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This is the appearance of the candidate vaccine ‘BNT162’ from Pfizer and the German biotechnology company Bioentech, which has been officially registered with the WHO as a phase 3 clinical trial. Provided by Bio Entech
On the 9th (local time), the results of the self-analysis of some of the results of the phase 3 clinical trials of new coronavirus infections (COVID-19, Corona 19) candidate for vaccines that are being developed by the company are released. German biotechnology Bioentech and the American pharmaceutical company Pfizer. did. It was found that about 90% of the vaccinated people did not contract a viral infection. It is the result of raising expectations for vaccine development, but it is only an intermediate result of the company’s self-aggregation while phase 3 clinical trials are still in full swing and, above all, specific data is not disclosed, so that the candidate material is really effective and safety is guaranteed. It seems that it will not be possible to confirm if it is done after a little more time.
Pfizer CEO Albert Bulla said in a statement on the company’s website on the 9th, “The corona19 candidate vaccine, which is being developed together with Bioentech, showed positive efficacy in the final phase of clinical trials.” , said “Corona 19 We confirmed that more than 90% of the participants who had never been infected had avoided infection by COVID-19”.
Pfizer and Bioentech is a nucleic acid vaccine in which a genetic material (mRNA) that can produce a viral protein (antibody) that can trigger an immune response in the body is wrapped in a small bag of lipids and injected into the body. human. Two shots are given up to the booster shot. There is the disadvantage that it requires additional technology to wrap and inject using a lipid membrane, and because all adjuvants (adjuvants) injected together with the nucleic acid itself are unstable, it requires a low temperature distribution of minus 70 degrees. Another factor of concern is that there are no previous successful cases of new vaccine methods.
However, it has the advantage of rapid development, which is why, in addition to Pfizer and Bioentech, US Modena, etc., they developed the fastest candidate vaccines and became a foothold to enter clinical trials. Pfizer and Bioentech entered the third phase of clinical trials in July, and in the third phase, more than 43,500 volunteers from around the world participated, sequentially inoculating candidates and being monitored for corona 19 infection. The proportion of people who received up to two vaccinations on day 8 was 38,955.
Pfizer and Bioentech analyzed 94 people who became infected with Corona 19 among those who received the vaccine or placebo (placebo) twice in a clinical trial. As a result, it was confirmed that more than 90% of vaccinations showed a preventive effect against Corona 19 on the seventh day after the second vaccination and 28 days after the first vaccination.
“This will be the first, but important, step in bringing a safe and effective vaccine to the world,” Buerer said. “We will work closely with regulatory authorities to ensure that the vaccine is delivered where it is most needed.”
However, it said it would not apply for emergency use approval from the US Food and Drug Administration (FDA) right away. “We still need more data on safety,” said Bulla. “We will accumulate more safety data in ongoing clinical trials.” Additionally, he said data on whether it can be produced continuously while maintaining the quality of the vaccine is also accumulating at the same time. “On November 3, we will be able to meet the FDA’s emergency use approval requirements.”
Pfizer researchers are developing vaccine candidates. Pfizer Twitter screenshot
This result is a partial result of phase 3 clinical trials published by Pfizer in the form of a statement. Several volunteers were analyzed and specific data such as age, sex, race and other characteristics of the population, and the rate of antibody formation and duration were not revealed. Therefore, it is difficult to predict success based solely on this result.
Furthermore, side effects or toxicity, which are the most important factors in vaccine development, are not mentioned, so it is expected that it will be necessary to confirm whether safety has been guaranteed. Bulla’s CEO also said that additional safety data needs to be obtained and it is estimated that a safety assessment has not yet been conducted. Regarding the prospect of Pfizer vaccine candidates, the results of the first safety assessment, announced in the third week of November, are expected to be an important decision.
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