Moderna Inc.’s (NASDAQ: MRNA) COVID-19 Vaccine Booster Under EU Review

Moderna Inc.’s (NASDAQ: MRNA) COVID-19 vaccine booster shot is under review by the EU regarding the possibility of administration after six months of the second shot in people above 12 years.

EU regulator reviewing Moderna’s booster vaccine shot 

The EMA review comes following a statement last week that it was planning to approve a booster shot for the Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) vaccine almost a month following the review process.  The US FDA approved the Pfizer-BioNTech booster shot on adults above 65 years, people exposed to the virus, and those at risk of severe disease. In addition, the approval clears the path for rapid approval of booster shots to those that have received the second dose.

European regulators, unlike US counterparts, are yet to approve any COVID-19 vaccine booster shots. But, an increasing number of cases and infections could prompt the EU to take other precautionary steps like approving booster coronavirus vaccine doses.

The EU regulator said, “Although EMA and ECDC (European Centre for Disease Prevention and Control) do not consider the need for COVID-19 vaccine booster doses to be urgent in the general population, EMA is evaluating the present application to ensure evidence is available to support further doses as necessary.”

EMA says more data necessary on merit for boosters 

Already an application for the Moderna vaccine, Spikevax, is in the process, including results of its ongoing study.  Most EU nations have decided to give the booster shot even though there face higher legal risks since there is no formal approval from the EU regulator, EMA, which holds that giving booster shots lacks merit. The EMA has said before the there is a need for additional data before approval of booster shots.

The EU Commission said, “Booster doses are currently not part of the marketing authorisation of COVID-19 vaccines and have not yet been subject to a scientific assessment by EMA in the absence of sufficient data.”