Covid vaccines consultation

I have put my name forward for trialling the Oxford vaccine.

Furret

I have put my name forward for trialling the Oxford vaccine.

That is so admirable!

I’m too frightened as DH is high risk and I feel too anxious about possibly passing it on. I know it doesn’t make sense, but there you are.

It is not uncommon for dispensations to be sought and granted to use drugs in the licensing process but not yet licensed where there is a critical need or where it is being used in a situation it is not licensed. Many a critically ill child has been returned to health by doctors, in a last desperate effort giving the child a drug only licensed for adults.

I believe during the Ebola epidemic, some vaccines were used ahead of licensing, the need was so desperate.

M0nica

It is not uncommon for dispensations to be sought and granted to use drugs in the licensing process but not yet licensed where there is a critical need or where it is being used in a situation it is not licensed. Many a critically ill child has been returned to health by doctors, in a last desperate effort giving the child a drug only licensed for adults.

I believe during the Ebola epidemic, some vaccines were used ahead of licensing, the need was so desperate.

I know

M0nica

It is not uncommon for dispensations to be sought and granted to use drugs in the licensing process but not yet licensed where there is a critical need or where it is being used in a situation it is not licensed. Many a critically ill child has been returned to health by doctors, in a last desperate effort giving the child a drug only licensed for adults.

I believe during the Ebola epidemic, some vaccines were used ahead of licensing, the need was so desperate.

Thanks for this information M0nica, its very relevant to the current situation.

I think the issue of drugs being used off-licence is related to scale surely?

From my oracle ?

She isn’t remotely political, so may not be aware of the latest wheeze by the government.

“I assume this is related to COVID. All drugs cannot make market without trials. This is written in law (Thalidomide, and various other cases ) and after that all drugs must be tested to a standard. Each country has regulations determining what that testing must be. MHRA have what we all call the “Orange Guide”. These standards are in place and are the same whatever the drug.
Licensing involves a review of the trials work and a review of the facility where the drug is to be produced by trained auditors. I suppose bypassing licensing would mean not carrying out the audits and therefore there would be no ongoing assurance for the patient that their drug is manufactured to the conditions laid out in the Orange Guide (or equivalent In other countries). Licenses are maintained with regular (approx 3 year) audits.
Given the legal cases I can’t see that a government would be allowed to completely bypass licensing. They may be able to expediate certain parts of the licensing process but that would be all”

I’m no further forward really☹️

I am concerned that playing fast and loose with medicines is part of Cummings’, ERG and like minded individuals plan for a “bonfire of regulations”

Why unlicensed drugs are sometimes prescribed:

www.ouh.nhs.uk/patient-guide/leaflets/files/12048Punlicensed.pdf

I'm still not clear why new legislation is needed if unlicensed drugs can already be prescribed. Does anybody know what's new?

growstuff

Why unlicensed drugs are sometimes prescribed:

www.ouh.nhs.uk/patient-guide/leaflets/files/12048Punlicensed.pdf

I'm still not clear why new legislation is needed if unlicensed drugs can already be prescribed. Does anybody know what's new?

That is exactly why I’m worried

I share your concern. I've always accepted every vaccination going and I would probably accept a Covid-19 one, but I'll certainly want to check it out. It's sad that I really don't trust the government at all.

I posted that I thought it might be about scale. I have a vague memory of off licence prescribing being very focused on individual patients and individual prescribing clinicians. I don’t know of an example in recent times where an off licence medicine has been prescribed to huge numbers of patients in a blanket fashion. Maybe that’s the issue

You could be right. I have a feeling (but could be wrong) that doctors need authorisation to prescribe off-licence, so maybe it bypasses that.

growstuff I'm still not clear why new legislation is needed if unlicensed drugs can already be prescribed. Does anybody know what's new?

