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Pfizer has requested emergency use of its vaccine from the US Food and Drug Administration (FDA). / AP Yonhap News
Pfizer and Bioentech, a leader in the development of vaccines for infection by the new coronavirus (Corona 19), applied to the United States Food and Drug Administration (FDA) for the emergency use of their vaccines.
According to Reuters on the 20th, Pfizer said it expects the FDA to approve emergency use by the middle of next month, and if approved, it will act to expedite distribution. Pfizer expects to make possible the preparation of 50 million doses of vaccine this year, a quantity capable of 25 million people.
Rush-use approval is a temporary measure to increase drug use in the event of a public health crisis, and approval requirements are not relatively more stringent than formal procedures. The FDA has tentatively set up a meeting to discuss vaccine-related issues from 8-10 next month, the news agency said.
Previously, Pfizer, an American pharmaceutical company, and Bioentech of Germany announced that the COVID-19 vaccine their company was developing had a 95% infection prevention effect as a result of the final analysis of the phase 3 clinical trial, and that it did not significant security issues were found. This is a much higher review than the 90% advertised previously.
The vaccine showed 94% of the COVID-19 prevention effects even in the elderly over 65, who are at high risk of severity and death from corona 19. No serious side effects were reported.
However, it is at a disadvantage compared to its competitor Modena, which is capable of distributing general vaccines at low temperatures, as it requires a cryogenic distribution network of minus 70 degrees Celsius for storage. At 2-8 degrees of video, the effect can only be maintained for up to 5 days. In some countries, even purchasing vaccines can make transportation very difficult, CNBC noted.
The price is 19.5 dollars (about 2.1739 won) per serving, which is about half cheaper than in Modena. Thanks to the increased speed of development, contracts have already been made with several countries. As of the 11th, the European Union (EU) decided to buy 300 million times and signed a purchase contract with Japan (120 million times) and the United States (100 million times). The United Kingdom, Canada, Australia and Chile also decided to buy more than 10 million doses of the vaccine.
Reporter Kim Jung-eun [email protected]
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