Galvez: AstraZeneca's COVID-19 vaccine to go through stringent testing before PH use

Aleta Nieva Nishimori, ABS-CBN News

Posted at Nov 28 2020 09:57 AM | Updated as of Nov 28 2020 02:45 PM

Vials with a sticker reading "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed AstraZeneca logo in this illustration taken Oct. 31, 2020. Dado Ruvic, Reuters/File

MANILA (UPDATE) - The Philippines' COVID-19 vaccine czar Secretary Carlito Galvez Jr. on Saturday allayed fears on potential local use of British drug group AstraZeneca’s coronavirus vaccine amid questions on its efficacy, saying it would still undergo stringent clinical trial in the country.

Galvez, chief implementer of the National Task Force Against COVID-19, said science is a revolving process and issues about the vaccine could still be corrected.

“Ang gagawin po natin, hindi natin gagamitin ang isang vaccine kapag hindi nag rollout sa kaniyang pinanggalingan. 'Wag po silang mabahala, kasi may proseso po tayo. Mataas po ang ating regulatory process,” ayon kay Galvez.

(We will not use a vaccine that has not rolled out in its country or origin. Don’t worry because we have a process. We have a high regulatory process.)

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In a separate public briefing, Health Undersecretary Maria Rosario Vergeire gave as much assurance.

“Yes, there is regulatory oversight ang gobyerno natin. Hindi natin papayagan na makapasok sa ating merkado kung sakaling wala pang rehistro, authority from FDA kasi hindi natin masisiguro kung ito ay ligtas at ito ay epektibo,” she said.

(The government has regulatory oversight. We will not allow it to enter our market if its not registered and it does not have the authority from the FDA because we are not sure if its safe and effective.)

AstraZeneca and its partner, the University of Oxford, announced on Monday that it was seeking regulatory approval for the vaccine after it showed an average 70 percent effectiveness.

That rate jumped to 90 percent when an initial half-dose then a full dose was given, similar to that in rival vaccines in development by Pfizer/BioNTech and Moderna.

But US scientists have said the higher rate of effectiveness came during tests in people aged 55 and under, and was discovered by accident during the clinical trials, suggesting the regimen's efficacy in crucial older age groups is unproven in this interim data.

The Philippines has sought AstraZeneca's responses on questions about its efficacy as the private sector prepared to sign a deal to buy doses of its COVID-19 vaccine.

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In an interview on TeleRadyo, Galvez explained that the money which will be used to purchase COVID-19 vaccines would come from the World Bank and the Asian Development Bank.
“Mayroon po silang napaka-stringent regulatory requirements, meaning pasado sa WHO, pangalawa dapat may 2 o 3 regulatory clearance either from US, from UK at saka from other countries,” he said.

(They have stringent regulatory requirements, meaning it should pass assessment by the WHO (World Health Organization), secondly it has to have 2 o 3 regulatory clearance either from US, UK and other countries.)

On Friday, the Philippines and private firms inked a supply agreement for AstraZeneca's vaccine. The private firms will pay for the vaccine and donate half of the supply to the government.

The deal will secure 2.6 million doses of the vaccine, set to arrive in the Philippines in May or June 2021.

“Ito naman ay mga negosasyon pa lang na ginagawa sa ngayon. If the private sector, para bang nagkaroon na sila ng para bang paunang agreements with these companies, hindi naman po ‘yan mangyayari hanggang hindi nakakapasa po ang mga bakunang ‘yan dito sa regulatory process natin,” Vergeire said.

(For now, these are still negotiations. If the private sector made initial agreements with these companies, it would not push through if these vaccines fail to pass our regulatory process.)

The Philippines will procure several vaccines, not just one brand, Galvez said.

“Ang kukunin natin ay portfolio of more or less 5 o 6 vaccines. Lately, naglabas ang 3 na leading na vaccines, kasama ang Pfizer, Moderna at AstraZeneca, so doon tayo tumutok kasi sila ang nasa advance stages,” he said.

(We will get a portfolio of more or less 5 to 6 vaccines. Lately, the three leading vaccines including Pfizer, Moderno and AstraZeneca have released [results] so we are focused on them because they are already in the advance stages.)

But these vaccines must pass the vaccine expert panel evaluation and selection as well as the ethics board review, and secure emergency use authorization.

“Wala pa tayong klaro kung sino ang magiging magaling at saka safe at effective. Hanggang ngayon patuloy pa rin ang trial po nila. Wala pa pong nagkakaroon ng tinatawag na emergency authoritization kung di 'yung Sinovac lang at itong Gamaleya,” he said, referring to the Chinese and Russian vaccines currently in limited use.

(We don’t know yet which one will be effective and safe. Until now they are still conducting trials. No one has received emergency authorization except for Sinovac and Gamaleya.)

Galvez said it is important to have advance market commitment so that the Philippines will not be at the tail end of the wold supply and demand. Malacañang earlier bared the President has authorized advance payment to secure supply.

“Ang Sinovac po na-clear na po sila ng tinatawag nating vaccine expert panel at saka po undergoing sila ng ethics review board malapit na silang mabigyan ng FDA ng emergency use authorization kasi mayroon na silang emergency use authorization from China,” he said, referring to the Chinese-developed vaccine.

(Sinovac has been cleared by what we call the vaccine expert panel and they are now undergoing the ethics review board and is close to being given emergency use authorization by the FDA because they already have emergency use authorization from China.)

He said its distributor in the Philippines has given a good offer where the Philippines may order 5 million doses for the first quarter of 2021. The goal is to have 20 million doses, with 5 million procured per quarter he said.