and second doses of Sputnik V can be as long as six months, so no need to worry because the vaccines are arriving soon,” Galvez explained.

This month, the country expects to receive the first batch of government-procured Sputnik V Light vaccines consisting of 1 million doses.

“The Sputnik V Light is more efficient because we will be able to protect more people faster. This would eliminate the problem wherein people fail to return for their second dose,” Galvez noted.

As of September 15, the country has received a total of 57,547,610 vaccine doses from various manufacturers, of which over 36 million doses were procured by the national government.

The country has also breached the 40 million mark in terms of COVID-19 jabs administered, with 40,030,388 shots given as of September 15. Of this number, 17,675,959 were fully vaccinated and 22,354,429 received their first dose.

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