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Interim analysis of the first phase 3 clinical trial of a COVID-19 vaccine conducted by Pfizer, an American pharmaceutical company, and Bio & Tech in Germany
94 of 43,000 participants were infected with COVID-19 … less than 10% of those infected with dual vaccines
Performance far exceeds expert expectations … Continuous safety assessment
Vaccines have already started to be manufactured …
The results of the first interim analysis of the phase 3 clinical trial of the COVID-19 vaccine being jointly developed by a US and German company were released, and foreign media such as The Guardian and Reuters reported that the effect was greater than 90%.
How many people participated in this trial and what numbers did they get?
According to a statement from the US pharmaceutical company Pfizer on the 9th (local time), there were no serious side effects in a large-scale clinical trial with German Bio & Tech, involving more than 43,000 people.
They have been vaccinated or given a placebo, such as the meningitis vaccine, to determine if the vaccine is effective, and neither they nor their doctors know which vaccine they received.
Of these, 94 people were infected with Corona 19, and the analysis found that 90% of infected people did not receive the vaccine, which is less than 10% of the cases that received the vaccine and were infected with Corona 19.
Although Pfizer had three times more infections than originally planned, it means that fewer than 8 of 94 people were infected with the vaccine because 90% of those infected were not vaccinated.
To confirm efficacy, Pfizer will continue clinical trials of up to 164 COVID-19 cases among vaccinated and unvaccinated group participants, and will be able to reach this number by early December, given that the infection rate in the U.S. is increasing rapidly. I saw.
The clinical results have not yet been published in medical journals as the first interim analysis, and will be published when the full clinical results are published.
Performance far exceeds expert expectations … Continuous safety assessment
“Today is a great day for public health and the potential to get us all out of the way,” said Bill Gruber, chief vaccine scientist at Pfizer.
The Guardian reported that their analysis performed far better than most experts expected, marking a possible end to the infectious disease pandemic that has caused numerous deaths worldwide, stalled the economy and shook everyday life.
“Today is a wonderful day for science and humanity,” said Dr. Albert Bulla, CEO of Pfizer.
The company says it will take until the third week of November to collect the necessary safety data, after which it will submit the documents to regulatory authorities for approval, and this early approval means that the first dose will be administered to workers at the health before the end of the year. .
The US Food and Drug Administration (FDA) has stated that it will need to be monitored for at least two months in the future. Some say it is a high number.
Clinical trials of the University of Oxford and AstraZeneca vaccines based on technologies other than Pfizer and Bio & Tech’s mRNA vaccine using the genetic code are expected to have interim results this month or early December.
Vaccines have already started to be manufactured …
To save time, Pfizer said it started manufacturing the vaccine before it knew it would work.
Now they hope to produce enough vaccines this year to protect up to 50 million or 25 million people, and up to 1.3 billion by 2021.
The UK is said to have bought 30 million vaccines, and many countries have already ordered vaccines from Pfizer and Bio & Tech. This is enough for 15 million people because it requires two doses, and the EU plans to insure and distribute 200 million doses.
Pfizer also signed a $ 1.95 billion contract with the United States government to provide 100 million vaccines starting this year.
On the other hand, according to statistics from Johns Hopkins University, the number of corona 19 infections worldwide reached 5,054 million and around 1,259,000 deaths.
According to the Korea Centers for Disease Control and Prevention, at 0 o’clock on the 9th, the number of new confirmed cases in Korea was 126, the number of seriously ill patients increased by 57, and the number of deaths increased. by 2 to a total of 480.
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