[ad_1]
Reporter Seongmin Kim, Biosviewer
AstraZeneca-Oxford University receives approval from UK regulators to resume clinical trials in accordance with UK Safety Commission recommendations … “Final phase 3 clinical data can be obtained from will be sent to regulatory authorities before the end of this year …
▲ Pascal Soriot, AstraZeneca CEO, company data
Phase 3 clinical trials of ‘AZD1222’, a COVID-19 vaccine developed jointly by AstraZeneca and the University of Oxford, have been resumed and were temporarily suspended due to ‘side effect issues’ during the clinical trial. This appears to have ended the controversy over AZD1222, which has been a hot topic in the industry for the past 6 days.
AstraZeneca will be able to secure the final data to be sent to regulators before the end of this year according to the original plan. AZD1222 is a vaccine designed to deliver the spike protein of the SARS-CoV-2 virus, which causes corona 19 infection, to a chimpanzee adenovirus vector, and the body’s immune system attacks and kills it.
AstraZeneca announced on the 12th (local time) that AZD1222 has resumed clinical trials in the UK following confirmation that the vaccine is safe from the UK Pharmaceutical and Healthcare Regulatory Agency (MHRA). AstraZeneca explained: “After the UK commission investigated, it recommended to the MHRA that it was safe to resume testing in the UK.”
In the AZD1222 clinical trial on day 6, the news that a patient had symptoms of transverse myelitis, a rare inflammatory spinal disease, and the clinical trial was stopped, came out through some media. This patient was not confirmed, but showed characteristic neurological symptoms in patients with transverse myelitis. The news made the industry anxious and demanded an official clarification from AstraZeneca.
The controversy grew when AstraZeneca did not immediately respond. And, three days after the clinical trial was stopped (ninth), he announced his official position. He explained that he has voluntarily stopped all global clinical trials so that independent committees and regulators can review safety data by following standard review procedures. In order to maintain integrity in the clinical development process, the procedure was followed according to the principle in situations where side effects are reported.
Speaking at the Tortoise Media conference on the 10th, Pascal Soriot, CEO of AstraZeneca, said: “If clinical trials can be resumed according to the review of the safety committee, the data will be sent to the regulatory authorities before the end of this year. It is expected to be able to assure. After that, it depends on how quickly regulators review and approve it. “We can get the vaccine later this year or early next year.”
In addition, CEO Pascal showed a confident demeanor saying, “I’m ready from a manufacturing point of view.” AstraZeneca has laid the groundwork to produce around 3 billion doses in collaboration with global partners at SK Bioscience to distribute vaccines around the world, including the United States, Japan, China, Europe, Brazil, India, Australia, and developing countries. I put it.
Faced with this situation, some analysts have a negative view that it will take weeks or even months to investigate the problem of side effects, escalating tensions. However, as the clinical trial was canceled faster than expected, it was a ‘sigh’ reaction.
However, the controversy is not entirely over. In a statement released this time by AstraZeneca and the University of Oxford, when they explained that additional medical information about the patient’s side effects would be kept confidential, some voices criticized. Information on all clinical investigators and participants will later be published in the global clinical registry in accordance with clinical trials and regulatory standards.
According to the Oxford University disclosure, around 18,000 people have received the AZD1222 vaccine so far, and symptoms such as mild to moderate levels of chills, fatigue and fever have developed as side effects.
Meanwhile, there was a reason AstraZeneca responded more sensitively to the Corona 19 vaccine safety issue.
This is because large-scale clinical trials are advancing at an unprecedented rate in light of the special circumstances of the Corona 19 pendemic around the world. Also, since the vaccine is intended for the general population, it is important to ensure good safety data. In general, in vaccine clinical trials, safety data is tracked from participants 2 to 3 years after vaccination, and the entire clinical development process takes 5 to 10 years. However, as the situation is dire, clinical development is being completed in a short period of one to two years, and China and Russia have already urgently approved the Corona 19 vaccine.
Consequently, at an unprecedented rate, the industry raised concerns about side effects. In that sense, this controversy over side effects is raising the headlines that re-verification is needed to “clinically prove the safety of vaccines.”
Pfizer, BioNTech and Moderna, currently leading competitors, are accelerating with the Corona 19 vaccine at the forefront. Pfizer and BioEntech announced on the 12th that they will recruit an additional 14,000 of the existing 30,000 to include more diverse patients, and are aggressively scaling up phase 3 clinical trials.
▲ Adenovirus-based ‘AZD1222’ Mechanism of Action, University of Oxford data
[ad_2]
