Biotech Values

[IanFromSI]

Normally we listen to the FDA. This should decisively end the discussion given that both the FDA and the Supplier are in agreement. However, I doubt that it will. Sadly.

BRIEF-FDA Statement On Following The Authorized Dosing Schedules For COVID-19 Vaccines

2021-01-04 07:46:40 PM ET (Reuters)


Jan 4 (Reuters) -

* FDA STATEMENT ON FOLLOWING THE AUTHORIZED DOSING SCHEDULES FOR COVID-19 VACCINES

* FDA SAYS "TWO DIFFERENT MRNA VACCINES HAVE NOW SHOWN REMARKABLE EFFECTIVENESS OF ABOUT 95% IN PREVENTING COVID-19 INFECTION IN ADULTS"

* FDA - "SUGGESTING CHANGES TO THE FDA-AUTHORIZED DOSING OR SCHEDULES OF THESE VACCINES IS PREMATURE AND NOT ROOTED SOLIDLY IN THE AVAILABLE EVIDENCE"

* FDA - AVAILABLE DATA CONTINUE TO SUPPORT THE USE OF TWO SPECIFIED DOSES OF EACH AUTHORIZED VACCINE AT SPECIFIED INTERVALS

* FDA-FOR PFIZER-BIONTECH VACCINE, INTERVAL IS 21 DAYS BETWEEN 1ST & 2ND DOSE; FOR MODERNA COVID-19 VACCINE, INTERVAL IS 28 DAYS BETWEEN 1ST & 2ND DOSE

* FDA- "WHAT WE HAVE SEEN IS THAT THE DATA IN THE FIRMS’ SUBMISSIONS REGARDING THE FIRST DOSE IS COMMONLY BEING MISINTERPRETED"

* FDA- UNTIL VACCINE MAKERS HAVE DATA SUPPORTING CHANGE, WE CONTINUE TO STRONGLY RECOMMEND HEALTH CARE PROVIDERS FOLLOW FDA-AUTHORIZED DOSING SCHEDULE