Second COVID-19 Vaccine Launch Imminent in US... FDA Advisory Panel Recommends Approval for Moderna Vaccine (Comprehensive)

Vaccinations for 20 Million People Planned by Year-End
Transportation Expected to Be Easier Than the Challenging Pfizer Vaccine

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Kim Suhwan] The Vaccine and Related Biological Products Advisory Committee (VRBPAC), an advisory body to the U.S. Food and Drug Administration (FDA), has recommended the emergency use authorization of the novel coronavirus disease (COVID-19) vaccine developed by the pharmaceutical company Moderna. Once the FDA's official approval and the Centers for Disease Control and Prevention (CDC)'s vaccination authorization are passed, it is expected to become the second commercially available vaccine in the United States. As with the previously approved Pfizer vaccine, the remaining approval procedures are expected to proceed very quickly, with vaccinations anticipated to begin as early as the beginning of next week. Moderna's vaccine is expected to be easier to transport than Pfizer's vaccine due to less stringent transportation conditions.

According to foreign media such as CNN on the 17th (local time), VRBPAC reviewed the emergency use authorization agenda for Moderna's COVID-19 vaccine and passed it with 20 votes in favor, 0 against, and 1 abstention, recommending the FDA to authorize its use. At the meeting, VRBPAC judged that the benefits of vaccinating adults aged 18 and over with Moderna's vaccine outweigh the risks.

Accordingly, the FDA is expected to grant emergency use authorization as early as that evening, enabling nationwide distribution from the 21st. According to CNBC, the remaining approval procedures include the FDA's official approval, the CDC advisory committee's vaccination recommendation, and the CDC's official vaccination authorization. Considering the time taken for the Pfizer vaccine's approval and vaccination, CNBC reported that the follow-up procedures for Moderna's approval are expected to be completed within 2 to 3 days. If the FDA grants emergency use authorization, the United States will be the first country in the world to approve Moderna's vaccine. Unlike the Pfizer vaccine, which was approved for individuals aged 16 and older, Moderna's vaccine is expected to be authorized only for adults aged 18 and over. This is because clinical trials for minors are currently underway, and results have not yet been released.

Easier Transportation Compared to Pfizer Vaccine... Initial Supply Twice as Much

According to the medical media Stat News, unlike Pfizer's vaccine, which must be stored at ultra-low temperatures below minus 70 degrees Celsius during delivery, Moderna's vaccine can be stored at temperatures between 2.2 and 7.8 degrees Celsius for up to 30 days, making its distribution easier than Pfizer's vaccine. The U.S. government's vaccine development and distribution plan, Operation Warp Speed, is also reported to have prepared an initial supply of Moderna's vaccine approximately twice that of Pfizer's vaccine.

Previously, at a press briefing, Gustav Perna, Chief Operating Officer (COO) of Operation Warp Speed and a U.S. Army General, stated, "Moderna's vaccine will be shipped immediately after health authorities' approval, with 5.9 million doses transported, twice the amount of Pfizer's vaccine." Pfizer's vaccine had 2.9 million doses shipped nationwide immediately after approval. General Perna added, "By the end of the year, we will supply 40 million doses together with Pfizer's vaccine." Considering that both vaccines require at least two doses, it is expected that up to 20 million Americans will be vaccinated within the year.

Meanwhile, the European Medicines Agency (EMA), the body responsible for vaccine approval in the European Union (EU), announced that in response to the imminent U.S. approval, it will advance the review schedule for Moderna's emergency use authorization from January 12 to January 6. Once approved by the EMA, vaccinations with Moderna's vaccine are expected to begin in all 27 member countries.

This content was produced with the assistance of AI translation services.