Emergency approval despite controversy over efficacy…Begin vaccination at the beginning of the new year
UK regulators have approved the emergency use of AstraZeneca’s COVID-19 vaccine for the first time in the world.
AstraZeneca announced on the 30th (local time) that it has been approved for urgent supply of the Corona 19 vaccine in the UK and that it has released the first dose and that vaccination can be started early in the new year.
The UK Medicines and Health Care Product Regulatory Authority (MHRA) has approved AstraZeneca’s COVID-19 vaccine AZD1222 for the use of active immunity in people over 18 years of age.
This vaccine uses a replication-defective chimpanzee virus vector and is recommended to be administered twice, at intervals of 4 to 12 weeks.
Approved therapy has been shown to be safe and effective in preventing symptomatic COVID-19 in clinical trials.
However, after administering the full dose, the half-dose regimen showed 90% efficacy, while the two-time full-dose regimen showed a lower efficacy of 62%, which is controversial.
No serious cases and hospitalizations were reported after 14 days or more after the second vaccination.
The MHRA’s decision is based on advice from an independent pharmaceutical committee after an ongoing review of clinical trial data that includes an interim analysis of a phase III clinical program led by Oxford University in the UK.
Clinical trial data was published in the international journal The Lancet on the 8th of this month.
AstraZeneca is working with the English Department of Public Health and the National Health Service (NHS) England to support vaccine launch and distribution in the UK as recommended by MHRA and the UK Joint Vaccination and Immunization Committee.
As part of an agreement with the government, it aims to supply up to 100 million doses within the first quarter of next year.
“Today is an important day for millions of people in the UK when this new vaccine becomes available,” said Pascal Soriot, CEO of AstraZeneca. It will be.
“Thank you to AstraZeneca and Oxford University, many colleagues from the UK government and tens of thousands of clinical trial participants.”
Additional safety and efficacy data for vaccines continues to accumulate in ongoing clinical trials.
AstraZeneca will continue to work with regulatory authorities around the world to assist in the screening of emergency supply or conditional marketing permits.
It also applied for listing on the World Health Organization’s (WHO) Emergency Use List (EUL) to accelerate vaccine delivery in low- and middle-income countries.
AstraZeneca announced that it is building a vaccine production capacity of up to 3 billion doses globally in 2021 through cooperation with global partners.
AstraZeneca’s vaccine can be stored, transported, and handled for at least 6 months under normal refrigeration (2-8 degrees Celsius) and can be vaccinated within existing medical settings.
Copyright © Medical News Unauthorized reproduction and redistribution prohibited