"US FDA Reviewing Approval for Moderna Booster Shot Use"

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[Image source=Reuters Yonhap News]

[Asia Economy Reporter Kim Suhwan] The U.S. Food and Drug Administration (FDA) is reportedly actively reviewing the approval of Moderna's COVID-19 vaccine booster shot (an additional dose to enhance immune efficacy).

According to the Wall Street Journal (WSJ) on the 2nd (local time), the FDA is currently reviewing whether to approve the use of Moderna's booster shot and is examining clinical data related to the booster shot.

The report states that the FDA is expected to approve administering the booster shot six months after completing the second dose of the Moderna vaccine.

Earlier, Moderna announced clinical data last month showing that the booster shot is effective against the Delta variant, and the day before, it submitted clinical data to the FDA to apply for booster shot approval.

When announcing the clinical data last month, Moderna stated that its booster shot, containing 50 micrograms, demonstrated enhanced immune efficacy against variants such as the Delta variant. The 50 micrograms is half the dose of the original 100 micrograms used in the initial vaccination.

Based on this data, Moderna requested the FDA to approve the booster shot dose at 50 micrograms. However, the FDA is reportedly considering authorizing the use of 100 micrograms as a booster shot to respond quickly to variants and enhance immune efficacy.

According to sources, there is a consensus within the FDA that Moderna's booster shot shows vaccine efficacy against variant viruses.

However, it is reported that no conclusion has yet been reached regarding booster shot approval due to insufficient non-clinical data to verify the validity of the clinical evidence.

[Image source=Reuters Yonhap News]

Inside the FDA, the Wall Street Journal reported that there is also a proposal to authorize the use of booster shots with doses lower than 100 micrograms to reduce side effects.

However, WSJ pointed out that if the booster shot dose differs from the original first and second doses, medical staff at vaccination sites may need to prepare separate procedures for the booster shot, which could cause confusion.

Additionally, if the booster shot is administered at a lower dose than the original vaccine, there is a higher possibility of surplus vaccine stock. If the surplus is not used promptly, it may eventually have to be discarded.

Previously, Janssen also applied for booster shot approval.

To this end, the company submitted booster shot clinical results to the FDA last month. According to sources, the FDA is currently expected to authorize Pfizer and Janssen booster shots at the same dose as a single initial dose.

The United States is currently rushing to start booster shot administration quickly due to the spread of the Delta variant. The Joe Biden administration plans to begin nationwide booster shot vaccinations as early as the 20th.

However, the World Health Organization (WHO) has requested a one-month delay in booster shot administration, citing low vaccination rates in low-income countries.

Meanwhile, Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), who oversees the country's infectious disease response policy, said that if booster shot administration is approved, "it would be no surprise."

On this day, Fauci said that the decision authority regarding booster shot administration lies with the FDA but added, "The claim that a third dose will extend the duration of the immune response is reasonable."

His remarks are seen as supporting the Biden administration's booster shot vaccination plan.

[Image source=AP Yonhap News]

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