Early trials of a Russian vaccine show no adverse effects

PRELIMINARY RESULTS from Russian coronavirus vaccine trials suggest the candidates suffered no serious adverse events and there was also an antibody response.

Results from two early- phase vaccine trials, in a total of 76 people, indicate that two formulations of a two- part vaccine have a good safety profile with no serious adverse events detected over 42 days.

The findings, published in the Lancet, also found the candidates induced an antibody response in all participants within 21 days.

Secondary outcomes from the trial suggest the vaccines also produce a T- cell response within 28 days.

The paper reports findings from two trials lasting 42 days.

One looked at a frozen formulation of the vaccine, and another involving a lyophilised ( freezedried) formulation.

It is envisaged that the frozen formulation will be for large- scale use, using existing global supply chains for vaccines.

The freeze- dried formulation was developed for hard- to- reach regions as it is more stable and can be stored at two to eight centigrade, the researchers said.

The trials involved healthy adults aged 18- 60, who remained in hospital for the first 28 days of the trial.

Professor Alexander Gintsburg, of the N F Gamaleya National Research Centre for Epidemiology and Microbiology in Russia, said: “This provisional licensure requires a large- scale study, allows vaccination in a consented general population in the context of a phase 3 trial, allows the vaccine to be brought into use in a population under strict pharmacovigilance ( drug safety measures), and to provide vaccination of risk groups.”

The phase 3 clinical trial of the vaccine plans to include 40,000 volunteers from different age and risk groups.