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FDA to let AstraZeneca’s coronavirus vaccine trials resume in the US

US regulators said on Wednesday that AstraZeneca can resume the US arm of its trial of Oxford University’s coronavirus vaccine, according to documents obtained by the Wall Street Journal. 

AstraZeneca paused global trials on September 8 due to what it called at the time an ‘unexplained illness’ in a British volunteer. 

Tests resumed on September 8 in the UK, but US Food and Drug Administration (FDA) officials conducted an independent investigation. 

Meanwhile, a participant in the Brazil arm of the trial died on Wednesday, but Oxford University determined that there was ‘no safety concern’ over the vaccine and related to the death and international trials are up and running again. 

FDA regulators will allow AstraZeneca to resume its trials of Oxford University's coronavirus vaccine, according to documents obtained by the Wall Street Journal. It comes weeks after trials were paused over a mysterious spinal problem in a UK trial participant and well after trials were resumed elsewhere

FDA regulators will allow AstraZeneca to resume its trials of Oxford University's coronavirus vaccine, according to documents obtained by the Wall Street Journal. It comes weeks after trials were paused over a mysterious spinal problem in a UK trial participant and well after trials were resumed elsewhere

FDA regulators will allow AstraZeneca to resume its trials of Oxford University’s coronavirus vaccine, according to documents obtained by the Wall Street Journal. It comes weeks after trials were paused over a mysterious spinal problem in a UK trial participant and well after trials were resumed elsewhere 

The head of Operation Warp Speed foresaw the resume, saying Thursday he expected the paused coronavirus vaccine trials for AstraZeneca and to resume this  week, and hoped the same would be true for Johnson & Johnson’s trials. 

AstraZeneca and Johnson & Johnson each put their respective trials on hold after participants fell inexplicably ill.

But Dr Moncef Slaoui, who leads the government’s plan to fast-track the production of millions of vaccine doses, says he believes a announcement from the US Food and Drug Administration (FDA) is approaching.    

‘It’s for the FDA to announce and decide but I understand that this is imminent,’ Slaoui told Bloomberg.

‘I hope that the J&J trial also will restart later this week.’  

Dr Moncef Slaoui, the chief of Operation Warp Speed, says he expects two paused coronavirus trials to resume this week. Pictured: Slaoui stands on the podium before President Donald Trump speaks during a news conference at the White House, September 18

Dr Moncef Slaoui, the chief of Operation Warp Speed, says he expects two paused coronavirus trials to resume this week. Pictured: Slaoui stands on the podium before President Donald Trump speaks during a news conference at the White House, September 18

Dr Moncef Slaoui, the chief of Operation Warp Speed, says he expects two paused coronavirus trials to resume this week. Pictured: Slaoui stands on the podium before President Donald Trump speaks during a news conference at the White House, September 18

AstraZeneca's US arm was placed on hold on September 8 when a British participant suffered a serious reaction that triggered spinal cord inflammation

AstraZeneca's US arm was placed on hold on September 8 when a British participant suffered a serious reaction that triggered spinal cord inflammation

Johnson & Johnson's COVID-19 vaccine trial was paused on October 12 after a volunteer developed an 'unexplained illness'

Johnson & Johnson's COVID-19 vaccine trial was paused on October 12 after a volunteer developed an 'unexplained illness'

AstraZeneca’s (left) US arm was placed on hold on September 8 when a British participant suffered a serious reaction that triggered spinal cord inflammation. Johnson & Johnson’s (right) COVID-19 vaccine trial was paused on October 12 after a volunteer developed an ‘unexplained illness’

Both companies are developing what are known as a viral vector vaccines.

These immunizations combine genetic material from the new virus with the genes of the adenovirus, which causes the common cold.

The portion taken from SARS-CoV-2 codes for the spike protein that the coronavirus uses to enter and infect cells in order to train the body to recognized the virus and induce an immune response if infected.

This is the same technology that J&J used to make an experimental Ebola vaccine for people in the Democratic Republic of Congo in late 2019. 

Slaoui said there is currently no evidence to suggest viral vector vaccines are less safe than other vaccine types being developed to combat COVID-19. 

‘I have not seen data at all that suggests these platform technologies have a problem,’ he told Bloomberg.

AstraZeneca’s late-stage study, being conducted with the University of Oxford, was put on hold on September 8 when a British participant was rushed to the hospital after suffering a serious reaction that triggered spinal cord inflammation. 

An internal safety report revealed the British patient was diagnosed with transverse myelitis, an inflammation of a section of the spinal cord.

The condition damages the myelin sheath, an insulating barrier of fatty protein that protects the nerves, and interrupts messages sent by spinal cord nerves.

This results in pain, weakness, abnormal sensations, and problems of the bladder and bowel – and can even lead to permanent paralysis. 

Testing has since resumed at all other sites, but not in the US.

Now, four sources briefed on the matter, who asked to remain anonymous, say they have been told the trial could resume later this week, according to Reuters.

Allowing testing to resume likely means the FDA believes illness suffered by the British patient was not linked to the experimental vaccine. 

However, the FDA is requiring researchers conducting the trial to add information about the incident to consent forms signed by study participants, according to one of the sources.

Meanwhile, J&J’s COVID-19 vaccine trial was paused on October 12 after a volunteer developed an ‘unexplained illness.’ 

The company has declined to provide further details about the nature of the illness and cited patient privacy.  

‘We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,’ a spokesperson said. 

J&J has refused to answer whether the participant received the vaccine or the placebo and if the trial has been paused before. 

Source: Daily Mail

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