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No Novavax shots until safety proven: government

SK Bioscience on standby to begin production of 40 million Novavax doses for local consumption

A woman holds a small bottle labeled with a
A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in front of displayed Novavax logo in this illustration taken, October 30, 2020. (Reuters-Yonhap)

South Korea has cleared potential roadblocks for the local production of Novavax’s COVID-19 vaccine, but it will have to wait until the drug’s safety is proven, government officials said Tuesday.

“We’re not considering putting (Novavax shots) to use prior to the authorization process,” Baek Young-ha, who is in charge of the government’s vaccine procurement, told a press briefing Tuesday.

The official also sought to clarify an earlier comment by Health Ministry officials that the Novavax vaccine’s production process had begun.

The ministry, in its briefing on the current status of the coronavirus inoculation campaign to President Moon Jae-in, said that the first locally-produced shot of Novavax vaccine will come out as early as June and that the contracted amount of doses would be rolled out in earnest in the third quarter. “The production process has begun,” an official said at the time.

An official from local drugmaker SK Bioscience, which is to contract manufacture the vaccines at a local factory, said the company has not yet began producing them, but is on standby to do so.

South Korea signed a deal to procure 40 million doses of Novavax vaccines, enough to inoculate 20 million people.

“(The comment means) anything that could arise as a problem for the production process has been checked,” the official explained, adding that production will begin when the drug receives the necessary approvals from drug authorities.

The prospect of Novavax vaccines’ arrival here has received much attention as South Korea struggles to secure enough doses to inoculate its people and achieve a herd immunity by November. Currently, there are only two types of vaccines currently available -- those from AstraZeneca and Pfizer.

According to Ministry of Health and Welfare data, South Korea has secured 3.37 million doses of COVID-19 vaccines to date, accounting for around 18.6 percent of the vaccines the government has planned to supply in the country by the first half of the year.

South Korea will receive 1.66 million doses of AstraZeneca COVID-19 vaccine in May and 297,000 doses of Pfizer’s vaccine by June, through the World Health Organization’s global vaccine project, known as the COVAX Facility.

The country would receive an additional 7 million doses of AstraZeneca’s COVID-19 vaccine between May and June and 5.75 million doses of Pfizer’s between April and June.

Although authorities are ramping up efforts to tweak its inoculation plan, they are expected to experience difficulties in achieving herd immunity as planned as supply of other vaccines have been delayed or are at a standstill.

On Monday, when asked if South Korea would reach herd immunity, the health authority said it would try its best, leaving rooms for doubts.

Local experts also expressed concerns that it could be difficult to inoculate Novavax’s vaccine in June due to safety issues. Novavax’s jab has not been approved by the European Medicines Agency or the US FDA.

Novavax CEO Stanley Erck in March said he expected to receive approval from the EMA as early as between April and May, while anticipating the US FDA’s approval one or two months later than that.

As for COVID-19 vaccines from Janssen and Moderna, the government has not laid out any supply plans yet. The South Korean government previously aimed to import vaccines from Janssen and Moderna during the second half of the year. But how many doses the government would be able to bring in or when the government would receive those vaccines have not been decided.

To speed up COVID-19 vaccine supplies here, the Health Ministry would provide 68.7 billion won ($61.1 million) to support their vaccine development, the government announced during the emergency meeting on Monday.

The ministry said it would inject the money to help phase three clinical studies of five local companies during the second half. The five companies include SK Bioscience, EuBiologics, Cellid, Genexine and GeneOne Life Science.

South Korea started its inoculation campaign on Feb. 26, aiming to achieve herd immunity for its 52 million population by November. The country’s inoculation rate, however, remains at around 2.2 percent, or 1.15 million people.

By Shim Woo-hyun (ws@heraldcorp.com)
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