Member Info for RegulatorUK

Looking at my Covid portfolio, most stocks have taken a hit this morning. In many cases, it's nervous PIs selling out as they think the first vaccination is the beginning of the end...

...whilst long term holders who have done their research understand this is just the beginning. Covid isn't going anywhere fast.

"Me too RegulatorUK, I’m expecting something intraday though, no pre 8am."

Funnily enough, I'm thinking the same.

I have a very good feeling about this week...

Just in case anyone's wondering how 'secret' the vaccine trials and NHS staff involvement in them has been, a simple google will show lots of stories about this, e.g.:

https://www.uhs.nhs.uk/ClinicalResearchinSouthampton/Research/Facilities/NIHR-Southampton-Clinical-Research-Facility/News-and-updates/Articles/COVID-19-vaccine-trial-calls-for-more-volunteers.aspx

https://www.cuh.nhs.uk/news/cambridgeshire-trusts-join-covid-19-vaccine-trial/

You'll also find that NHS staff are being asked to join in the Janssen trial (of a vaccine from Johnson & Johnson). Again - not secret but full open and out there...

"regulator
you calling me and the woman a liar?"

I'm giving you the facts.

- NHS staff have been part of the Oxford/AZ clinical trials since the beginning (my partner started back in April)
- they get tested weekly (using a swab) but don't get the results, as it's a blind trial.
- they are not required to sign an NDA (they do agree not to get tested outside the trial).

"from what i heard over the weekend, there is too much clandestine things happening,
oxford vaccine given to the NHS nurses since june with blood testing for antibodies
my partner is a hair stylist and her client is a nurse, they were not allowed to discuss this before as the signed a NDA
but a typical woman didnt get me all the details and the next time she will see her is in the new year"

Nice conspiracy theory but:

- NHS staff have been part of the Oxford/AZ vaccine trial (my partner's one of them) since the beginning.
- they get tested weekly - but don't get the results (as it's a blind RCT)
- they're not required to sign an NDA.

"Is there a known lft antibody test that uses saliva ?"

"Personally, I haven't heard or read of one. Only blood LFT for antibody so far but happy to be corrected."

It's about need. Saliva-based LFTs haven't been developed because there hasn't been a need for them (we really haven't had a pandemic on this scale since the 1918 'Flu Pandemic) - existing testing methods have been able to cope with demand.

This pandemic is stretching the capacity of traditional testing methods. The scale of this pandemic, and the need for rapid, reliable testing means that new testing methods - such as saliva based LFTs - is being developed, as the need now exists (and the funding is there for the development).

"Omega spent 8 years developing and testing the Burnett Institute’s Visitect CD4 test in order to secure WHO prequalification. They’re dealing with a lot of countries with dodgy financial records (note continuing delays with the Nigerian order) so need the security of WHO money up front. If the test was so important to HIV sufferers, one would have expected a reservoir of orders to have built up over those 8 years waiting for the WHO prequalification to burst the dam. 4 months after approval and zilch. The test looks over hyped and I think the antibody test will be the same. The government will struggle to roll out the vaccine never mind faffing about with inaccurate lateral flow tests."

I'm not even going to bother picking apart this b0110x. Straight into the green bin for this troll...

"Chuggley yes I’m aware the roache is lab based but as far as I’m aware I still don’t believe it has MHRA approval as stated on the site?"

It's weasel wording by the company flogging the test. 'Home test' actually means 'home sample'.

"You can't pick up antibody in saliva or sputum. Blood is the only place that pick up a detectable level."

That's nonsense. The clinical data is out there showing that antibodies are readily detectable in saliva (e.g. https://immunology.sciencemag.org/content/5/52/eabe5511#:~:text=Anti%2DSARS%2DCoV%2D2,by%2016%E2%80%9330%20days%20PSO.&text=IgG%20responses%20in%20saliva%20may,correlation%20with%20serum%20IgG%20responses )

"RegulatorUK, CTEA have an App/BlockChain tech as well. The BC can easily handle the data, but certainly know news from CTEA. Stab in the dark if it is them."

