Government expected to approve AstraZeneca vaccine by next week

The Indian government is likely to approve the COVID vaccine of Oxford/AstraZeneca for emergency use by next week as its local manufacturer has submitted the additional data sought by the authorities.

The move will make India the first country to give the regulatory green light for Britain’s drugmaker vaccine as the British medicine regulator continues examining data from the trials of the vaccine.

The world’s largest vaccine making country, India, plans on inoculating its citizens by January 2021. The government has also been considering giving emergency use authorization applications for vaccines made by the local company Bharat Biotech and Pfizer.

AstraZeneca significant for low-income countries:

The shot of the AstraZeneca/Oxford vaccine has been considered essential for the low-income countries as well as those with a hot climate because it is easier to transport, cheaper, and can be easily stored for long periods at normal fridge temperatures.

Getting the Coronavirus vaccine to the second-most populous country in the world with one of the highest infection rates will prove to be a major step in a fight against the pandemic.

Pfizer, AstraZeneca, and Bharat Biotech: Three vaccines in line to get approval in India

The Central Drugs Standard Control Organisation of India had first reviewed the three applications of the potential vaccine candidates on December 9, 2020. The body sought more information from all the companies, including Serum Institute of India which has been making AstraZeneca shots.

SII has already provided all the data and the authorities have now been waiting for more details from Pfizer. More additional information regarding the potential vaccine has also been expected from Bharat Biotech.

To pace the process of the COVID vaccine in India, the health officials have been in direct contact with the British officials over the shots of AstraZeneca and there are strong indications that approval will come by next week.

Data of late-stage trial backs AstraZeneca’s expected approval:

The talks of expected approval of AstraZeneca has come after the data from the vaccine’s late-stage trial in Brazil and UK released and showed that the vaccine has efficacy of 62% for trial participants who were given two full doses, but 90% for a small subgroup who were given a half, then a full-dose.

For AstraZeneca, the Indian regulators have been considering the two-full dose shots even though, it shows a lower success rate.

No vaccine supply deal signed:

The Indian government has not yet signed the vaccine supply deal with any company. However, the Serum Institute of India has already stockpiled more than 50 million doses of AstraZeneca and plans on making a total of 400 million doses by July 2021.