COVID Vaccine !

[lane]

It is sobering to be constantly reminded, at the briefings and elsewhere, that despite having come so far so quickly, there is so much we still don't know.

 

[Ajax Bay]

Are these emergency authorisations? I thought the EMA had so far issued the more-stringent conditional authorisations, not emergency ones like the UK MHRA.
Apparently based on nothing

@roubaixtuesday is the expert on this area, I think. I don't know if this is primarily terminology (see his earlier post on this, and the governance of medicines regulation EMA/MHRA). I wonder whether "more-stringent conditional authorisations" are the best approach for a pandemic emergency. Happy to back the UK approach here.
I've answered the 'completely incorrect' aspect and its basis in my post above.

 

[roubaixtuesday]

@roubaixtuesday is the expert on this area, I think. I don't know if this is primarily terminology (see his earlier post on this, and the governance of medicines regulation EMA/MRHA). I wonder whether "more-stringent conditional authorisations" are the best approacch for a pandemic emergency. Happy to back the UK approach here.
I've answered the 'completely incorrect' aspect and its basis in my post above.

UK approval is "Temporary" - available to member states when they deem it necessary for public health regardless of EMA review - there does not even have to be any EMA review of the data whatsoever for this. Hungary have said they will do this for the Russia vaccine, I believe, which is not being reviewed by EMA at all.

EMA approval will be "conditional" for the whole EU - conditional on completion of further studies. A routine procedure for areas of high unmet medical need eg if a company has very good early data on a cancer drug, it might get conditional approval.

Full approval will not be given yet.

"Emergency" is often used interchangeably with either or both of the above, unhelpfully.

 

[winjim]

"AstraZeneca’s main trial in Britain started testing on adults no older than 55 because it initially focused on healthcare personnel and front line workers in active duty." [Comment: Because AZ knew that those trial participants (like @winjim maybe) were more likely to be exposed to the virus and therefore the trial requirement (volume of infections in the placebo group) could be met in a shorter time frame.]

I had already volunteered but we got an email at work asking for participants. We also only signed up for a single dose initially but they changed the study protocol part way through.

 

[lane]

It does seem in some ways the Oxford trial data is inferior to the others. Or at least more questions.

 

[Milkfloat]

I would love to see some up to date figures on who is getting the vaccine. I know locally at least 5 people in their 40s with no clinical need who have had their first dose. A couple of NHS backroom staff who work from home almost exclusively and a 3 volunteers at a local vaccination centre. One of them even called me up and offered a dose if I could get down within the next 30 minutes. Surely, like flights they could just overbook by a small percentage rather than dragging randoms off the street.

 

[lane]

The German government has challenged reports of a lower-than-expected efficacy rate of the AstraZeneca vaccine for older people, while reiterating concerns about the British-Swedish pharmaceutical giant’s data reporting.

A later statement by the German health ministry suggested that the report had mixed up the efficacy rate for over 65s with the number of seniors involved in AstraZeneca’s trials.

“At first sight it appears that two things have been muddled in the reports”, said the statement. “Around 8% of participants in the AstraZeneca efficacy trials were aged between 56 and 69 years old, only three to four percent were over 70. This does not result in an efficacy of only 8% among seniors.”

But the German government also voiced concerns about AstraZeneca’s data reporting: “It has been known since the autumn that fewer seniors were included in the trials supplied by AstraZeneca than the trials of other manufacturers.”

Scientists have previously raised questions about the representative value of AstraZeneca’s trial design.

https://www.theguardian.com/world/2...es-astrazeneca-covid-vaccine-efficacy-reports

 

[Ajax Bay]

I would love to see some up to date figures on who is getting the vaccine. I know locally at least 5 people in their 40s with no clinical need who have had their first dose. A couple of NHS backroom staff who work from home almost exclusively and a 3 volunteers at a local vaccination centre. One of them even called me up and offered a dose if I could get down within the next 30 minutes. Surely, like flights they could just overbook by a small percentage rather than dragging randoms off the street.

I understand that Head NHS addressed this head on last week. He said that all centres should assemble and maintain a list of eligible (ie over 80s or others in Groups 1 and 2) who could be called on at short notice to come and take a vaccine, at the end of each day. And that that list should NOT be randoms: it needed to be people in Groups 1 and 2 (maybe implied at a stretch people from Groups 3 and 4). NB This will be easier with the increased and independent mobility of O/75s.
There is a natural and proper reluctance not to 'waste' doses (so give them to whomever we can 'get in'), but there are also communication/PR issues if this is not handled as well as it could be. I guess the additional effort to do that has to be balanced against everything else to make the campaign a success. The numbers vaccinated outside the first 4 groups will be miniscule, but each of those allows a 'look at what's going wrong' story (which I know was not your thrust, @Milkfloat ).
Part of the framework is that (talking GP surgeries here) primary care go out of their way, year in, year out, to look after people. So the idea of inviting a surplus to attend (aka overbooking) and then turning a few away at the end of the day (or when supplies run out) is an anathema. You'd never do that in normal times. But better that all the doses available go into O/70 arms and a few are disappointed each day (with a stab promise the following day I suggest), than doses are wasted, heaven forbid disposed of (which Head NHS did not suggest).
Note for my GP surgery: I can ride down to you in about 3 minutes with 3 minutes warning. You have my phone number.

 

[lane]

Is there a policy on volunteers working at vaccination centers getting vaccinated. There was an MP on the news the other day - in his 40s - getting his. Working at a vaccination centre and said it was to encourage others to get the vaccine.

 

[newfhouse]

Is there a policy on volunteers working at vaccination centers getting vaccinated. There was an MP on the news the other day - in his 40s - getting his. Working at a vaccination centre and said it was to encourage others to get the vaccine.

“Volunteer” may be overstating his involvement. It seems he spent an afternoon there and there’s a vague hint that he may consider offering another couple of hours now he’s been caught out.

 

[vickster]

Is there a policy on volunteers working at vaccination centers getting vaccinated. There was an MP on the news the other day - in his 40s - getting his. Working at a vaccination centre and said it was to encourage others to get the vaccine.

They use left over Pfizer doses rather than wasting them is my understanding from a friend who has been vaccinated (she’d be in group 6 I believe). She has done at least 4 shifts and has been a very active volunteer since last spring (doing lots of shopping for shielders etc)

I don't understand why non clinical non frontline nhs staff who work at home are being called in and not just being used to mop up and avoid waste?

 

[lane]

There does seem to be lack of transparency in all this.

 

[vickster]

There does seem to be lack of transparency in all this.

In what?

 

[mjr]

There does seem to be lack of transparency in all this.

In how the unexpectedly-unallocated doses are being used?

I suggest it is inevitable in such a large fast rollout. Personally, I am fairly relaxed with a "jab now, punish later if needed" approach if some centres are found to have strayed from the now-stated more-doses-than-booked-patients approach and been phoning friends.

No-one will thank anyone if doses are dumped when they could have been used.

 

[BoldonLad]

People from Nottingham beings sent to Boston and those from Derbyshire to Birmingham, which is surprising because Derby has a large vaccination centre at the velodrome.

I have no idea if this is true of not, but, eldest daughter, (Senior Practice Nurse in GP Surgery), who, in addition to her day job, is working one (midweek) day, and Saturday/Sunday doing vaccinations, tells me that, some appointments are being arranged by GP's, these are directing people to local vaccination points, other appointments are being sent out to PHE, and, these are directing people all over the place.