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Approved for use in South American countries following the United Kingdom
Controversy due to lack of data on the ‘rubber band effect’
Expectation of fast distribution due to economical and convenient distribution
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The evaluation of AstraZeneca’s new coronavirus (Corona 19) infectious disease vaccine, which has been approved for emergency use in some South American countries, such as the United Kingdom, Argentina and El Salvador, is very uneven.
The United States and the European Union (EU) estimate that information on the AstraZeneca vaccine is still insufficient.
On the other hand, there is also the expectation that it will be the most potent vaccine to respond to Corona 19, highlighting the advantages of being cheap and easy to transport.
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━ “No specific or clear data” … Pfizer Modena’s contrast effect is low |
The AFP news agency reported on the 30th of last month (local time) that the AstraZeneca vaccine will be difficult to obtain approval for use by the European Medicines Agency (EMA) in January.
In a statement that day, the EMA said: “For conditional marketing approval (emergency use), additional information is needed on issues related to the quality, safety and efficacy of this vaccine. We ask AstraZeneca to submit additional data.” . Said. “Evaluation of the results of clinical trials in the UK, Brazil and South Africa is ongoing 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 predicted that the AstraZeneca vaccine would be approved in April next year, delaying the initially expected time by two months.
“It is important to note that one vaccine for Americans has a 95% prevention rate, while the other vaccine has an ‘X%’ (unknown),” said Montsef Slawi, executive director of the United States Vaccine Development Program. “Ultra-Fast Operation”. “We need a specific and clear number, not the sum of other clinical trials done with 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%.
An AstraZeneca spokeswoman said: “We have continued to send data to authorities and are working closely with EMA to obtain official conditional marketing authorization.”
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━ Low price advantages and easy distribution … Sufficient availability |
On the other hand, the New York Times (NYT) evaluated that the AstraZeneca vaccine had 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.
In the case of Pfizer vaccine, it must be transported at an extremely low temperature of -70 ± 10 degrees Celsius. Furthermore, Modena announced that the vaccine is stable for 6 months at -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.
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Under the contract in the US, the price for two doses of the Pfizer vaccine is £ 29.47 (about 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). It’s only a tenth of the price compared to Pfizer, Moder, or Vaccines.
AstraZeneca announced its target vaccine production volume 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 of the London School of Hygiene and Tropical Medicine said “this is very good news for the world” regarding UK approval for the urgent use of the AstraZeneca vaccine. “This vaccine will increase access to the vaccine in the international community.”
/ Reporter Noh Hee-young [email protected]
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