To fast-track the vaccine approval process in the country, the UK drug regulator has started rolling review of COVID-19 vaccines developed of Pfizer Inc. and AstraZeneca Plc, according to Bloomberg.
Rolling reviews allow regulators to see clinical data in real time and have discussions with companies about ongoing trials and manufacturing processes so that approvals can be granted more quickly. The approach is designed to speed up access to drugs and vaccines when there is a public health need.
The move supports the UK’s plans to potentially move ahead of the European Union on clearing a vaccine.
Pfizer said this week that it hadn’t yet reached a key milestone that will help researchers know how effective the shot is. AstraZeneca and Oxford are also targeting publication of advanced-stage trial data this year.
A COVID-19 vaccine may be available for some people before Christmas, Kate Bingham, the chair of the UK government’s vaccine taskforce said in an interview.
"The first phase III efficacy data from the leading vaccine candidates are due by the end of 2020, subject to accruing sufficient rates of infection within the clinical trial cohorts to show the vaccines' efficacy. The primary endpoint is to show that the vaccine can protect against SARS-CoV-2 infection and reduce symptom burden," Bingham wrote in medical journal The Lancet on Tuesday.
"If the first two vaccines, or either of them, show that they are both safe and effective, I think there is a possibility that vaccine roll out will start this side of Christmas, but otherwise I think it's more realistic to expect it to be early next year," Kate Bingham said on BBC television.(mint)
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