By Ludwig Burger
(Reuters) – AstraZeneca’s suspension of global trials of its crownvirus vaccine under investigation after the disease on the UK issue has called customers into question the early deployment of one of the top-19 coVID vaccines in development.
AstraZeneca, who is preparing the vaccine with researchers at the University of Oxford, said Tuesday that he had suspended complex trials to allow an independent committee to review protection knowledge and that it was being implemented to minimize any possible effects on the timetable.
The patient would experience neurological symptoms related to a rare inflammatory spinal disorder called transverse myelitis. AstraZeneca said Wednesday that a definitive diagnosis is still pending while additional testing is being performed.
The director of the US National Institutes of Health, Francis Collins, said in a Senate committee hearing Wednesday that work is being prepared “to see if anyone else who has won this vaccine or any other could have had a similar discovery of a spinal cord problem. “
The trial halt follows reports that the United States aims to speed up approval or approval of a vaccine ahead of the November presidential election. political tension to speed up the process.
AstraZeneca has already agreed to deliver approximately 3 billion doses to governments around the world, more than any other vaccine project.
The company also showed Wednesday that it briefly discontinued the vaccine trial in July after a volunteer on the test was found to have sclerosis. An independent review panel concluded that MS was not related to the vaccine.
When asked if the most recent rupture would slow down the progression process, UK Health Secretary Matt Hancock said, “Not necessarily, but in what they locate when they do the research. “
‘ROUTINE ACTION’
The UK medical regulator said it was urgently reviewing for data on whether trials could be restarted as temporarily as possible.
“People are in poor health for a multitude of reasons, and the assigned team will now take an in-depth look at the cause of this person’s illness and whether it is similar to whether or not they won the vaccine,” Doug said. Brown, executive director of the British Society for Immunology.
The Financial Times cited others related to the lawsuit who said it could resume early next week, after the study’s independent knowledge oversight committee investigated.
AstraZeneca commented on when the test might restart.
The suspension of AstraZeneca’s shares would fall by 3%, but they closed with a 0. 4% hike on Wednesday.
The UK trial started in May with more than 12,000 participants between the ages of five and 70.
AstraZeneca’s complex US trial, targeting 30,000 participants, was unveiled last week. The vaccine, AZD1222, is also in phase III clinical trials in Brazil and South Africa.
Additional trials are planned in Japan and Russia, with 50,000 participants worldwide.
South Korea has said it will review its plan to participate in making the vaccine. The Health Ministry official Yoon Tae-ho said such suspensions from clinical trials were not unusual “because the dots interact. “
Leukocare of Germany, which is running on a vaccine for AstraZeneca but at an earlier stage, agreed that protection considerations will likely remain in giant trials.
“When 20,000 people are inoculated, it is a fact that at some point serious side effects will occur. As soon as it becomes clear that a link to the vaccine can be ruled out, the trial continues,” chief executive Michael Scholl said.
The vaccine uses an innocent adenovirus to transmit the genetics of the target coronavirus, which helps the immune formula build an arsenal opposed to long-term infection.
A technique is followed through CanSino in China, the Gamaleya Institute in Russia and Johnson
Supporters of the candidate Gamaleya, Russia’s first COVID-19 vaccine, noted that it is an adenovirus in humans, while the British candidate uses an adenovirus discovered in chimpanzees.
“We have consistently draw attention to the fact that the human adenoviral platform is much safer and much more studied than any other new platform,” Russian sovereign fund director Kirill Dmitriev told Reuters.
By opting for a chimpanzee virus as a vector, AstraZeneca and Leukocare seek to avoid the threat that the immune formula attacks the vector than coronavirus due to past combat with adenovirus.
The Serum Institute of India had said that its trials of the AstraZeneca vaccine were ongoing and had not encountered any problems.
On Wednesday night, V. G. Somani, the Comptroller General of Medicines in India, asked Serum why trials in India are not suspended until patient protection is established. Serum said he would stick to the Comptroller General’s instructions.
(Information through Guy Fauconbridge, Estelle Shirbon, Kate Kelland in London and Deena Beasley in Los Angeles; additional information through Peter Henderson in San Francisco, Carl O’Donnell in New York, Rocky Swift in Tokyo, Sangmi Cha in Seoul and Miyoung Kim in Singapore; edited through Emelia Sithole-Matarise and Bill Berkrot)