Summary
- The clinical trial registers in the US showed that the British pharma major AstraZeneca PLC has removed children from the final stage trial of its Covid-19 vaccine in Britain.
- The Phase 3 trial of the vaccine consisted of more than 12,000 participants, including children above 5 years of age with prior permission of their parents
The clinical trial registers in the United States showed that the British pharma major AstraZeneca PLC (LON: AZN), which has been developing vaccines with Oxford University, has removed children from the final stage trial of its Covid-19 vaccine in Britain.
Earlier, the Phase 3 trial of its vaccine candidate AZD1222, which consisted more than 12,000 participants, included children above five years of age with prior permission of their parents. However, on 10 December, the trial data under the National Library of Medicine of the US was updated in order to withdraw the sub-group.
Other major competitors of AstraZeneca involved in the development of the coronavirus vaccine such as Johnson & Johnson, Moderna and Pfizer are testing their potential vaccine on children above the age of 12 years to study its effect in a wider age group.
The AstraZeneca/Oxford University vaccine uses adenovirus, a weakened version of a common cold causing infection which spikes the protein level that the novel coronavirus uses to take over the human cells. By vaccination, this protein is produced inside the human body, which safeguards the immune system from the virus attack.
AstraZeneca had published its trial data last month which indicated that the vaccine is 70 per cent efficient in fighting against the novel coronavirus.
However, the pharma giant had been under the radar of some of the critics claiming that the overall efficacy rate was 62 per cent only, and the 90 per cent figure covered a sub-group of less than 3,000 people who were given a lower dose initially.
To Know More: Do Read: AstraZeneca (LON:AZN) Vaccine Model Yet to Clear the Doubts of US Regulator
In order to clear all doubts, the researchers of AstraZeneca released the full data of their clinical trials in the Lancet medical journal on 8 December, which revealed that the vaccine is capable of fighting 70 per cent of the cases, which they claimed, none of the vaccine developers has done such a thing so far.
David Prior, the Chairman of the National Health Service of the UK, said that the Oxford-AstraZeneca could be granted approval for the vaccine in Britain within a few days. In the FICCI's annual general meeting on 12 December, Prior said that their hopes are pinned on the vaccine and they are expecting to get the approval within a few days.
He also stated that the pandemic can also be seen as an opportunity that has paved the way for whole new fields of research and development. The coronavirus crisis has shown how unprepared the world is to deal with a health emergency and it also led to extraordinary research and innovation.
Prior said that it was the job of the regulatory authorities to ensure all vaccines meet the efficacy and safety standards. The Medicines and Healthcare Products Regulatory Agency (MHRA) is currently evaluating the best dosage regimen for the AstraZeneca-Oxford vaccine.
Last week, Britain started the inoculation program of Pfizer/BioNTech’s vaccine, after receiving EUA approval from MHRA. AstraZeneca, which was once ahead of all the vaccine developers, has now been overtaken by other developers like Pfizer and its German partner BioNTech.