It is significant for India, as Pune based Serum Institute of India has tied up with AstraZeneca to deploy the vaccine in the country
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 Wednesday.
The ‘emergency use authorisation (EUA)’ is for the 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.
The authorisation in the U.K. is significant for India, as the Pune based Serum Institute of India (SII) has tied up with AstraZeneca to deploy the vaccine in India. India’s drug regulators, on December 9, asked the SII to furnish more evidence of the vaccine’s efficacy after the company applied for an EUA in India. 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 the committee is expected to deliberate on the SII’s application on Wednesday and review the data on the basis of which the EUA was granted in the U.K. A nod from the regulators in the U.K. or the U.S. “works very favourably” for the SII, the scientist said.
Were Indian regulators to approve, at least 50 million doses of the vaccine would 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 the 2021.
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 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.
This article is auto-generated by Algorithm Source: www.thehindu.com