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COVID vaccines. A primer.

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Vaccines may be the solution to ending the COVID-19 pandemic. Vaccines typically take several years to develop. But COVID vaccines are being developed at warp speed. More than 200 vaccines are in development.
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COVID vaccines in development are using different approaches

What are the stages of development of a vaccine?

Preclinical stage: Lab and animal studies to evaluate whether the candidate vaccine can trigger immune response
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Phase I trials: Done in a small group of volunteers to determine safety, dosage, and learn about the immune response it generates.

Phase II trials: Larger number of healthy volunteers (typically in the 100s or less) to learn more about safety and effectiveness.
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Phase III trials: Large trials with thousands of people to confirm that the vaccine is safe and effective, and to identify potential rare side-effects. These trials compare the vaccine to placebo.

Regulatory review: A government agency (eg FDA) reviews data & approves vaccine
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Manufacturing: Making vaccine in bulk, packaging, shipping to sites for administration. This can happen simultaneously with regulatory review.

Phase IV: Post approval, real-world effectiveness of the vaccine is monitored.
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What are some leading COVID vaccines in development?

Moderna vaccine: gene based vaccine that delivers manufactured mRNA that carries instructions for making viral proteins into vaccinated person’s cells. Phase III trial began in July; target 30,000 participants by late Oct
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The Moderna vaccine trial is currently enrolling participants in the United States. Those who are interested can go to the coronaviruspreventionnetwork.org website and sign up to volunteer in the study. Enrollment ends in October
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Oxford vaccine: adenovirus vector vaccine where a gene from the SARS-CoV-2 virus has been inserted into a chimpanzee adenovirus. In the person given the vaccine, the modified adenovirus makes a SARS-CoV-2 protein which then stimulates the immune system against COVID-19.
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The Oxford vaccine is currently enrolling 5,000 subjects in the Phase III trial in Brazil and will also be studied in the UK, South Africa and the United States. Preliminary results are expected by November.
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Vaccines in Phase III trials
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What does this mean?
Two COVID vaccines are in Phase III trials outside of China. China has 3 additional vaccines in Phase III. However best case scenario is that we are still several months from having a vaccine for clinical use.
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