Alastair Grant / AP
Drug maker AstraZeneca announced on Saturday that its COVID-19 vaccine studies had resumed in the United Kingdom, but not yet in the United States. Vaccine trials worldwide were suspended earlier this week after a British participant in one of the studies developed a neurological disorder.
The vaccine candidate was developed by the University of Oxford together with AstraZeneca. The goal of the large studies is to see if the vaccine can prevent COVID-19 and if it is safe.
Although initial studies did not show serious vaccine side effects, rare complications from a vaccine, if any, may not arise until it has been administered to thousands, tens of thousands, or thousands of people.
On Sunday, AstraZeneca says: All studies around the world on this particular vaccine candidate were interrupted after a volunteer in the UK developed symptoms related to transverse myelitis, an inflammation of the spinal cord that can lead to paralysis.
According to a statement from the pharmaceutical company on Saturday, the studies were suspended “to allow verification of safety data by independent committees and international regulators.”
The statement went on to say that the committee had completed its investigation and advised the UK Healthcare Regulatory Authority Compliant with the Food and Drug Administration that UK trials can be safely resumed.
In an email to NPR Saturday, an AstraZeneca spokesperson said, “The company will continue to work with health authorities around the world, including the FDA, to seek advice on when other clinical trials can resume.”
AstraZeneca said that it cannot disclose further medical information as it is the sponsor of the study, but added in its statement, “All investigators and participants in the study will be updated with the relevant information and it will be updated in global as per the clinical study published clinical registries and regulatory standards. “
The partnership between AstraZeneca and Oxford is one of the efforts to develop vaccines against the most distant coronavirus. The company recently started a phase 3 study in the United States that aims to enroll 30,000 volunteers.
In late July, results from a preliminary safety and efficacy study found that more than two-thirds of people who received the experimental vaccine reported fatigue and headaches after inoculation. Muscle pain and fever were also common. But the researchers said at the time that among the more than 500 people vaccinated, there were no “serious side effects” and that most of the effects were “mild or moderate”.
In May, the Trump administration awarded AstraZeneca up to $ 1.2 billion from the Biomedical Advanced Research and Development Authority as part of Operation Warp Speed. The government pushed for a widespread coronavirus vaccine by January.