FUDiabetes

COVID-19 Vaccine Info

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Can someone elaborate on the difference between the current emergency usage approval and an FDA fully-approved vaccine? Several months ago my endo suggested it would be prudent to wait for either full approval, or wait 3-months after the start of public administration to see if there are relatively rare but serious side effects that show up with widespread use. Now that the CDC is advising the states to open vaccination to a broader spectrum of the public, whether to wait 3 months (mid-March) is becoming a real question.

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That’s a really good question! All I can say is that my husband has gone ahead with the vaccine (retired physician but still on staff) and just got his second dose. He has a different autoimmune disorder but reviewed the evidence and felt confident proceeding.

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I wouldn’t worry about waiting 3 months; in a month I’m guessing 20+ million people will have been vaccinated and rare side effects will be readily apparent.

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I found a plausibly trustworthy Q&A article that tells me when to trust a covid vaccine. The bottom line answer for me seems to be to wait 6 weeks after the start of widespread distribution. In other words, maybe wait until February.

The tidbits of interest to me are these.

The current vaccines have an EUA (emergency use authorization) rather than an approved BLA (biologics application). Usually an EUA would require the FDA advisory committee to judge that the vaccine may be effective, and evidence shows that it’s safe enough to declare the benefits outweigh the risks. But for the COVID vaccines, they used a higher standard, almost equivalent to the BLA, namely that at least one proper phase 3 clinical trial shows safety and efficacy in a clear and compelling fashion, plus at least 2 months of post-trial data on at least half the trial population. (For a BLA they normally require 6 months of post-trial data to show safety and effectiveness.)

And this: “ ‘When vaccines cause serious and occasionally fatal adverse events, they invariably occur within six weeks,’ said Offit, who serves on the FDA’s advisory committee."

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If you are able to get a vaccine before Thanksgiving, more props to you! I’m thinking it’ll be months and months for most people my age, although I’m keeping my fingers crossed that my 82-year-old dad and 74-year-old mother can get it in the next month.

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@TiaG California (I’m assuming your relatives are there, apologies if not) just opened up Tier 1b phase 1 and lowered the age requirement to 65. They expect to open Tier 1b phase 2 in late Feb.

T1 diabetics are now listed in California as Tier 1c so possibly early Spring?

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In Montana, our original vaccine schedule, announced by at the time Gov. Bullock, was: “Phase 1b includes an estimated 90,000 Montanans, such as persons aged 75 years old or older, frontline essential workers, those residing in congregate care and correctional facilities, and American Indians and other people of color who may be at elevated risk for COVID-19.”

“Phase 1c are those aged 65 years and older, person aged 16-64 at high risk due to underlying medical conditions, along with essential workers.”

So, people of color had priority over white people with underlying medical conditions. And whites with medical conditions were of no higher priority than everyone 65 years plus. I was shocked when I read it. Sound racist to you?

Fortunately, newly elected Gov. Greg Gianforte has revised the schedule. Phase 1b now prioritizes people over 70 years of age and those with specific medical conditions. Essential workers including first responders, teachers and grocery store clerks have been reassigned to Phase 1c.

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A local tribe donated the excess from their allotment to the locals over age 65. Sequim is basically a retirement community. The tribe was not subject to the delay imposed by WA before seniors (70+ per WA) are allowed to get vaccinated. The tribe made the right call.

The rest of the state needs more local leadership to step up like the tribe did.

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