Britain presses on with AstraZeneca vaccine amid questions over trial data

[snoop1130]

Britain presses on with AstraZeneca vaccine amid questions over trial data

By Alistair Smout and Karen Lema

 

FILE PHOTO: Britain's Health Secretary Matt Hancock speaks during a media briefing at Downing Street, amid the coronavirus disease (COVID-19) outbreak, in London, Britain November 20, 2020. Trevor Adams/Pool via Reuters/File Photo

 

LONDON/MANILA (Reuters) - Britain gave AstraZeneca's COVID-19 vaccine a vote of confidence on Friday when it asked its regulator to assess it for a rollout after experts raised questions about trial data and the company said it may run another study to gauge the shot's efficacy.

 

The UK government has secured 100 million doses of the vaccine, developed by AstraZeneca and Oxford University, the most supplies it has ordered of any shot to fight the pandemic.

 

The British drugmaker expects 4 million doses to be available in the country by the end of next month, and Health Secretary Matt Hancock aims for a rollout to begin before Christmas.

 

"We have formally asked the regulator to assess the Oxford/AstraZeneca vaccine, to understand the data and determine whether it meets rigorous safety standards," Hancock said.

 

"This letter is an important step towards deploying a vaccine as quickly as safely possible."

 

Britain's Medicines and Healthcare products Regulatory Agency (MHRA) started an accelerated "rolling review" of the vaccine at the start of this month as data comes in on safety and efficacy.

 

In the global race to develop vaccines against COVID-19, AstraZeneca's candidate is viewed as offering one of the best hopes for many developing countries because of its cheaper price and ability to be transported at normal fridge temperatures.

 

Officials in the Philippines said on Friday they would secure 2.6 million shots of the AstraZeneca shot - the country's first supply deal for a COVID-19 vaccine - and were negotiating a possible purchase of a further 1 million doses.

 

The announcements came despite some scientists raising doubts about the robustness of results showing the shot was 90% effective in a sub-group of trial participants who, by error initially, received a half dose followed by a full dose.

 

AstraZeneca had released trial data on Monday that showed its experimental vaccine prevented on average 70% of COVID-19 cases in late-stage trials in Britain and Brazil.

 

While the success rate was 90% in the sub-group, some experts said the relatively small number of participants made it harder to be confident in the findings.

 

AstraZeneca said the administering of the half dose in the trial had been reviewed and approved by independent data safety monitors and the UK regulator, adding that the regulator publicly confirmed there was "no concern".

 

CEO Pascal Soriot said on Thursday, though, that the drugmaker was likely to run an additional global trial to assess the efficacy of its vaccine using the lower dosage.

 

CONFUSION 'PROBLEMATIC'

 

Pauline Londeix, co-founder of French drug transparency group OT-Med, said the apparent confusion over the trial results was "very problematic for public confidence in vaccines".

 

"It has largely to do with the race drugmakers are engaged in currently, which leads them to present vaccine candidates in the best possible way and not release full protocols and results. It is the opposite of what is needed in our view."

 

Nonetheless, Britain's top science adviser said on Thursday that the interim results showed the AstraZeneca vaccine was successful.

 

"The headline result is the vaccine works and that's very exciting," Patrick Vallance said during a news conference with Prime Minister Boris Johnson.

 

Shares in AstraZeneca were down 0.8% at around 0830 GMT. They have fallen about 7% since it reported the vaccine data on Monday.

 

Only 2,741 volunteers were in the sub-group of the AstraZeneca-Oxford trial that gave the 90% efficacy read-out, a fraction of the tens of thousands in trials that resulted in the above 90% efficacy data released earlier this month for Pfizer-BioNTech's and Moderna's vaccines.

 

"Sub-group analyses in randomised controlled trials are always fraught with difficulties," said Paul Hunter, a professor of medicine at Britain's University of East Anglia.

 

"In order to have faith in the results," Hunter said, any sub-group analysis "should be sufficiently powered" with large numbers of volunteers to take readings from.

 

'NUMBER OF VARIABLES'

 

In contrast to AstraZeneca's stock price drop this week, Moderna has rallied 22% since releasing its vaccine trial data on Nov. 16 and Pfizer and BioNTech are up 6% and 14% respectively since announcing their successful data on Nov. 9.

