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.
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.
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.
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."
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.
@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?
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.
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.
Seems pretty cool that out of the 6-8 top contenders, it looks like at least 4 are going to be safe and effective. That is great odds when the next pandemic hits. Hopefully they figure out how to shorten the timeline even further from this one.
An ominous but realistic prediction. 
Not really trying to be ominous, just realistic. Pandemics have played a large role in human history, thankfully we currently have tools that can help with pandemics we encounter. It is honestly a good time to be alive from the medical standpoint.
I think even the Moderna and Pfizer vaccines are supposedly less effective (though still reasonably so is my impression) against the new South African strain, which is already in the US…
With world travel the way it currently is, I think we can safely say that no country that allows for international travel without enforcing a 14 day quarantine on the way in is going to miss out on any of the possible variants. The two countries that have fared really well (Australia and NZ) have the benefit of a limited number of ports of entry to watch, and have been really strict on the 14 day quarantine into the country. I can’t see that being enforced in the US or Europe in any meaningful way.
So explain that J&J thing. It is not as effective, but because it does not require the extreme refrigeration and only requires a single shot, they are still going to roll that one out to us, right?
I think the fact that extreme refrigeration is not required means it will be easier to distribute in parts of the world that do not have the infrastructure support the others require.
I think the other part is that some people will only get one of their two shots. When you model a vaccine’s effectiveness (which is basically its real world performance, not the ideal efficacy in the trial) you probably have to account for the fact that a two-shot regimen won’t have 100% compliance. If like 10 to 15% of people don’t get their second shots, the effectiveness of the J&J and Moderna/PFizer might be similar.
Also, what the health department people care about at this point is severe disease and hospitalization. Transmission would be great to get under control with the vaccines, but we don’t yet know how much asymptomatic spread it’s going to stop and right now herd immunity is a ways off. All these vaccines are doing a decent-to-excellent job of stopping severe disease, so just getting more people vaccinated with anything will be better than nothing.
Well many vaccines aren’t nearly as effective as the Moderna and Pfizer ones. No flu vaccine is effective as those. It’s great that they are as effective as they are, and an amazing breakthrough in vaccine tech, but not the standard at which we judge vaccines to be effective or not. If it takes until late 2021 to get everyone one of the mRNA vaccines, we potentially save many lives by rolling out the J&J vaccine in the meantime. But it drives home the point that getting vaccinated does not mean a person can drop all precautions, especially given that they may well still be able spread the virus regardless of efficacy.
Also some people are being super weird about the mRNA thing and refuse to take it, so they could instead opt for the less effective, viral vectored one. I’d definitely prefer the mRNA one if given a choice, but would take whatever I can get first.