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Pavle Zelic of the Agency for Medicines and Medical Devices stated in the Studio N1 Live program that all the experts from this institution work day and night to study the documentation of the Pfizer vaccine, as well as the samples of the Russian vaccine Sputnik V, and that Every effort will be made to finish it asap. “Every day of our work means human lives, and we will dedicate ourselves fully to these issues in the coming days,” he said.
Let us remind you, the documentation for the registration of the coronavirus vaccine from the company Pfizer and Biontek arrived in Serbia yesterday, and analyzes of the first doses of Russian vaccines are also expected.
On December 2, an application was submitted for the issuance of a vaccine permit for the company “Pfizer”, that is, “Biontek”, while samples were submitted for the Sputnik V vaccine, manufactured by the Gamalej Institute of Russia. The agency immediately took over the work in these cases. We are talking about the Pfizer vaccine, our experts are working on the evaluation of the documentation that was presented in order to be able to issue the drug license, ”says Zelic.
Explain that the entire process is defined by law and statutes that are in line with current directives in the European Union and WHO.
“What we are absolutely aware of is that every day of our work means human lives, that we will fully dedicate ourselves to these issues in the coming days, and we will soon reach the final answer on whether these vaccines meet the very high standards that we expect see. data on efficiency and safety, “says Zelic.
When asked if Pfizer vaccine samples arrived at the Agency, he replied that the documentation has come up so far, while in the continuation of the process the analysis of the vaccine samples will be planned, as it appears for all vaccines and imported drugs.
“This is a regular procedure in extraordinary circumstances, so it is done quickly, and the law allows us to issue this permit under an accelerated procedure. The data we want to see is the entire vaccine development process, everything we heard months ago in the media must now be under our control, as is the case with the United States Food and Drug Administration or the European Agency. of Medicines in Amsterdam, “said Zelic.
He believes that this is a great opportunity for our country not to wait for permission from other regulatory bodies, and points out that “our fate is in our hands”, that is, for our experts to analyze vaccines.
“The specificity of vaccine testing is testing healthy volunteers. Very often, they wonder how it is possible to come up with a solution so quickly when we know that drugs and vaccines have evolved over the years.” They could have been included, simply included. I came across the fact that 51 vaccines are currently being tested, 13 are in the third phase and 163 vaccines are in the preclinical phase, “reveals Zelic.
However, he warns that there are differences between the “histories” of companies and the control of regulatory bodies, which must now confirm this.
“All of our experts who can deal with this are working around the clock, and we are fully committed to the task most important to all of us, so that we can find an answer in a highly professional manner,” said Zelic.
Speaking of the samples received from the “Sputnik V” vaccine, he stated that they are being studied in our laboratories and that the difference is mainly in storage. Pfizer is stored at -70 degrees, Sputnik V vaccine is stored at -18 degrees.
“They are fundamentally different, there are differences in vaccine manufacturing technologies. We hope to confirm that any method by which an effective product has been developed is less important. It is important that vaccines reach citizens as soon as possible. “he said.
Zelic concludes that the entire vaccine verification process is at the beginning, adding that he will do his best to comply with all the procedures, but also that he will do his best to finish everything as soon as possible.
“An application was submitted in the United States on November 20, and its main meeting is expected to take place on December 10, at which the fate of that vaccine will be decided. Our key parameter is to obtain a permit from the country of origin, in the case of the Pfizer vaccine, the Food Agency. medicines, and other reference countries, we refer mainly to Canada, Japan and Switzerland ”, concludes Zelic.
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