The ugly fruit

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There is overwhelming public interest to support COVID-19 vaccine development. In fact many have already done this. As the UK gears up to participate in its third vaccine study called ENSEMBLE, a Phase 3 clinical trial with the Janssen developed Ad26-vectored vaccine candidate shortly with participants drawn from the NHS vaccines registry, the lack of transparent participant information is surprising. To date, I’ve yet to see one. Granted, I’ve never scrutinized a vaccine study before, but surely the same regulations apply here as for other clinical trials?

With that in mind are you surprised if I said that Janssen had to temporarily halt development in the US due to an adverse reaction? What adverse reaction you may wonder, I wondered also ever since Oct 11 after recruitment was paused, and continue to wander:

“A trial of another vaccine, being developed by Johnson & Johnson, was paused on Oct. 11.  According to a person familiar with the matter, a male volunteer in his twenties had a cerebral haemorrhage and transverse sinus venous thrombosis. The Washington Post, citing two sources, said this case was a stroke.” STAT news, Oct 23.

Intellectual property be damned, where are the peer-reviewed case publications detailing point by point what went wrong with these vaccines? Surely, this is also of paramount importance to the public? Accountability even. We have no right to poke fun at the Russians, when we are behaving in a similar fashion in the West.

Figure: Russia and the Covid19 vaccine readiness (British Medical Journal, the BMJ)

About the author

Neuro Doc Gnanapavan

13 comments

  • I assume that in the US the Food and Drug Administration will review details of all adverse events, and receive specifics about them test subjects, as part of its approval process. But, I can’t speak about procedures in Britain or the EU.

    • They will get the details just like for all trials and britain and the EU will be no different in wanting to see this information

    • Apparently FDA has given the go ahead (they would not have been able to resume otherwise). However, there is no listing on their website!

  • Welcome aboard the transparency train NDG. MD is our conductor, while we scream out of the windows….where is the data!! I much prefer a round-trip over a one way ticket.

  • Slightly off-topic:
    what’s your take on short term, high-dose vitamin D supplementation for prevention of coronavirus disease infection?

    Hot or not?

    • There is data, QMUL is doing a trial along with Uncle Tom Cobbly and all. I suspect marginal gain but chomping on vitamin D.

      • There are several confounders with vitamin D in clinical trials as well as other supplementation that people take regularly. I’m a walking pharmacy myself taking omega-3 (with vitamin D), multivitamins, B-complex and I also take glucosaminoglycans as a supplement. The latter is for hip pain caused by rowing and rock climbing, but in the list that I take it is the only tablet that provides a noticeable symptomatic difference. I stopped the zinc because I couldn’t really think of a reason for why I was taking it!

    • As always the medical profession are considering this the wrong way round. Your body should have vitamin d, it it something your body naturally has. The un-natural state is to be deficient. It is something the body makes and in midsummer on full exposure to sun it will make about 10,000IU a day. In winter it makes none (in the UK) and your body muddles through. So vitamin d does not improve the function of the immune system, a lack of vitamin d screws it up. It is the lack of vitamin d that makes you susceptible, vitamin d does not protect you. This means you don’t get a linear dose relationship. Consider also that almost every cell in the body has a vitamin d receptor and then think what a shortage will do.

      Consider that the skin colour of humans fades as you move from the equator, that is so you burn in the spring to shorten the winter. Consider the evolutionary pressure to do this and then tell me vitamin is not important.

      It is like saying that vitamin C has no effect on health because if you give people who a replete more you see no effect. But at low enough levels you die. It is not a linear relationship and it is not that vitamin c is good for you it is a deficiency that is bad.

      • To paraphase your last point: a car driving with a 3/4 full gas tank doesn’t really run any faster than a car with a tank that’s half empty…

        Anyone disagreeing probably owns a petrol station…

          • They don’t run so low the fuel pump picks up air as they go round the corners. They make a value judgement based on what is required but it is always above the minimum required to function. And by definition deficient is where you are below the minimum required to function and at least 50% of the population is deficient.

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