It's not CTEA, and the handling of the data is somewhat of an irrelevance.

It's about having organisations outside the NHS/PHE/T&T sphere carrying out antigen testing. That's generally a big no-no, given that Covid is a notifiable disease.

Heathrow had to have PHE staff on site to be able to carry out their recent tests.

"If I were a skeptical person I'd say that's why they aren't giving the vaccine to NHS workers now."

Let's be clear...

- the decision on priorities was always going to be one for the JCVI;
- there is always a significant difference between what the government says it has ordered (40 million doses) and what it has actually ordered (800,00 doses) - because they're lying politicians;
- we knew there would be issues around storage and distribution of the Pfizer vaccine - particularly with the impacts of Brexit;
- Pfizer have produced less than they suggested they would by now.

The re-prioritisation is nothing to do with safety... and everything to do with government spin and over-promising.

"Can you just give them a call and tell them to hurry the feck up with our test as the care homes are screeming out for it now."

I couldn't possibly comment... ;-)

"https://www.uktech.news/news/rapid-15-minute-covid-19-antigen-testing-now-at-outdoor-cinema-in-uk-20201203

Anybody know which test for this? Suggests an app to log results?"

I've flagged this to my contacts at the MHRA enforcement team. In the article it suggests they be using an antigen test which, when I checked, hasn't been given EUA. Also there's the whole issue about what happens with any positive tests, given Covid is a notifiable disease.

"The AZ vaccine rapidly degrades the closer you get to room temperature. The temperature you mention has a limited time span of a few days, any warmer then it`s a few hours."

The Oxford/AZ vaccine is of a type that healthcare settings/professionals around the world - including in LMI countries - are used to handling.

Somebody may have put a spanner in their works (:whistle:) as it appears they're proposing to use an unauthorised antigen test and we're talking about a notifiable disease... my contacts at MHRA are not happy bunnies.

"I thought JVT said it was perfectly safe, so why this?

https://uk.reuters.com/article/uk-health-coronavirus-britain-vaccines/britain-to-cover-covid-19-vaccine-side-effects-under-damages-scheme-idUKKBN28D2VB"

I refer you to the answers given earlier:

"All of the Covid vaccines have been given the same legal protection - it's not just Pfizer. The reason being is that the manufacturers have been asked to develop the vaccines in a much shorter timeframe than normal (e.g. by running phases concurrently)."

"There's risk with every new medicine and medical device - which is why it normally takes much longer to develop, test and roll them out. Vaccines will normally go to a 'test country' (e.g. NZ) for first roll out before any world-wide roll out.

I can understand why manufacturers want some air cover - they're being pushed beyond their comfort zone when it comes to process. It doesn't necessarily mean the vaccines aren't safe."

"I understand.... but doesn't show confidence.... we're being told there's no risk. But manufacturers clearly acknowledge there is"

There's risk with every new medicine and medical device - which is why it normally takes much longer to develop, test and roll them out. Vaccines will normally go to a 'test country' (e.g. NZ) for first roll out before any world-wide roll out.

I can understand why manufacturers want some air cover - they're being pushed beyond their comfort zone when it comes to process. It doesn't necessarily mean the vaccines aren't safe.

"Any lawyers on here understand it better? A binding Heads of terms?"

Heads of terms = agreement in principle of the terms, timetable etc. for the agreement a binding contract. Not generally binding but it will depend on the specific HoT.

"So - if the science is so good , the testing so rigorous and confidence so high - not withstanding MRHA authorization
Why this then : https://www.msn.com/en-gb/news/uknews/coronavirus-vaccine-pfizer-given-protection-from-legal-action-by-uk-government/ar-BB1bzBv0"

All of the Covid vaccines have been given the same legal protection - it's not just Pfizer. The reason being is that the manufacturers have been asked to develop the vaccines in a much shorter timeframe than normal (e.g. by running phases concurrently).