AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the United Kingdom, with the first doses being released on Wednesday, so that vaccinations may begin early in the New Year, the company said in a statement on Wednesday.
This is significant for India, as the Pune-based Serum Institute of India (SII) has tied up with AstraZeneca to deploy the vaccine in the country. “This is a great and encouraging news. We will wait for the final approval from Indian regulators,” Adar Poonawala, CEO, SII, said.
India’s drug regulators, in a meeting convened just hours after the approval accorded to AstraZeneca, reviewed an application by the SII for ‘emergency use authorisation’ (EUA).
However, the Health Ministry, in a statement, said the Subject Expert Committee of the DCGI (Drugs Controller General of India) was still analysing “additional data” and would reconvene on Friday. Applications of Bharat Biotech, which is testing its ‘Covaxin’ vaccine candidate; and Pfizer, with its m-RNA vaccine, were also reviewed.
The EUA is for active immunisation of individuals of 18 years or older and recommends two doses with an interval of between four and 12 weeks. “This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose,” the statement noted.
An EUA allows an organisation to launch vaccine without putting it through the full range of tests that a new untested vaccine must usually go through.
A scientist connected to the approval process of new vaccines told The Hindu that a nod from regulators in the U.K. or the U.S. “works very favourably” for the SII.
Neither company has announced the results of the ongoing phase-3 trials that test the vaccine candidate in thousands of volunteers in India.
Both AstraZeneca and Pfizer have been approved in the U.K. and the U.S. respectively after they publicised data from their ongoing phase-3 trials.
Were Indian regulators to approve, at least 50 million doses of the vaccine would reportedly be available to Indians and would go some way to aid the nearly 300 million priority individuals--healthcare workers, police personnel, those with co-morbid disease conditions--that are expected to be inoculated in the first half of 2021.
The U.K. government, in a statement, said it had “accepted” the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise the Oxford University/AstraZeneca vaccine for use.
No sub-zero refrigeration
Unlike the Pfizer and Moderna vaccines, the ‘Oxford vaccine’ doesn’t require sub-zero refrigeration and is reportedly more conducive to be distributed in India.
AstraZeneca aims to supply millions of doses in the first quarter as part of an agreement with the government to supply up to 100 million doses in total.
The U.K. health regulator’s decision was based on independent advice from its Commission on Human Medicines following a rolling review of the trial data that included an interim analysis of the Phase III programme led by the University of Oxford. The data were also published in The Lancet on December 8, 2020.
AstraZeneca said it was working with its global partners to be able to manufacture up to three billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals.
AZD1222, as the vaccine candidate is called, was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
