Florida is completely screwing up vaccinating its older population. Lee County set up 7 distribution sites with 300 doses each and told everyone it was first-come-first-serve. That led to seniors lining up at the sites the day before and camping out overnight and sites running out of doses early in the day. Lee County has something like 250k+ people over 65 and they didn’t foresee problems with this plan 
I must apologise - I have been caught out by the speed of events in my specialist area.
When medicines agencies assess a medicine, they produce an Assessment Report; and, after due consultation with the medicine developer (essentially to agree what is commercially sensitive information which should not be published), release a version to the public (a Public Assessment Report, natch.)
Regarding the Pfizer vaccine:
The (UK) MHRA surprised me because I didn’t think they would publish a PAR for a drug which, after all, they haven’t actually licensed (it’s available on an emergency temporary basis). I can only assume that because of extraordinary public interest (or somesuch) they have done so. Here (PDF warning) is the UK PAR.
The EMA (EU), on the other hand, have granted a licence (Marketing Authorisation) - just over a week ago, and were able to more or less simultaneously issue a PAR (!). Once again, PDF warning, here it is.
The two reports represent two separate assessments of (pretty much) the same data package. The EMA report is the more comprehensive.
I haven’t looked through these yet - I’ll take a look when I get the chance - but they offer an insight into the development program of the drug and the thinking of the regulatory agencies.
j
PS: here’s a US review document - not the Summary Basis for Approval that I’m used to, but that may be because it’s an emergency use approval, strange times and all that. There’s entertainment to be had from spotting the cut-and-pastes from the sponsor’s data package. For example, Figure 2 (page 29) I recognise from one (or possibly both) of the PARs posted above. (It’s eye catching because of how well it illustrates onset of protection after the first dose).
j
My sister lives in FL and is saying that out-of-state seniors are also getting vaccine doses that were intended for (and based on) Florida resident populations, so she’s concerned about those doses not getting to her age group in a timely manner because of that. I don’t know the facts on this, though.
Considering the number of senior snowbirds in Florida, they probably should have based the number of doses on that. If they are in Florida now, what are they supposed to do? Undertake risky travel back to their home states? (I realize that some of them may have previously traveled during the pandemic to get there.)
Another Republican politician has COVID.
Agreed. I have no idea how doses were actually allocated, but doses distributed in December ought to have been based on expected winter residency, not legal voting residency.
Is that an easy number to figure? Especially this year when at least some snowbirds would have stayed home.
Every half-way competent government has an idea of the size of the major industries in its area. Just as the government of Florida ought to know about how many doctors and school children they have, they ought to know about how many winter residents they have.
In the interim, a pit thread.
“(CNN)Florida’s county-by-county plan to vaccinate its elderly population has created a mass scramble for a limited number of doses, leading to hourslong lines at vaccination sites and overwhelmed county hotlines and websites.
In southwest Florida, the Lee County Department of Health encouraged anyone 65 and older and high-risk frontline health care workers to come to one of seven vaccination sites. Each site had just 300 vaccine doses, and “no appointment is necessary,” the county said.
The first-come, first-serve plan led to huge lines forming overnight Tuesday as people camped out on lawn chairs and waited for hours.”
As linked above, “First come, first serve. Line up if you want one!” sounds like the plan.
Each state is making its own plan. I doubt my state will do that. They certainly haven’t, yet – so far all the vaccine in my state has gone to medical providers and nursing-home residents in a mostly orderly way.
But I don’t know what my state WILL do. I know we have three big tiers, each of which is further prioritized. The first tier is medical workers and nursing home residents (approximately) and because those groups tend to cluster and be easy to identify, that tier should be pretty straightforward. The third tier will be “everyone else”, and depending on whether they plan to prioritize it, it might involve first-come, first serve, but that tier is not supposed to open up until there’s enough vaccine for everyone who wants it.
I’m wondering about tier 2, mostly, which is non-covid-facing healthcare providers, essential workers, people with co-morbidities, and those who are older. That tier is supposed to be prioritized, but I have no clue how it will be administered. My mom will be in that tier, though, and I will be responsible for getting her to a vaccine provider, and I want to make sure she gets her spot in line.
This is the plan in Texas (so far):
https://dshs.state.tx.us/coronavirus/immunize/vaccine.aspx
I don’t think it’s fair to expect them to know the volume of winter residents this year. They’d have an idea of a normal year but it’s not like snowbirds register when they arrive in Florida.
