in October 23, local time, The Paper learned from the Oxford University vaccine research and development team that Coronavirus vaccine (hereinafter referred to as Oxford vaccine) developed in cooperation with the British pharmaceutical company AstraZeneca has resumed clinical trials in the United States. So far, clinical trials of the vaccine in the world have resumed.
On October 23, the Oxford University vaccine team sent an email to The Paper, stating that after the team’s vaccine restarted clinical trials in the United Kingdom, Brazil, South Africa and Japan, the U.S. Food and Drug Administration (FDA) approved the renewal in the United States on the same day. Started clinical trials of “ChAdOx1 nCov-2019” Oxford vaccine.
In an e-mail statement, the team stated that on September 6 this year, “a standard review procedure” triggered a “voluntary suspension” of Oxford vaccines worldwide to allow an independent committee to review safety data. Before the suspension of the trial, Oxford Vaccine has been one of the most advanced vaccines in global vaccine development and is expected to be approved for use before the end of the year. However, clinical trials of the vaccine in the United States were shelved for more than a month.
“Now, the U.S. FDA and international regulatory agencies in other clinical trial sites around the world have come to the same conclusion. They believe that clinical trials of Oxford vaccines can be resumed safely.”
According to US media reports, the FDA concluded that the Oxford vaccine is not the cause of the side effects of the volunteers’ nervous system, although the connection cannot be completely ruled out.
Professor Andrew Pollard, the chief researcher of the Oxford University vaccine research and development team, said in an email statement that after the FDA announced that it is safe to conduct the vaccine trial in the United States, its partner AstraZeneca will start selling 30,000 in the United States. Vaccine trials were conducted on volunteers, bringing the number of large-scale Phase III clinical trials conducted by the team worldwide to 50,000. Pollard said, “We will continue to adhere to strict security procedures, and at the same time take action as soon as possible, so as to start protecting people around the world from this terrible virus as soon as possible.”
The statement also emphasized that Oxford University and AstraZeneca have provided information in accordance with the requirements of international guidelines and regulatory agencies, and will continue to update relevant information of all trial investigators and participants, and will disclose it in accordance with clinical trials and regulatory standards.
On September 8, local time, a volunteer in the Oxford vaccine clinical trial in the United Kingdom was found to have an “unexplainable disease.” According to foreign media reports, his neurological symptoms were related to a rare and severe myelitis-horizontal. Myelitis is consistent, but the news has not been officially confirmed.
Since then, suspended clinical trials have been resumed in the United Kingdom, Brazil, India and other countries, but in the United States, AstraZeneca’s Covid-19 vaccine trials have not been approved to resume.
On October 21, the Brazilian National Health Supervision Agency stated that a 28-year-old Brazilian volunteer who participated in the Oxford vaccine clinical trial had died, but the trial was still allowed to continue. It was later learned that the dead volunteer was not vaccinated.
In addition, also due to an “unexplained disease” in a volunteer, Johnson & Johnson’s Covid-19 vaccine candidate also decided on October 13 to “research suspension”, but it is different from the previous “clinical trial suspension” of the Oxford vaccine team.