British drug major AstraZeneca Plc.’s COVID-19 vaccine, co-developed by the University of Oxford, has been approved for emergency supply in the UK.
The company is releasing the first doses today so that vaccinations may begin early in the New Year. 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 Medicines and Healthcare products Regulatory Agency or MHRA has provided authorisation for emergency supply of “COVID-19 Vaccine AstraZeneca”, formerly AZD1222, for the active immunisation of individuals 18 years or older.
In November, AstraZeneca and its vaccine partner Oxford University published initial results of the vaccine study, but faced questions about the results after they acknowledged a manufacturing error. The company then said it was planning an additional global trial to confirm the 90% efficacy rate of its Covid-19 vaccine candidate at lower dosage.
The UK’s rapid emergency regulatory approval is the first authorisation for this vaccine. UK became the first Western country to start mass vaccination against Covid-19 on December 8 after MHRA granted emergency authorisation to the Pfizer-BioNTech COVID-19 vaccine.
The Pfizer-BioNTech COVID-19 vaccine has now been approved in the U.S., which started mass vaccination on December 14. Moderna’s COVID-19 vaccine mRNA-1273 also was approved for emergency use in the U.S. on December 18.
The newly authorized COVID-19 Vaccine AstraZeneca has been co-invented by the University of Oxford and its spin-out company, Vaccitech.
As per the authorization, two doses will be administered with an interval of between four and 12 weeks. The company noted that this regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalizations more than 14 days after the second dose.
AstraZeneca is working with government health agencies, Public Health England and National Health Service England, to support the deployment and roll out of the vaccine in the country.
The company is also seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low- and middle-income countries.
Matt Hancock, UK Secretary of State for Health and Social Care, added that the vaccine will be made available to some of the poorest regions of the world at low cost.
AstraZeneca 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 MHRA’s decision was based on a rolling review of trial data that included an interim analysis of the Phase III program led by the University of Oxford. In addition to this, AstraZeneca is conducting a large trial in the US and globally. In total, Oxford University and AstraZeneca expect to enrol up to 60,000 participants globally.
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