Federal Health Regulators Authorized Resumption of U.S. Studies on AstraZeneca AZN’s Leading Covid-19 Vaccine Candidate 0.08%
PLC and the University of Oxford, according to a person familiar with the matter and the documents reviewed by the Wall Street Journal.
The U.S. Food and Drug Administration has completed its review of two cases of a possible neurological side effect that appeared in two people as part of clinical research testing the shot. The agency told AstraZeneca that the advanced stage trial in the United States could resume, the company said on Friday.
The decision, which was first reported by The Wall Street Journal, came after the FDA did not find the vaccine to be responsible for the two cases, although the agency could not rule out a link either. , said a person familiar with the matter.
The agency plans to require researchers to notify study subjects of the cases and monitor them for any related neurological event, such as numbness, the person said.
This decision “allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic. We should be reassured by the care taken by independent regulators to protect the public and ensure the safety of the vaccine before it is authorized for use, ”Pascal Soriot, CEO of AstraZeneca, said in a statement.
The vaccine is among the most advanced in development. If it is found to be operating safely, it could be one of the first, if not the first, to receive the green light from regulators for widespread use.
The vaccine was on track to be cleared for widespread use by the end of the year, if it was found to work safely in late stage testing.
Last month, however, AstraZeneca suspended testing of the vaccine worldwide, including the United States, after a British woman developed a mysterious neurological disease. A US health official said the event involved a spinal cord problem.
The illness followed a break in testing in July after an unexplained illness in a test subject. The researchers first told the study subjects that the case involved a neurological disorder known as transverse myelitis. AstraZeneca later said the case turned out to be multiple sclerosis unrelated to the vaccine and testing resumed.
Studies testing the vaccine around the world then resumed after regulators outside of the United States determined it was safe to do so, with the exception of an advanced stage trial in the United States, because the FDA was still investigating both events.
The FDA spent weeks exploring whether the two cases involved transverse myelitis and whether the vaccine was responsible for the disease, the person said.
A spokesperson for AstraZeneca said the company is working with the FDA so they can assess whether the US trial can resume. All studies testing the shots are being closely watched for safety, including by health regulators in various countries, the spokesperson said.
Reuters previously reported that the US trial could resume this week.
Transverse myelitis is a known side effect of vaccines but is rarely associated with injections. Other times, it is an early symptom of the nervous system disease, multiple sclerosis, unrelated to the vaccine.
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The condition refers to inflammation of the spinal cord involving the destruction of a white fat, known as myelin, which insulates the fibers of nerve cells. It prevents the nerves in the spinal cord from sending messages to the rest of the body.
Cases are rare, with only about 1,400 diagnosed each year in the United States. The cause is unknown. It can trigger a variety of symptoms, including weak arms and legs, as well as sharp pain, numbness, and tingling.
This can sometimes lead to paraplegia which requires the use of a wheelchair.
Investigational vaccines are being studied, in trials that progressively test vaccines on an increasing number of volunteers, both to test effectiveness and to look for any side effects that could harm people if regulators gave the vaccine. green light for vaccines and they were then widely administered.
To protect the subjects from the trials, independent researchers who had no role in the development of the vaccine, or in the company that would sell it, are looking for any signs that the vaccine could be harmful. This data safety watch chart assesses side effects in subjects.
Side effects often appear in trials evaluating drugs and vaccines, and studies are frequently put on hold for researchers and regulators to ensure their continuation is safe.
Since the AstraZeneca and Oxford vaccine trial was suspended, studies by Johnson & Johnsonof
Covid-19 vaccine candidate and a combination of antibodies from Eli Lilly & Co. and Gilead Sciences Inc. of
antiviral remdesivir have been discontinued.
AstraZeneca was among the drugmakers who have pledged not to seek regulatory clearance for widespread use of their Covid-19 vaccines until the vaccines are found to work safely in late stage testing.
—Joseph Walker contributed to this article.
Write to Thomas M. Burton at [email protected]
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