What AstraZeneca has to say about cessation of coronavirus vaccine trials – Announcement



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AstraZeneca CEO Pascal Sorio said today that it will be known before the end of the year whether the company’s experimental coronavirus vaccine offers protection to humans, provided the British-Swedish group can soon repeat the unproven clinical trials. .

AstraZeneca announced Wednesday that the global testing of its coronavirus vaccine, which is underway in many countries, is on hold after a “possibly unexplained illness” appeared in a volunteer.

This volunteer is said to have neurological symptoms associated with a rare inflammation of the spinal cord, called transverse myelitis.

Sorio stressed that it is very common to suspend research on a vaccine, but this time the difference is that everyone is closely following developments in this regard.

“In fact, it is very common and many experts can tell you,” he said. “The difference from other clinical trials of vaccines is that not everyone is looking at them.” They stop, investigate and start again, “she explained.

The AstraZeneca head clarified that the pharmacist does not know the volunteer’s clear diagnosis, adding that it is not clear that he has developed transverse myelitis and that more tests are needed.

Sorio noted that the diagnosis will be sent to an independent safety committee, which will inform the pharmaceutical company if it can continue with clinical trials.

AstraZeneca will deliver the vaccines to the countries at the same time in order to ensure their fair and equitable distribution, said the head of the company. He added that the pharmaceutical industry is close to increasing its production capacity to 3 billion doses in laboratories around the world, in order to prevent governments from restricting the distribution of the vaccine.

The vaccine, developed by AstraZeneca in conjunction with the University of Oxford, has been named by the World Health Organization as probably the world’s leading candidate vaccine against COVID-19 and the most advanced in terms of its development.

The announcement of the company in more detail:

As part of the ongoing randomized controlled clinical trials of the AZD1222 coronavirus vaccine from the University of Oxford and AstraZeneca, a standard evaluation procedure was activated that resulted in the deliberate cessation of vaccination in evaluating safety data. of a single unexplained illness event observed in the phase III trial in the UK.

This is a routine action to be taken in the event of a potentially unexplained illness in one of the tests, and is being investigated to ensure that the integrity of the tests is maintained.

In large clinical trials, random disease is observed and these must be independently evaluated. AstraZeneca is working to accelerate the evaluation of this unique event to minimize the potential impact on the clinical trial schedule. We are committed to the safety of the participants and to the highest standards of our testing.
CEO Pascal Soriot said: “At AstraZeneca we put science, safety and the interests of society at the center of our work. This temporary suspension is living proof that we are committed to these principles, and a single incident observed at one of our test centers is being evaluated by a panel of independent experts. We will receive guidance from this committee on the date of the resumption of clinical trials so that we can continue our work as soon as possible to provide the vaccine widely and equitably, without benefit, during the pandemic. “

AZD1222

The AZD1222 was jointly developed by the University of Oxford and its subsidiary, Vaccitech. It uses a non-replicating chimpanzee viral vector, which is based on an attenuated version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material for the SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, which primes the immune system to attack the SARS-CoV-2 virus if it later infects the body.

AstraZeneca

AstraZeneca (LSE / STO / NYSE: AZN) is a science-based global biopharmaceutical company focused on the discovery, development and commercialization of prescription drugs, primarily for the treatment of diseases in three therapeutic categories: Oncology, Cardiovascular, Kidney Disease , metabolic and respiratory. Headquartered in Cambridge, UK, AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients around the world. Visit the website astrazeneca.com and follow the Company on Twitter @AstraZeneca.

Source: skai.gr

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