Thanks ATL,
I think the regulators are clearly looking to approve in a multinational way, but that doesn't preclude one nation from acting first. Germany certainly seems intent on making the vaccine available, so if anyone were to act first, it would probably be Germany. To a degree, I believe the same can be said for the U.K. which with Brexit is free to act on it's own.
Frankly, I wish that the regulators were free to act on what's in front of their eyes. If they have been made privy to the data, why insist on the production of a BLA before the approval of something that is clearly benefitting a substantial percentage of those participating in the trial.
I know that in medicine things are done in the manner they've always been done, the question is why? If it's absolutely clear that something is working, why wait the many months, often years, that it takes to go through all the hoops established by the regulators. I know they're working on shortcuts, but they still take many months, and cost many millions. Where would we be with Covid-19 if they hadn't done the EUA, and having done the EUA and seen the results in hundreds of millions of patients, why can't they grant approval without spending millions to apply for it, and evaluate it. It seems to me that results should speak for themselves.
I cannot say how many people are saying, I won't take the Covid-19 vaccine until it's approved by the FDA, why not approve it now and end this objection. I believe that their are some who say, you cannot force a certain class of people to take it until it's approved, just get the approval out of the way for the vaccines that are clearly protecting tens to hundreds of millions.
Some times we do things in a traditional manner without asking why. I'm reminded of the story of the British teaching others on how to use a cannon properly. They had a four man team, each had a purpose. Each time the cannon was fired, one person raised their hands and brought them back down. When asked what that person was doing, they didn't know until they traced it back, that person had been part of the team since cannons were moved by horses, when the cannon was fired the horses would rear up, and he'd bring them back down. When the horses were eliminated, the person wasn't. I don't know if the British eliminated that person, but the other nation did.
Gary
