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Emergency approval despite efficacy controversy … Begin vaccination early in the new year
Regulators in the UK 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 the urgent supply of Corona 19 vaccine in the UK and that it has launched the first dose and that vaccination can start early in the new year.
The UK Medicines and Healthcare Products Regulatory Authority (MHRA) has approved AstraZeneca’s AZD1222 COVID-19 vaccine for active immunity use in people over 18 years of age.
This vaccine uses a replication-defective chimpanzee virus vector and is recommended twice every 4 to 12 weeks.
The 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 an efficacy of 90%, whereas the two-full-dose regimen showed less than 62% efficacy, which is controversial.
No serious cases or hospitalizations were reported after 14 days or more after the second vaccination.
The MHRA decision is based on the advice of an independent pharmaceutical committee following an ongoing review of clinical trial data including interim analysis of a phase III clinical program led by the University of Oxford in the UK .
The data from the clinical trials were published in the international journal The Lancet on the 8th of this month.
AstraZeneca is working with England’s Department of Public Health and England’s National Health Service (NHS) to support the launch and distribution of vaccines in the UK as recommended by the MHRA and the Joint Committee on Vaccination and Immunity. UK.
As part of an agreement with the government, it aims to supply up to 100 million doses in 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, “he said.
“Thanks to AstraZeneca and the University of Oxford, many UK government colleagues and tens of thousands of clinical trial participants.”
Additional data on the safety and efficacy of vaccines continue to accumulate in ongoing clinical trials.
AstraZeneca will continue to work with regulatory authorities around the world to assist in the selection of emergency supplies or conditional marketing permits.
It also applied for inclusion on the World Health Organization (WHO) Emergency Use List (EUL) to accelerate vaccine delivery in low- and middle-income countries.
AstraZeneca announced that it is developing a vaccine production capacity of up to 3 billion doses globally in 2021 through cooperation with global partners.
AstraZeneca vaccine can be stored, transported and handled for at least 6 months in normal refrigeration (2-8 degrees Celsius) and can be vaccinated within the existing medical environment.
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