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S. Korea allows 'comparative clinical trials' for approving domestic COVID-19 vaccine candidates Updated: 2021-07-01 06:56:40 KST

Every vaccine needs to go through phase three clinical trials before being officially authorized for use.
In these trials, one group of people will be given the vaccine candidate,…while another group will be given a fake dose,known as a "placebo".
The researchers then compare the level of immunity between the two groups.

At the start of the pandemic, this was the only way to test a vaccine, because there were no other vaccines to compare new candidates with.

But now, with a handful of vaccines out, South Korea has decided to allow "comparative clinical trials" instead.
These will compare the candidates with the existing vaccines,involving a relatively small group of some 4-thousand participants.
This way, the country can speed up the approval procedure.

"Recruiting participants takes a lot of time,especially now when the vaccination drive is in full flow,and conducting such a large-scale study takes huge amounts of money."

Conventionally, the two vaccines being compared should be of the same platform.
An mRNA vaccine candidate should be compared with another mRNA vaccine such as Moderna or Pfizer.

But South Korean authorities will allow the comparison of vaccines from different platforms, which could shorten the process even more, for some local candidates.

Those include SK Biosicence's subunit vaccine, whose clinical trials would otherwise be put on hold, until its pair - Novavax - is approved by the U.S. FDA.
The same was expected for Genexine's DNA-based vaccine,… as no similar vaccines are currently available on the market.

Despite the revised guidelines, local vaccine candidates will have to go through an additional hurdle.
They should be proven to be just as effective or more effective in preventing variants, as the comparison vaccine.
Based on these guidelines, the country could approve its first homegrown COVID-19 vaccine, by the first half of 2022.
Lee Kyung-eun, Arirang News.
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