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When Professor Vytautas Usonis asked if the state of development of the vaccine at this time was such that we could go to vaccinate soon, he assured that we would have to wait, but the intermediate results are very good news in any case.
“We keep repeating that vaccine development is a process. The data now released are the interim results of a phase III study, a study involving tens of thousands of volunteers. Of course we will await the final results, but any positive intermediate results are good news that we are on the right track. I think this is how you should judge and the media knows how to pick good headlines.
And I would say that it is the result of regular, meticulous and hard work. It is also important that after this stage, the results are better than expected. It is very good news, but time and time again we have to wait until the end of the investigation so that we can say that these are the final results ”, assured the professor in the program.
When asked how many of these phases there are and when we can expect the final result, V. Usonis explained that even after the vaccine development is completed and recorded, a surveillance regimen is still applied to discover various unpleasant side effects.
“The third phase is the last phase before the product is registered. It is true that even after vaccination registration, which has been used under the so-called surveillance regimen for some time, more attention is paid to adverse events after vaccination, but once the third phase studies are completed , the vaccine drugs can be registered, “replied V.
Vaccinate younger adults first
According to him, the vaccine would be given first to young adults and only later to elderly or chronically ill people.
“Most of the study participants are young adults (18-55) and healthy individuals. It’s true that research has already started with older people, but so far these are only the first steps. Of course, it happens with each vaccine that the first indications are for a vaccine for adults, then for a younger adult and then, if you already have that vaccine, more research is done in sensitive groups, people with various diseases, older people.
Therefore, it is more likely that the first indications are young adults and elderly patients with chronic diseases: they will have to wait ”, answered V. Usonis.
He spoke of side effects.
According to the professor, side effects are possible, but for a coronavirus vaccine, the pain does not exceed normal levels.
“In fact, we repeat many times that vaccination is a biological process, and when a vaccine is injected into a muscle, the substances in the vaccine can irritate the surrounding tissues. This can be painful and these things are carefully recorded in clinical trials: how long does the pain last, what is its intensity, etc., but in any case, if the pain is unacceptably severe, or these cases recur with unacceptable frequency, solutions are being sought, but “What is published today about all coronavirus vaccines is pain, but generally it does not exceed normal levels,” said the professor.
When asked if any special equipment would be needed to store or deliver the vaccine, the professor assured that it was the responsibility of the manufacturers to present the vaccine safely in the vaccination room.
“First of all, let’s wait for the study to finish and, after completing it, we will see what transport temperature is needed. On the other hand, this (temperature) is not an exclusively new thing. Today, vaccines widely used in the early stages of their use were also required to be transported frozen. For example, we can mention the chickenpox vaccine.
Spread of COVID-19
And by developing vaccines, they develop that they are stable, that they can be transported at normal temperatures. So at this point you have to wait. On the other hand, this problem is known and all manufacturers today are already planning how that vaccine will be supplied, what the cold chain will be. And there is a lot of experience in the world, vaccines from the same years of clinical trials travel in special containers with special cold recording equipment, and opening a container is possible only after making sure that the cold chain has not been damaged and Similar. This is an additional concern, but as a general rule, it is the responsibility of the manufacturers to present the vaccine in such a way that it reaches the vaccination office safely, ”said the professor.
Results exceeded expectations
It is recalled that the coronavirus vaccine developed by Pfizer Inc. and BioNTech SE prevented more than 90% of infections.This information came to light after a large study involving tens of thousands of volunteers. So far, this is the most promising scientific achievement in the fight against coronavirus.
With the beginning of the eighth month of the worst pandemic in a hundred years, these preliminary results will encourage companies to ask regulators for permission to use the vaccine immediately if more research shows that it is safe. The findings are based on an interim analysis conducted on 94 COVID-19 subjects. Testing of the vaccine will continue until the number reaches 164. If the preliminary data and safety information that Pfizer expects to receive in about a week is also encouraging, the world may have an essential new tool for managing a pandemic that has been charged more than 1 year. , 2 millions. lives.
“This is the best news for the world, the United States, and public health,” said William Gruber, senior vice president of clinical research and vaccine development at Pfizer. The results exceeded even the highest expectations, he admitted.
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