I wouldn’t fault them if their estimate was off, or based on last year.
I mean, how do they know who “lives there”? It’s much the same problem.
“These” being the med agency assessment reports for the Pfizer covid vaccine.
OK, so I skimmed the EMA report (ie, the EU one). Some highlights from the assessment - page number and notes.
P8 – it’s a conditional Marketing Authorisation [MA]. This is a proper MA, but (obviously) with conditions, like having an ongoing obligation to provide additional clinical information and frequent review of risk/benefit – this type of MA is used to urgently address an unmet medical need. (See detail in Type of Application and aspects on development, P13; examples bulleted on P36 et seq; see also P140)
P9 – this was a rolling review (you send it when you got it and we’ll look at it straight away). First case of this I have seen (but not the last, I would imagine).
P27 - Shipping validation includes
The selected shipping methods include shipping containers designed to maintain product temperature through a combination of insulation and dry ice. The applicant has prior experience with these passive thermal conveyances and has demonstrated that they maintain the -90 to -60 °C temperature range during product shipments, including minor shipping delays and short exposures to extreme temperatures occasionally observed during shipping and handling. All shipments are continuously monitored using temperature data loggers.
P31 – there’s a recommendation for the applicant to investigate whether storage at higher temperatures is possible – it may be that the development program was overcautious with storage temperatures. Also, could the in-use storage times (before dilution, when the product is being stored at regular fridge temperatures) be extended beyond 5 days?
P82 – great graph showing onset of protection. Very striking visual representation of the result.
P95 – efficacy across subgroups
For both primary endpoints, no clinically meaningful differences in VE [vaccine efficacy] by subgroup were observed by age group, country, ethnicity, sex, or race in the dose 2 evaluable efficacy population, with VE estimates that ranged from 91.2% to 100.0%. Efficacy was consistent across relevant subgroups.
The report then emphasises the importance of the finding of good VE in the >65 population. Likewise >75, but with small subject numbers; and for >85 the subject numbers are too low to confidently say anything much at this stage.
P96 – pertinent to the new variant covid, at the time of application no genome sequencing of virus samples collected during the clinical study had been carried out (but this is planned going forwards).
P97 – because this is a conditional MA granted on the basis of a submission made much earlier in the development program than is the norm, the pivotal study is continuing in order to provide further efficacy (and safety) data, and the final report must be submitted by December 2023. This is a specific obligation of the MA.
P114 – safety evaluation
The safety evaluation is based on one ongoing Phase 2/3 study that at the time of data cut-off (14- Nov-20) included 43,448 subjects who received either two doses of BNT162b2 30µg (n=21 720) or placebo (n=21 728). Overall, the reported reactogenicity profile are in line with any authorised vaccine. In addition, the frequency of reported AEs and SAEs [Serious Adverse Events] were low. The emerging safety profile is presently considered favourable. Long term safety data, interaction with other vaccines, data on use in pregnancy and other subgroups (e.g. frail subjects, or subjects with pre-existing autoimmune diseases) are missing at this stage.
This is to be resolved by a 2 year follow-up on the study population. Wiki page on reactogenicity.
P117 – proposals by the applicant to ensure traceability include using tracking devices on every shipping container. These will log 24/7 and in real time the GPS location and temperature.
P118 et seq - describe post-marketing safety follow-up activities. Very comprehensive, as you might expect.
P127 - in a step I have never seen before, the US packaging may be used in Europe until Feb 2021. There is then a period where EU packaging in English only will be used until Q2 2022; and after that regular EU packaging (in all member state language versions) is to be used.
There are also other derogations.
j
But not really. Florida residents pay taxes, have Florida driver’s licenses/cars, go to school and a bunch of other ways to help estimate the population. Most snowbirds own a condo or trailer and just show up and start living there for some individually chosen time period.
In 2005, the number of senior snowbirds was estimated at 800,000. I’m sure by 2019 it would have been well over a million. While it’s certain that the pandemic reduced migration this year, it would have been prudent to assume several hundred thousand non-residents would be present in Florida this winter.
But generally wouldn’t snowbirds choose to have a Florida residence so as to avoid state income tax? Whether they legally should be considered Florida residents is another matter entirely, but my impression is that people with property in both Florida and a northern state would make Florida their official address.
I bet there are at least three ad agencies who have a really good idea what the usual snowbird numbers are, divided out into income levels. They may have a decent estimate of current snowbird numbers.