AstraZeneca resumes UK trials of COVID-19 vaccine halted by patient illness

By Michael Holden

 

A test tube labelled with the Vaccine is seen in front of AstraZeneca logo in this illustration taken, September 9, 2020. REUTERS/Dado Ruvic/Illustration

 

LONDON (Reuters) - AstraZeneca has resumed British clinical trials of its COVID-19 vaccine, one of the most advanced in development, after getting the green light from safety watchdogs, the company said on Saturday.

 

The late-stage trials of the experimental vaccine, developed with researchers from the University of Oxford, were suspended this week after an illness in a study subject in Britain, casting doubts on an early rollout.

 

"On 6 September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators," AstraZeneca said.

 

It added that safety reviewers had recommended to Britain's Medicines Health Regulatory Authority (MHRA) that it was safe to resume the British trials.

 

The patient involved in the study had been reportedly suffering from neurological symptoms associated with a rare spinal inflammatory disorder called transverse myelitis.

 

AstraZeneca, based in Cambridge, said it could not disclose further medical information.

 

"The Company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic," AstraZeneca said.

 

It declined to elaborate further on when other global trials were expected to restart.

 

The Serum Institute of India said it would restart its trials once it had permission from the Drugs Controller General of India.

 

Brazil's health regulator ANVISA said it was awaiting notice from the British MHRA confirming that resumption of trials has been authorized before resuming in Brazil.

 

The Federal University of Sao Paulo, which is conducting the paused trials, said in a statement that 4,600 of the planned 5,000 volunteers have been recruited and vaccinated without any of them reporting any serious health issues.

 

Governments around the world are desperate for a vaccine to help end the pandemic, which has caused more than 900,000 deaths and global economic turmoil. The World Health Organization (WHO) had flagged AstraZeneca's as the most promising.

 

The vaccine is in late-stage clinical trials in the United States, Britain, Brazil and South Africa and additional trials are planned in Japan and Russia.

 

'WAKE-UP CALL'

 

The pause of the trials came after reports that the United States was aiming for fast-track authorization or approval of a vaccine before November's presidential election.

 

Leading U.S. and European vaccine developers have pledged to uphold scientific safety and efficacy standards for their experimental vaccines and not bow to political pressures to rush the process.

 

AstraZeneca has already agreed to supply close to three billion doses to governments across the globe - more than any other vaccine project.

 

The WHO's chief scientist said the pause in the trials should serve as a "wake-up" call that there would be ups and downs in the development of a vaccine.

 

"Inevitably with such a large trial there will be times when safety issues arise," said Peter Openshaw, professor of experimental medicine at Imperial College London.

 

"We must all hope that there are no future events and that the vaccine proves both safe and effective."

 

(Reporting by Michael Holden; Additional reporting by Radhika Anilkumar in Bengaluru and Anthony Boadle in Brasilia; Editing by William Maclean, Pravin Char and Helen Popper)

 

-- © Copyright Reuters 2020-09-13

 

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Keep going, don't give up and don't let politics interfere.

23 minutes ago, rooster59 said:

AstraZeneca, based in Cambridge, said it could not disclose further medical information.

Could not or would not disclose further info.Could not suggests it cannot,if they cannot it should ring alarm bells.

20 minutes ago, FarFlungFalang said:

Could not or would not disclose further info.Could not suggests it cannot,if they cannot it should ring alarm bells.

No alarm bells. In the UK its called patient confidentiality. Oxford University/Astra Zenica are following procedures to the letter, as they should. The difference between its vaccine and others is that it will be thoroughly tested and distributed throughout the world on a not for profit basis. Why take the rest when you can have the best? I'll be waiting for the Astra Zenica vaccine even if its not the first available.

Great news, can do no more than keep fingers crossed now.

