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Healthcare & Pharmaceuticals

Chile regulator greenlights Sinovac COVID-19 vaccine for emergency use

4 minute read

An employee holds a vial containing CoronaVac, Sinovac Biotech's vaccine against the coronavirus disease (COVID-19), at Butantan biomedical production center in Sao Paulo, Brazil January 12, 2021. REUTERS/Amanda Perobelli

SANTIAGO, Jan 20 (Reuters) - Chile's health regulator approved the emergency roll-out of the COVID-19 vaccine manufactured by China's Sinovac Biotech Ltd (SVA.O) on Wednesday but stipulated that it should not be used for the higher-risk over-60s group.

The decision clears the way for over 10 million doses of CoronaVac approved on Wednesday for emergency use to be given to Chileans between the ages of 18 and 59.

Heriberto Garcia, director of the Public Health Institute (ISP), said "very encouraging" data from late-stage trials and the ISP's own investigations suggested CoronaVac was a "safe and effective vaccine to fight the pandemic."

Ten members of the ISP advisory board approved the vaccine roll-out, while two voted against it and one abstained. The two medical experts who voted against said they wanted to see more data on the vaccine trials.

The Sinovac vaccine has also been approved and is being rolled out in Brazil, Turkey, and Indonesia, but there are some concerns over its efficacy.

Chile's health minister, Enrique Paris, hailed the approval but said the Sinovac vaccine would not initially be given to the over-60s on the recommendation of the regulator's committee of experts, who said they first wanted to see more late stage trial data on the safety and efficacy of the shot for the over-60s.

Instead, the minister said that the vulnerable older population would be vaccinated with the shot made by Pfizer (PFE.N) and BioNTech (22UAy.DE), which has had an efficacy rate of over 90% in trials.

The minister said Chile would use 10 million doses of the Pfizer/BioNTech vaccine it has ordered to inoculate the around 1.8 million Chileans over the age of 60. Previously, it has used the Pfizer vaccine largely for healthcare workers.

"For now we will stick with the recommendation of that expert group," he said. "We will use all the Pfizer doses we can for the elderly so as not to leave them without vaccines. I hope that our vaccination timeline will not change."

Chile is hosting a late-stage clinical trial of the Sinovac vaccine and had ordered 60 million doses to be administered to its population of 18 million over three years.

A delivery of around 2 million Sinovac doses is expected as early as Monday, the science ministry told Reuters.

TRIAL DATA

Data from the Sinovac vaccine's late-stage clinical trial in Brazil earlier this month sparked concern among some other potential buyers after it showed the vaccine was 50.4% effective at preventing symptomatic infections, including "very mild" cases. Previously released data said CoronaVac showed 78% efficacy against "mild-to-severe" cases. read more

The ISP said data from Chile's own CoronaVac trial was not yet available, but it had examined data from trials in other countries. The regulator sent two inspectors to the Sinovac factory in Beijing in November.

Chile became the first country in South America to start vaccinating against COVID-19 with the arrival of 10,000 doses of the Pfizer-BioNTech vaccine on Christmas Eve.

Since then, the country has taken delivery of a total of 154,000 doses of the Pfizer vaccine, inoculating 45,000 health workers and lately some older Chileans with one dose and at least 8,360 with a second, according to health ministry figures.

The ISP is also weighing approval of AstraZeneca's (AZN.L) vaccine for emergency use - Chile has already ordered 14.4 million doses.

Reporting by Aislinn Laing and Fabian Cambero

Our Standards: The Thomson Reuters Trust Principles.

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