Regulators will decide the dosing regimen for AstraZeneca-Oxford COVID-19 vaccine
Individual regulatory bodies in the U.K., Europe, and the United States will be the ones to ultimately give the green light as to which dosing regimen is appropriate.
“Our job as scientists is to generate the data and make that publicly available for people to scrutinize and scientists to scrutinize and also now for the regulators and policymakers to scrutinize. These decisions are not for us to make,” said Prof Andrew Pollard of Oxford University, chief investigator on the trials.
The U.S. Food and Drug Administration (FDA) seemed to be extremely thorough in giving a go-ahead. FDA raised concerns about the limited ethnicity data in the trials and the absence of older people at the highest risk, as most participants were under 55, according to The Guardian.
“We will be submitting the data to the FDA, but our best assumption is that we will need the study readout from the U.S. before we are likely to get approval,” said Mene Pangalos, executive vice-president of biopharmaceuticals R&D at AstraZeneca.
The U.K. earlier became the first to distribute the clinically approved Pfizer-BioNTech-COVID-19 vaccine.
Marking a decisive turning point in the COVID-19 fight, 90-year-old Margaret Keenan earlier became the first recipient of the Pfizer-BioNTech COVID-19 vaccine in the U.K., with the country starting a global immunization program dubbed as “V-Day.”
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