What are the odds?

[BrotherJJ]

What do you believe the odds are, that the FDA, will authorize this treatment here in the USA?

I'll start with slim to NONE.

New patent-free COVID vaccine developed as “gift to the world” (newatlas.com)

 

[essentialsaltes]

Have they submitted to the FDA for approval?

 

[Subduction Zone]

Have they submitted to the FDA for approval?

The Washington Post has an interesting article from December 30th on it. It sounds promising. There is a lack of clinical data on it. But I guess it is good enough for India right now.

 

[Ponderous Curmudgeon]

What do you believe the odds are, that the FDA, will authorize this treatment here in the USA?

I'll start with slim to NONE.

New patent-free COVID vaccine developed as “gift to the world” (newatlas.com)

I somehow doubt that they are even interested in spending the money on FDA approval but would rather aim at WHO approval.

 

[Nithavela]

Any fetal stem cells used in the development or testing?

 

[ThatRobGuy]

Well, the tricky part with this vaccine is that they'll likely to have to re-run their tests to gauge efficacy against Omicron (they were testing it against Delta), and based on other articles, it can't be modified as quickly to adjust to new variants should that need ever arise.

There's likely not any significant safety concerns with it, but with regards to whether or not it would be approved for use in the US, there really wouldn't be much of a point in the US of using up the FDA and CDC's time reviewing a 4th vaccine, when we already have 3 approved ones, they're no-cost to the US citizens who receive them, and we don't have a shortage.

It would likely be a lot of time & effort involved to get it approved for US use, and for what? So vaccine-hesitant folks could have a 4th kind they'd also refuse to take?

Doesn't make sense to introduce a 4th vaccine option (in a country that already has 3 decent options, and literally had such a large surplus, that we were having to throw millions of them away because people were refusing to take them)


I think they should just stay the course with what they're currently doing with this one, which is tailor this to be a solution for low-income countries that desperately want more vaccines, but can't afford the current options.

 

[Subduction Zone]

Well, the tricky part with this vaccine is that they'll likely to have to re-run their tests to gauge efficacy against Omicron (they were testing it against Delta), and based on other articles, it can't be modified as quickly to adjust to new variants should that need ever arise.

There's likely not any significant safety concerns with it, but with regards to whether or not it would be approved for use in the US, there really wouldn't be much of a point in the US of using up the FDA and CDC's time reviewing a 4th vaccine, when we already have 3 approved ones, they're no-cost to the US citizens who receive them, and we don't have a shortage.

It would likely be a lot of time & effort involved to get it approved for US use, and for what? So vaccine-hesitant folks could have a 4th kind they'd also refuse to take?

Doesn't make sense to introduce a 4th vaccine option (in a country that already has 3 decent options, and literally had such a large surplus, that we were having to throw millions of them away because people were refusing to take them)


I think they should just stay the course with what they're currently doing with this one, which is tailor this to be a solution for low-income countries that desperately want more vaccines, but can't afford the current options.

As you said the rest of the world needs to be vaccinated and we do not need to be pushing up the price for the rest of the world. I am hopeful for this new vaccine.