EMA starts rolling review of Moderna’s Omicron-targeting vaccine, as well as Pfizer-BioNTech rival

The vaccines have been adapted to target the Omicron variant, which has been the dominant variant globally since the beginning of the year 

The US-based vaccine maker said last week that the so-called bivalent vaccine produced a better immune response against Omicron than the original shot.  

The EMA also started a rolling review of the mRNA, variant-adapted vaccine created by Pfizer and BioNTech last Wednesday. A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency. Here, the regulator assesses the data as it becomes available, and the process continues until there is enough data for a formal marketing application. 

Omicron cases have been surging across the world, fuelled by the highly transmissible BA.4 and BA.5 sub-variants. The US Centers for Disease Control and Prevention (CDC) said that these sub lineages make up about 8.3% and 13.3% of cases respectively in the US, as of June 11. BA.4 and BA.5 have also been designated variants of concern in Europe, however the BA.2.12.1 sub-variant remains the most prevalent.  

According to a study published recently in Nature, people who were infected with Omicron early in its spread may be vulnerable to reinfection by later sub-variants due to mutations that have developed.  

Vaccinated patients with Omicron BA.1 breakthrough infections developed antibodies that could neutralise that virus plus the original SARS-CoV-2 virus, but mutations in the BA.2.12.1, BA.4, and BA.5 sub lineages allow them to evade antibody protection.  

Several international bodies have raised concerns over the global relaxation of COVID rules in the last six months, warning that cases are likely to surge again as autumn and winter close in. 

In May, the White House announced that America could record as many as 100 million Covid-19 infections in the latter half of this year, while WHO Director-General Tedros Adhanom Ghebreyesus warned the pandemic was ‘certainly not over’.