Paused AstraZeneca and Johnson & Johnson Coronavirus Vaccine Trials Expected to Resume This WEEK, Says Operation Warp Speed Chief
The chief of Operation Warp Speed said he expects two interrupted trials of coronavirus vaccines to resume next week.
AstraZeneca Plc and Johnson & Johnson each put their respective trials on hold after the participants inexplicably became ill.
But Dr. Moncef Slaouo, who leads the government’s plan to accelerate production of millions of vaccine doses, says he believes an announcement from the U.S. Food and Drug Administration (FDA) is approaching.
‘It is up to the FDA to announce and decide this, but I understand this is imminent,’ Slaoui said Bloomberg.
“I hope the J&J trial will start again later this week.”
Operation Warp Speed chief Dr. Moncef Slaoui says he expects two interrupted coronavirus trials to resume this week. Pictured: Slaoui takes to the stage before President Donald Trump speaks at a White House press conference on Sept. 18
AstraZeneca’s US arm (left) was put on hold on September 8 when a British participant had a severe reaction that caused inflammation of the spinal cord. Johnson & Johnson’s (right) COVID-19 vaccine trial was interrupted on Oct. 12 after a volunteer developed an ‘unexplained disease’
Both companies are developing a so-called viral vector vaccine.
The immunization combines genetic material from the new virus with the genes of the adenovirus, which causes colds.
It encodes the spike protein that the coronavirus uses to invade and infect cells in order to train the body to recognize the virus and elicit an immune response if it is infected.
This is the same technology that J&J used in late 2019 to create an experimental Ebola vaccine for people in the Democratic Republic of Congo.
Slaoui said there is currently no evidence that viral vector vaccines are any less safe than other vaccine types being developed to combat COVID-19.
“I have not seen any data to indicate that these platform technologies have a problem,” he told Bloomberg.
AstraZeneca’s late-stage study, which is being conducted with the University of Oxford, was halted on September 8 when a British participant was rushed to hospital after a severe reaction that caused inflammation of the spinal cord.
An internal security report revealed the British patient was diagnosed with transverse myelitis, an inflammation of part of the spinal cord.
The condition damages the myelin sheath, an insulating barrier of fatty proteins that protects the nerves and interrupts messages sent by the nerves of the spinal cord.
This results in pain, weakness, abnormal feelings, and bladder and bowel problems – and can even lead to permanent paralysis.
Testing has since resumed on all other sites, but not in the US.
According to Reuters, four sources briefed on the matter who asked to remain anonymous say the trial could resume later this week.
Allowing testing to resume likely means that the FDA believes that the disease the British patient contracted was not related to the experimental vaccine.
However, according to one source, the FDA requires investigators conducting the investigation to add information about the incident to consent forms signed by study participants.
Meanwhile, J & J’s COVID-19 vaccine study was interrupted on Oct. 12 after a volunteer developed an “ unexplained illness. ”
The company has declined to provide further details about the nature of the disease and the said patient privacy.
‘We must respect the privacy of this participant. We are also learning more about this participant’s illness, and it is important to have all the facts before sharing additional information, ”said a spokesperson.
J&J declined to answer whether the participant received the vaccine or the placebo and whether the trial was interrupted earlier.