Now detained, AstraZeneca trials were also in India


Written by Amitabh Sinha | Pune |

September 9, 2020 9:47:23 am


A sign with the AstraZeneca Plc logo stands on the company’s DaVinci building at Melbourn Science Park in Cambridge, UK (Photographer: Jason Alden / Bloomberg)

Phase 3 clinical trials of a coronavirus vaccine being developed by AstraZeneca, in collaboration with the University of Oxford, have been halted worldwide after a participant in England reported serious side effects.

This is the same vaccine whose phase 2 trials had started in india also last month. Permission has also been granted to conduct phase 3 trials in India. This vaccine has long been considered one of the most promising in development. Countries have already reserved more than 1 billion doses of this vaccine, even as human trials continued.

In a sentenceAstraZeneca described its decision to stop the trials as “a routine action that should happen whenever there is potentially unexplained illness in one of the trials.” It is described as a precautionary step. The side effects are not unexpected in the participants, but this is reported to be not only serious, but so far unexplained.

Phase 3 clinical trials of this vaccine were being conducted at more than 60 sites in the United States, in addition to sites in Brazil and South Africa. In England and India, phase 2 and phase 3 trials were being carried out together.

While there are still no question marks about vaccine safety, this incident highlights the uncertainties inherent in vaccine development and the importance of scrupulously following all steps in clinical trials.

Read also | At what stage are Covid-19 vaccine candidates in testing phase in India? A summary of the main players

astrazeneca, astrazeneca vaccine, oxford vaccine, astrazeneca oxford vaccine, astrazeneca vaccine update Laboratory technicians work at biopharmaceutical company mAbxience on an experimental coronavirus vaccine developed by the University of Oxford and the AstraZeneca laboratory in Garin, Argentina. (AP Photo: Natacha Pisarenko, file)

In the current rush to produce a coronavirus vaccine, given the prevailing emergency health situation, a number of standard regulatory procedures have been overlooked, raising concern among many scientists and experts.

A coronavirus vaccine was expected to be ready early next year. That in itself would have made it the most rapidly developed vaccine. But now, there is an attempt, especially in the United States, to launch the vaccine. this year itself. There is also a political push for the vaccine to be released before the November 3 presidential election. President Donald Trump, who is seeking re-election, has repeatedly said that a vaccine could be available this year, possibly also before the November 3 deadline. The availability of the vaccine is considered to increase your chances of re-election.

But in other places as well, there has been a rush to introduce a coronavirus vaccine, even if that meant skipping phase 3 clinical trials entirely. That’s what has happened in the case of Russian vaccineand a couple of candidates in China. These vaccines have been approved in their countries, without phase 3 trials having started. It is only now, after much criticism, that these vaccines are also preparing to undergo phase 3 trials.

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