C/Net Summary of Status of COVID19 Vaccine.
Coronavirus vaccines, treatments and chloroquine: Everything you need to know
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When will a vaccine be available?
Fauci, of the infectious diseases institute,
posits that a vaccine is roughly a year and a half away, even though we're likely to see human trials start within the next month or two. This, according to a 60 Minutes interview with Fauci in March, is a fast turnaround.
"The good news is we did it more quickly than we've ever done it," Fauci told 60 Minutes. (Note: 60 Minutes and CNET share a common parent company, ViacomCBS.) "The sobering news is that it's not ready for prime time, for what we're going through now."
Why does vaccine production take so long? There are many steps involved and a lot of regulatory hurdles to jump through.
"For any medicine to be sold it needs to go through the standard process of clinical trials including phase 1 [to] 3 trials," said Bruce Thompson, dean of health at Swinburne University in Australia. "We need to ensure that the medicine is safe, will not do harm, and know how effective it is."
Scientists can't assume their vaccine design will just work -- they have to test, test and test again. They have to recruit thousands of people to ensure the safety of a vaccine and how useful it will be. The process can be broken down into six phases:
- Vaccine design: Scientists study a pathogen and decide on how they will get the immune system to recognize it.
- Animal studies: A new vaccine is tested in animal models for disease to show that it works and has no extreme adverse effects.
- Clinical trials (phase I): These represent the first tests in human beings and test the safety, dose and side effects of a vaccine. These trials only enroll a small cohort of patients.
- Clinical trials (phase II): This is a deeper analysis of how the drug or vaccine actually works biologically. It involves a larger cohort of patients and assesses the physiological responses and interactions with the treatment. For instance, a coronavirus trial may assess if a vaccine stimulates the immune system in a certain way.
- Clinical trials (phase III): The final phase of trials sees an even greater amount of people tested over a long period of time.
- Regulatory approval: The final hurdle sees regulatory agencies, like the US Food and Drug Administration, the European Medicines Agency and Australia's Therapeutic Goods Administration, take a look at the available evidence from experiments and trials and conclude whether a vaccine should be given the all-clear as a treatment option.
Traditionally, then, it could take a decade or more for a new vaccine to go from design to approval. In addition, once the regulatory processes have concluded a vaccine is safe, the drug companies have to send production into overdrive, so they can manufacture enough of the vaccine to increase immunity in the wider population.
With SARS-CoV-2, the process is being expedited in some instances.
As STATnews reports, the vaccine in development by Moderna has moved from design straight into Phase I clinical trials of its mRNA vaccine, skipping tests in animal models. Those tests will take place
at Seattle's Kaiser Permanente Washington Health Institute, and patients are now being enrolled.
