Moderna Seeks EUA for a 2nd COVID Booster Dose: What to Know

Moderna has applied to amend their COVID vaccine EUA to allow a 4th dose to all 'boosted' adults over 18 in the US.

Moderna is seeking an Emergency Use Authorization from the US FDA for a fourth shot of their COVID-19 vaccine for all adults who have received a booster dose of any approved COVID vaccine, the company announced on Thursday, 17 March.

We have submitted a request to the U.S. FDA for an amendment to the emergency use authorization to allow for a fourth dose of our #COVID19 vaccine in adults 18 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. pic.twitter.com/aDV71C7DA1

— Moderna (@moderna_tx) March 18, 2022

At the Moment, Moderna has an emegrancy use authorisation to offer a third booster dose of 50 µg of Moderna's mRNA COVID vaccine to all adults over the age of 18 in the US.

In a statement released by the company on Thursday, Moderna said they sought to amend this EUA to include a fourth booster dose "to provide flexibility for the U.S. Centres for Disease Control and Prevention (CDC) and healthcare providers to determine the appropriate use of an additional booster dose."

In the statement, the company added that clinical trials for Moderna's Omicron-specic mRNA booster shots are ongoing, and that they are also working on a bivalent Omicron-specic booster

Do We Need a 4th Booster Dose?

Moderna also said that they applied for the request to amend the EUA based on clinical data on the effectiveness of the vaccine against the Omicron variant generated in the US and Israel.

Whether a fourth booster dose can better protect against the Omicron variant has been a topic of contention among experts.

In light of rising cases in Europe, countries like Sweden have already started recommending a fourth COVID shot to high risk patients, frontline workers and the elderly.

On the other hand, a recent study conducted in Israel suggests that a second booster dose would provide a slight boost in immunity at best.

Moderna COVID vaccines in India

Back in July, Niti Aayog member, DR VK Paul, had said that the government was working actively to facilitate the import and distribution of Moderna COVID vaccines in India.

Indian pharmaceutical company Cipla was granted authorisation to import the mRNA vaccines, however there have been no updates on when these might be rolled out in India.