These extracts from the consultation document might clarify this a bit:

Regulation 174 of the HMRs allows the licensing authority to permit a temporary authorisation for the supply of an unlicensed medicinal product for use in response to certain specific types of public health threat – the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation.
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A COVID-19 vaccine would only be authorised in this way if the licensing authority was satisfied that there was sufficient evidence to demonstrate the safety, quality and efficacy of the vaccine, in the particular context in which the licensing authority was asked to take that decision.
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The proposed amendments build on and add to the existing text for regulation 174, which we are not proposing to alter. While it is implicit that under regulation 174, as currently drafted, a decision to authorise the supply an unlicensed medicinal product could carry certain conditions, this is not expressly articulated.

To provide transparency, we propose to amend the HMRs to make it explicit that the supply of products, including COVID-19 vaccines, which is temporarily authorised under regulation 174 may be subject to conditions. The imposition of conditions enables the licensing authority to define the safeguards that are a pre-requisite for the safe supply and use of the product and without which authorisation would not be valid. This can range from specifying whom the product is suitable for, setting batch testing and quality assurance standards, and ensuring that appropriate storage is in place throughout the supply chain. Given its importance, it is appropriate to articulate this element of the licensing authority’s decision-making more fully in the legislation.

There is a lot more there but I don't want to copy everything. What I note from the document is that it is still the licencing authority which would decide if a vaccine should be distributed. Having read part of the document, I actually feel better about the whole thing. I'll probably have a go at the rest of the document this afternoon. Of course I am not a specialist in this area.

my feelings exactly growstuff- as expressed in another thread where I was accused of scaremongering for no reason.

I believe new legislation will be required because of the vast scale of things- and the fact the people receiving an unlicensed treatment are not actually sick.

We have young friends with a child with a terrible degenerative disease, and they have fought very hard for him to be given an unlicensed drug, as it is his only hope- without it he will be totally uncapacitated and die within a couple of years. With it, he may keep more capacity for a better life for a few more years.

Thanks Alegrias. It makes it all a bit clearer.

www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/prescribing-and-managing-medicines-and-devices/prescribing-unlicensed-medicines

This from the GMC covers what I had in the back of my mind- an individual patient and individual doctor. Alegs post clarifies the issue re mass vaccination. Between us we’ve nailed it I think ?#GNfactcheckersruleok

Thanks everyone. Much further forward.

Facts'r'us

If I am not mistaken, Oxford Uni are working closely with Pfeizer on the vaccine. They have had very good results from thousands of humans in the trials.
In a press conference, Trump states that they are already manufacturing the vac (Pfeizer and others) ready for the first lot of vaccines to be given to HCA and the vulnerable, then the general public, hopefully starting at the end of October.
The troops will be distributing thoughout US as well as other countries. They are just waiting for the go-ahead.
I don't know if UK will be using it before January because of EU directives on vaccinations.
I will be at the front of the queue though! I am fed up with being isolated.

Crafty what’s you source for that? I wouldn’t believe a word Trump says about the vaccine. Remember voting has opened in the US now.

Pfizer is working with BioNTech, a German technology company, on a vaccine. Oxford Uni is working with AstraZeneca.

I wouldn't believe a word Trump says either. The pharma companies have a vested interest in promoting their products (and might just be over-optimistic) because they want people to invest in "their" trials and they want to keep their shareholders happy.

Pfizer and BioNTech say they could be ready to distribute by the end of 2020, so I don't know where Trump is getting the idea it will be ready in October.

www.thepharmaletter.com/article/progress-on-biontech-and-pfizer-s-covid-19-vaccine-candidate-bnt162b2

Well I won’t be first in the queue that’s for sure certainly won’t trust such a rushed through vaccine I ll take my chances with the virus It will wear itself out at some point and as long as they invest in medications to help with the illness itself I think that’s where the Trials should concentrate

There are excellent trials going on investigating a range of therapeutic treatments as well as the vaccine research. It’s a pity you didn’t listen to the Sarah Gilbert programme Bluebell to better understand the Oxford trial rather than repeating false rumours about the process being rushed.Wheres you evidence for saying that?.