India could have 8 vaccines ready for authorisation in near future

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As many as eight vaccine candidates for Covid-19 are under different stages of clinical trials which could be ready for authorization in near future, the ministry of health and family welfare informed in a press briefing on Tuesday.

The union health ministry informed that the eight vaccines include AstraZeneca and Oxford university developed and Serum Institute of India manufactured Covishield, Covaxin by Bharat Biotech Limited, ZyCoV-D by Zydus Cadila, Russian vaccine candidate Sputnik-V, NVX-CoV2373 by SII, HGCO19 by Geneva, and two unlabeled vaccines — Recombinant Protein Antigen based vaccine by Biological E Limited — and Inactivated rabies vector platform by Bharat Biotech.

While the former five vaccine candidates have entered either phase II or phase III clinical trials, the latter three are in pre-clinical trial phases, the ministry informed.

Meanwhile, two vaccine candidates — Covishield and Covaxin — are in the third stage of clinical trials. They have applied for emergency use authorization to the Drug Controller General of India (DCGI). Their application is a pending review which is expected to happen on Wednesday by the subject expert committee (SEC) for the vaccines.

However, the application for the emergency use authorization (EUA) of Covaxina and Covishied has followed after Pfizer’s BNT162b2 which was the first vaccine candidate to seek the EUA.

Union health secretary Rajesh Bhushan informed that few of the vaccine candidates may receive a license for authorization in the next few weeks.

“The complete immunization in all the eight candidates would require 2-3 doses of it inoculated at the gap of 3 to 4 weeks,” he added. He also cautioned that COVID precautions must be undertaken even after the vaccination

Pfizer India had submitted an application on December 4 to the DCGI seeking emergency use authorization (EUA) for its Covid-19 vaccine in India. Following this, the Serum institute also filed for the EUA while Bharat Biotech’s applied for the same on Monday.

Pfizer applied for EUA in India after it received permission for temporary authorization for its emergency use in the UK last week. The UK on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against COVID-19, with the UK regulator Medicines and Healthcare products Regulatory Agency granted approval to Pfizer’s vaccine for EUA on Wednesday last week. Pfizer’s vaccine would require -70 degrees of celsius temperature for its storage.

Experts have raised doubts that the extremely low temperature required for storing the vaccine poses a big challenge for its delivery in a country like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult.

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