AstraZeneca Releases 111-Page COVID-19 Vaccine Trial Blueprint
Pharma company AstraZeneca has released a 111-page trial blueprint, after several questions were raised about its Covid-19 vaccine trials since two participants in the UK reported illness
After concerns over the safety of its COVID-19 vaccine, AstraZeneca has released a 111-page trial blueprint in a bid to increase transparency about its testing of products.
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According to reports, experts have been particularly concerned because of the company¡¯s refusal to provide details about serious neurological illnesses in two participants, both women, who received its experimental vaccine in Britain.
After the UK authorities announced that the illness reported was not related to the vaccine shot AstraZeneca resumed its trial.
AFP
However, the United States has not yet permitted the resumption of Oxford vaccine trial.
AstraZeneca's trial blueprint says that its goal is to develop a vaccine with 50 per cent effectiveness. It is the same threshold that the Food and Drug Administration (FDA) has fixed in its guidance for COVID-19 vaccines.
Also Read: COVID-19 Vaccine By AstraZeneca Reaches Phase 3 Clinical Trials In US, Begins Late-stage Study
To determine with statistical confidence whether the company has met that target, there will have to be 150 people ill with confirmed coronavirus among participants who were vaccinated or received placebo shots, reports Business Today.
Reuters
If the vaccine is 50 per cent effective at that point of time, the company may stop the trial early and apply for authorisation from the government to release the vaccine for emergency use.
Also Read: Pharma Giant AstraZeneca To Mass Produce Oxford COVID Vaccine For No Profit To Help Millions
The final phase of human clinical trial of Oxford-AstraZeneca's Covishield will begin at the Sassoon General Hospital in Pune next week, after Drugs Controller General of India gave Serum Institute of India (SII) a go-ahead to continue its trial.
Disclaimer: While there have been several different types of treatments being given to COVID-19 patients across the world, there isn¡¯t any one drug that has worked as a sure-shot treatment yet. Don¡¯t self medicate/stock up and always consult your doctor/medical health professional.