EMA starts review of latecomer GSK/Sanofi COVID-19 vaccine

The EMA has kicked off a rolling review of a COVID-19 vaccine from Sanofi and GlaxoSmithKline, which started a 35,000-patient phase 3 trial in May.

The vaccine – now dubbed Vidprevtyn – is based on a recombinant protein antigen developed by Sanofi’s vaccines unit Sanofi Pasteur, and also includes an immune-boosting adjuvant developed by GSK that aims to boost its efficacy.

Although it will be a late entrant into the EU’s vaccination programme even if approved, the shot does have one key characteristic that could make it an important addition to the current vaccine armamentarium.

The phase 3 trial being run in support of approval is using a two-shot regimen, with the first dose targeting the original SARS-CoV-2 virus and the second targeting beta (B.1.351) variant first identified in South Africa.

According to some studies, beta may be the most likely to evade immune responses stimulated by the currently available shots as well as some antibody drugs for SARS-CoV-2, and is also thought to be more transmissible.

Circulating levels of beta in France has been cited as the reason for the UK’s decision to make travellers from the country continue to quarantine on arrival, even though it has relaxed almost all other COVID-19 restrictions.

So far the EU has approved four COVID-19 vaccines – two mRNA shots from Pfizer/BioNTech and Moderna, and two based on adenoviral vectors from AstraZeneca and Johnson & Johnson.

Four more are under rolling review, including another adjuvanted recombinant protein vaccine from Novavax, a third mRNA-based shot from CureVax, Russia’s adenoviral Sputnik V and a jab based on an inactivated virus developed by China’s Sinovac Life Sciences.

Combining recombinant protein antigens with an adjuvant is a tried and tested approach in vaccine development, and the developers of this type are hoping that they may be able to generate long-lasting immune system responses.

There’s also the possibility that the recombinant shots may sidestep rare side effects seen with the current adenoviral and mRNA vaccines.

In a statement, the EMA said it is starting its rolling review based on preliminary results from laboratory studies early clinical studies in adults, and will consider the phase 3 trial results when they become available – likely sometime in the third quarter, according to Sanofi and GSK estimates.

Kineret reviewed COVID-related respiratory failure

News of the Vidprevtyn review emerged shortly after the EMA said it was evaluating Sobi’s Kineret (anakinra) as a treatment for adults with COVID-19 who have pneumonia that could progress to  severe respiratory failure.

Kineret, an interleukin-1 receptor antagonist, is already approved to treat rheumatoid arthritis, rare arthritis condition Still’s disease, and two inflammatory conditions called cryopyrin-associated periodic syndromes (CAPS) and familial Mediterranean fever.

The EMA is reviewing the results of two clinical trials that were carried out to see if it can treat the runaway inflammatory response associated with severe COVID-19 in hospitalised adult patients.

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