Indian drug regulators, in a meeting called a few hours after approval, reviewed a request from the Serum Institute of India for the emergency use of jab.
AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses launched on Wednesday, so vaccines can begin early in the New Year, the company said in a statement Wednesday.
This is significant for India, as the Pune-based Serum Institute of India (SII) has partnered with AstraZeneca to roll out the vaccine in the country. “This is great and encouraging news. We will await final approval from the Indian regulators, ”said Adar Poonawala, SII CEO.
India’s drug regulators, in a meeting called a few hours after AstraZeneca’s approval, reviewed an application from SII for an ’emergency use authorization’ (EUA).
However, the Health Ministry, in a statement, said that the Committee of Experts on Matters of the DCGI (Comptroller General of Drugs of India) was still analyzing “additional data” and would meet again on Friday. Applications from Bharat Biotech, which is testing its ‘Covaxin’ vaccine candidate; and Pfizer, with its mRNA vaccine, were also reviewed.
The EUA is for active immunization of people over 18 years of age and recommends two doses four to 12 weeks apart. “In clinical trials, this regimen was shown to be safe and effective in preventing symptomatic COVID-19, with no severe cases or hospitalizations more than 14 days after the second dose,” the statement said.
An EUA allows an organization to launch a vaccine without subjecting it to the full range of tests that a new, untested vaccine must normally go through.
A scientist linked to the approval process for new vaccines said The Hindu that a nod from regulators in the UK or US “works very favorably” for the SII.
No company has announced the results of ongoing phase 3 trials testing the candidate vaccine on thousands of volunteers in India.
AstraZeneca and Pfizer have both been approved in the UK and the US, respectively, after they published data from their ongoing phase 3 trials.
If approved by Indian regulators, at least 50 million doses of the vaccine would be available to Indians and would help the nearly 300 million priority people in some way: healthcare workers, police personnel, people with comorbid illnesses. expected to be inoculated in the first half of 2021.
The UK government, in a statement, said it had “accepted” the recommendation of the Medicines and Healthcare Products Regulatory Agency (MHRA) to authorize the use of the Oxford University / AstraZeneca vaccine.
No sub-zero refrigeration
Unlike the Pfizer and Moderna vaccines, the ‘Oxford vaccine’ does not require subzero refrigeration and is reportedly more conducive to distribution 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 UK health regulator’s decision was based on independent advice from its Commission for Human Medicines after an ongoing review of the trial data that included an interim review of the Phase III program led by the University of Oxford. The data was 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 continuous basis, pending regulatory approvals.
AZD1222, as the candidate vaccine is called, was co-invented by the University of Oxford and its spin-off 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 for the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, which prepares the immune system to attack the SARS-CoV-2 virus if it later infects the body.
.
