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BPOM approves China's Sinovac vaccine for the elderly

That strategy was partially due to limited data on the vaccine’s safety for the elderly, authorities have said.

Stanley Widianto and Maikel Jefriando (Reuters)
Jakarta
Sun, February 7, 2021

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BPOM approves China's Sinovac vaccine for the elderly People’s hope: A health worker holds up the Sinovac COVID-19 vaccine in a vial at Jurang Mangu community health center (Puskesmas) in South Tangerang, Banten, on Friday. The government has allocated a budget of Rp 20.9 trillion (US$1.49 billion) for procurement of Sinovac’s COVID-19 vaccine and may allow private companies to procure their own vaccines as business representatives called for them to be able to inoculate staff or sell vaccines to the public. (JP/Seto Wardhana)

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ndonesia has approved Sinovac Biotech’s COVID-19 vaccine for use in the elderly, a letter from the food and drug agency shows, potentially changing the country’s strategy which has prioritised its working population first.

That strategy was partially due to limited data on the vaccine’s safety for the elderly, authorities have said.

The Food and Drug Monitoring Agency (BPOM) said in a letter seen by Reuters that it had authorised the use of Sinovac’s CoronaVac for the elderly “taking into account the emergency situation of the COVID-19 pandemic and the limited information on the benefits and safety of that vaccine”.

It was sent to Sinovac’s Indonesian partner, state-owned Bio Farma.

Wiku Adisasmito, spokesman for the country’s COVID-19 task force, confirmed the authenticity of the letter.

Bio Farma confirmed receiving the letter, though did not provide further details.

A rollout of Sinovac’s vaccine in Indonesia last month involved 3 million doses and was aimed at medical workers and public servants.

Government data shows nearly 800,000 have received their first shot, but authorities said they are set to produce 25 million more by the end of March.

Indonesia, which has suffered more than 31,000 deaths from COVID-19, aims to vaccinate more than 180 million people, or roughly two-thirds of its population of 270 million, within a year.

Read also: In Indonesia, self-isolation is luxury not everyone can afford

Several countries such as the United States and Britain that have already begun vaccinations are giving priority to elderly people who are more vulnerable to the respiratory disease.

Indonesia’s health ministry declined to comment, though it has said the elderly are set to receive the vaccine by April.

China’s Sinovac said on Saturday that CoronaVac had been approved for use by the general public by China’s medical products regulator.

A Phase I and II trial in China showed the vaccine could safely trigger immune response for older participants but Sinovac cautioned that data for the protection rate among people aged 60 and above was “limited”.

“When the relevant institutions ...use this vaccine, the necessity of inoculating this product should be evaluated in consideration of the health status and exposure risk of this age group,” it said.

Pandu Riono, an epidemiologist at the University of Indonesia, said that “if we want to stem the number of hospitalisations, we should chase immunisation for the elderly.”

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