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Jakman, the reports are finally coming out regarding the AZ vaccine. What they've achieved is astounding, but the result is not as positive as the 90% initially suggested. There are issues with the other two vaccines as well and with time we'll become privy to the data. For reference I'll restate the points I made before:
> the fda required them both to submit two months of data post inoculation, which means they will have 2 months of data. Why did they just provide the first weeks data showing 95% and nothing at 1 month and 2 months? Do the benefits tail off?
> the placebo groups had lower than expected incidence of disease. Why was that? Can it be explained through volunteer bias?
e.g. more of those who are careful (socially distance, wear masks and practice hygiene) registered for the trial, if they are careful to begin with, could they have had a lower infection inoculant i.e. a less symptomatic infection.
> The vaccine trials were not designed to answer the question of whether the vaccine reduces viral shedding (spreading). What are the expected values?
> For those who did get infected, why did they? Were they of particular age group or other indications e.g. diabetes?
> The suggestion is that we continue wearing masks and socially distance even after getting vaccinated. How likely are we to return to normal?
Bruce you might find this article of interest
https://www.wired.com/story/the-astrazeneca-covid-vaccine-data-isnt-up-to-snuff/
Elsol, there were a number of issues with the AZ-Oxford trial. Their total participants was 20,000. There were 30 cases in the vaccinated and 101 in the control.
There was an accidental half-dose sent out to 2700 subjects that gave them the positive results at 90%. But, the remaining patients were at 62 percent effective. It's almost impossible to draw a reasonable conclusion from such a small subset especially when picking out an adverse signal. AZ didn't present their initial efficacy data clearly. Without more clarity, you would think that this could be 90% efficacy or it could be far less. I think there will be a lot of issues for approval, and the likelihood of AZ approval in the US will be much less than 95%. I'd be surprised if they get approval as it is and may require more work.
MATML74
May I refer you to the Wall Street Journal of 19 November which states strong response in a review promising immune responses in the elderly with fewer side effects
The FDA has reviewed the SNG001 pre-IND materials including preclinical and Chemistry and Manufacturing Control (CMC) data, the results of the Phase II study in COVID-19 patients and the proposed Phase III protocol. The FDA has provided Synairgen with guidance on the Phase III clinical study to support the potential registration of SNG001 for the treatment of COVID-19. The Company plans to file an IND application as soon as possible to allow the Phase III study to be initiated. Synairgen will continue to work closely with the FDA as development continues.
Need to know when IND filed -RNS
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
Then informed of RNS first patient dosed on trial.
I believe all this will be done before end of Q4 and will get lots of news end of January.
Big Pharma will be watching every step !!!!!!!!!!!!!!!!!!!
RM is doing great job. EMA and FDA operate slightly differently.
Gonna be great. I am completely chilled. Night night
Elsol, can you point me in the direction where you have read all the data about the azn vaccine. There are many questions have been raised about the data particularly mixing of the trial data from Brazil and the UK. Also as far as I have read they have not released any numbers on the efficacy in the elderly. If you have a link to share that would be great.
FinCap target of £4 would appear good on positive trial results. My target is £3. My only problem is when are we going to hit resistance ???.
As for vaccines, not convinced. Imop quite a lot of political spin at play. As mentioned before I believe we will be waiting for a vaccine in a years time.
Time will tell.
Positive news in Phase 3 and minimum SP will be £5 before formal approval. Then its anybody's guess...........
Marik why do you expect the AZ Oxford vaccine not to proceed to approval and launch. Its an odd assumption. I think its 95%+ probability by January.....Note- All those injected with the actual vaccine in the phase III trial in the UK and Brazil did NOT develop any serious Covid symptoms and / or death unlike the placebo group. That seems pretty effective a vaccine to me or am I missing something?? If you are wrong with your assumption as I suspect that means there will be many more cheap vax shots available by year end 2021 in the world. And don't forget the vax will be given first to the aged and high risk people so the residual population will be less at risk of serious infection..
Feel free to share this with other boards if it seems applicable.
Very good post; well done
We've recently had incredible scientific results from the Pfizer and Moderna vaccines has given many hope. For the financial markets, this has created volatility due to over reactive selling and buying. Synairgen is case example of a covid-19 stock, but my reasoning is applicable for others as well.
SNG has a clinical trial about to start for phase 3, with positive covid-19 and COPD data for phase 2. Despite exceptional results from phase 2, SNG has been oversold heavily compared to other covid-19 stocks on vaccine news. The results from phase-2 covid trials were exceptional and the likelihood of the trial ending early is possible. The cost of the treatment at $3000 is low compared to hospitalisation costs. Vaccines although very positive have a multitude of issues.
There are billions of people to immunise and even if we assume that all countries have the same infrastructure as the EU, US and UK to deliver (100’s of thousands jabs per day per country) and are as efficient in delivering the jab, we can’t get the vaccine rolled out before Aug-Sept 2021. Also note that the two vaccines, Pfizer and Moderna are likely to get approval, but AZ is unlikely (can discuss this later). Both Pfizer and Moderna can supply 50 million doses by the end of this year and around 1.3 billion by the end of 2021. If each person needs two doses then the world will have a shortfall for around 6.5bn people. These manufacturing volume and distribution bottlenecks imply that realistically speaking, you can’t get 60-70% of the world vaccinated with 2 jabs per person before Oct-Nov 2021.
SNG phase 3 is expected to finish end of January, results and EUA/full authorisation will follow. In Feb/March, the SNG001 demand in developed countries will amount to 100,000 per WEEK. SNG are aiming for a manufacturing capacity of 100,000 per MONTH. However this number is expected to be 5 times this for the rest of the world.
Pfizer vaccine press release provided data at 1 week and not for the additional data at 1 month and 2 months. This was picked up by an FDA advisory board memeber, who points out that the data was available but Pfizer decided not to submit it in their preliminary release. The >90% immunity is therefore to be taken with a pinch of salt.
Assume that the vaccines will reduce the virus shedding to zero, protect all age groups, co-morbidities and genders (which is highly unlikely), and all those immunised remain protected for a long period of time. Even then the expected numbers protected will be closer to 75% not >90%. Which means that SNG001 will be continuously required at the rate of 50-100,000 per month well beyond the next 12 months.
As news flows out from SNG, Moderna, Pfizer over the next 6 weeks, expect the share price to shoot up. I’m making an assumption that on news of positive phase 3, the expected $300M revenues per month will take the share price to £4 per share. Following approval, I expect it to more than double.
GLA