In this news, we discuss the Exclusive: U.S. trial of AstraZeneca COVID-19 vaccine may resume this week – sources.
CHICAGO / WASHINGTON (Reuters) – The trial of AstraZeneca Plc’s AZN.L COVID-19 vaccine in the United States is expected to resume as soon as this week, after the United States Food and Drug Administration completed its review of a serious illness, four sources told Reuters.
The large US trial of advanced AstraZeneca has been on hold since September 6, after a participant in the company’s UK trial fell ill with what was suspected to be a rare inflammatory spine disorder called transverse myelitis.
The sources, who were briefed on the matter but asked to remain anonymous, said they were told the trial could resume later this week. It is not known how the FDA would characterize the disease, they said.
An FDA spokeswoman declined to comment.
The agency is asking researchers leading the trial to add information about the incident to consent forms signed by study participants, according to one of the sources.
UK regulatory authorities have previously examined the disease and determined that there was “not enough evidence to say for sure” whether or not it was. related to the vaccine. This allowed the trial to resume in the UK, according to an updated draft consent form shared with Reuters.
“In this case, after reviewing the information, the independent assessors and the Medicines and Health Products Regulatory Agency (MHRA) recommended that the vaccinations continue,” the draft consent form says. “Close monitoring of the affected person and other participants will continue.”
Regulators in Brazil, India and South Africa have also allowed AstraZeneca to resume vaccine trials there.
AstraZeneca, which is developing the vaccine with researchers at the University of Oxford, had been seen as a pioneer in the race to produce a COVID-19 vaccine until its trials were put on hold to investigate disease. The first large-scale trial data in the United States on the vaccines from Pfizer Inc PFE.N and Moderna Inc MRNA.O are expected next month.
Johnson & Johnson JNJ.N last week suspended its Phase III COVID-19 vaccine trial to investigate an unexplained illness in one of the study participants. At the time of the announcement, the company was unsure whether the volunteer had received their vaccine or a placebo.
A spokesperson for J&J said on Tuesday the study was on hiatus as the company continued its review of medical information before deciding to resume the trial. J&J noted that his “study break” was voluntary, unlike AstraZeneca’s “regulatory suspension”, which is imposed by health authorities.
Vaccines are seen as essential to help end the pandemic that has hit economies around the world and claimed more than one million lives – including more than 220,000 in the United States.
In response to a request regarding the AstraZeneca trial, UK regulators shared with Reuters a draft template letter to UK vaccine trial participants, dated October 14 and signed by the COVID-19 vaccine team at Oxford. He says the US FDA has “finished its analysis” and that vaccination in the US would resume shortly.
The FDA “came to the same conclusion as other drug regulators, including the MHRA,” the letter says.
The Health Research Authority, which helps oversee medical research in the UK, said in an email to Reuters it had reviewed the communication to ensure it was appropriate to ensure the informed consent of volunteers at the ‘study. He could not confirm that the letter had been issued.
A spokeswoman for AstraZeneca said the communication did not come from the company and that she “could not verify the content,” referring to the draft letter to study participants.
“We also cannot comment on a pending FDA decision,” she said. The Oxford study team did not respond to requests for comment.
NOT ENOUGH PROOF
In another of the papers intended for trial participants, the Oxford vaccine study team noted that there was insufficient evidence to link the neurological problem seen in the UK trial. United to the vaccine.
Dr Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia who reviewed the document, said it can be difficult to link a rare side effect specifically to a vaccine to the exclusion of other causes. potential.
Transverse myelitis, which the study volunteer reportedly developed, typically occurs at a rate of 1 in 200,000 people, Offit said, so it would be unusual to see it in a trial in 9,000 people.
Other viruses, including those that cause West Nile and polio, can trigger the disease, as can physical trauma.
Regulators need to assess whether a rare side effect is vaccine-related and could recur against COVID-19-related illness and death, Offit said. “This is always the line you follow.”
Reporting by Julie Steenhuysen and Marisa Taylor; Editing by Bill Berkrot
Original © Thomson Reuters