Duque: FDA may revise Sinovac jab advisory if data backs vaccination for seniors

MANILA, Philippines — The Food and Drug Administration’s (FDA) advisory for China-made CoronaVac of Sinovac Biotech may change if new data supports that the COVID-19 jab is safe for senior citizens.

Health Secretary Francisco Duque III said this Wednesday, explaining that while he is yet to receive any new advisory from Sinovac regarding the use of Coronavac for the elderly, FDA can alter its previous notice on the vaccine.

FDA previously advised against using CoronaVac for seniors or those aged above 60 in the absence of a concrete study on its use for the said age range, and since its efficacy rate is lower compared to other COVID-19 shots.

“Hindi ko alam kung merong bagong advise, so we will have to verify kung merong bagong advisory that’s coming from Sinovac, kasi the reason hindi naman ‘yan ibinigay dahil kulang na kulang ‘yong datos kung ano ba ‘yong efficacy rate doon sa 60 and above,” Duque said in an interview with ABS-CBN’s Teleradyo.

(I don’t know if there is new advice, so we will have to verify if there is a new advisory coming from Sinovac because the reason why their vaccines were not given to seniors because they lack the data on the efficacy rate for those aged 60 and above.)

“So baka may bago na sila (data) kasi alam mo, very dynamic eh (So maybe they have a new data because you know, it’s very dynamic),” he added.

According to Duque, Sinovac should forward the documents and before FDA changes its previous advisory, the data should be clear about whether it is safe and effective for senior citizens.

However, he disclosed that some health workers who are also senior citizens have written and signed waivers just to be vaccinated against the dreaded respiratory illness caused by coronavirus SARS-CoV-2.

“(FDA’s advisory is) based on the Sinovac advisory, kaya dapat ang Sinovac magpapadala ng datos na magpapapakitang malinaw na malinaw kung ano ang efficacy nito doon sa mga 60 years and above, so baka meron naman silang information na hindi ko pa nalalaman as we speak,” the Department of Health (DOH) chief said.

(FDA’s advisory is based on Sinovac’s advisory, that’s why Sinovac should send their data to show clearly what the efficacy ratings are for those aged 60 and above, so maybe they now have new information that I have not come across yet as we speak.)

“Kailangan may datos […] So ‘yon (FDA) naman ang ating sinusunod, pero may mga iba nga na gustong magpaturok na, dahil gustong magkaroon na ng proteksyon, ‘yong iba yata kung ‘di ako nagkakamali parang sumulat, pumirma ng waiver,” he added.

(We need data. So we follow FDA, but there are some older people who opted to have themselves vaccinated now because they need protection, so some people — if I’m not mistaken — wrote and signed a waiver.)

FDA’s advisory on Sinovac’s Coronavac became controversial as even with an emergency use authorization (EUA), the body did not advise its administration for health workers due to its low efficacy ratings.

Sinovac had registered varying efficacy rates, but FDA used the 50.4 percent rating – way lower than Pfizer and Moderna’s recorded efficacy rate of at least 90 percent.

READ: Despite EUA, FDA advises vs using Sinovac on healthcare workers, seniors due to low efficacy

Eventually, the government task force on COVID-19 permitted the use of CoronaVac on health workers.

READ: Sinovac says vaccine may be used on health workers, elderly even with just above 50% efficacy

READ: Sinovac vaccine OK for health workers not treating Covid-19 patients – FDA

Currently, the Philippines is using two vaccines in its inoculation drive: Coronavac and the AstraZeneca jab.

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