AstraZeneca expects latest results to show that shot DOES work against UK 'super-covid' AND reduces transmission

AstraZeneca expects results from the US clinical trial of its COVID-19 vaccine in the next four to six weeks, the firm's research chief Mene Pangalos said on Friday.

The US has a contract for 300 million doses of the Oxford University-designed shot, expected to be delivered this year.

Oxford and AstraZeneca's vaccine is already approved in the UK, but was delayed in the US amid regulators' criticisms that the trial data contained errors, such as an accidental dosing regimen.

But encouraging findings about the 70 percent effective shot continue to roll in. Oxford also announced Friday that preliminary tests suggest that its vaccine is about as effective against the UK's B117 variant as it is against earlier circulating forms.

And UK officials said Friday that additional data from AstraZeneca's trials suggest the shot is effective in people over 65, after the first data review suggested the shot's potency dropped off in the elderly.

But the US has been insistent upon basing its vaccine authorizations on trials conducted domestically, and thoroughly reviewed by its Food and Drug Administration (FDA). With final data at least a month away, it could be March or April by the time AstraZeneca's vaccine is added to the American arsenal.

Asked about when the U.S. trial results would be ready, given high transmission rates during the trial, Pangalos said that they had been high during 'the latter period of the trial.'

'I think we're getting very close to getting data. I would say in the next four to six weeks we should have the results for that study reading out,' he told reporters.

Some experts had expected the data sooner than that, given the high infection rates in the United States during the period of testing.

AstraZeneca's shot has already been rolled out in the UK, where the 70 percent more infectious B117 variant is now dominant and triggered a massive surge of infections and the strictest lockdowns the country has seen.

That lockdown came as Britain started rolling out the AstraZeneca vaccine.

Over 10 million people have received a first dose of either AstraZeneca or Pfizer's shot. Moderna's is approved in the UK, but has not yet been rolled out because the country did not turn in its dose order soon enough.

Britain had said that it believed the vaccines were effective against variants that are circulating in the UK.

'Data from our trials of the ChAdOx1 vaccine in the United Kingdom indicate that the vaccine not only protects against the original pandemic virus, but also protects against the novel variant, B117, which caused the surge in disease from the end of 2020 across the UK,' said Andrew Pollard, Chief Investigator on the Oxford vaccine trial.

Oxford and AstaZeneca have continued to test trial participants for COVID-19 in ongoing UK trials.

Between October 2020 and January 14, the investigators sequenced the genomes found in samples taken from 323 covid-positive people who had received either Oxford's shot or a placebo, according to a pre-print study that has not yet been peer-reviewed.

Those who got the real vaccine had lower viral loads and remained positive for a shorter period of time - despite the fact that the level of neutralizing antibodies was about nine-fold lower.

However, the vaccine was about equally good at preventing people from developing symptomatic COVID-19 from B117 as it has been against older types of the virus.

Other recent data also suggests that Oxford's vaccine reduces transmission - an important function no other vaccine has proven to play (although they likely do have some effect on the ability of the virus to spread).

Still, Sarah Gilbert, co-developer of the vaccine, said that, although the vaccine had efficacy against the UK variant, it might need to be adapted for a future variant.

'We are working with AstraZeneca to optimize the pipeline required for a strain change should one become necessary,' Gilbert said.

The mounting positive findings about Oxford's jab has raised questions about the FDA's reluctance to at least begin reviewing international data from its trials, even if it is a little messy.

AstraZeneca CEO Pangalos said in a Wednesday press briefing that he doesn't think that completing the US trial will be necessary 'in terms of getting an approval.'

But there hasn't been any evident activity from the FDA so far, despite the agency's decision to expedite review of data from US-based Novavax's ongoing trials.

Waiting for 'cleaner data' from the completion of AstraZeneca's US trials would be 'a reasonable decision under normal circumstance,' Dr Ashish Jha, dean of the Brown University School of Public Health, told The Hill.

But, 'there's a reasonable question to ask: are these normal circumstances?' he added.

https://www.dailymail.co.uk/health/article-9228513/AstraZeneca-expects-U-S-trial-results-4-6-weeks-research-chief-says.html

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Oxford/AstraZeneca's Covid vaccine IS effective for over 65s, say experts privy to new data

More evidence is emerging that the Oxford Covid vaccine works in older people, according to vaccine experts in the UK.

Sir Munir Pirmohamed, boss of the Commission on Human Medicines, today said regulators had received extra information from Oxford University and AstraZeneca scientists to prove their jab was safe and effective for over-65s.

The data, which is not yet publicly available, is coming now from same clinical trials in the UK and around the world that got it approved in the first place. They enrolled thousands more older people after the jab was green-lighted.

European leaders have ruffled the vaccine-maker's feathers in recent weeks by claiming the vaccine doesn't work on older people and refusing to use it.

