Is Russian vaccine (sputnik-V) not too early for 3rd phase testing? Russian officials have said they plan to start mass vaccination in October which is considered too early for the phase 3.
Phases of vaccine testing and approvalhttps://www.cdc.gov/vaccines/basics/test-approve.htmlClinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety. Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed.
There are
thousands of people that will be given the vaccine during the phase three. From BBC news, I read these comments:
BBC News - Coronavirus: Russia calls international concern over vaccine 'groundless'
https://www.bbc.co.uk/news/world-europe-53751017On Wednesday, Germany's health minister expressed concern that it had not been properly tested.
"It can be dangerous to start vaccinating millions... of people too early because it could pretty much kill the acceptance of vaccination if it goes wrong," Jens Spahn told local media.
"Based on everything we know... this has not been sufficiently tested," he added. "It's not about being first somehow - it's about having a safe vaccine."
Elsewhere in Europe, Isabelle Imbert, a researcher at the French National Centre for Scientific Research in Marseille, said promising a cure too early could be "very dangerous".
We do not know the methodology or the results of their clinical trials," she told Le Parisien.
And in the US, the country's top virus expert, Dr Anthony Fauci, said he doubted Russia's claims.
"I hope that the Russians have actually definitively proven that the vaccine is safe and effective," he told National Geographic. "I seriously doubt that they've done that."
Meanwhile the Moscow-based Association of Clinical Trials Organizations (Acto), which represents the world's top drug companies in Russia, urged the health ministry to postpone approval until after phase-three trials.
Acto executive director Svetlana Zavidova told the Russian MedPortal site that a decision on mass vaccination had been carried out after combined first- and second-phase tests on 76 people, and that it was impossible to confirm the efficacy of a drug on this basis.
What do you think about this?Despite rapid progress, most experts think any vaccine would not become widely available until mid-2021.