Posts Tagged ‘product development’

The race for a COVID-19 vaccine: What’s ahead ?

Reporter: Irina Robu, PhD

Researchers are conducting over 100 coronavirus vaccines studies, as they race to produce the first serum to protect people from COVID-19. Its uncertain which one would be successful, but what is certain is that without the vaccine, life would not return to normal anywhere on the world.

Usually, a vaccine takes 20 to 15 years to develop, but Moderna Therapeutics, a U.S. pharmaceutical company will test their vaccine on tens of thousands of people which are in critical phase 3. Even though many vaccines are tested now, only ten candidates are currently in clinical trials. The process to develop a vaccine is complicated and requires time and money.

However, in order to develop a vaccine, a pathogen has to be identified. After several in vitro trials, the vaccine is tested in mice, then in a non-human primate model. After these preclinical studies show  promising results, then the next step is to into clinical trials i.e. human testing. The human testing, occurs in various steps. The first step, phase 1 clinical trial is usually a small trial with 20 to 100 patients. The goal of this step is to asses the toxicity of the vaccine. Once, the first step clinical trials are completed and the results show positive result on toxicity and safety, progress to phase 2 trials can be started. Phase 2 clinical trials include 200 to 400 patients. In this phase, immunogenicity of the vaccine it is tested as well as how long it is effective.  Then, the last step is phase 3 clinical trial which can include as many as 30,000 people. The last phase it assesses whether the vaccine works on a broader scale.

Once the vaccine is effective, companies have to increase production to develop more than 7 billion doses. But due to the large number of people requiring this vaccine, scientists have to look at how to increase the manufacturing capability and distribution. In order to produce them effectively, a portfolio of vaccines have to be used.






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