Doubts about Oxford Vaccine Data

[IslandGyal]

• NOT AN ANTI VAXXER

www.nytimes.com/2020/11/25/business/coronavirus-vaccine-astrazeneca-oxford.html

This article is concerning that there are several flaws with the Oxford vaccine research and data.

I think media need to look at this, ignoring the vaccine nationalism about this being a ‘British’ vaccine. It’s obviously effective to some extent but it seems that Pfizer and Moderna data is more robust and solid.

@cathyandclare

What is the relevance of this though if he was in the placebo group?

I was responding to the comments that there were no serious infections in the placebo group. I am very firmly in the stop obsessing over twitter comments and wait for the published paper team!!

If they’d included the same amount of data as Pfizer and Moderna did in their press releases, speculation would not be required.

It’s odd that they didn’t release the severe cases number in the placebo group. It would be a positive selling point, as it was for the other Pfizer and Moderna, proof that the zero severe cases in the vaccinated group was meaningful.

Until they clarify that I remain worried by this comment from Katie Ewer, one of the Oxford people, in a BI article:

Notably, instead of using a placebo to compare its results against, some of the trials used a meningitis vaccine as its control. That control group also had zero cases of severe COVID-19.

It remains to be seen whether the shot can actually outperform the control in preventing the worst outcomes of the disease.

"It may just be chance that we just happen to not have any cases in the 20,000 people we've vaccinated, or it could just be that we're picking people up earlier when they get infected than the general population," Ewer said.

www.businessinsider.com/6-key-questions-on-astrazenecas-coronavirus-vaccine-2020-11?r=US&IR=T

I wonder if that means they haven’t had any severe cases in the U.K. trial (but have in Brazil)? Perhaps the meningitis vaccine they’re using as a placebo here is stimulating the immune system and inhibiting severe infection?

I am firmly pro-vax, but
Notably, instead of using a placebo to compare its results against, some of the trials used a meningitis vaccine as its control is worth thinking about since the MMR vaccine has been found in other studies to help with Covid-19 outcomes - in fact, many vaccine help with Covid-19 outcomes because they rev-up the immune system.

But I agree with those pp who say leave it to the regulator. The MHRA seems perfectly capable of assessing these things for us.

AstraZeneca have just announced they will begin new trials.

Looks like a delay to oxford vaccine - new trials to take place.

Link? Just googled and can't find anything

www.bloomberg.com/news/articles/2020-11-26/astra-likely-to-run-fresh-global-covid-vaccine-trial-ceo-says

I don’t think there will necessarily be a delay to the U.K. approval, but they’ve given up on getting US FDA approval with their current patchwork quilt results.

So, not a delay that will affect the UK. There may be a delay in the US as they won't accept the first lot of data (financial reasons may play a part in this and wanting to "win" the race for a vaccine)

Really wish people would post links and not just spout dramatic one sentence posts clearly meant to worry people

If UK approves and US waits for second trial do you think this will undermine faith in AstraZeneca vaccine?

I’m assuming you wouldn’t know which vaccine you were getting when you get the shot.

For blue skies - thank you for the link

I don’t think for the FDA it is about nationalism. It is about the rigour and quality of the clinical trial data.

It is mind boggling that they got the dosage wrong in a massively high profile clinical trial. Where were the checks? And what other errors have gone unnoticed?

I am slightly more worried now. I don't think the FDA would worry about nationalism if it meant they could vaccinate more of their population.
If the USA have enough vaccines for now with Moderna (USA based) and Pfizzer then they can afford to be rigorous.
Does the MHRA have that luxury with the massive political pressure since the UK pretty much relied on the AZ Oxford vaccine in terms of the high-volume vaccination of the wider population. I do worry that the political fallout of MHRA not approving AZ Oxford would be so huge for the conservative government.
Not that I don't have 100% faith in MHRA in all other respects.
But the UK government has not ordered equivalent high volumes of any other vaccine.

I think for now we have to dismiss the 90% figure, and rely on the 62% one. From the Guardian:

Paul Hunter, professor in medicine at the University of East Anglia and an adviser on methodology to the World Health Organization, said he was always wary of sub-group analyses in trials.

