Moderna submits application for full FDA approval for its COVID-19 vaccine

Moderna Inc on Wednesday said it had submitted an application for full approval of its COVID-19 vaccine in the U.S., on course to obtain the second such license from federal regulators.

The drugmaker said in a statement that it had launched the process in June for the Biologics License Application (BLA) and has been supplying the efficacy data of its vaccine to the U.S. Food and Drug Administrator (FDA) as it became available in clinical testing.

The Phase 3 clinical study of the vaccine showed an efficacy rate of 93%, and it said the effectiveness remains durable through six months after the second dose.

The two-shot regimen currently holds an emergency-use authorization (EUA) for people 18 years of age and above, which is valid for the duration of the pandemic.

On Monday, FDA granted complete approval to Pfizer and BioNTech SE’s vaccine, making it the first such authorization from the regulators to encourage more people to get vaccination amid the growing Delta variant.

Both the Moderna and Pfizer Inc vaccines use messenger RNA technology to build up immunity among vaccine recipients against the coronavirus.

The vaccines from the two drugmakers have accounted for most immunizations in the U.S., Centers for Disease Control and Prevention (CDC) data shows.

Although the typical review of a BLA takes up to eight months, the FDA has turned to “sprint teams” to expedite the process for COVID-19 vaccines and reviewed the Pfizer-BioNTech vaccine within three months.

For a BLA approval, regulators evaluate a significant amount of safety, efficacy, and manufacturing data and also inspect manufacturing facilities.

The Biden administration hopes that a quick full approval can boost the confidence and encourage Americans to seek vaccination, and it will also make it easier for companies, universities and state and local governments to mandate vaccination.

However, last week, Washington Post reported that the U.S. Centers for Disease Control and Prevention (CDC) has started an investigation on reports of Canadian data that Moderna’s vaccine may be linked to a higher risk of heart inflammation in younger adults, especially males below the age of 30, citing people familiar with the review.

Moderna jumped more than 5.6% to $413.80, reaching the intraday high after the market opened. However, during the midday trading, the shares have dropped 3.9% since then and are changing hands at $397.80.

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