Forum Topic

Government & NHS consultation re distributing/using human med. regulations to support COVID

This to me looks like a (an unwelcome) game changer. Please read and complete if you are interested https://www.gov.uk/government/consultations/distributing-vaccines-and-treatments-for-covid-19-and-flu/consultation-document-changes-to-human-medicine-regulations-to-support-the-rollout-of-covid-19-vaccines

Joy Griffiths ● 2235d12 Comments

Wow! I'm not sure I've got time to read it all before the consultation ends tomorrow, though quite how much the Government cares what we think is a moot point. Fancy an armful? They must have run out of small furry mammals to stick their needles in. (I'm going for my flu jab on October 1st, I wonder what will be in it.)

Bruce Hammal ● 2235d

Hi Joy, thanks for posting this, I hadn't seen it.I work in regulatory affairs so this is my field (although not specifically in vaccines). What I can't see is how much data will need to be provided to support this temporary authorisation.  It just says "sufficient evidence to demonstrate the safety, quality and efficacy of the vaccine."  I assume this will not be enough to support a full or conditional approval so I would really like to know exactly what will be required. The part about the MAHs, manufactures and healthcare professionals having immunity from civil liability is also interesting!

Tracy Jenkins ● 2235d

Joy,Thanks for the heads up. Here is my response:Temporary authorisation of the supply of unlicensed productsI feel that these proposals are a reaction to our limited understanding of the virus earlier this year.  We now know that the trajectory of Covid-19 infections and deaths has followed a steep rise and shallower decline in most countries as population immunity develops.  Some countries such as Sweden and Tanzania have controlled the virus in a measured way without imposing severe restrictions.  Therefore it seems to me that given continuing vigilance and following non pharmaceutical intervention guidelines there should be sufficient time to develop and roll out vaccines to vulnerable people, thus obviating the need for the proposed measures.I note that in the consultation document there are no estimates of death and injury in scenarios where unlicensed vaccines administered by an expanded workforce result in harmful effects.I suggest that if it is felt necessary to go ahead with these proposals that the first to receive the vaccines should be: senior management of all the companies involved; all politicians approving this; heads of healthcare organisations etc. Civil liability and immunityThe consultation says "it is unfair also to ask them to take responsibility for the consequences of the use of that medicine in the way that they normally would".  Implying that the public will be asked to suffer the consequences of the use of that medicine.  No estimates of risk are provided so you are asking us to agree to an open ended exposure  to danger with no quantification of the costs and benefits.

Andy Riley ● 2235d

I am getting increasingly concerned by the use of "temporary" measures to enable various kinds of changes that would normally demand far more consultation and scrutiny. Today, traffic, tomorrow, vaccines, the day after - who knows? "Temporary suspension of democracy possibly? Crikey, I'm turning into Michael Brown!

Bruce Hammal ● 2235d

Bruce, don't worry, it will be temporary.

Andy Riley ● 2235d

When the unproven, unsafe, unlicensed vaccine is 'ready', the government won't be worried about people's health then; they'll be trying to force the poison down everyone, even though the vast majority will have perfectly working immune systems, which have proven to deal with 'covid' adequately.

Michael Brown ● 2235d

another interesting quote from the consultation :'These amendments on the easement of advertising restrictions are not limited to unlicensed vaccines only, but are intended to apply to all the public health purposes that would justify temporary authorisation of the distribution of an unlicensed vaccine or other treatment listed in regulation 174.This means that, in relation to medicines advertising, the permitted campaigns could relate to any medicinal product use in response to “…the suspected or confirmed spread of… pathogenic agents… toxins… chemical agents or…nuclear radiation…”.'

Claudia Jachtmann ● 2235d

for bringing this to our attention,had not seen this before

Claudia Jachtmann ● 2235d

I went out for dinner last night, the first time I have been in a restaurant since March, albeit sitting outside. It took about half an hour to enter the premises directly into the garden area due to compulsorily signing into a track and trace system for which the people in front of us were charged by their provider. The restaurant also insisted on card payment only. I will not be doing anything like that again. Apparently as from tomorrow ALL restaurants, nail bars, hairdressers etc ... will be legally required to ensure all customers do likewise. This will mean not only it being recorded where you are but who you are with, when you arrived and potentially what you ate, drank, credit card details and, because you’ve given access to your mobile phone, anything else you do/go/buy from that point forward. Am I a believer in a conspiracy? Well, after last night I’m seeing many things in a very different light.

Joy Griffiths ● 2235d

apologies for getting my thanks wrong in previous post

Claudia Jachtmann ● 2235d

Big Data is now a trillion dollar industry, bigger than oiland this is data about every single one of usI used to work in tech indstry for many decades,and I left when it turned to what I considered to be the dark side, a long time agoI don't have a mobile phone and you may want to look into why Silicon valley moguls don't want their own children to have smart devices etc

Claudia Jachtmann ● 2235d

"Am I a believer in a conspiracy? Well, after last night I’m seeing many things in a very different light".Well said Joy, lets hope more of us realise what's happening. I doubt if Steve Taylor would agree with you sentiments though...

Brian Coyle ● 2234d