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Indonesia first to give emergency authorisation for Novavax COVID-19 vaccine

Indonesia first to give emergency authorisation for Novavax COVID-19 vaccine

An illustration picture shows vials with Covid-19 Vaccine stickers attached and syringes with the logo of US biotech company Novavax, on Nov 17, 2020. (Photo: JUSTIN TALLIS / AFP)

JAKARTA: Biotechnology company Novavax said on Monday (Nov 1) that Indonesia has given the world's first emergency use authorisation for its COVID-19 vaccine, which uses a different technology than currently used shots.

For Indonesia, the shot will be manufactured by the world's largest vaccine manufacturer, Serum Institute, and sold under the Indian company's brand name, Covovax.

Novavax said initial shipments into Indonesia are expected to begin imminently.

The two-dose vaccine does not require the extremely cold storage temperatures that some other vaccines need, which could allow it to play an important role in boosting supplies in poorer countries around the world.

It is made with lab-grown copies of the spike protein that coats the coronavirus - very different from widely used mRNA vaccines such as Pfizer and Moderna that deliver genetic instructions for the body to make its own spike protein.

The emergency authorisation of the vaccine is a “very important step” for Indonesia's COVID-19 vaccination programme, Indonesian epidemiologist Dicky Budiman said.

“This vaccine will be much easier to transport, store and distribute in a place like Indonesia, where we have many islands,” he said.

Budiman said if the rollout of the vaccine is successful, it could lead to its approval and use in other developing nations.

The need for more vaccines remains critical in many countries, including Indonesia.

In June, US-based Novavax announced that the vaccine had proven about 90 per cent effective against symptomatic COVID-19, including against a variety of concerning variants of the coronavirus, in a study of nearly 30,000 people in the US and Mexico. It also worked against variants circulating in those countries at the time, it said.

The company said side effects were mild and included tenderness at the injection site, headache, aches and pains and fatigue.

In October, it addressed concerns that production of the vaccine had been slowed due to a lack of raw materials and other issues, saying it planned to “achieve a capacity of 150 million doses per month by the end of the fourth quarter” through partnerships with Serum Institute of India, SK Bioscience in South Korea and Takeda in Japan, among others.

The company said on Friday it was preparing to seek regulatory approval for a rollout in Japan early next year.

Novavax said it has already filed for authorisation of the vaccine in the United Kingdom, European Union, Canada, Australia, India and the Philippines.

Indonesia was battered by a deadly wave of COVID-19 fueled by the Delta variant and post-holiday travel from June through August. New cases have now dropped, averaging fewer than 1,000 a day since mid-October.

About 36 per cent of people in Indonesia have received two doses of a vaccine, and about 58 per cent have received one dose, according to the Ministry of Health.

More than 143,400 people have died from the virus in Indonesia. The number is thought to be an undercount due to low testing and tracing.

Source: Agencies/ic