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Final clinical trials of the coronavirus vaccine, developed by the pharmaceutical company AstraZeneca and the University of Oxford, were suspended after an adverse reaction in a participant in the United Kingdom.
Pharmaceutical company AstraZeneca, which is working with Oxford University to develop the vaccine, described the hiatus as “routine.”
The AstraZeneca-Oxford University vaccine is considered a strong candidate among dozens of developing countries around the world.
The vaccine was among more than 10 in phase 3 and has already been tested in recent weeks in about 30,000 participants in the United States, as well as the United Kingdom, Brazil and South Africa. Phase 3 vaccine trials often involve thousands of participants and can take several years.
An independent investigation is examining the safety data before regulators decide whether the test can be restarted, says BBC Medical Editor Fergus Walsh.
“In large trials, side effects occur randomly, but the safety of the vaccine must be verified,” said a spokesman for the University of Oxford.
This is the second time the vaccine has been stopped. Such events are routine in large trials and occur each time a volunteer is admitted to the hospital when the cause of their illness is not immediately apparent.
It is believed that testing could resume in a few days.
Stat News, the medical site that broke the news, reported that details of the participant’s adverse reaction in the UK have not yet been released.
Mosialos for pTemporary interruption of phase III of the vaccine study.
In a post, LSE health policy professor Elias Mosialos comments on the development of the AstraZeneca vaccine, saying: Kingdom. This is the second time this has happened with the Oxford vaccine.
For the first time, one of the participants was hospitalized for a previously unknown underlying disease, that is, for a cause independent of the vaccine.
Interruptions in clinical trials are not uncommon and it is not clear how long they will last. There are several different reactions that can be described as suspected serious side effects and symptoms requiring hospitalization.
It is not yet immediately clear at what stage of the clinical trial the adverse reaction occurred, although there is a possibility that it may be related to the ongoing phase II / III trial in the UK. In the United States, the vaccine is being tested in phase III clinical trials.
Although it is not yet clear how serious and common the side effects may be, the finding could affect how quickly efficacy data from UK clinical trials will be available. This data is considered an integral part of any license approval attempt.
In Large phase III clinical trials make it easier to detect side effects. These must be reviewed by independent and regulatory committees to determine what happened. It may not be serious, but it can be. An independent panel of experts will review all the data.
I have repeatedly stressed that safety is just as important as the efficacy of vaccines and that regulators should not compromise the vaccine approval process.
We will find out what really happened and how important it is in the coming days. “
Trump’s desire for the vaccine
US President Donald Trump has said he wants a vaccine available in the United States before the Nov.3 election, but his comments have raised fears that politics may take precedence over vaccine safety.
On Tuesday, a team of nine companies developing Covid-19 vaccines tried to reassure the public by announcing a “historic promise” to meet scientific and ethical standards in the search for a vaccine.
AstraZeneca is among the nine companies that signed the pledge to apply for approval only after the vaccines are completed in three phases of the clinical trial.
The other parties are industry giants Johnson & Johnson, BioNTech, GlaxoSmithKline, Pfizer, Merk, Moderna, Sanofi, and Novavax.
They promised that “the safety and well-being of vaccinated people is always the first priority.”
The World Health Organization (WHO) says around 180 candidate vaccines are being tested worldwide, but none have completed clinical trials.
The agency said it does not expect any vaccine to meet efficacy and safety standards to be approved this year due to the time required for vaccine trials to be safely available to the public.
However, China and Russia have started vaccinating with homegrown vaccines. The WHO still refers to all of them as clinical trials.
Meanwhile, the US National Food and Drug Administration (FDA) has suggested that coronavirus vaccines may be approved before a third phase of clinical trials is completed.
Last week, the US Centers for Disease Control and Prevention asked states to consider waiving certain requirements to be ready to distribute a potential vaccine by November 1, two days before the presidential election. November 3. .
With information from the BBC
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