UK, first emergency approval of AstraZeneca vaccine … What about national introduction?



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Global pharmaceutical companies AstraZeneca and the University of Oxford are developing a vaccine that can practically kill COVID-19.  Source = Newsis
Global pharmaceutical companies AstraZeneca and the University of Oxford are developing a vaccine that can practically kill COVID-19. Source = Newsis

[이코노믹리뷰=곽예지 기자] For the first time in the world, the UK government has approved the urgent use of a new vaccine against coronavirus infection (Corona 19), which is being jointly developed by AstraZeneca and the University of Oxford, the world’s first.

According to the pharmaceutical and biological industry on the 31st, the UK Ministry of Health accepted the recommendations of the UK Pharmaceutical and Healthcare Regulatory Authority (MHRA) and made the same decision. Consequently, the industry predicts that the AstraZeneca vaccine will ship on the 4th of next month.

While the UK is in a rush, the US has pushed back the expected approval time by two months from the original plan and is paying attention to Korea’s approval schedule.

3When you get vaccinated every month … Up to 80% effect

AstraZeneca explained that when its vaccine is given twice at three-month intervals, the immune effect increases by up to 80%. In addition, he added that the immune effect appears 22 days after the single dose, and the effect lasts at least 3 months.

The AstraZeneca vaccine has been approved for use in subjects over 18 years of age. Several experts have determined that the vaccine could also be used in pregnant or nursing women if the benefit outweighs the potential risk.

In relation to the COVID-19 mutant virus that recently started in the UK and has spread around the world, more research is needed on the efficacy of the vaccine. MHRA Commissioner Dr. Jun Lane said: “We are working to determine if the vaccine is effective with respect to the new mutation.”

Sir Münir Pirmohamed, Chairman of the Committee of the Human Drug Specialists Working Group, said: “Further research is needed to determine whether the vaccine reduces mutagenic infections.” “There is no data yet to explain this.”

Previously, the AstraZeneca vaccine had an average immune effect of 70.4% during clinical trials. However, over the course of the trial, if the first vaccine was given half a dose by mistake and the second full dose was given, the preventive effect increased to 90%, raising doubts.

Consequently, the United States Food and Drug Administration (FDA) expressed a negative position on the approval of the use of the vaccine, saying that it has not been explained why the efficacy of the AstraZeneca vaccine varies depending on the first and the second dose. On the other hand, the British authorities argued that it was difficult to compare the results, as there were no trials comparing the Pfizer and AstraZeneca vaccines approved for use.

AstraZeneca Pascal Sorio, Chief Executive Officer (CEO) emphasized: “Our vaccine has been shown to be effective in preventing COVID-19, it is easy to store, easy to inoculate and is provided on a non-profit basis.”

The Pfizer vaccine was previously reported to be 95% effective and the Modena vaccine to be 94.5% effective.

Source = Newsis
Source = Newsis

Domestic supply contract for 10 million people … expected to be introduced in February-March next year

Controversy continues regarding the efficacy and reliability of the Corona 19 vaccine developed by AstraZeneca, but distribution has already started with the signing of a contract to supply the AstraZeneca vaccine to 10 million people in Korea. Consequently, it will be introduced between February and March next year.

The Ministry of Food and Drug Safety initiated a review upon receipt of AstraZeneca data for non-clinical trials and quality data, which is safety data and animal testing.

The United States government has ordered 300 million doses of the AstraZeneca vaccine.

“If all goes well, it is expected to be approved for emergency use in the United States in April,” said Monsef Slawi, executive director of the United States’ Corona 19 vaccine development program, a ‘super fast operation’ team.

This is postponed at least two months from the existing US government plan, and is expected to go through the FDA’s emergency use approval process starting in February of next year.

On the other hand, AstraZeneca vaccine can be stored, transported and handled for at least 6 months between 2 and 8 degrees Celsius, which is a general refrigerated condition. It is expected that it can be stored and administered in the existing medical environment compared to Pfizer, which requires cryogenic storage at -70 degrees Celsius, and the Modena vaccine, which requires storage at -20 degrees Celsius.

As such, although AstraZeneca’s vaccine is the best in terms of price and delivery compared to the Pfizer and Modena vaccines, many experts still question the results of AstraZeneca’s COVID-19 vaccine trials.

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