COVID Vaccine !

[PK99]

I'm going to hazard a guess testing is carried out on the young and healthy. Whereas there is no restriction on who gets infected with the virus in general circulation. I wonder how the old and frail will get on with the vaccine.

In that guess you are wrong. The requests for volunteers makes clear that all age groups are needed and stable controlled, long term conditions are not a bar.

I'm 65 and take 6 meds daily, yet got through the first cut but was ruled out at the detailed history stage as one of my conditions is an autoimmune condition prone to random "Flares" - a Flare over the year-long duration of the trial would have been an issue. It would, apparently, rule me out of most drug trials.

 

[RoadRider400]

In that guess you are wrong. The requests for volunteers makes clear that all age groups are needed and stable controlled, long term conditions are not a bar.

I'm 65 and take 6 meds daily, yet got through the first cut but was ruled out at the detailed history stage as one of my conditions is an autoimmune condition prone to random "Flares" - a Flare over the year-long duration of the trial would have been an issue. It would, apparently, rule me out of most drug trials.

So just the healthy then
I wonder if they going to pre screen people who get the vaccine when its rolled out to the general public.

 

[roubaixtuesday]

.

So just the healthy then
I wonder if they going to pre screen people who get the vaccine when its rolled out to the general public.

If you're interested, exclusion criteria are here. There are very few conditions that exclude you.

Normally, the label awarded to a treatment will be in line with the exclusion criteria for the trial, so you would not be eligible for the vaccine if not eligible for the trial.

• Participation in COVID-19 prophylactic drug trials for the duration of the study. Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalisation due to COVID-19. The COV002 study team should be informed as soon as possible. • Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study. Note: Disclosure of serostatus post enrolment may accidently unblind participants to group allocation. Participation in COV002 can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys • Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination, with the .exception of the licensed seasonal influenza vaccination and the licenced pneumococcal vaccination. Participants will be encouraged to receive these vaccination at least 7 days before or after their study vaccine. • Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines). ). This exclusion criteria will not apply to group 11, as recruitment will be targeted at those volunteers who previously received a ChAdOx1 vectored vaccine. • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. • Any confirmed or suspected immunosuppressive or immunodeficient state (except group 12, where HIV infected participants are allowed); asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤14 days) • History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY • Any history of angioedema. • Any history of anaphylaxis. • Pregnancy, lactation or willingness/intention to become pregnant during the study. • Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). • History of serious psychiatric condition likely to affect participation in the study. • Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture. • Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban) • Suspected or known current alcohol or drug dependency. • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data. • Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed) • History of laboratory confirmed COVID-19 (except groups 5d, 9, 10 and 11). - Seropositivity to SARS-CoV-2 before enrolment (except groups 5d, 9, 10 and 11) - NB: volunteers with previous PCR positive results are also allowed in groups 9, 10 and 11

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001228-32/GB

[edit, this is actually for the AZ/Oxford trial. the Pfizer equivalent is here https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002641-42/DE note that for the Pfizer trial most exclusions only apply to phase I, not to the larger phase III]

 

[PK99]

So just the healthy then
I wonder if they going to pre screen people who get the vaccine when its rolled out to the general public.

Please read my post properly, I was rejected for a specific form of condition that can produce random unpredictable flares of illness that could confound any drug trial.

MY CONDITION WOULD NOT BE A BAR TO HAVING THE VACCINE - as was confirmed by the senior doctor doing the screen interview.

I have the flu jab every year but would not be accepted for a flu jab trial.

 

[lazybloke]

MY CONDITION WOULD NOT BE A BAR TO HAVING THE VACCINE - as was confirmed by the senior doctor doing the screen interview.

That's good news for you.

Others won't be so lucky, so will be depending on the vaccination programme to deliver herd immunity.
Alas, J van-Tam has today confirmed today that children will NOT be vaccinated, and there still no plan to vaccinate adults under the age of 50 (unless they fall into the already defined categories).

Surely that means herd immunity is a pipe-dream; the disease will continue to circulate among half the population.
Bad news for those with undiagnosed underlying health conditions.
Bad news for those that CANNOT be vaccinated (for medical reasons).

