It has been yet another busy medical day in our ‘new-normal’ coronavirus world. Today, the Phase One results of the University of Oxford vaccine were published, confirming positive reports tantalisingly leaked last week. Also making the news is a press release from the pharmaceutical company Synairgen, touting very positive initial results from its inhaled protein, interferon-beta, in treating hospitalised patients with coronavirus.
In days gone by the publishing of results of a Phase One vaccine study would barely generate a ripple, even in the relevant medical speciality. But of course, this is no ordinary trial and we are truly in extraordinary times.
All medical products undergo a trial process, starting with studies which look purely at safety (not efficacy). Many trials fail at this stage. You may recall the disastrous Northwick Park study in 2006 which saw six healthy young people develop multiple organ failure from exposure. Once this hurdle is passed then a larger scale trial to look at efficacy is undertaken and if successful, a licence is applied for and distribution follows.
Today, the preliminary findings for ChAdOx1 nCoV-19 (the Covid-19 vaccine) appear to show that it has surpassed expectations. Firstly, the safety hurdle seems to have been met, although 70 per cent of the 1,077 volunteers apparently did report fever or headache. Secondly, and in line with the bullish press releases last week, the vaccine garners both an antibody and T-cell response which it is hoped may provide lasting immunity to the disease. This is vital as studies have shown that patient antibody levels may fall after just three months.
There are the usual caveats: the study was over a very small timeframe and was not intended to show if it is a working vaccine, so we know little of its long-term safety or effectiveness.
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