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What happened
“I have never felt so much joy professionally. We jump like children, with joy for humanity, for scientific progress, because the end of this terrible pandemic is visible!” – said in an interview with the BBC the head of the Pfizer research group, Mikael Dalston.
The reason for the scientist’s joy was the final stage of testing a vaccine that, presumably, should help humanity to cope with the coronavirus pandemic.
On November 9, 2020, the American pharmaceutical company Pfizer, where Dalston works, announced that the BNT162b2 coronavirus vaccine, developed in conjunction with the German laboratory BioNTech, showed an effectiveness greater than 90% in the third and final phase of the clinical trials.
UPDATE: We are proud to announce, along with @BioNTech_Group, that our mRNA based #vaccine candidate has shown, in an interim analysis, initial evidence of efficacy against # COVID-19 in participants without prior evidence of SARS-CoV-2 infection.
– Pfizer Inc. (@pfizer) November 9, 2020
At this stage, 43,538 volunteers participated in the trial. Among them, after the introduction of the vaccine, the coronavirus was detected only in 94 people. The vaccine was more than 90% effective seven days after the second dose, Pfizer said.
The third phase of the trial involves a large-scale study in thousands of volunteers. Pharmaceutical companies carried them out in six countries around the world: the United States, Germany, Brazil, Argentina, South Africa and Turkey.
Help “GORDON”… The first phase of vaccine clinical trials is carried out with a small group of healthy volunteers. Its goal is to ensure that the new drug does not pose a serious medical risk to patients, according to the website of the pharmaceutical company GSK Pharma.
The second phase allows the vaccine to be tested in more people. Its purpose is to test the efficacy of a drug in treating a disease and the optimal dose. At this stage, the effectiveness of the drug is compared to a placebo.
The third phase involves a larger study. Hundreds and even thousands of participants from different countries can participate in it. In this phase, researchers obtain data on the safety and efficacy of a new drug or vaccine when applied to a group of patients.
At the moment, no safety problems have been identified for the vaccine, but the trials will continue until the final analysis of the effectiveness of the vaccine, for which it will be necessary to accumulate a total of 164 confirmed cases of COVID-19.
In addition, final conclusions on the safety of the vaccine and possible side effects after use should be made public. However, the developers have already promised in a couple of weeks, on November 20, to apply for a license to start mass production of the vaccine.
According to the World Health Organization, there are currently 47 COVID-19 vaccine manufacturers in the world who are candidates for clinical evaluation of the produced vaccine. 155 companies are conducting preclinical trials. However, it was the Pfizer and BioNTech vaccines that demonstrated such high efficacy.
Vaccine characteristics.
Based on the results of the study, two vaccines should be given three weeks apart. Tests have shown that one week after the second dose, the body is 90% protected.
Another important characteristic of the vaccine is that it must be stored in special refrigerators at a temperature of -80 ºС, and it cannot be taken out of this ultra-cold environment more than four times. The vast majority of vaccines do not require storage at such a temperature and therefore problems may arise with the transport of a new vaccine.
According to The Wall Street Journal, Pfizer has developed a suitcase-sized reusable container filled with dry ice and equipped with GPS trackers to administer the vaccine. You can store 1 to 5 thousand doses of the vaccine at the desired temperature for 10 days.
Help “GORDON”… The phase III clinical trial of the BNT162b2 vaccine began on July 27. Pfizer said it is testing the COVID-19 vaccine in teens ages 16 to 17. In the United States, Moderna and AstraZeneca are conducting large-scale clinical trials of potential coronavirus vaccines other than Pfizer.
One of the biggest questions now, after the final stages of vaccine trials, is how many people should be vaccinated to stop the pandemic. Air Force columnist James Gallagher believes it is still difficult to give an exact figure, as it remains to be seen how effective the vaccine will be in the event of a mass introduction. But there is an opinion, he notes, that 60-70% of the world’s population will have to acquire immunity to the coronavirus to stop its spread. In other words, even if the vaccine works without problems, to develop herd immunity it will have to vaccinate billions of people around the world.
In addition, there are other questions. For example, how long will immunity last after vaccination? Will the vaccine stop the spread of the virus or just the manifestation of its symptoms? How effective is the vaccine for older people, for whom the coronavirus is especially dangerous?
Despite the pending questions, several scientists consider that the invention of the vaccine in such a short time is a true advance. “Because of this news, I had a smile from ear to ear,” quotes The Guardian Oxford University professor Peter Gorby, a specialist in infectious diseases and global health. this is a watershed moment. “
Forecast for the future
On November 11, the official website of the pharmaceutical company reported that Pfizer and BioNTech had reached an agreement to supply 200 million doses of vaccine to EU countries, with the option to request an additional 100 million doses. If regulatory authorities, the news says, approve the vaccine, deliveries are expected by the end of 2020.
The vaccine will be manufactured directly in the US, Germany and Belgium. According to preliminary forecasts, up to 1.3 billion doses of the vaccine will be produced in 2021. The UK, for example, has already ordered 10 million doses by the end of 2020, plus another 30 million later. Japan has reserved 120 million doses.
However, most experts believe that the vaccine will be widely available only in mid-2021, says BBC News Ukraine.
The European Commissioner for Health, Stella Kyriakides, highlighted that inthe vaccine will not become a “miracle solution” that makes the coronavirus disappear immediately. Even after the coronavirus vaccine appears, he said, it will take some time to continue to comply with the restrictions.
“We all need to understand that even after having a safe, effective and affordable vaccine, it will not be the silver bullet that changes the situation and makes COVID-19 disappear immediately. Even after that, it will be necessary to comply with the restrictions.” .. Therefore, there is hope. But I want everyone to understand: we must continue to comply with the precautions that are already in use. It is very important to protect ourselves and the most vulnerable people around us, ”he said. Kiriakides.
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