Covid 19 Vaccine Trials
A volunteer in the AstraZeneca vaccine trials died in Brazil. He was a young man and was receiving the placebo or saline solution. They halted the trials, but they now have now resumed. https://www.bloomberg.com/news/articles/2020-10-21/astrazeneca-dips-on-report-of-brazil-death-in-vaccine-trial
Moderna’s vaccine trials are now fully enrolled; 1/3rd are minorities and 1/4th are over 65. They have over 30,000 participants and are set to begin new trials with new enrollment. The data from the first trials should be available in mid-November. https://www.washingtonpost.com/health/2020/10/22/vaccine-trial-moderna/
Pfizer has about 39,000 enrollees of whom about 34,000 have received their second shot. Results should be available the third week in November as well. They are working with a German company, Bio n Tech. https://www.washingtonpost.com/health/2020/10/21/vaccine-progress-coronavirus/
The Johnson and Johnson trials were halted last week when a participant became ill. They are expected to resume this week; there is no information yet on the participant’s illness. https://www.cnn.com/2020/10/19/health/johnson-and-johnson-vaccine-trial-transparency/index.html
We need to remember that the vaccine must be safe and effective as approved by the federal regulatory authorities. In this case, effective means 50% effective. So it’s not a cure all like for example the polio vaccine or the small pox vaccination.
FDA (Federal Drug Administration) has to approve the safety and efficacy of the Covid 19 vaccine. Participants have to be monitored for at least 2 months to assure they are disease and vaccine complication free. Earlier this month FDA reiterated its regulatory standards and authority to approve vaccines. https://www.fda.gov/news-events/fda-brief/fda-brief-fda-issues-guidance-emergency-use-authorization-covid-19-vaccines An Advisory Panel reviews the work and science of the vaccine manufacturer and its vaccine tests. The Head of HHS, Alex Azar and the White House are contemplating firing Dr. Stephen Hahn who heads up the FDA, but may wait ‘til after the election. https://www.politico.com/news/2020/10/22/azar-plans-oust-hahn-fda-431139
Once it is approved; it has to be manufactured and distributed and administered. https://www.npr.org/sections/health-shots/2020/10/16/924247360/facing-many-unknowns-states-rush-to-plan-distribution-of-covid-19-vaccines The distribution of the Moderna and Pfizer vaccines requires super cold storage throughout, and it will require two shots with appropriate spacing. The Johnson and Johnson vaccine does not require super cold transportation and storage and does not require two shots.
Who get the shots and when? They say “first responders (like medical personnel)” will be first, then high- risk persons (age and/or chronic diseases that make them high risk), then kids and parents, then everyone else. https://www.nationalacademies.org/news/2020/10/national-academies-release-framework-for-equitable-allocation-of-a-covid-19-vaccine-for-adoption-by-hhs-state-tribal-local-and-territorial-authorities and https://www.cdph.ca.gov/Programs/CID/DCDC/CDPH%20Document%20Library/COVID-19/COVID-19-Vaccination-Plan-California-Interim-Draft_V1.0.pdf Maybe the first shots will be around the Christmas holidays and the general population might get vaccinated next summer if all goes extremely well.
So keep wearing your masks, social distancing and no parties.
Prepared by: Lucien Wulsin
Dated: 10/22/20