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Twenty doses of the Sputnik V vaccine, which according to government announcements will arrive in Serbia by the end of this week, must first undergo microbiological and toxicological tests at the Agency for Medicines and Medical Devices (ALIMS), and then this body must verify all medical documentation. follow the vaccine before issuing permits for its use.
Photo: EPA-EFE / HOTLI SIMANJUNTAKAs it is extensive documentation, this work can last up to seven months, with the Medicines Law allowing that in exceptional situations, such as an epidemic, not all the regulations are followed, but the so-called temporary license of a medicine is issued.
Epidemiologist Zoran Radovanović explains that the first tests at ALIMS should determine if there is contamination of the vaccine, that is, if it contains heavy metals.
However, he notes that, in this case, it is unusual for the manufacturer to choose which dose to test.
– In general, the practice is that if, for example, the manufacturer sends you 200,000 doses, you randomly test a certain number of vaccines. In this case, we are already getting 20 doses to examine. After this examination, the Medicines Agency verifies all the documentation accompanying the vaccine, which is very extensive, and this procedure can take up to 210 days, says Radovanovic, noting that it is often mistakenly believed that consulting with the Agency involves repeating all previous clinical stages of testing. . It also adds that ALIMS has requirements similar to those in force in the European Union regarding the accuracy and completeness of the data provided with the vaccine.
The Serbian government announced on Monday that 20 doses of the Russian vaccine will arrive in Serbia and will be tested in a laboratory.
On that occasion, Prime Minister Ana Brnabić said that the Government, together with the President of the Republic, is working to make the coronavirus vaccine available to the citizens of Serbia as soon as possible, emphasizing that the goal is for citizens to choose which vaccine to receive. approvals of the competent health institutions of the Republic of Serbia.
The Sputnik V vaccine was previously approved for use in Russia in August, at a time when phase three of the clinical trial of this vaccine had not yet begun.
For that reason, many Western experts have questioned the entire development process of this vaccine, while on the other hand, Russian officials have claimed that the vaccine is completely safe.
After Sputnik V was approved for use, the third phase of the clinical trial of this vaccine began, involving 40,000 subjects in Russia, as well as in Belarus, the United Arab Emirates, Venezuela, and India.
According to the latest official information, during the third phase it was determined that Sputnik V is extremely efficient, in 91.4 percent of cases at 28 days and in 95 percent at 42 days.
It was also announced that the vaccine does not cause serious side effects.
According to the official website of this vaccine, more than 50 countries have so far requested more than 1.2 billion doses of Sputnik V, and contracts for the production of this vaccine have been signed in India, Brazil, China and South Korea.
At the same time, the first doses can be delivered outside of Russia in January 2021.
Among EU countries, only Hungary has so far expressed its intention to acquire a Russian vaccine, drawing criticism from other members, as Sputnik V is not licensed to use the European Medicines Agency (EMA).
As Euobserver reported yesterday, Hungary can buy and distribute the Russian corona vaccine, but only if it is based on emergency procedures and if it keeps it within its borders.
– The vaccine can not be used anywhere in the rest of the EU, said yesterday the representative for the media of the European Commission, Eric Mamer.
Since registering a drug requires a long and extensive procedure, and there is pressure during an epidemic to receive the vaccine as soon as possible, the vaccine may not pass all standard procedures before obtaining a marketing authorization.
As Dragisa Calic, a Yukom attorney explains, the vaccine may also receive a temporary permit for use.
– The Medicines Law allows that in the event of an epidemic or some other emergency situation, not all the regulations that regulate this area are followed, that is, it is possible that ALIMS issues a temporary permit for a medicine. At the same time, the government may prescribe different conditions or procedures for issuing a license for a drug. During the state of emergency, for example, we had a Regulation on requirements, standards and use of medical devices, which allowed the use of devices that were not manufactured according to prescribed standards. After the lifting of the state of emergency, this decree was repealed and, in the meantime, no significant changes were made to the existing regulations, Ćalić explains to Danas.
Delic: The profession must have the last word
Infectious disease specialist Dragan Delic tells Danas that the good news is that the Medicines Agency will examine the Russian vaccine and that the profession must give the last word in terms of efficacy and safety. “I would not a priori be in favor or against the Sputnik V vaccine. It is necessary for the vaccine to go through the entire procedure defined by law in the Drug Agency, and that in the end our experts give a final assessment of whether this vaccine must be used in Serbia. ” “Delic says.
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