After a few years of doctors telling me to get it I finally got the flu jab for the same reasons you’ve stated. I doubt I’ve ever had the flu as I believe you KNOW when you’ve had it.
We’ll probably be rolling out one of the Covid vaccines early in the new year and as a result of our good friends😉 across the Irish Sea offering to do a trial run, most of us here will see by Feb / March that short term this should be OK.
I think I may be in the at risk group so will probably be offered it sooner rather than later but seen as the wife and kids aren’t at immediate risk we’ll discuss them getting it if I haven’t dropped off after a period of time.
My understanding is that Pfizer’s trial tested the hypothesis that the recipients would not contract the virus at all, so my presumption is that no contraction means no contagion. The Moderna trial appears to test something different, allowing for the possibility of cases but preventing harm. You aren’t missing any data, I may be missing some sort of qualification on the part of Pfizer about asymptomatic cases.
Wow - I did not realize Ireland was so well placed in the queue for either Pfizer or Astra-Zeneca. The Moderna one is basically spoken for by the US until around March.
Really? That seems like a massive oversight, given the likelihood of how serious of a vector they are. I had assumed that there was a ‘test-out’ protocol for the subjects.
The European Union has criticised the UK’s rapid approval of Pfizer and BioNTech’s Covid-19 vaccine, saying its own procedure was more thorough.
The move to grant emergency authorisation to the Pfizer/BioNTech was made under an ultra-fast, emergency approval process.
It allowed the British drugs regulator to temporarily authorise the vaccine only ten days after it began examining data from large-scale trials.
In an unusually blunt statement, the European Medicines Agency (EMA), which is in charge of approving Covid-19 vaccines for the EU, said its longer approval procedure was more appropriate.
It said it was based on more evidence and required more checks than the emergency procedure chosen by Britain.
The agency said yesterday it would decide by 29 December whether to provisionally authorise the vaccine from US drugmaker Pfizer and its German partner BioNTech.
A spokesman for the European Commission said the EMA’s procedure was “the most effective regulatory mechanism to grant all EU citizens’ access to a safe and effective vaccine”, as it was based on more evidence.
Given this criticism, should we, in the UK, be concerned at the haste with which the vaccine has been approved for use?
I don’t mean we’ll have had it by Feb /March, just that by then we may see the short term results from the UK but i’m just going by the news, more still to do but I think we’re down for 5 different vaccines at this point, hedging our bets. Most of the stuff is made here anyway.
I think there is going to be only one way that becomes obvious…
I am somewhat puzzled, I thought that EU approval was still nominally required in the UK until 12/31 - is that not the case for Emergency Authorization?
Under EU rules, the vaccine must be authorised by the EMA, but individual EU memeber states can use an emergency procedure that allows them a temporary dispensation to distribute and use a vaccine.
Yeah, me too, I was fairly suprised when I read/heard that and have been trying to find out more about it since then. All I got so far is that it wasn’t part of the studies/trials and we’ll learn more about it as we go along…
Canada has the largest portfolio per capita in the world, and a government that is happy to tell you that as an answer to the ‘when’ question. What I was surprised to hear was Ireland having that much access that early - I had assumed Ireland was going to rely largely on EU level distribution in the early going, but the timetable you suggest is roughly comparable to the one the US is setting out. Canada right now will be 50% perhaps 10 months from now.
Prior to Brexit the regulatory process for approving a biotech product in the EU was mind bendingly confusing and beurocratic. While some products had to be submitted through the CHMP at the EMA for full centralized EU approval, most were given the option of going through them or going to a specific country’s regulatory authority. the latter was typically a much quicker and stream lined process than going to central approval, and given that the EU countries applied universal reciprocity, approval by the MHRA in the UK more or less granted full EU wide approval as well. Had Pfizer have submitted this through the CHMP at the EMA I’d expect them to still be discussing among themselves who should be the rapporteur.
I’m not sure how vaccines fall into this (very possibly a category that needed centralized CHMP approval) or how Brexit has changed that, but my overall point was I would expect that if a regulatory pathway existed for the MHRA to approve this vaccine then I would expect them to do it as routine quicker than the CHMP would.
Ah, that is closer to my understanding - might see healthcare workers vaccinated by then or earlier, but general availability will take longer.
In my state of irritation at the lack of simple clear answers, I do try to remind myself that you could find credible discussions in June suggesting that an effective vaccine might not be possible.
All of the efficacy endpoints in their trial refer to COVID-19 rather than infection or cases. This means they following up with those who claim to be symptomatic and then confirming the presence of COVID in those people and counting that as a case of COVID-19. So like you said, no standardized way of checking for non-symptomatic infection.
Eric Topel, one of the main reviewers at the FDA’s Vaccine Advisory Board made a significant criticism of these design decisions when it first came to light. I’m pretty sure it is the same with Moderna.
Cheers. Confirms what I had thought and found in the German media/experts.
I’m somewhat surprised how little coverage this is getting, as it might prove to be quite consequential. Essentially it means that people who have been vaccinated will have to behave more or less the same as before (to protect others) until we know more about it. Will be interesting to see if people take that to heart though.
I dont know enough about this to debate you properly. I just wrote something from memory. You undoubtedly know the details better than me on this particular issue so I wont say anything against what you write. Previous to corona, I wasnt that interested in vaccines etc. I prefer not to say anything for fear that I may write something that isn’t correct.
