AstraZeneca expects new vaccine trial data to be available this year after reporting an increase in third-quarter sales.
“Results from late-stage trials are anticipated later this year, depending on the rate of infection within the communities where the clinical trials are being conducted. Data readouts will be submitted to regulators and published in peer-reviewed scientific journals,” AstraZeneca said as it released its results.
The British pharmaceutical giant said global product sales, excluding payments from collaborations, soared by 7% to $6.52 billion for the three months ending on September 30, on a constant-currency basis.
According to AstraZeneca’s Chief Executive Pascal Soriot, the results suggested that the drugmaker “made encouraging headway in the quarter, despite the ongoing disruption from the Covid-19 pandemic.” The company was able to sustain its full-year guidance.
The company is developing a Covid-19 vaccine in collaboration with the University of Oxford. The vaccine candidate, which has the technical name AZD1222, is in late-stage clinical trials that are taking place in the U.K., Brazil, South Africa, and the U.S and currently with around 23,000 participants.
Trials in the U.K. and U.S. had to be postponed due to unexplained illnesses reported on two participants but both got the approval from regulators to operate again when these were believed to not have been related to the vaccine.
AstraZeneca issued an update on the vaccine’s development, saying it had developed the same immune response in older and younger adults.
Deal with the government
AstraZeneca has secured a $486 million deal from the US government. The company will supply up to 100,000 doses of Covid-19 antibody treatment.
The deal was awarded under President Donald Trump’s Operation Warp Speed. Under the agreement, AstraZeneca will produce a monoclonal antibody cocktail that can stop Covid-19, particularly in high-risk populations like those over 80 years old, according to the US Department of Health and Human Services said.
According to AstraZeneca, it aims to distribute around 100,000 doses starting toward the end of the year. With this, the US government could get an additional one million doses in 2021 under a separate deal.
The drugmaker will conduct two studies to assess the treatment, AZD7442, which is a cocktail of two monoclonal antibodies.
Their trial will determine the safety and efficacy of the antibody treatment to stop infection for up to 12 months in about 5,000 participants. The other trial will study post-exposure preventative and pre-emptive treatment in around 1,100 participants.
In September, US Health and Human Services Secretary Alex Azar said the company’s late-stage trial of coronavirus vaccine is still on hold.
He said that federal investigators are still looking for “answers to important questions” regarding the safety of patients.
“Look at the AstraZeneca program, phase three clinical trial, a lot of hope. Single serious adverse event report in the United Kingdom, global shutdown and hold of the clinical trials,” Azar said during his interview on CNBC’s “Squawk Box.”
“Still on hold here in the United States as the (U.S. Food and Drug Administration) seeks answers to important questions to verify safety information around those vaccines. Plan is by the book, we’re keeping patient safety at the center of everything we do,” he said.
AstraZeneca spokeswoman Michele Meixell confirmed that the AstraZeneca late-stage trial of coronavirus vaccine is still on hold.
