Vaccinated America Has Had Enough

[BumRushDaShow]

51. Actually re: this--

It was the FDA's decision to not go through the OFFICIAL AUTHORIZATION process, but to release the vaccine on an EMERGENCY AUTHORIZATION basis.

The "official authorization" process for vaccines normally takes several years (definitely not 6 months), which gives time for firms to set up and carry out various trials and then compile and submit their efficacy and safety data to the various Vaccine Committees for review (and later, discussions, including answers to questions from Committee members). The best practices look to having at least a year or more of data in order to also uncover and track any long-term issues, post-vaccination. The minimum efficacy goal is at least 50% effectiveness.

But in situations like this when you have a severe global pandemic, they will go ahead and authorize vaccines (or other drugs) for "Emergency Use" in an abbreviated process, because of a health emergency and no other product out there shown to be effective. And in this case, the firms had already started trialing their vaccines, and with about 6 months of data, were able to apply for the authorization, with the expectation that their trials would continue for the rest of a trial period (a year or more), when they could submit their final data to get full authorization.

It's been anticipated that at least Pfizer and Moderna will present their final data and seek the full authorization some time this fall (and I *think* they were considering whether to also include any data for use of boosters and/or updated versions of their entities too).

Regarding the Defense Production Act, it was invoked - https://www.npr.org/sections/health-shots/2021/03/13/976531488/defense-production-act-speeds-up-vaccine-production

But then you might recall this issue - https://www.baltimoresun.com/coronavirus/bs-hs-emergent-vaccine-halted-20210419-jebhmgem4jcidmo3pxptk7c46y-story.html

There was an initial House Oversight Committee hearing in May and I believe they anticipate meeting again because they didn't get all the documents requested the first go around. Some quick highlights of that -

Using that Act for manufacture of a biologic is not like using it to construct certain devices such as ventilators (where the Act was invoked and subsequently, an extreme excess of them were made and now sit fallow because they are not really the right kind - https://www.reuters.com/article/us-health-coronavirus-ventilators-insigh/the-u-s-has-spent-billions-stockpiling-ventilators-but-many-wont-save-critically-ill-covid-19-patients-idUSKBN28C1N6)