The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) have reconfirmed the safety and efficacy of AstraZeneca (AZ) and Oxford University’s COVID-19 vaccine.

The MHRA reviewed a small number of thromboembolic events in over 11 million people who have received AZ/Oxford’s vaccine in the UK.

The regulatory agency concluded that the benefits of the jab ‘far outweigh’ any risks following a ‘rigorous’ scientific review, AZ said in a statement.

Following this review, the MHRA added that there is no evidence that blood clots in veins are occurring more than what would be expected in the absence of vaccination.
A ‘detailed’ review of five reports in the UK of a rare and specific type of blood clot – known as sinus vein thrombosis – occurring with lowered platelets (thrombocytopenia) is ongoing.

However, the MHRA said that this has been reported in less than one in a million people vaccinated in the UK so far and can occur naturally, with no causal association with the vaccine established.

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has launched a rolling review of Russia’s Sputnik V COVID-19 vaccine.

Sputnik V was developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology, with the EU applicant for the vaccine being R-Pharm Germany.

The CHMP began the rolling review on the back of results from laboratory studies and clinical studies of the vaccine in adults, which suggest that it triggers the production of antibodies and immune cells that target the SARS-CoV-2 virus.

In December, the Russian Direct Investment Fund (RDIF) confirmed efficacy of over 90% for the Sputnik V vaccine.

GlaxoSmithKline (GSK) and Canadian biopharma company Medicago have launched a Phase III trial of their adjuvanted plant-derived COVID-19 vaccine candidate.

The vaccine uses Coronavirus-Like-Particle (CoVLP) technology, composed of recombinant spike (S) glycoprotein expressed as virus-like-particles (VLPs) administered alongside GSK’s pandemic adjuvant.

Medicago has received approval from Canadian and US regulatory authorities to begin enrolment of healthy adults into the Phase III trial based on “positive interim Phase II results”. Initially, the trial will enrol healthy adults aged 18 to 65 years old, followed by elderly adults aged 65 and over and adults with comorbidities.

The companies added that the Phase II trial of the vaccine is nearing completion, with results expected to be made public in April 2021.