Nearly from day one of this so called "pandemic", the media and politicians all over the world were shouting the same: and this is, what should makes you wonder! What was the mechanism, the information channels to make them doing this.

the phrases are:

the only solution is a vaccine

(how did they know that? at that time the knowledge of covid19 was very rare. In the past, there was never a vaccine invented to stop the the flu from appearing year by year, and also in some years with the same deathrate (not exactly! ) like covid 19 . At that time, they did not even know, how dangerous this new virus is  (the death rate was overrated at that time by factor 10 ) .

"the new normal"

from where did they get this phrase? who told them to say this. How could they know at that time, that everything (!) has to be changed?

you see, as been educated in scientific research, for me it is very amazing, that all these politicians and journalists did know this solution of a phenomen, they told us was new. For me, as a scientist, if there is a very new phenomen, you start with your hypothesis, develop models and start researching. This was not done. THEY knew exactly from the beginning (!!) that we need a "NEW NORMAL" and  a vaccine to solve the issue.

There was as much as possible pressure  to find a vaccine, and the governments of the world could not be quicker to offer  amounts of money , in a dimension never been the case before, to develop such a vaccine.

With all this pressure now, does anybody really feel comfortable about the idea of getting this vaccine? It is obviously, they are circumventing the normal procedures which are made up, for the safety of the vaccine. With this small timeframe, you do not known, what will be the longtime effects of such a vaccine. and  - god have mercy!- if they will really be successful in vaccinating the biggest part of the whole mankind there is no way of withdraw this global experiment!

Edited September 13, 20205 yr by dieter1
spelling

11 hours ago, FarFlungFalang said:

Could not or would not disclose further info.Could not suggests it cannot,if they cannot it should ring alarm bells.

 

Hardly.

 

Patient confidentiality.

12 minutes ago, dieter1 said:

With all this pressure now, does anybody really feel comfortable about the idea of getting this vaccine? It is obviously, they are circumventing the normal procedures which are made up, for the safety of the vaccine. With this small timeframe, you do not known, what will be the longtime effects of such a vaccine. and  - god have mercy!- if they will really be successful in vaccinating the biggest part of the whole mankind there is no way of withdraw this global experiment!

 

On the contrary, everything that has been reported (for this particular manufacturer, at least) indicates they are fully following normal procedures despite political pressure.

 

Now the Russian vaccine, approved before even completing Phase II trials, is another matter.

17 minutes ago, dieter1 said:

Nearly from day one of this so called "pandemic", the media and politicians all over the world were shouting the same: and this is, what should makes you wonder! What was the mechanism, the information channels to make them doing this.

the phrases are:

the only solution is a vaccine

(how did they know that? at that time the knowledge of covid19 was very rare. In the past, there was never a vaccine invented to stop the the flu from appearing year by year, and also in some years with the same deathrate (not exactly! ) like covid 19 . At that time, they did not even know, how dangerous this new virus is  (the death rate was overrated at that time by factor 10 ) .

"the new normal"

from where did they get this phrase? who told them to say this. How could they know at that time, that everything (!) has to be changed?

you see, as been educated in scientific research, for me it is very amazing, that all these politicians and journalists did know this solution of a phenomen, they told us was new. For me, as a scientist, if there is a very new phenomen, you start with your hypothesis, develop models and start researching. This was not done. THEY knew exactly from the beginning (!!) that we need a "NEW NORMAL" and  a vaccine to solve the issue.

There was as much as possible pressure  to find a vaccine, and the governments of the world could not be quicker to offer  amounts of money , in a dimension never been the case before, to develop such a vaccine.

With all this pressure now, does anybody really feel comfortable about the idea of getting this vaccine? It is obviously, they are circumventing the normal procedures which are made up, for the safety of the vaccine. With this small timeframe, you do not known, what will be the longtime effects of such a vaccine. and  - god have mercy!- if they will really be successful in vaccinating the biggest part of the whole mankind there is no way of withdraw this global experiment!

You mention you're a scientist, may I ask what kind, in what field and what your expertise with clinical trials is?

Edited September 13, 20205 yr by stevenl