AstraZeneca has resumed the U.S. study of its experimental COVID-19 vaccine after regulatory approval, and Johnson & Johnson is preparing to resume the study early next week.
Important points:
- Both vaccine candidates had been forced to drop out of US studies after participating diseases
- However, both were cleared for resumption after the vaccines were found not to be the cause
- The race for a vaccine comes as coronavirus infections rise in dozen of countries
The news signaled progress against the novel coronavirus, which has infected more than 41 million people worldwide and comes 10 days before a US presidential election that may be contingent on plans to fight the pandemic.
AstraZeneca, a leading vaccine developer, suspended its US study on September 6 after a report of a serious neurological condition suspected to be transverse myelitis in a participant in the company’s UK study.
Johnson & Johnson halted its large, late-stage study last week after a study participant fell ill.
Both companies have signed contracts to supply vaccines to the US and other governments if they are approved by regulators.
The Australian government also has a contract with Astra Zeneca to manufacture the vaccine locally, if successful.
Officials and experts have raised concerns that political pressure is undermining the Food and Drug Administration (FDA) oversight process, and about a quarter of Americans say they are reluctant to take a COVID-19 vaccine.
“As this study resumes, I hope the message sent to the public is that we are following procedures with the highest ethical standards and are not disrupting the FDA regulatory process,” Matthew Hepburn, director of vaccine development at Operation Warp Speed, told a public -private partnership to accelerate vaccination efforts.
Infections are increasing in 80 countries as people in the northern hemisphere spend more time indoors as winter approaches.
J&J said the security panel, known as the data and safety oversight body, recommended the drug maker to resume study recruitment after it found no evidence that the vaccine made a volunteer sick.
J&J expects to resume its study in the US on Monday or Tuesday and remains on track to generate data from the study on the vaccine’s effectiveness by late 2020 or early 2021, said Paul Stoffels, chief scientist by J & J.
J&J is also in talks with other regulators to reopen a lawsuit outside of the United States, the company said.
So far, the medical association has not identified a clear cause for the patient’s illness.
J&J is unable to reveal details about the patient’s illness due to the patient’s privacy policy, said Dr. Stoffels.
AstraZeneca said it was not uncommon for some study participants to get sick during large-scale vaccination trials, but the U.S. Food and Drug Administration had reviewed all of the safety data from the trials around the world and deemed it safe to continue testing the vaccine.
The AstraZeneca studies in the UK, Brazil and South Africa resumed last month despite the US Food and Drug Administration continuing its investigation into the case.
Reuters reported earlier this week that the FDA had completed its review and that AstraZeneca’s US study was due to resume this week, citing four sources familiar with the situation.
AstraZeneca’s vaccine is being developed in collaboration with researchers from Oxford University.
Reuters
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