The European Medicines Agency (EMA) said last week that it would hold an extraordinary meeting on Thursday, September 1, 2022, to discuss Moderna Inc (NASDAQ: MRNA) and Pfizer Inc’s (NYSE: PFE) applications for modified vaccine boosters targeting the Omicron variant. 

Moderna and Pfizer submit data on booster vaccines. 

The new vaccines, dubbed bivalent shots, seek to address the BA.1 subvariant of the initial COVID-19 virus that originated in China. Moderna submitted an application to the European regulator for Spikevax, its COVID-19 vaccine, and Pfizer and its partner BioNTech submitted an application for Comirnaty. The extraordinary meeting will include the evaluation of these two applications. 

COVID-19 vaccines are set to get updates with boosters created to address the Omicron variant, which is widespread globally. Besides the BA.1 variant, other subvariants emerged over the spring, which include BA.4 and BA.5. in June, the US FDA asked drug manufacturers to create boosters targeting the two strains with Moderna and Pfizer/BioNTech, indicating that they had submitted vaccine data on the BA.4 and BA.5 subvariants. 

The UK issued conditional approval to Moderna’s booster 

At the start of the month, Britain became the first nation to approve Moderna’s vaccine, the world’s maiden bivalent vaccine targeting the Omicron variant and the original strain of the virus. In addition, the United Kingdom Medicines Regulator (MHRA) issued conditional approval to Moderna’s booster shot for adults. As a result, the UK’s Joint Committee on Vaccination and Immunisation (JCVI) is expected to recommend the vaccine’s deployment in the country. 

Clinical study data that demonstrated the booster elicited a significant immune reaction against the Omicron (BA.1) and the initial 2020 virus, according to the MHRA, served as the foundation for that conclusion.

According to Moderna, study findings from a 4th dose of the variant-adapted injection increased the amount of virus-neutralizing antigens towards the Omicron variant by eight times. The MHRA also highlighted a preliminary analysis where it was discovered that the shot produced a strong immunological response versus the dominant Omicron strains BA.4 and BA.5.