Two colleagues at work today were sent home with fevers and having lost their sense of taste. I shared a room with one of them twice, although not for the 15 minutes required for it to be classed as close contact. Still a little nervous.

 

[PaulB]

This vaccine should be tested on members of the government. If they survive, it's safe. If they don't survive, the country's safe. It's a win-win situation.

 

[classic33]

I'm aware of 0 deaths in a trial of 40,000 volunteers.
However, 1 in 100 Covid 19 infections result in death, and some survivors will suffer from Long Covid.

With those numbers, I'm definitely taking the vaccine, assuming no contraindications.

Two, in Brazil, but it didn't warrant halting the trial of one. But halted the trial of the second involved.

https://news.sky.com/story/coronavi...-death-of-volunteer-who-took-placebo-12110476

https://news.sky.com/story/coronavi...e-after-unrelated-death-of-volunteer-12128957

 

[qigong chimp]

Diverting though all this undoubtably is, the big question is will a role be found for Maxine Peake to front the vaccination programme?

 

[lazybloke]

Two, in Brazil, but it didn't warrant halting the trial of one. But halted the trial of the second involved.

https://news.sky.com/story/coronavi...-death-of-volunteer-who-took-placebo-12110476

https://news.sky.com/story/coronavi...e-after-unrelated-death-of-volunteer-12128957

Different vaccine?

 

[PaulB]

Diverting though all this undoubtably is, the big question is will a role be found for Maxine Peake to front the vaccination programme?

What, so we can say, "Pass the vaccine, Maxine?"

 

[Mo1959]

Diverting though all this undoubtably is, the big question is will a role be found for Maxine Peake to front the vaccination programme?

She’s too busy trying to get us to install smart meters!

 

[classic33]

Different vaccine?

The Oxford one or the Chinese one?

 

[PK99]

Two, in Brazil, but it didn't warrant halting the trial of one. But halted the trial of the second involved.

https://news.sky.com/story/coronavi...-death-of-volunteer-who-took-placebo-12110476

https://news.sky.com/story/coronavi...e-after-unrelated-death-of-volunteer-12128957

The first had had the placebo not the vaccine, ispo facto the vaccine was not the cause. No need to halt the trial.

The second was a political decision - the president does not like the testing program.

With 10's of thousands of people involved in a trail some are bound to die of causes not related to the vaccine

 

[classic33]

The first had had the placebo not the vaccine*, ispo facto the vaccine was not the cause. No need to halt the trial.

The second was a political decision - the president does not like the testing program.

With 10's of thousands of people involved in a trail some are bound to die of causes not related to the vaccine

For the Oxford vaccine, from the piece linked.
*"this hasn't been officially confirmed

For the Chinese trial
"Brazil's health regulator has halted clinical trials of a coronavirus vaccine being made by Chinese drug firm Sinovac after a "serious adverse effect".

No mention of the president not liking the trial due to a polical decision.

Edited to add
Three deaths
https://wjla.com/news/health/astraz...ntinue-after-brazil-announces-volunteer-death

 

[winjim]

Two, in Brazil, but it didn't warrant halting the trial of one. But halted the trial of the second involved.

https://news.sky.com/story/coronavi...-death-of-volunteer-who-took-placebo-12110476

The first had had the placebo not the vaccine, ispo facto the vaccine was not the cause. No need to halt the trial.

Who said they had a placebo? Because firstly they're wrong, this is not a placebo controlled trial. Secondly, I don't know specifically what the case is for fatalities in Brazil, but for adverse events in this country, that is not information that would be available to the study participants or to the researchers because that would unblind them and potentially jeapordise the entire study. The trial is halted and unblinded data is provided to an independent panel who assess whether it is safe to continue the trial.

My guess is that the Oxford trial was not halted this time because all participants have already been given both injections and they're just in the observation phase so halting now would be meaningless. The trial was halted over the summer between initial and booster injections so the independent panel could assess reports of peripheral neuropathy in some participants but they gave the go-ahead to continue.

Halting trials in order to assess safety data is a perfectly normal part of the process. It's kind of the point.