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Moderna Seeks FDA Approval for COVID-19 Vaccine

Review underway for full approval of Pfizer-BioNTech vaccine, as well

August 05, 2021

COVID-19 Vaccine Syringe Graphic

Moderna plans to submit its application for full approval of its COVID-19 vaccine to the U.S. Food and Drug Administration (FDA) by the end of the month, company officials said today.

In a statement, the company said a final analysis of Phase Three study data showed the vaccine had 93 percent efficacy six months after the second dose. The company also said it is conducting a Phase Two study for an mRNA booster that would specifically target the variants of concern in the U.S., including the Gamma, Beta, and Delta variants.

“We are pleased that our COVID-19 vaccine is showing durable efficacy of 93 percent through six months, but recognize that the Delta variant is a significant new threat so we must remain vigilant,” Stéphane Bancel, Moderna CEO, said in a statement.

The announcement comes as the FDA continues its review of Pfizer-BioNTech’s COVID-19 vaccine. In a statement, FDA officials said they were conducting “an all-hands-on-deck approach” to review the application.

During December, both Pfizer-BioNTech and Moderna received emergency use authorization (EUA) after a thorough review of clinical trial data. The Pfizer-BioNTech vaccine has been approved for use in people 12 and older. The Moderna vaccine is approved for adults 18 and older. The EUA allows the vaccines to be used during the pandemic.

The full approval of the COVID-19 vaccines would enable them to be used after the pandemic ends. As part of the full application process, the companies must submit additional clinical study data to support the licensure of the vaccine, as well as manufacturing and facility data, and labeling information.

HAP will continue to monitor updates about the FDA approval process and provide updates to members.

As the nation continues to see an increase in COVID-19 cases due to the Delta variant, HAP joins organizations across the nation urging everyone who is eligible to receive the COVID-19 vaccine. The vaccines are safe, effective, and provide protection against severe cases of COVID-19.

If you have questions or concerns, don’t hesitate to contact your health care provider for more information. Vaccine appointments can be found online.