Late-stage coronavirus vaccine trials run by AstraZeneca and Johnson & Johnson have resumed in the United States because the companies said Friday that some volunteers had serious illnesses unrelated to vaccines.
Federal health regulators gave AstraZeneca the green light after a six-week pause, concluding that there was no evidence the experimental vaccine directly caused neurological side effects in the two participants. The AstraZeneca was first reported by The Wall Street Journal.
Johnson & Johnson stated that its trial, which was on a break for 11 days, Will restart It was determined after the company’s investigation that a study volunteer had no apparent cause for a “serious medical incident”. To maintain the integrity of the test, the company said, it did not check whether the volunteer had received the vaccine or placebo.
Former Acting Chief Scientist of Food and Drug Administration Dr. The Louisiana Borio welcomed the announcements, stating the urgent need for many vaccines to survive the race for a product that could protect the global population from coronovirus, which had already been killed. More than one million people worldwide.
Dr. “Demand for safe and effective Kovid vaccines exceeds the production capacity of any manufacturer,” Borio said. “We really need many in the area.”
An FDA spokesman declined to comment Friday afternoon.
AstraZeneca and Johnson & Johnson are now two of the four companies in the late-stage clinical trial in the US for the experimental coronavirus vaccine. Both companies are using adenoviruses, which usually cause harmless colds. The adenovirus is engineered so that it can alter the coronovirus gene in human cells.
Two of their high-profile competitors, Modern and Pfizer, are also using technology based on genetic material known as mRNAs, in advanced tests. Distributed in human cells, mRNA promotes the production of coronovirus proteins, triggering an immune response.
AstraZeneca quickly entered clinical trials, enrolling thousands of volunteers for its vaccine trials worldwide, including Brazil, India, South Africa and the UK. A large, late stage trial in the United States stopped at the end of August. But all tests were On September 6, after the halt days. A volunteer receiving the vaccine in the United Kingdom reportedly experienced symptoms of transverse myelitis, or spinal cord inflammation, triggering a global halt to the company’s efforts.
The incident caused some concern among experts, who stated that a similar adverse neurological event, reported months earlier, occurred in another vaccine volunteer. While this earlier incident prompted its own stagnation in AstraZeneca’s trials, an independent safety board eventually determined that it was unrelated to the vaccine, allowing the study to resume.
After the second AstraZeneca stop in September, overseas trials resumed rapidly in most countries. But the American hiatus remained constant, with some details of why it was released.
According to two vaccine experts familiar with the situation who were not authorized to discuss it publicly, the FDA did not directly tie the vaccine to the two neurological diseases, although it could not be ruled out. Experts said the company advised the study to alert the study to related symptoms such as weakness and numbness, which could point to a mild case of transverse myelitis, the experts said.
Johnson & Johnson began its Phase 3 trial in September at 60,000 volunteers. On October 12, the company announced its own trial stoppage, raising concerns that one of its volunteers had a disease. The company has mostly kept quiet about the details of the incident.
“There are several possible factors that could be the cause of the incident,” the company said. “Based on the information gathered to date and input from independent experts, the company has not found any evidence that the vaccine candidate caused the incident.”
Adverse events are not uncommon in large-scale vaccine trials. In some cases, they are caused by a vaccine. But investigations usually reveal that they are coincidences – a simple matter of chance.
Prior to the pause, the two companies had indicated that they would submit their vaccines for emergency authorization from the Food and Drug Administration within a few months. Maybe even by the end of the year. It is unclear whether these plans have now been put into flux in the wake of test delays. According to the statement, the results of AstraZeneca’s late-stage trials are still expected later this year. Johnson & Johnson has not provided an updated estimate in its statement.