(Alliance News) - AstraZeneca PLC late on Monday said it has expanded US trials of its Covid-19 vaccine and the drugmaker added that its applications for regulatory approvals across the globe will meet "stringent" requirements.
The US probe of the AZD1222 vaccine will see trial centres recruit up to 30,000 adults from a variety of ethnic groups and will also include those with underlying medical conditions which leave them more exposed to the SARS-CoV-2 virus.
"Participants are being randomised to receive two doses of either AZD1222 or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline control. The trial is assessing efficacy and safety of the vaccine in all participants, and local and systemic reactions and immune responses will be assessed in 3,000 participants," Astra said.
In July, AstraZeneca ported encouraging interim results from a trial of the vaccine, being developed alongside Oxford University.
The much-anticipated findings showed that a single dose of AZD1222 resulted in a four-fold increase in antibodies fighting SARS-CoV-2, the virus strain which causes Covid-19.
Also on Monday, Astra said outlined its "commitment to the highest safety standards and to broad and equitable access around the world" for its Covid-19 vaccine.
"At the heart of AstraZeneca's core values is to 'follow the science' and adhere to the highest scientific and clinical standards, making the safety and efficacy of the vaccine of paramount importance. The company's submissions for market authorisation will meet the stringent requirements established by regulators everywhere around the world," the company said.
The statement came after reports on Sunday raised the possibility that a future vaccine against the coronavirus might be given emergency approval in the US before the end of trials designed to ensure its safety and effectiveness.
A request for such extraordinary approval would have to come from the vaccine developer, Stephen Hahn - the head of the US Food & Drug Administration - told the Financial Times.
"If they do that before the end of Phase Three," which involves large-scale human testing, "we may find that appropriate. We may find that inappropriate, we will make a determination."
But Hahn insisted he was not acting under pressure from President Donald Trump, who has been pushing hard for a vaccine, saying one might be ready before US elections November 3.
By Eric Cunha; ericcunha@alliancenews.com
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