Russia’s vaccine not fully tested
Experts caution against hasty approval
THERE is cautious excitement in the pharmaceutical world and among health professionals after Russia announced it had become the first country to approve a Covid-19 vaccine.
However, local medical and health professionals have cautioned against a too optimistic view on the efficacy of the vaccine.
The Russian-made vaccine is at the start of phase 3 of clinical trials. However, little information has been given on whether this has begun.
Dr Melinda Suchard, the head of the Centre for Vaccines and Immunology at the National Institute for Communicable Diseases, said: “We watch development of the Russian vaccine with interest, but currently the vaccine has only undergone phase 1 and phase 2 testing, results of which have not been made public.
“Phase 1 trials test safety of a vaccine, phase 2 tests whether the vaccine can induce an immune response which can be measured in a laboratory such as antibodies or T cells. Phase 3 trials test whether a vaccine can protect against the disease of interest.”
Suchard said it would be premature to discuss accessing the vaccine as there was no available evidence yet of its efficacy in protecting individuals from Covid-19.
The vaccine was produced by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology and is also called Gam-Covid-Vac Lyo or Sputnik V. Reports since the announcement was made on Tuesday have indicated that the data from the trial of Sputnik V has not been published and there is no data that indicates it would actually protect.
“Russia has given regulatory approval for use of the vaccine before phase 3 trials, which is unusual in modern vaccine development. It is encouraging that this is an additional vaccine entering phase 3 testing globally, but an objective assessment can only be given following results of a phase 3 trial being made publicly available,” Suchard said.
South African Medical Research Council president and chief executive Professor Glenda Gray said: “All vaccines should be fully evaluated for safety and efficacy. That data should be available to the public and to the regulatory authorities… There is no exception for any country or any pharmaceutical company.”
However, The World Health Organization (WHO) said it would need to review the vaccine’s safety and efficacy data in order to give the vaccine approval and the full go-ahead for large-scale production.
The WHO also urged that full processes be carried out, and that mass production of the vaccine should not be done until phase 2 and 3 of clinical
trials are complete – a key indicator of a vaccine’s safety and efficacy.
Vaccinologist and senior researcher at UCT’s Vaccines for Africa Initiative, Dr Benjamin Kagina, said: “The vaccine has not been pre-qualified by the WHO. The South African government never recommends the use of a vaccine without sufficient evidence of many elements, among which is vaccine safety and efficacy. So I don’t think the government would hasten the Russian vaccine at this stage.”
The head of Infectious Diseases and HIV Medicine at UCT, Professor Marc Mendelson, said the main concern around the vaccine was the accelerated time frame for introduction of a mass vaccination programme of Russian citizens.
“Like medicines, vaccines have to go through a rigorous set of human trials ranging from small safety trials, to larger safety, reactogenicity and immunogenicity trials, culminating with a randomised controlled trial which is placebo controlled, where many thousands of participants are randomly assigned to receive the vaccine or a placebo, which includes a rigorous evaluation of how well the vaccine stimulates immunity,” he said.
Professor and the head of Medical Virology at Stellenbosch University, Wolfgang Preiser, said: “This is bad news. There is no justification in cutting corners. The vaccine testing and licensing process has been designed to ensure safety and efficacy, and here none of this seems to have been done.”