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For British drugmaker AstraZeneca, it has recently been problematic. In the trial of the company’s new coronavirus vaccine in India, one participant said he had an adverse reaction after an injection of a new coronavirus vaccine that was in the last stage of testing.
India’s Medical Regulatory Agency, the Indian Medical Research Council (Indian Medical Research Council), said it was helping to investigate the allegations of the participants. On November 29, the agency told Reuters that it had not found a “direct cause and effect” and that it had no plans to terminate the AstraZeneca vaccine trial.
The participant who made the accusation is 40 years old and said that after injecting the AstraZeneca vaccine at the test site in Chennai, India, on October 1, he experienced serious “neuronal and psychological” side effects. He proposed a request for financial compensation of 50 million rupees (about $ 676,000) and called for the entire process of testing, production and distribution of AstraZeneca vaccines to “stop immediately”.
The Serum Institute of India, the vaccine manufacturer responsible for the AstraZeneca vaccine trial in India, stated in a statement to the Economic Times of India that the symptoms and vaccines of the trial participants The experiment itself “is not relevant at all way”. He believed the man’s accusations were “malicious and wrong” and said he would claim $ 13.5 million for it.
The Serum Institute of India is reported to have produced millions of doses of the AstraZeneca vaccine.
The Medical Research Council of India, the Serum Institute of India, AstraZeneca, and Oxford Vaccine Group (AstraZeneca’s vaccination partner) did not immediately respond to Fortune’s request for comment.
In September of this year, AstraZeneca had a post-test outage event. Due to a suspected adverse reaction from a British trial participant, the company suspended clinical trials worldwide.
After the reviewers confirmed the vaccine’s safety, AstraZeneca reopened the vaccine trial in the UK on 12 September after a four-day suspension. The Serum Institute of India received approval to resume the trial on September 16, while the United States will have to wait a bit later and restart the vaccine trial in October.
In fact, the AstraZeneca vaccine trial was criticized before trial participants made the allegations. Last week, the company was approved for a clear lack of transparency in the analysis of clinical trials.
On November 23, AstraZeneca announced that a preliminary analysis of data from its late-stage clinical trial showed the effectiveness of the company’s new coronavirus vaccine candidate was 62% or 90%, depending on the dose injected by participants. Before AstraZeneca issued a statement, Pfizer and Moderna’s new corona vaccine test results reported an effective rate of more than 90%.
AstraZeneca’s trial results and the outlook for the vaccines have been largely optimistic because its vaccines are relatively inexpensive, easy to produce, and suitable for use in low-income countries. Pfizer and Moderna vaccines require extremely low storage temperatures. Compared to AstraZeneca vaccines, they are easy to store and transport.
But AstraZeneca and Oxford came under fire within days of announcing the good news about the vaccine. Critics noted that AstraZeneca had omitted some initial information about the trial results. Because the researchers mistakenly injected the half-dose vaccine as a full dose to a group of participants, AstraZeneca obtained a 90% effective result. It is also wrong.
In this regard, AstraZeneca defended the results and methods of its tests, saying that it used the “highest standard” and will carry out additional analyzes. (Chinese Fortune Network)
Compiler: Yang Eryi
A participant in AstraZeneca’s COVID-19 vaccine trial in India claims he had an adverse reaction after receiving an injection of the coronavirus vaccine that is in an advanced stage of testing, adding to a list of Recent problems for the experimental immunization of the British pharmaceutical company.
The Indian Council for Medical Research (ICMR), India’s medical research regulator, is assisting in an investigation into the participant’s allegation, but told Reuters on November 29 that there is currently “no immediate cause for concern.” nor are there plans to stop the trial.
The 40-year-old trial participant, who received the vaccine injections on October 1 at a trial site in Chennai, India, said he experienced acute “neurological and psychological” side effects after receiving the vaccine. He is looking for 50 million rupees, about $ 676,000, in compensation. The man also called for testing, manufacturing and distribution of the AstraZeneca vaccine to be “stopped immediately.”
The Serum Institute of India, the vaccine manufacturer conducting the AstraZeneca vaccine trials in India, said in a statement to the Economic Times of India that there is “absolutely no correlation” between the man’s condition and the vaccine trial. He called the man’s accusations “malicious and ill-conceived” and said he would seek around $ 13.5 million in damages for the allegations.
The Serum Institute has already produced millions of doses of the AstraZeneca vaccine.
The ICMR, the Serum Institute, AstraZeneca and the Oxford Vaccine Group, which developed the AstraZeneca vaccine, did not immediately respond to requests for comment from Fortune.
AstraZeneca experienced a late-stage trial setback in September when it halted clinical trials around the world due to a suspected adverse reaction in a UK-based trial participant.
Vaccine trials in the UK resumed on 12 September, four days after suspension, following confirmation from safety reviewers that it was safe to do so; The Serum Institute received approval to resume testing on September 16; Trials in the United States resumed in October.
The accusations by the Indian trial participants follow last week’s criticism of AstraZeneca for an apparent lack of transparency in the clinical trial analysis.
On November 23, AstraZeneca announced that an early analysis of data from its late-stage clinical trial showed that its COVID-19 vaccine candidate was 62% or 90% effective, depending on how the doses were administered to the patients. participants. The AstraZeneca announcement followed the results of Pfizer and Moderna’s COVID-19 vaccine trial, which had reported efficacy rates of 90% or more.
AstraZeneca’s results were widely considered positive and promising, especially since its candidate is relatively cheap and easy to produce, and a large portion of its doses are scheduled to go to low-income countries. It is also easier to transport and store than Pfizer and Moderna vaccines because it does not require ultra-low storage temperatures.
But days after its November 23 news, AstraZeneca and Oxford came under fire for initially omitting certain information about the trial’s results, including that the 90% efficacy rate was discovered by mistake, when researchers inadvertently administered it to a group of participants half a dose of the vaccine instead of the full dose.
AstraZeneca defended its results and methods, saying it used the “highest standards” and would conduct further analysis.
