Moderna has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted conditional authorisation for the use of Omicron-containing bivalent COVID-19 booster vaccine, mRNA-1273.214.

The treatment, which is also known as Spikevax Bivalent Omicron will be used as a booster dose for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals of 18 years and older. Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine that contains mRNA-1273 (the current authorised booster) and a vaccine candidate targeting the Omicron variant of concern.

“We are delighted with the MHRA’s authorisation of Spikevax Bivalent Original/Omicron, our next-generation COVID-19 vaccine. This represents the first authorisation of an Omicron-containing bivalent vaccine, further highlighting the dedication and leadership of the UK public health authorities in helping to end the COVID-19 pandemic,” said Stéphane Bancel, Chief Executive Officer at Moderna.

“mRNA-1273.214 has consistently shown superior breadth of immune response over mRNA-1273 in clinical trials. This bivalent vaccine has an important role to play in protecting people in the UK from COVID-19 as we enter the winter months.”
The decision from the MHRA is based on clinical trial data from a phase 2/3 trial, in which mRNA-1273.214 met all primary endpoints, including superior neutralising antibody response against Omicron when compared to a dose of mRNA-1273 in baseline participants.

A booster dose of mRNA-1273.214 increased neutralising geometric mean titres against Omicron approximately eight-fold above baseline levels.

In addition, mRNA-1273.214 elicited neutralising antibody responses against Omicron sub-variants compared to the currently authorised booster regardless of prior infection status or age.

Moderna is currently working with the Vaccines Taskforce, UK Health Security Agency and NHS to make Spikevax Bivalent Original/Omicron available to the UK public. Moderna has completed regulatory submissions for mRNA-1273.214 in Australia, Canada and the EU and expects further authorisation decisions in the coming weeks. 

SyneuRx – a company focused on the development of drugs for COVID-19 and multiple central nervous system disorders – has announced results from its phase 2 clinical trial evaluating the efficacy and safety of SNB01, a novel COVID-19 oral antiviral candidate.

89 participants suffering from breakthrough or unvaccinated cases of COVID-19 were randomised evenly into high-dose, low-dose and placebo groups. The phase 2 study showed that SNB01 – also known as Pentarlandir – can reduce the inflammation caused by COVID and improve overall health.

In five out of six inflammatory markers studied, Pentarlandir treatment groups showed either statistical signals of greater reductions in the inflammatory markers or a clear trend of greater reductions.

Meanwhile, many secondary endpoints also showed encouraging trends. In particular, the Pentarlandir treatment groups exhibited greater improvement in overall health status. In terms of clinical symptoms, Pentarlandir groups were also associated with a greater reduction in total COVID-19 symptoms than the placebo group. On average, Pentarlandir groups were associated with fewer days of worsening symptoms in half of the 24 COVID symptoms measured.

Pentarlandir was very well tolerated in both high- and low-dose groups with no serious adverse event. There were a limited number of adverse events overall (15%), most of which were mild in intensity. Only a few cases (4%) were related to the treatment drug.

Higher dose treatment did not elicit more treatment-related adverse events. There were no cases of hospitalisation, death, or discontinuation of the study due to adverse events.

SyneuRx is expected to launch the phase 3 study in the coming months. An optimal dose will be selected and the scope will expand to evaluate Pentarlandir’s broad-spectrum antiviral activity in inhibiting SARS-CoV-2 as well as influenza viruses.