A British drugmaker that last week made headlines when it paused clinical trials of a vaccine against Covid-19 due to an unexpected adverse event has resumed the studies, following regulatory approval.
London-based AstraZeneca said Saturday that it had resumed trials in the U.K. of AZD1222 after confirmation by the country’s drug regulator, the Medicines Health Regulatory Authority, or MHRA. The announcement closely follows reports last week that the U.K. studies of the vaccine against SARS-CoV-2, which AstraZeneca is developing with the University of Oxford, had been paused after a participant experienced a “potentially unexplained illness” that The New York Times had reported was transverse myelitis, an inflammation of the spinal cord that was nevertheless not confirmed to be directly related to the vaccine.
Shares of AstraZeneca rose about 1% over their Friday closing prices on the New York and London stock exchanges after markets opened Monday. The company’s stock had fallen more than 1% on both markets last Wednesday.
The company said that on Sept. 6, the standard review process triggered a voluntary pause to vaccination across all global trials to allow for a review of safety data, with the U.K. committee recommending to the MHRA that it was safe to resume. However, AstraZeneca and the University of Oxford said that they “cannot disclose further medical information.”
The company is one of several running large Phase III trials of vaccines against SARS-CoV-2. Others include Moderna and Pfizer, which is partnered with German biotech firm BioNTech. Over the weekend, Pfizer CEO Albert Bourla told CBS’ “Face the Nation” that there was a good possibility that the company would know by the end of next month if its vaccine, BNT162b2, would work.
Still, the case of AstraZeneca highlights concerns among the public and medical experts about the risks of rushing a vaccine to market, especially under political pressure. AstraZeneca, Pfizer, BioNTech and Moderna were among the nine companies whose CEOs signed a statement released last week pledging not to cut corners.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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