CoronaVac safety ‘remarkable’ across all age groups, including elderly – expert panel head

MANILA, Philippines — The safety of CoronaVac, the COVID-19 vaccine developed by China-based Sinovac BioTech, showed “remarkable” results across all age groups, including the elderly, according to Dr. Nina Gloriani, the head of the vaccine development expert panel of the Department of Science and Technology (DOST).

“Clinical trial findings showed that the Sinovac’s CoronaVac is well tolerated among older individuals,” Gloriani said in a Department of Health (DOH) media forum on Tuesday.

Gloriani then disclosed some details of the panel’s recommendation on the use of CoronaVac for senior citizens after they were asked to revisit data from the clinical trials amid the Philippines’ lack of supply of the AstraZeneca vaccine.

But last February, when the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for CoronaVac, it recommended against using it on senior citizens due to a lack of concrete studies.

“Under the EUA, you can modify, amend as the data come in,” Gloriani noted.

In the government’s vaccine rollout, the elderly were immunized first with AstraZeneca’s vaccine.

Now, in recommending the use of CoronaVac on the elderly, Gloriani said the panel highlighted the country’s “very limited options” in the face of a “worsening pandemic.”

“Individuals aged 60 years or older are at an increased risk of severe illness and death from COVID-19, particularly if they have underlying medical conditions,” she noted.

She said all the evidence from the clinical trials conducted in Brazil and China showed that the “incidence of adverse reactions in different dose groups was similar” — which is an “indication that there was no dose-related concern with regard to safety.”

“Moreover, all adverse reactions were mild and moderate in severity, and pain at the injection site was the most commonly reported event,” Gloriani said.

Further, she said that Sinovac’s jab “generated antibody responses similar to the general population and the elderly.”

“We are saying that likely benefits outweigh the risk. The overall findings demonstrated that these vaccines induce neutralizing antibodies and have good safety profiles both in the general population and the elderly,” she added.

Nevertheless, she underscored that vaccine recipients should be monitored “while waiting for additional pending supporting data.”

The DOH and the FDA already approved the vaccine expert panel’s recommendation last week.

They stressed, however, that senior citizens should first have a thorough assessment of their health status and risk of exposure before getting vaccinated with CoronaVac.

According to Gloriani, clinical trials specifically on the use of CoronaVac on those aged 60 and above will likely begin in May.

“So this clinical trial will add to that data,” she said during the forum. “They’re still laying the groundwork. So this is really for the 60 years and above.”

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