Moderna "Omicron Booster Shot Clinical Trials and Approval Process Expected to Begin in March Next Year"

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Kwon Jae-hee] The U.S. pharmaceutical company Moderna is developing a booster shot (third dose) targeting the new COVID-19 variant Omicron, and it is expected to enter clinical trials and approval procedures as early as March next year.

According to major foreign media on the 1st (local time), Moderna CEO Stephen Hoge stated, "A 'customized' booster shot targeting the Omicron variant appears to be the fastest solution against Omicron," adding, "We have already started the development program."

He said, "Even after development is completed, it may take about 3 to 4 more months to submit data and conduct mid-stage clinical trials before receiving approval from the U.S. Food and Drug Administration (FDA)."

Due to this situation, CEO Hoge predicted, "It is realistically difficult for a booster shot targeting the Omicron variant to be available before March next year, and it may be released in the second quarter."

However, he also mentioned that the FDA, which is currently verifying the efficacy of existing vaccines against the Omicron variant, might shorten the approval period.

In the U.S., large-scale clinical trials are not required each time a new version of the flu vaccine is released to respond to new variants after initial approval, and this practice could be applied to COVID-19 vaccines as well.

Although not much is yet known about the Omicron variant, opinions from various sectors suggest it may be more contagious than other variants.

Concerns have been raised that it could neutralize existing COVID-19 vaccines because it has more than 32 mutations only in the spike protein that binds to antibodies.

CEO Hoge speculated that the reduction in effectiveness of existing vaccines due to the Omicron variant will be significant.

He said, "The mutations that most significantly reduced vaccine effectiveness were confirmed in previous Delta and Beta variants," adding, "All those mutations are present in the Omicron variant."

Meanwhile, CEO Hoge added that, apart from the Omicron-specific booster shot, Moderna is also researching a multi-antibody vaccine targeting four COVID-19 variants including Omicron, which will also take several months to complete development.