RALEIGH, N.C. (WNCN) – Monday morning Moderna was the firs pharmaceutical company to move into the third phase of clinical trials for a COVID-19 vaccine candidate.
Developing a vaccine typically takes years of trial and error. The FDA and federal government have made special allowances to speed up the process.
So how did Moderna get to this stage?
Step one is the exploratory stage where scientists learn about a virus. Next is the pre-clinical stage where animals are tested to ensure safety.
Then there is the clinical development. It splits up into the three phases of testing.
In phase one, the candidate vaccine is given to less than 100 people. If it is determined to be safe- it moves into phase 2 where its given to hundreds of people. Those people are split into different group like age or health condition to learn about immunity. Phase 3, involves thousands of people to learn more about effectiveness and safety.
Moderna was currently the furthest along in the U.S.. They are the only pharmaceutical company currently in clinical trials.
If they pass this step, they can apply for approval from the FDA. Once granted approval, companies can move into large scale manufacturing. The FDA would continue monitor the vaccine’s production including doing facility inspections as long as the manufacturer holds a license for the vaccine.
Operation Warp Speed
The federal program, Operation Warp Speed has a goal of making 300 million doses of vaccine available by January 2021.
In the last few months, the Health and Human Services has announced the following funds to develop a vaccine:
- $456 million for Johnson & Johnson’s candidate vaccine
- $483 million for Moderna’s candidate vaccine
- $1.2 billion in support for AstraZeneca’s candidate vaccine developed with the University of Oxford
The following funds were granted to assist with vaccine distribution:
- $138 million to ApiJect for more than 100 million prefilled syringes
- $204 million to Corning to produce an additional 164 million Valor Glass vials each year if needed
- $143 million to SiO2 Materials Science to produce more glass-coated plastic containers for vaccines
More potential vaccines
There are currently 25 candidate vaccines coming down the pipleline. While some are listed in phase 3 of clinical development, they are not currently running tests. Some are recruiting, other have not started that process yet.
Duke–NUS Medical School is on the FDA’s candidate vaccine list. They are currently in phase 2.
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