The vaccine candidate developed by the Oxford University and pharmaceutical company AstraZeneca has entered the phase 3 human clinical trials in the US. The phase 3 trials for the candidate are already underway in numerous countries like India, South Africa, England, and Brazil, according to a report in The Indian Express. Moreover, trials for the vaccine are also likely to begin in Japan and Russia soon. The US trials are likely to include around 30,000 participants. On a global scale, the vaccine candidate trials are expected to be conducted on 50,000 participants.
The phase 2 testing of the vaccine in India began last week, and the combined phase 2 and phase 3 trials could have about 1,600 participants, the report stated. The researchers in the US hope that the initial data from these trials can be collected by October so that there can be a possibility for the vaccine to receive emergency use authorisation before the country goes into its Presidential elections.
If reports are to be believed, AstraZeneca and the US government had reached understanding where the former’s candidate could get emergency use authorisation if the data from phase 3 trials was favourable. These reports have, however, been denied by AstraZeneca. However, the report states that recently, there have been indications that the country might get an early vaccine – even before the trials are completed and the data analysed. The US Food and Drug Administration (FDA), which gives regulatory approval to drugs, has also stated that it could grant suitable vaccine candidates emergency authorisations before the completion of phase 3 trials. However, they said this approval was hinged on the FDA feeling like the candidate’s benefits outweighed its risks.
Meanwhile, drug company Pfizer, which is also among the leading developers for coronavirus vaccine, reportedly said that early data from the phase 3 trials for its candidate would be available by October. – The Financial Express