Moderna Submits EUA for Fourth Booster Dose of COVID-19 Vaccine

Moderna has submitted an amended application to the FDA for an Emergency Use Authorization (EUA) for its Spikevax COVID-19 vaccine for a fourth booster dose in individuals 18 years of age and older who have received an initial booster of any authorized or approved COVID-19 vaccine.

The EUA submission follows a similar action this week by Pfizer Inc and BioNTech, who submitted an EUA application for an additional fourth booster dose of their COVID-19 vaccine for adults 65 years of age and older who received an initial booster of any of the authorized or approved COVID-19 vaccines.

A Delta and Omicron hybrid variant was identified earlier this week called Delta 21J/AY.4-Omicron 21K/BA.1, which has been referred to as “Deltacron,” a recombinant virus that contains genes from both variants. This variant appears to be the most contagious strain thus far, with some medical experts calling it as contagious as the measles. Cases have increased in China and Europe, as many countries including the United States, have begun to relax COVID-19 restrictions.

American public health officials said they are monitoring the variant, but have not as of yet altered guidance on mask-wearing or other prevention measures. Earlier this year, the FDA approved the Moderna vaccine as a 2-dose primary series for individuals 18 years of age and older.

“Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death,” Moderna CEO Stéphane Bancel, said in a press release. “The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus.”

Moderna's vaccine has been approved in more than 70 countries, including Canada, Japan, the European Union, the UK, and Israel, according to Moderna.

In late January, the company announced it had begun a phase 2 clinical trial extension for an Omicron-specific booster (mRNA-1273.529) vaccine candidate. Moderna said it was an extension of an earlier study analyzing the immunogenicity, safety, and reactogenicity of mRNA-1273.529 as a single booster dose in adults 18 years of age and older.

Earlier this year in a Pharmacy Times expert panel discussion, key opinion leaders noted the importance of staying up to date with vaccine boosters.

“From my perspective, get vaccinated. If you’re in a high-risk, high-exposure position or if you’re high risk, get the booster. Let’s move forward,” said Peter Salgo, MD, during the discussion. “The more people who are immune to this, the fewer passages through human beings this virus goes through, the fewer mutations, the less we have to worry about.”

Reference

Moderna Submits Amendment To The Emergency Use Authorization For An Additional Booster Dose Of Its COVID-19 Vaccine In The U.S. Moderna. [news release]. March 17, 2022. https://investors.modernatx.com/news/news-details/2022/Moderna-Submits-Amendment-to-the-Emergency-Use-Authorization-for-an-Additional-Booster-Dose-of-its-COVID-19-Vaccine-in-the-U.S/default.aspx