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Argentina and El Salvador approved for use after the UK
Controversy due to lack of data on ‘rubber band effect’ … Expectation of rapid distribution due to economical and convenient distribution
There are mixed evaluations of AstraZeneca’s novel coronavirus (Corona 19) infectious disease vaccine, which has been approved for emergency use in the UK and some countries in South America.
The United States and the European Union (EU) estimate that information on the AstraZeneca vaccine is still insufficient.
At the same time, it is expected to be the most promising vaccine to respond to Corona 19, given the advantages of low price and not difficult transport conditions.
◇ “No specific and clear data” … Less effective than Pfizer and Modena
The AFP news agency reported on the 30th (local time) that the AstraZeneca vaccine will be difficult to obtain approval for use by the European Medicines Agency (EMA) in January next year.
In a statement issued today, EMA said: “For conditional marketing approval (emergency use), we need additional information on issues related to the quality, safety and efficacy of this vaccine. We request additional data from AstraZeneca.” Said.
It also ordered: “Evaluation of the results of clinical trials in the UK, Brazil and South Africa continues, and additional information is needed to complete this evaluation.”
EMA Deputy Director Noel Wasshun also predicted that the AstraZeneca vaccine would be difficult to obtain conditional marketing approval in January of next year.
The AstraZeneca vaccine was controversial due to a lack of basic data and the ‘rubber band immunity effect’ that the prevention rate varies by dose.
The United States also delayed approval of the AstraZeneca vaccine by two months, expecting it to be next April.
“It is important that the vaccine given to Americans has a 95% prevention rate, while the other vaccine has an ‘X%’ (unknown),” said Montsef Slawi, executive director of the US vaccine development program. “Super fast operation”. “We need a specific and clear number, not a sum of different clinical trials performed with different materials.”
He also noted that “the effect of the AstraZeneca vaccine in the elderly is virtually unknown.”
This is because the elderly rarely participated in existing clinical trials.
The Pfizer vaccine has an immune efficacy of 95% and Moderna 94.5%, while the average for AstraZeneca drops to 70.4%.
“We have continued to send data to the authorities and are working closely with EMA to obtain official conditional approval,” the AstraZeneca spokesperson said.
◇ Low price and easy distribution
On the other hand, the New York Times (NYT) evaluated that the AstraZeneca vaccine has the conditions to become a vaccine that will dominate the world.
The AstraZeneca vaccine has the advantage of being able to transport, store and administer the vaccine for at least 6 months at a normal refrigerator temperature of 2 to 8 degrees Celsius.
Pfizer Corona 19 vaccine must be transported at an extremely low temperature of minus 70 ± 10 degrees Celsius.
Modena announced that the vaccine is stable for 6 months at minus 20 degrees Celsius and remains stable for 30 days at 2-8 degrees Celsius.
The AstraZeneca vaccine is cheaper than Pfizer and Moder or the vaccines, so it is expected to be easier to distribute in developing countries.
Under a contract in the US, two doses of the Pfizer vaccine cost £ 29.47 (approximately 43,000 won).
Moderna’s price drops for large orders, but is the most expensive, reaching 23.99 to 27.74 pounds (about 35,000 to 41,000 won) per serving.
On the other hand, the EU decided to buy the AstraZeneca vaccine at 2.23 pounds (about 3,300 won).
AstraZeneca has announced a vaccine production target of 3 billion doses for next year.
Considering that two doses per person are required, about a fifth of the world’s population can fit, and the number of contracts is the highest globally.
Professor Stephen Evans from the London School of Hygiene and Tropical Medicine said “very good news for the world” regarding the UK’s approval for the urgent use of the AstraZeneca vaccine. “This vaccine will increase access to the vaccine in the international community.”
/ yunhap news