“Most of the time when you get these incredibly good results in a sub-group analysis, you have to be incredibly careful about believing them,” he told the Guardian. There could be something about the smaller group that was not true of the larger group.

He was also worried by the suggestion the sub-group had nobody over 55. “I’m not saying this isn’t going to be a fantastic vaccine at the end of the day, but we need a lot better understanding of the data,” he said

www.theguardian.com/world/2020/nov/26/scrutiny-grows-over-oxford-universityastrazeneca-vaccine

I don't know what people hope to gain with all this speculation and hypothesising to be honest. The data will be peer reviewed and released until then no-one can answer anything with any certainty.

It is mind boggling that they got the dosage wrong in a massively high profile clinical trial. Where were the checks? And what other errors have gone unnoticed
If one nurse or doctor does this they can lose their job. If this happens in a normal clinical trial, it will be halted, safety committees consulted, monitors/auditors consulted, urgent safety measures introduced. Why have everyone been so blase in this trial to the extent now they can basically laugh about it because it turned out OK in the end.

@Sunshinegirl82

I don't know what people hope to gain with all this speculation and hypothesising to be honest. The data will be peer reviewed and released until then no-one can answer anything with any certainty.

Just chatting I guess. Isolation at home will do that to a person.

@Sunshinegirl82

I don't know what people hope to gain with all this speculation and hypothesising to be honest. The data will be peer reviewed and released until then no-one can answer anything with any certainty.

The key points about the sub-group are public now, and Astra-Zeneca have announced a new trial in acknowledgement that for the US, at least, the data is not yet compelling. That’s worthy of discussion.

And to be fair, this news item is high up on the Daily Fail's website, so not exactly subversive minority trouble-making (although that now sounds like a contradiction... )

Plus I work in the field so I am interested in discussing it, although obvs my knowledge of virology is not at professor level.

From Reuters:

Beyond headline efficacy rates, AstraZeneca’s data release gave little for scientists to work on. It did not say how many infections occurred in the sub-group, for example, or in the group that got two full doses, or in the placebo group.

“A lot of questions are left unanswered,” said Morgane Bomsel, an expert at the French National Centre of Scientific Research, adding: “We are under the impression they (AstraZeneca) are selectively picking out the data.”

www.reuters.com/article/us-health-coronavirus-astrazeneca-data-a-idUSKBN2861WS

If you want to go round and round in circles with no hope of answering your own questions until more data is out then go for it I guess!

I refuse to look on the Daily Mail I'm afraid, I pretty much take the view that it's fairly safe to assume the opposite of anything they report is closer to the truth!

@Sunshinegirl82

If you want to go round and round in circles with no hope of answering your own questions until more data is out then go for it I guess!

I refuse to look on the Daily Mail I'm afraid, I pretty much take the view that it's fairly safe to assume the opposite of anything they report is closer to the truth!

Every major news outlet is reporting on this.

They should never have headlined wi5h that small sub-group in these results, given it did not include over 55s, and involved a bunch of recipients from one location vaccinated over just a few weeks. It was a blatant bit of cherry picking to make the vaccine appear vaguely in the ballpark of the other two already announced. It’s shambolic, honestly, and they’ve rightly been called out on it by the global scientific community.

The vaccine may well be highly efficient at reducing severe illness, which is what matters most, and hopefully the full results published in the Lancet show that, but this is a PR misstep.

I'm not interested in PR missteps, I don't really care about the press release, no decision is going to be based on it. I'm interested in how well the vaccine works overall in the context of its stability at room temperature and consequently its accessibility and until the peer reviewed data is out that question can't be answered.

@Sunshinegirl82

I don't know what people hope to gain with all this speculation and hypothesising to be honest. The data will be peer reviewed and released until then no-one can answer anything with any certainty.

This. It’s so high profile that every little possibility is being reported on in the media and undermining the whole thing. For all we know, the peer reviewed data will be promising and all this speculation will just undermine confidence and have a detrimental effect in the long run!

Agree with all above, plus now the Fail are reporting 'concerns' about the Moderna and Pfizer vaccines (mask use, SD etc), so obviously not worthy of taking seriously, except insofar as keeping abreast with popularist mentality, which unfortunately is currently ruling the country.