COVID-19 Vaccine Development Advances

Vaccines undergo a rigorous process to be approved for use by the FDA. Typically, more than a year's time is required. Research identifies candidate antigens to elicit an immune response. This pre-Clinical work is conducted in lab experiments often using animal models.

With data from pre-clinical studies establishing that the vaccine is safe, three phases of clinical trials are required before the  vaccine can be widely used in humans.

Phase 1 - Small groups of people take the vaccine to confirm safety in humans

Phase 2 - Larger numbers of people are give the vaccines and the results (immune response among them) are analyzed by group (age, gender, physical health, etc.) to help guide who can take the vaccine safety and if the correct response is had.

Phase 3 - Thousands of trial participants, representing the target population, receive the vaccine. Participants are monitored to establish safety and efficacy.

At the end of the trial, data are analyzed to determine if the vaccine is effective and safe for distribution.

Phase 4 studies, ongoing after approval, are common for vaccines, to confirm continued safety and efficacy.

Last week, Calatent, Inc. announced an agreement with Janssen Pharmaceuticals, a J&J company, paving the way to delivery of COVID-19 vaccine pending successful clinical trials (see press release below)

Janssen Pharmaceuticals had launched its development of the vaccine in January. Janssen projected that the vaccine could be ready for use by emergency authorization in early 2021. Go the the link below for details.

https://www.jnj.com/johnson-johnson-announces-a-lead-vaccine-candidate-for-covid-19-landmark-new-partnership-with-u-s-department-of-health-human-services-and-commitment-to-supply-one-billion-vaccines-worldwide-for-emergency-pandemic-use