COVID-19 updates: Fastest vaccine development ever
Latest updates about corona virus shows that scientists are working to develop the vaccine as fast as possible, but they say the process to guarantee its safety and efficacy is unchanged.
Dr. Soumya Swaminathan chief scientist at WHO: "As you know, we have about 40 vaccine candidates now in some stage of clinical trials, and 10 of them are in the Phase 3 trials, which are the late-stage clinical trials, which will tell us about both the efficacy and the safety."
She said that the earliest date for a vaccine to come onto the market to submit to regulators "is starting from December of 2020, into the early part of 2021."
The process of developing a vaccine from lab to clinic:
PRECLINICAL TESTING: Scientists test a new vaccine on cells and then give it to animals such as mice or monkeys to see if it produces an immune response.
There Are 59 confirmed preclinical vaccines in active development.
PHASE 1 SAFETY TRIALS: Scientists give the vaccine to a small number of people to test safety and dosage as well as to confirm that it stimulates the immune system.
PHASE 2 EXPANDED TRIALS: Scientists give the vaccine to hundreds of people split into groups, such as children and the elderly, to see if the vaccine acts differently in them. These trials further test the vaccine’s safety and ability to stimulate the immune system.
PHASE 3 EFFICACY TRIALS: Scientists give the vaccine to thousands of people and wait to see how many become infected, compared with volunteers who received a placebo. These trials can determine if the vaccine protects against the coronavirus. In June, the F.D.A. advised vaccine makers that they would want to see evidence that vaccines can protect at least 50 percent of those who receive it. In addition, Phase 3 trials are large enough to reveal evidence of relatively rare side effects that might be missed in earlier studies.
EARLY OR LIMITED APPROVAL: China and Russia have approved vaccines without waiting for the results of Phase 3 trials. Experts say the rushed process has serious risks.
APPROVAL: Regulators in each country review the trial results and decide whether to approve the vaccine or not. During a pandemic, a vaccine may receive emergency use authorization before getting formal approval. Once a vaccine is licensed, researchers continue to monitor people who receive it to make sure it’s safe and effective.
COMBINED PHASES: One way to accelerate vaccine development is to combine phases.
2020 October 27