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On the brink of new year, the AstraZeneca-OxfordUniversity’s Covid-19 vaccine was approved for emergency supply on home-turf, the United Kingdom. The first doses have been released today, so that vaccinations may begin early in 2021, AZ said.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) provided authorisation for emergency supply of the vaccine for the active immunisation of individuals 18 years or older. The authorisation recommends two doses administered with an interval of between four and 12 weeks. “This regimen was shown in clinical trials to be safe and effectiveat preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose,” a note from the British company said.
This adds to the repetorie of international Covid-19 vaccines that will be used in mass vaccination, following Pfizer and Moderna’s vaccines, for instance, that have also been approved in the UK (Pfizer) and the United States (Pfizer and Moderna).
The UK green light to the AZ-Oxford vaccine holds out hope in India, as the regulator is expected to take a similar line of action.
The vaccine that is said to be more suitable for the Indian market in terms of storage and distribution is being produced by Pune’s Serum Institute of India, to be marketed in India and other low and middle income countries. Serum Institute Chief Executive Adar Poonawalla said last week that about 50 million doses of the vaccine are stockpiled and ready to deploy, once the Indian regulator gives its go-ahead.
AZ is working with Public Health England and National Health Service England to support the deployment and roll out of the vaccine in the UK, in line with the MHRA and the UK’s Joint Committee on Vaccination and Immunisation dosing recommendation. The company 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, it added.
Pascal Soriot, Chief Executive Officer said, the vaccine has been shown to be effective, well-tolerated, simple to administer “and is supplied by AstraZeneca at no profit.” The AZ statement quoted Matt Hancock, UK Secretary of State for Health and Social Care saying, it was moment to celebrate British innovation –“not only are we responsible for discovering the first treatment to reduce mortality for Covid-19, this vaccine will be made available to some of the poorest regions of the world at a low cost, helping protect countless people from this awful disease”
Professor Andrew Pollard, Director of the Oxford Vaccine Group and Chief Investigator of the Oxford Vaccine Trial, added, “Though this is just the beginning, we will start to get ahead of the pandemic, protect health and economies when the vulnerable are vaccinated everywhere, as many as possible as soon possible.”
First authorisation
This is the first authorisation for this vaccine. And the MHRA’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 in December, the company pointed out.
Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials. AstraZeneca continues to work with regulatory authorities around the world to support their ongoing rolling reviews for emergency supply or conditional marketing authorisation during the health crisis. AstraZeneca is also seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low- and middle-income countries, the note said.
AZ is working with its global partners to continue building manufacturing capacity of up to three billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals. The vaccine can be stored, transported and handled at normal refrigerated conditions (two-eight degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings, it added.
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