Coronavirus update - NO MORE RESTRICTIONS

[lisvaneblue]

At this point, we don't know if the UK is right or wrong in theory. They are wrong, though, to recommend a different schedule of vaccine roll out that is backed by zero data. As someone else said, this strikes me as an act of sheer brilliance, or a brave cock-up that, at worst, could see us suffer longer with the pandemic than other nations who are slower at vaccinating, but are following the schedules as tested in the clinical trials.

Everyday I get more depressed at the way our home governments are handling this crisis. What concerns me about the change of tack with vaccines is that what they are doing is unproven, and this mass vaccination programme, the biggest the UK has ever done is going against the recommended dose regimes of the manufacturers. The experts have defended the action by saying that the data supports a 12 week interval between doses. There is some evidence that it does for the AZ vaccine, although its not what AZ recommend. There is no evidence for the Pfizer vaccine. In clinical trials 52% get a response from first dose, but Pfizer or anyone else doesn't know how long it lasts as the second jab was given at 3 weeks and showed a 95% long lasting response. The Vaccine experts went back to the Pfizer data and said one dose gives a 90% response and they are confident it will last 12 weeks ( but no evidence).

The 90% figure was obtained by extracting from the data all those patients who tested positive or showed symptoms within 10/14 days after the jab as they would not have built up an immunity. In real life what they say is rubbish because there will always be people who will get Covid shortly after having a jab.

50 million people will be vaccinated in UK, we know both vaccines work well when given at recommended dose intervals. Yet we are going to do it on a wing and a prayer with an unproven dose regime. Lord help us

[Gofer Blue]

Everyday I get more depressed at the way our home governments are handling this crisis. What concerns me about the change of tack with vaccines is that what they are doing is unproven, and this mass vaccination programme, the biggest the UK has ever done is going against the recommended dose regimes of the manufacturers. The experts have defended the action by saying that the data supports a 12 week interval between doses. There is some evidence that it does for the AZ vaccine, although its not what AZ recommend. There is no evidence for the Pfizer vaccine. In clinical trials 52% get a response from first dose, but Pfizer or anyone else doesn't know how long it lasts as the second jab was given at 3 weeks and showed a 95% long lasting response. The Vaccine experts went back to the Pfizer data and said one dose gives a 90% response and they are confident it will last 12 weeks ( but no evidence).

The 90% figure was obtained by extracting from the data all those patients who tested positive or showed symptoms within 10/14 days after the jab as they would not have built up an immunity. In real life what they say is rubbish because there will always be people who will get Covid shortly after having a jab.

50 million people will be vaccinated in UK, we know both vaccines work well when given at recommended dose intervals. Yet we are going to do it on a wing and a prayer with an unproven dose regime. Lord help us

As I mentioned in an earlier post above, surely this constitutes an unlicensed use of a medicinal product? Who takes ultimate responsibility for this - normally it would be the physician who prescribes the medicine, but in this case....?

[Allez Allez Allez]

As I mentioned in an earlier post above, surely this constitutes an unlicensed use of a medicinal product? Who takes ultimate responsibility for this - normally it would be the physician who prescribes the medicine, but in this case....?

There is little doubt to me that, in mixing the vaccines, in elongating the time between vaccines and in doing both without clinical trial and evidence, that the Government will shoulder the responsibility should things go wrong. The worst situation would be that we have a sizeable proportion of the populace vaccinated, but would have to go back to square one should the approach result in a lower efficacy rate for either/both vaccines meaning that a large proportion of the vulnerable are no longer immune as a result of the divergence.

This isn't a political comment, but imagine if we suddenly saw England needed to buy another 100 million doses in 4-6 months because this untrialled approach only provided short term immunity. This looks to be a desperate stab in the dark, and I am now starting to wonder if there are things bubbling under the surface (e.g. higher mortality with the new strain, more mutations, the emergence of a strain that is no longer covered by the vaccine) that is forcing the Government to act
a) unscientifically
b) unilaterally

[lisvaneblue]

As I mentioned in an earlier post above, surely this constitutes an unlicensed use of a medicinal product? Who takes ultimate responsibility for this - normally it would be the physician who prescribes the medicine, but in this case....?

Yes it does seem to be use of an unlicensed medicine and to the best of my knowledge the prescriber is still responsible as they know they are acting outside of the license. Further the government is blatantly advertising this unlicensed use.

Ive written to our minister of health in Wales and asked that he ensures when patients are offered the Pfizer vaccine they are told ahead of the jab that it is not being given in accordance with the manufacturer's protocol, that the 12 week dose schedule is unproven, although experts believe it should be effective.

The strategy being adopted for a mass vaccination programme is flawed. There is pressure to get mass vaccination done and in the rush the basics are being swept aside. This is all to make use of a 8/9 week window where those patients who should be returning for a second jab are being displaced by those needing a first.

After that period there is no gain and all risk as the population of the UK is being given an unproven schedule. And worse that window is already being lost. 1m people vaccinated in 20+ days indicates a lack of urgency, and another day lost yesterday. Seems we only have a pandemic 5 days a week.

[lisvaneblue]

As I mentioned in an earlier post above, surely this constitutes an unlicensed use of a medicinal product? Who takes ultimate responsibility for this - normally it would be the physician who prescribes the medicine, but in this case....?

I had a look on the MHRA website. There is no Marketing Authorisation as it is an emergency approval. The product information now says second jab 'after 3 weeks'