Doctors have warned a coronavirus vaccine may create dangerous side-effects and argued against a ‘no jab, no play’ policy. Vaccine development is typically a long and complex process that can take up to 15 years. Because of the urgency of the coronavirus pandemic, researchers are fast-tracking their testing, hoping to produce a safe and effective innoculation by next year. Australian Medical Association president Omar Korshid said even positive phase three trials would not prove the vaccine candidate is safe. ‘We have to acknowledge it is a rushed approval process and even if the phase three trials on this Oxford vaccine go really well, it’s still not absolutely proven that it is safe, not as proven as is normally the case,’ he told The Age newspaper.
‘That does increase the risk that there might be rare side effects … that we just don’t know about.’
Australia’s Commonwealth Scientific and Industrial Research Organisation (CSIRO) has been involved in fast-tracking the testing of the Oxford University candidate vaccine. In May, the CSIRO said it was already at the stage of pre-clinical trials – a position that typically takes up to two years to reach. In ordinary times, a vaccine must pass through the pre-clinical stage, animal testing, then two phases of human trials to study the safety, immunogenicity, proposed doses and method of delivery. If the vaccine passes these hurdles it moves to larger Phase III trials typically involving tens of thousands of people to catch any rare side-effects. Only then is it submitted for approval. The Oxford University AstraZeneca vaccine candidate is already undergoing phase three trials. To reach a vaccine within 15 months would be record time as the average vaccine takes 10 years to develop, according to The Lancet medical journal. Once a safe and effective vaccine is produced, herd immunity can be achieved by vaccinating the population, and life can return to normal. Australia’s chief nursing and midwifery officer Professor Alison McMillan said on Sunday that any vaccine approved in Australia would be subject to strong regulation to make sure it is safe Herd immunity means enough people have antibodies to the virus so it cannot spread. Dr Korshid said Australia’s peak doctors’ association is very supportive of vaccines generally as they have normally been through rigorous and extensive scientific testing. That cannot be said of the coronavirus vaccine candidates, however, of which more than 100 are in development around the world as scientists, governments and other organisations race to find a vaccine. A vaccine candidate usually has 10 years of testing through a pre-clinical stage, animal testing, two phases of human trials to study the safety, effectiveness and proposed doses before the final phase three trials involving tens of thousands of volunteers (stock picture) In August, Russian President Vladimir Putin sensationally declared that Russia had granted regulatory approval to a vaccine candidate named ‘Sputnik V’ after less than two months of human testing, without even finishing its final trials. Only about 10 per cent of clinical trials are successful and scientists fear Moscow has put national prestige before safety.