In the same week that politicians were slinging mud at AstraZeneca for scaling back its deliveries, many European countries openly criticised the vaccine, with France's President Macron calling it 'quasi-ineffective'.

Oxford scientists hit back against the claims, with Professor Andrew Pollard saying he didn't understand what Mr Macron's comment meant. And the team behind the ground-breaking vaccine said the idea that it didn't work had 'no basis'.

Numerous countries including Spain, Germany, France, Hungary, Sweden and Norway have suggested they won't give the jab to anyone over 65.

Scientists admit there is a lack of data definitively proving the vaccine works for elderly people but the data they do have suggests it doesn't affect them any less than it does younger people, in whom it is proven to prevent Covid-19.

Oxford and AstraZeneca chiefs said this week that they expect data on effectiveness in over-65s - who were in the same study as other age groups but a couple of months behind - in the next few weeks.

It comes as another study published today by Oxford found that the vaccine works just as well against the fast-spreading Kent variant B.1.1.7 which is now dominant in the UK.

Sir Munir said in a briefing today: 'There was no evidence that those people over 65 were not getting evidence of efficacy.

'Since then we've seen more data coming through from AstraZeneca as more people are completing the trial, which highlights again that efficacy in the elderly is seen, and there's no evidence of lack of efficacy.'

The data Sir Munir refers to is not yet publicly available and has been sent directly to the MHRA, the UK's vaccines regulator.

He added that elderly people were generating strong immune responses and said the most important thing was that both AstraZeneca's vaccine and a jab developed by Pfizer and BioNTech were preventing serious disease and deaths.

Asked about the suggestion that Britain had compromised on safety and efficacy standards, MHRA chief executive, Dr June Raine, defended the regulator's standards.

'I think our position is very clear in terms of the rigorous science that MHRA pursues in the interests of public confidence, public safety, and the effectiveness of these important vaccines,' she said.

Professor Andrew Pollard, the Oxford professor who is running the clinical trials of the jab, added: 'It's really for each country to take their own scientific advice... but it is authorised everywhere [in the European Union].'

He said: 'The point about efficacy depends very much on how you cut the data. 'You can cut it in different ways and get different data. That would be true of all vaccines in development.

'But [these results] show it has a high efficacy in disease and we are not seeing a high accumulation of hospitalised cases in those who have been vaccinated.'

Boris Johnson previously said he was not concerned by the European countries' move, adding the UK's world-leading regulator had 'made it clear' the shot was 'very good and efficacious'.

The issue that European countries have taken with the study is that the vaccine was only trialled on 660 people over the age of 65 in results that have been published so far.

The data is the same that was used by the UK Government to approve the jab, and regulators in Britain admitted there was not enough data to give a percentage estimate of its efficacy – while the Germans attempted to do it anyway.

But they were satisfied by the fact that the vaccine was well-tolerated and safe in the older people who did receive it, and the fact that their immune response appeared in lab tests to be the same as those in younger people, who featured more heavily in the trial.

In short, the Medicines and Healthcare products Regulatory Agency (MHRA) said they would not expect the vaccine to work any differently in older people than in other age groups.

They said: 'Efficacy and safety data are currently limited in individuals ≥65 years of age. No dosage adjustment is required.'

The study has enrolled more older people since it first reported results and continues to gather data on how the vaccine functions in that group.

The jab appears to be between 62 and 90 per cent effective in the adult population in general, according to Oxford University researchers.

A breakdown of the report showed that one out of 341 people who got the jab later tested positive for coronavirus. Meanwhile one in 319 people who got a fake jab, called a placebo, tested positive.

The whole point of a clinical trial is to compare the number of positive cases in the vaccine group to the number of positives in the non-vaccine group, to work out how well the jab works.

With the exact same number of cases in both groups and an almost identical number of participants, this is impossible to do.

A German analysis of the clinical trial of the vaccine, published on Twitter by a Berlin correspondent for The Times, showed that officials there estimated the efficacy of the vaccine to be just 6.3 per cent in over-65s.

To illustrate how unreliable the 6.3 per cent estimate is, experts in one German analysis of the study - which was shared on Twitter - included their confidence interval, which is a range of numbers they are almost certain the true number falls within.

The confidence interval suggests that scientists thought the true effectiveness of the vaccine in over-65s was somewhere between -1,405 per cent and 94.5 per cent. This means the estimate is wildly unreliable and a true figure cannot be calculated.

The jab appears to be between 62 and 90 per cent effective in the adult population in general, according to Oxford University researchers.

There are still concerns over the South African strain - with some studies showing jabs are less effective against it - and the Brazilian strain.

The Oxford group say they are currently testing their jab in South Africa on the variant, and are reviewing data to see whether they have any cases of the Brazilian variant from trials carried out in the country.

https://www.dailymail.co.uk/news/article-9228539/Oxford-AstraZenecas-Covid-vaccine-effective-65s.html

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