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Tuesday, March 02, 2021

Serum Institute gets WHO approval for global rollout of Covishield vaccine

AstraZeneca and Serum Institute of India will now work with the COVAX Facility to begin supplying the Covid-19 vaccine around the world, with the majority going to low and middle-income countries.

By: Express News Service | Pune |
Updated: February 16, 2021 12:26:47 pm
A health official draws a dose of the Covid-19 vaccine manufactured by the Serum Institute of India. (File)

AstraZeneca’s COVID-19 vaccine has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunisation to prevent COVID-19 in individuals 18 years of age and older, including those over 65, a company statement said.

The authorisation of COVID-19 Vaccine AstraZeneca, manufactured by AstraZeneca, and COVISHIELD, manufactured by Serum Institute of India (SII), enables global access to the vaccine during the pandemic.

The EUL allows for two doses of the vaccine to be administered at a four to 12-week interval. This regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose, the statement said.

The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) recommended a dosing interval of eight to 12 weeks. In addition, they also recommended use of the vaccine in countries where new variants, including the South African B1.351 variant, are prevalent.

AstraZeneca and SII will now work with the COVAX Facility to begin supplying the vaccine around the world, with the majority going to low and middle-income countries as quickly as possible. In the first half of 2021, it is hoped that more than 300 million doses of the vaccine will be made available to 145 countries through COVAX, pending supply and operational challenges. These doses will be allocated equitably according to the COVAX Allocation Framework.

Pascal Soriot, Chief Executive Officer, said in a statement issued today: “The approval endorses that the vaccine can be used to help protect populations across the world, including adults over 65 years and in countries where different variants of the SARS-CoV-2 virus are in circulation. This is a huge step towards ensuring global access to our vaccine and helping us fulfil our public health commitment to broad and equitable access at no profit during the pandemic.”

Adar Poonawalla, Chief Executive Officer, Serum Institute of India, said: “We have been waiting for this final milestone. I am happy and relieved that with the WHO’s EUL we will be able to start the deliveries to African and other low and middle-income countries immediately. Countries with a large population must be protected as soon as possible.”

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