INDONESIA – Novavax, an American-based biotechnology company, has announced that Indonesia has granted the world’s first emergency use authorization for its Covid-19 vaccine, which employs a different technology than currently used shots.
The vaccine does not require the extremely cold storage temperatures that some other vaccines do, which may allow it to play a significant role in increasing supplies in poorer countries around the world.
According to Novavax, the vaccine can be safely stored in traditional vaccine storage facilities because it is stored at 2° to 8° C, and this thermostability could help increase vaccine rates in difficult-to-reach areas.
The Novavax vaccine is a two-dose regimen shot made of lab-grown copies of the spike protein that coats the coronavirus.
This is in stark contrast to the widely used mRNA vaccines such as Pfizer and Moderna, which deliver genetic instructions for the body to produce its own spike protein.
The emergency authorization of the vaccine is a “very important step” for Indonesia’s Covid-19 vaccination program, 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.
The shot will be manufactured for Indonesia by the world’s largest vaccine manufacturer, Serum Institute in India (SII), and sold under the Indian company’s brand name, Covovax. Initial shipments into Indonesia are expected to begin soon, according to Novavax.
The World Health Organization (WHO) is also reviewing Novavax’s regulatory filing, and the company expects that review to be completed in the coming weeks, according to Chief Executive Stanley Erck.
Erck stated that Novavax has resolved all of its manufacturing challenges and does not anticipate any further regulatory concerns about its production processes.
He stated that Novavax is “in dialogue with the United States Food and Drug Administration, and… we anticipate a full submission within the next several weeks.”
Novavax had postponed filing for US approval, and Politico reported last month that the company was experiencing production and quality issues.
SII is authorized to manufacture the Novavax vaccine, and the company said it will apply for regulatory approval for other facilities, such as its Czech Republic plant, in the coming weeks.
“Access to supply of a safe and highly effective vaccine, coupled with the ease of its distribution, should be a critical enabler to help Indonesia control the current coronavirus outbreak,” said Adar Poonawalla, CEO, SII, in the press release.
“We continue to work with urgency to ensure the first protein-based COVID-19 vaccine option in Indonesia is available for all awaiting its arrival.”
In addition to this approval, Novavax and SII have applied for vaccine approval in India and the Philippines.
They have applied to the World Health Organization for an Emergency Use Listing and have completed a rolling submission for authorization with the United Kingdom, European Union, Canada, and Australia.