As the country continues to prepare for a possible vaccine rollout by January, top government sources have informed that India is likely to see the Oxford-AstraZeneca vaccine been approved for emergency use within the next few days.
The Central Drugs Standard Control Organisation’s (CDSCO) subject expert committee (SEC) is likely to meet this week. They will examine Serum Institute of India’s (SII) emergency-use authorisation (EUA) application for Oxford’s expected vaccine against coronavirus disease (COVID-19). As per the data submitted, the vaccine seems to be “satisfactory”.
However, the regulator is awaiting a whole analysis of the data of the vaccine so it can proceed without the approval of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to avoid further delay.
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A government official having informational updates on the vaccine has said
, “The subject expert committee is likely to be convened this week to go through the application.” He also informed that the committee is likely to allot the same date and time to Pfizer.
Earlier, they sought a fresh date to present their case on the EUA application of anti-COVID-19 Vaccine. The official giving this data has requested to keep his identity confidential.
With this, Oxford-AstraZeneca vaccine candidate is likely to be the first anti-COVID-19 vaccine granted approval for emergency use in our country.
Since Pfizer has yet not conducted any clinical trial in India for its vaccine candidate, the company may be directed to conduct a bridging study among the Indian population to understand the impact of the vaccine on the local population. However, the Pfizer vaccine has been approved already by several countries including the U.K., the U.S., and Bahrain.
Amid fears regarding the new mutated variant of COVID-19 strain detected in the UK, government officials have confirmed that it will not have any impact on the potential of rising vaccines being developed here in India and various other countries.
Currently, the government is executing a dry run as of December 28 & 29. The four states including, Gujarat, Andhra Pradesh, Assam, and Punjab will assess the readiness for the massive vaccination exercise. This exercise will not solely enable end-to-end mobilisation but will also check the COVID-19 vaccination program and usage of the Co-Win digital platform within the field.
Vanshika is an Intern with SheThePeople.TV