AstraZeneca COVID-19 Vaccine Research Paused After One Disease

Late-stage research on AstraZeneca’s COVID-19 vaccine candidate is temporarily pending, but the company is investigating whether the recipient’s “potentially unexplained” disease is a side effect of shots.

Although late-stage research on AstraZeneca’s COVID-19 vaccine candidate is temporarily pending, the company is investigating whether the recipient’s “unexplainable” illness is a side effect of shots. I will.

“The standard review process suspended vaccination to allow review of safety data,” the company said in a statement released Tuesday night.

AstraZeneca did not provide information about possible side effects other than calling it “a potentially unexplained illness.” of health The news site STAT first reported a suspension of testing and said possible side effects occurred in the UK.

AstraZeneca spokesman confirmed that the vaccination suspension covered studies in the United States and other countries. Late last month, AstraZeneca began recruiting 30,000 people in the United States for the largest vaccine study. We’re also testing the vaccine developed by Oxford University in thousands of people in the UK and in small studies in Brazil and South Africa.

The other two vaccine There is a huge final stage of testing in the United States. One by Moderna Inc. and another by Pfizer and BioNTech in Germany. Those two vaccine It works differently than AstraZeneca, and about two-thirds of the volunteers needed are already recruited in the study.

Temporary suspension of large-scale medical studies is not uncommon, and investigating serious or unexpected reactions is an essential part of safety testing. AstraZeneca pointed out that the problem may be accidental. Studies of thousands of people can cause all kinds of illnesses.

“We are working to expedite the review of a single event in order to minimize the potential impact on the trial timeline,” said the company statement.

The unexplained illness was so severe that it required hospitalization, and it was likely that it was not a mild side effect such as fever or myalgia, Deborah Fuller, a researcher at the University of Washington, has started a human test Not yet working on another COVID-19 vaccine, he said.

“This is not a worry,” Fuller said. Instead, it’s reassuring that the company pauses the investigation to see what’s going on and is closely monitoring it. health Of research participants.

Dr. Ashish Jha of Brown University said via Twitter that the significance of the interruption is unknown, but that finding an effective vaccine in the next few months is “still optimistic.”

“But optimism is not proof,” he wrote. “Let science drive this process.”

Angela Rasmussen, a virologist at Columbia University in New York, tweeted that the disease could be unrelated to the vaccine, but “an important part is to test it before it’s released to the general public. The reason is.”

During the third and final stages of testing, researchers look for signs of side effects that may not have been detected in previous patient studies. Due to the large size of these studies, they are considered the most important research step to address less common side effects and establish safety.

Clinical trials will also assess efficacy by tracking who gets sick and who does not get sick between vaccinated and dummy-shot patients.

Development took place on the same day that AstraZeneca and eight other pharmaceutical companies announced an unusual commitment to maintain the highest ethical and scientific standards in vaccine development.

The announcement follows concerns that President Donald Trump will pressure the US Food and Drug Administration to seek approval before the vaccine’s safety and efficacy are demonstrated.

The United States has invested billions of dollars in its efforts to rapidly develop multiple vaccines against COVID-19. However, the public’s fear that the vaccine is unsafe or ineffective will be disastrous and will undermine efforts to vaccinate millions of Americans.

FDA representatives did not immediately respond to requests for comment on Tuesday evening.

AstraZeneca shares traded in the US fell more than 6% in overtime trading, following reports that the case was suspended.

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Associated Press correspondents Matthew Perone and Carla K. Johnson contributed to this report.

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The Associated Press Health Sciences Department is supported by the Science Education Department of the Howard Hughes Medical Institute. AP is solely responsible for all content.