 

The U.S. regulator, the Food and Drug Administration (FDA), has not commented on AstraZeneca's vaccine trial results. The European Medicines Agency said on Thursday it would "assess data on the efficacy and safety of the vaccine in the coming weeks once they have been received from the company".

 

Moncef Slaoui, chief scientific adviser for the U.S. government's vaccine programme Operation Warp Speed, has also highlighted gaps in the trial data.

 

He said no-one in the subgroup that got the initial half dose was older than 55 - suggesting the regimen's efficacy in crucial older age groups is unproven in this interim data.

 

In the group that received a correct full dose followed by a full dose, he noted, older people were included.

 

"There are a number of variables that we need to understand, and what has been the role of each one of them in achieving the difference in efficacy," Slaoui told a briefing on Tuesday.

 

-- © Copyright Reuters 2020-11-27

 

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[Jack Mountain]

Yeah, let's vote about it! As if the virus is a democracy ... LOL

[bkk6060]

Experts say this is a problem. For starters, the group that initially received a half-dose of the vaccine in the U.K. did so by accident, the company first told Reuters

 

How many other "accidents" were there?

Terrible and scary countries have ordered it because it is "cheaper".

Geez, how much is health and life worth?

Unbelievable and sad, I would never take this UK produced vaccine.  

[Dagfinnur Traustason]

Go Matt! Your country´s way to handle the virus and wide incompetence for the care of your citizens, have already killed tens of tousands. Great Job!

 

Now let´s put all eggs on an unsecure and not enough tested vaccine. Maybe you´re lucky and can kill a lot more of your own.

[Walkabout]

This vaccine race . . . frightening.
This AstraZeneca vaccine is an adenovirus-based vaccine and until now, no adenovirus-based vaccine (e.g. HIV vaccine) has been successful, no one has been commercialized . . . the mRNA vaccine is even newer, never has been made before (e.g. Moderna, Pfizer . . . ) . . . and they want us to trust manufacturers (who got immunity not from the virus but from . . . .liability) that are rushing towards the money pots . . .

[mommysboy]

Since when has the standard been 90%.

 

It's greater than 50%.

 

[Walkabout]

How is the effectiveness of the vaccine measured? By comparing the number of people (vaccinated vs. placebo) who get sick in a period of time. If they have the gender, age, weight, general condition of the volunteers, and location . . . it seems they have no control on other factors (mask carrying, social contacts and behavior, . . .) at least, it is not reported in the data released. On the other hand, finding antigens in the blood is not a sign that you cannot get sick. So, 90% effectiveness???

[rabas]

3 hours ago, snoop1130 said:

He said no-one in the subgroup that got the initial half dose was older than 55 - suggesting the regimen's efficacy in crucial older age groups is unproven in this interim data.

It's well known that flu vaccines don't work as well in the elderly.  Why-flu-vaccines-dont-work-as-well-in-the-elderly

 

So it's hard to see how they claim the 90% is due solely to a dosing error based on a younger population.

 

Edited November 27, 2020 by rabas

[chilli42]

There are so many questions/issues from the scientific community on the Pfizer and Moderna vaccines they might as well go ahead.  If we were to “listen to the scientists” I am not sure any of these three vaccines would move forward.

[John Drake]

Figures. Thailand bought the buggy vaccine. What about the J&J single shot? How far away is that? And what about the aftereffects of taking the vaccine? Is it true that it puts you in bed for a couple of days? That doesn't sound pleasant. If someone has that happen to them after the first shot, how eager will they be to return for the second one?

[Patjqm]

20 hours ago, rabas said:

It's well known that flu vaccines don't work as well in the elderly.  Why-flu-vaccines-dont-work-as-well-in-the-elderly

 

So it's hard to see how they claim the 90% is due solely to a dosing error based on a younger population.

 

These tests are made with knowledge of the output that can be prouven by the test..... for ex none of the tests tested on immunity.... 

[mommysboy]

On 11/27/2020 at 10:53 PM, rabas said:

It's well known that flu vaccines don't work as well in the elderly.  Why-flu-vaccines-dont-work-as-well-in-the-elderly

 

So it's hard to see how they claim the 90% is due solely to a dosing error based on a younger population.

 

 

I'm still confused about the difference between contracting the virus and becoming ill. 

 

I can't help but think that given equal conditions, young and old people will become equally infected, however there will be a major difference in disease progression.

 

As we now know the Pfizer study may not be so hot at identifying asymptomatic infection.

[onthedarkside]

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