NIH questions AstraZeneca trial data, calls it 'incomplete'

[brooklynite]

Source: Washington Post

British-Swedish pharmaceutical firm AstraZeneca may have only used partial data when it announced the results from a U.S. trial of its coronavirus vaccine, the National Institute of Allergy and Infectious Diseases said Tuesday in a highly unusual rebuke.

The agency, part of the National Institutes of Health, said in a statement that it was concerned AstraZeneca used outdated information from the large-scale trial when it reported the results Monday, “which may have provided an incomplete view of the efficacy data.”

It urged the company, which developed its vaccine with Oxford University, to work with the U.S. Data Safety and Monitoring Board to review the data and release the updated information “as quickly as possible.” AstraZeneca had said Monday that the vaccine was shown to be 79 percent effective against symptomatic covid-19 — and that it was 100 percent effective against severe illness.

Scientists are describing the reaction as unusual and unprecedented for the agency.

Read more: https://www.washingtonpost.com/nation/2021/03/23/coronavirus-covid-live-updates-us/

[genxlib]

1. Here is my take

I don't think the US will ever approve this vaccine.

They should and would if it was really necessary.

But the other three are coming on board so fast that we will be largely over the hump by the time it could gear up and have any impact anyway.

But it will be so controversial that it would cause all kinds of stress. So I think we will end up just moving forward with the ones we have.

But rather than reject it outright, we are going to just string it along and run out the clock.

We are walking a fine line. We will keep it out of our vaccine mix without generating so much negative feedback so that it is still seen as valid elsewhere.

In the end, we will end up donating our share to COVAX and work with what we have.

To be clear, I don't think there is anything wrong with this vaccine. But I think it has been tainted with enough bad news that it just becomes problematic. There are all kinds of things about the above scenario that stink. First and foremost the idea that we can send something that we deem substandard to the poorer parts of the world. I don't like it but I think that is what will happen.

[Sgent]

2. AZ hasn't forced the issue

and asked for approval yet. They might choose to do so in the next month or two when they try selling it to Africa / S America just to have a FDA stamp of approval -- but I agree that I doubt they distribute it here. Biden also just "lent" Canada and Mexico millions of doses of the vaccine to speed up their immunizations since its used in those countries.

[genxlib]

3. You may be right

I had been thinking that it was a contract delivery issue. In other words, AZ did not submit for approval because it would have triggered the need to deliver on contracted doses. With the rollout going on in other Countries, I wondered if they might be running short and did not have the doses set aside for us. Delay of an application for approval effectively let them forego that delivery to us while they delivered on other contracts.

In hindsight, it might have been that they could see the writing on the wall that they might not get approved here. It would be better for them to not submit than to get rejected.

[LisaL]

5. They wouldn't be rejected if their data was solid, would they?

NT

[LisaL]

4. When the data was first released, Fauci was very positive.

But apparently, the data released was until Feb 17, yet presented as a complete data. I don't think USA had plans to not approve the vaccine. There is no giant conspiracy theory.

"Early Tuesday, Dr. Anthony Fauci, head of the government agency that released the information, said on Good Morning America the company released data available only through Feb. 17, while presenting it as if it were current information."
https://www.usatoday.com/story/news/nation/2021/03/23/us-astrazeneca-vaccine-trial/6962385002/