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

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


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

According to the pharmaceutical and bio industry on the 31st, the UK Ministry of Health accepted the recommendations of the UK Pharmaceutical and Health Care Products Regulatory Authority (MHRA) and made the same decision. Accordingly, the industry predicts that the AstraZeneca vaccine will be distributed as early as the 4th of next month.

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

3When vaccinated every month… Up to 80% effect

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

AstraZeneca’s 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 women or breastfeeding people if the benefits outweigh the potential risks.

In relation to the COVID-19 mutant virus that recently started in the UK and has spread around the world, further research is needed regarding the effectiveness of the vaccine. Dr. Jun Lane, director of MHRA, said, “We are working on whether the vaccine is effective with respect to the new mutation.”

Sir Münir Pirmohamed, chairman of the Working Group Committee on Human Drugs Specialists, said, “Additional research needs to be undertaken to determine if 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, in the course of the test, if a half dose was administered to the first vaccination by mistake and the second full dose was administered, the preventive effect increased to 90%, raising questions.

Accordingly, the US 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 AstraZeneca’s vaccine varies depending on the first and second doses. On the other hand, the British authorities argued that it was difficult to compare the results as there were no trials comparing Pfizer and AstraZeneca vaccines approved for use.

AstraZeneca Pascal Sorio Chief Executive Officer (CEO) stressed, “Our vaccine has been shown to be effective in preventing COVID-19, is easy to store, is simple to inoculate, and is supplied without profit.”

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

Source = Newsis
Source = Newsis

Domestic supply contract for 10 million people…planned 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 begun by signing a contract to supply AstraZeneca vaccine for 10 million people in Korea. Accordingly, it will be introduced between February and March next year.

The Ministry of Food and Drug Safety initiated a review by receiving data from AstraZeneca for non-clinical tests and quality data, which are safety and animal test data.

The US government has ordered 300 million doses of AstraZeneca vaccine.

“If everything goes well, emergency use in the United States is expected to be approved in April,” said Monsef Slawi, chief executive of the US’s Corona 19 vaccine development program,’Super-fast operation’ team.

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

On the other hand, AstraZeneca vaccine can be stored, transported, and handled for at least 6 months at 2 to 8 degrees Celsius under normal refrigeration. It is expected that it can be stored and administered in the existing medical environment compared to Pfizer’s, which requires cryogenic storage at -70 degrees Celsius and Modena’s 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 Pfizer and Modena vaccines, many experts are still questioning the results of AstraZeneca’s COVID-19 vaccine trials.

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