After being temporarily suspended while the causes of side effects suffered by a few volunteers were investigated, two large clinical trials for the COVID-19 vaccine will be resumed very soon.
The researchers found no evidence that the reactions were related to the injection of the experimental drug.
These are large-scale trials carried out by
the British pharmaceutical company Aztrazeneca Inc. with the University of Oxford,
as well as those carried out by this pharmaceutical company with
the American multinational Johnson & Johnson.
Both clinical trials for a COVID-19 vaccine are in the final stages of the process before obtaining approval for commercialization, involving thousands of volunteers.
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The Oxford vaccine
In the case of the Oxford vaccine, Aztrazeneca announced on Friday that regulators will allow it to resume testing its candidate in the United States.
These tests were stopped around the world in early September due to the illness of a British study volunteer.
Studies have already resumed in other countries and the pharmaceutical company said the Food and Drug Administration (FDA) gave the company the green light this Friday to resume testing within the country.
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The drugmaker said it was allowed to resume testing after the FDA "reviewed all the safety data from the trials globally and concluded that it was safe to resume the trial."
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The company said that testing has already resumed in the UK, Brazil, South Africa and Japan.
The AstraZeneca study in the United States
involves 30,000 people
, some of whom receive the vaccine and others a sham injection or placebo.
The tests were stopped after a participant in the UK developed severe neurological symptoms consisting of a rare inflammation of the spinal cord called transverse myelitis.
The decision to resume the trials came after the FDA did not find the vaccine to be responsible for this condition, although the agency was also unable to rule out a link, a person familiar with the matter told The Wall Street Journal, the first outlet. press to report the resumption of these trials.
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The Johnson & Johnson vaccine
Testing of Aztrazeneca's vaccine with Johnson & Johnson, which was also halted in early October, will also resume very soon after an independent committee investigated the case of a man in the trial who suffered a stroke.
The drugmaker received a green light from the FDA, according to a statement from Aztrazeneca.
In the trial, a man who received the vaccine suffered a stroke that may have been caused by an infection.
The researchers
concluded that what happened was not related to the injection
, after inspecting not only the medical details of the event, but also a safety database of 100,000 people who received vaccines using the same background technology.
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This trial was stopped in the United States since early September.
Johnson & Johnson's is the only vaccine that aims to protect people with a single injection.
Other candidates require a subsequent visit and a second injection three to four weeks after the first to trigger an immune response that protects against the coronavirus.
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It is common for when a possible adverse event occurs during a clinical trial,
testing is stopped so that an independent safety board can fully investigate
and determine if the problem was related to the vaccine.
A pause should not be a reason for fear, but rather for confidence that the pharmaceutical company in question is complying with the protocols before the approval and marketing of a new drug.
