Quote:
Originally Posted by Byte1
I read today that the Pfizer Covid 19 vaccine has been approved in the UK. Apparently, it can't be approved here until the panel (death panel?) meets later this month, so they can discuss whether or not it is safe for the U.S. I am sure that someone is going to post on here that they feel it is necessary for the wait. Sorry, but to me it sounds like the delay is political and not science when our leader demands that it be released and the powers that be smile and say it won't be allowed to be released until they say it can be released.
I wonder if those that consistently say that "other" countries are handling the virus better than us, will change their minds and begin to defend those that are hindering the release of the vaccine to the populace. Maybe those "important" folks that are holding it up under pretense of having a full calendar, are waiting for the death toll numbers to peak at a certain level?
I wonder if Pfizer being able to start distributing the vaccine overseas will impact the ability to provide sufficient amounts to the U.S. when the death panel finally meets and decides to allow our folks to obtain protection from the virus.
Just a few thoughts. Red tape and politics seem to be the norm in this country when it comes to any progress in pharmaceuticals.
|
Each sovereign nation has the responsibility to review on its own terms, by its own standards, and by its own regulatory agency any application for a market approval of a new drug (vaccine) in that nation. The main component of that review is the clinical study conducted by the drug sponsor. Many other factors are involved in that review process such as the indications, contraindications, warnings and cautions, all this sometimes refered to as the IFU (indications for use) and labelling for the drug. None of this has anything to do with 'death panels'. The primary issues for the FDA are the safety and efficacy of the new drug. All these factors can be different in each country so both the date of submission of the sponsor's application and the length of time for review can be significantly different. None of this is a political matter. After regulatory approval the distribution and sequence of treatment will be conducted mostly a logical order based primarily on the sponsor's ability to manufacture and supply the vaccine.