ZAGREB, 15 March, 2021 - The Croatian Agency for Medicinal Products and Medical Devices (HALMED) said on Monday that a preliminary inspection of documentation on the Russian Sputnik V COVID-19 vaccine was underway but that for the time being there would be no emergency imports of the vaccine.

HALMED today received documentation from the Health Ministry on the Russian vaccine and a team of ten HALMED experts in individual areas are conducting a preliminary inspection of the documentation to determine if the delivered documents comply with what had been requested.

The agency said that so far there had been no requests for emergency imports of the Russian vaccine and that there would not be any procedures of that kind for the time being.

HALMED will thoroughly inspect the documents forwarded by the Health Ministry and if necessary, request additional documents from the producer to ensure readiness for emergency imports should the need for them arise, the agency said.

The Russian vaccine is currently also being evaluated by the European Medicines Agency.

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March the 15th, 2021 - Croatian Health Minister Beros has spoken out about the EU vaccination rollout and the possibility of Croatia getting its hands on the Russian Sputnik vaccine without needing permission to do so from the EU. Theoretically, he says, it is possible.

As Poslovni Dnevnik writes, the question of whether Croatia is already experiencing the third wave of the pandemic, what is going on with mass vaccination, a look at the country´s epidemiological measures and the tourist season were questions answered by Health Minister Vili Beros on HRT.

This week we record 28 percent more infections than we did last week...

¨On the 384th day since the beginning of the pandemic in Croatia, apart from the newly infected, today there are 855 patients who were hospitalised, which is as many as 50 more than yesterday, meaning that in the last 24 hours, 92 people were hospitalised. This indicates that the virus remains very much around us and that we all need to be careful and act together. It´s extremely important that we follow the basic measures because these are factors that can prevent the spread of infection. In the context of the upcoming tourist season, this is exactly what needs to be constantly mentioned. We´re all responsible for what will happen tomorrow,¨ Minister Beros said.

When asked if there will be another tightening up of the measures at the national level if this trend of an increasing number of patients continues, Minister Beros stated that the National Civil Protection Headquarters has been emphasising the role of county headquarters since back in autumn and is trying to encourage staff to think locally. An example of this, he says, is down in Dubrovnik-Neretva County, their headquarters concluded that something had to change there and he thanked them for that. He added that they will think more about local action depending on the epidemiological situation, than about horisontal measures that would apply to the whole of Croatia.

¨328 thousand doses of vaccine were used and 257 thousand citizens have been vaccinated. 56.7 percent of these doses were related to those in the second vaccination group, ie the elderly and the chronically ill. The Croatian healthcare system is able to vaccinate even more, but things are being limited by the quantities of vaccines coming into Croatia that are less than what was agreed on and expected. The Prime Minister and everyone else are making efforts to respond to these challenges as well,¨ Minister Beros said.

The AstraZeneca vaccine

Minister Beros emphasised the importance of scientific evaluation of everything related to vaccination. He said that approximately a thousand people are hospitalised annually in Croatia for various sorts of thrombosis or embolism. Another 2,200 due to pulmonary embolism, and a total of 3,200 of our fellow citizens, or 9 are hospitalised daily due to thrombo-embolic incidents. From that, he notes, a certain part of them does die and will continue to die. Therefore, given the number of vaccinated people, it is unfortunately to be expected that such deaths will continue. It is important that side effects are reported frequently so that more research can be carried out.

¨The WHO has announced recently that over 268 million people in the world have been vaccinated with the AstraZeneca vaccine and that no significant deviations, incidents or deaths related to this vaccine have been found. This has been confirmed by our British colleagues who have extensive experience and a large number of vaccinated people,¨ the Minister added.

The Russian Sputnik vaccine and Croatia

¨We´re still oriented towards joint procurement through the European Commission (EC) and we believe that the circumstances will improve. Recent announcements by vaccine manufacturers that they will increase doses are in favour of this. However, if this is not the case, we will have to orient ourselves and organise ourselves towards some other manufacturers. Croatia has made contact with the Russian health authorities and some documentation has been received. Tomorrow we will start the evaluation process in HALMED. Whether this documentation is complete and how long the procedure will last, I cannot say at this moment in time,¨ said Minister Beros.

When asked what should happen for Croatia to start purchasing vaccines on its own, he answered that several factors are crucial:

¨This will depend on whether the EC will take our remarks into account in regard to the need for corrective mechanisms that will balance out the delivery of vaccines, furthermore, will the manufacturers, as announced, increase those deliveries, all these are elements that will play their role at some point. The task of this Government is to provide citizens with a safe, effective and quality vaccine. When we´re sure that a vaccine is like that, then we will open the doors to that vaccine, but not before.

It is theoretically possible to import the Russian vaccine through intervention imports. If necessary, I will personally support it because it will mean that European mechanisms have failed, which I believe will not happen,¨ concluded Minister Beros.

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ZAGREB, 4 March, 2021 - Prime Minister Andrej Plenković said on Thursday that the government is more than ready to procure the Russian Sputnik V vaccine once it is approved by the European Medicines Agency (EMA).

Speaking at a cabinet meeting, Plenković said that the government had asked the Russian side for additional documentation on the Sputnik V vaccine and underscored that a formal procedure for the EMA to approve it had apparently begun.

"We will do everything bilaterally to see the details. When the Agency approves the vaccine, we are more than ready to procure it," the prime minister said.

It is expected that EMA will approve the Johnson&Johnson vaccine this month which is, he said, another 900,000 doses, to be distributed according to a certain dynamic.

He said that according to current data, more than 242,000 doses had been used in Croatia, and that 121,000 people had received one, while 60,000 had received both doses.

He added that 42,500 people have registered online to be vaccinated and that about 3,000 had called a toll-free line.

Plenković underscored that Croatia still had a relatively good epidemiological situation. According to the weekly incidence rate, we are ranked fourth in the EU in terms of the lowest rate and we have the lowest incidence among Mediterranean countries and the second lowest among Central European countries, he said.

Although we are seeing a growth in recent days, of 26% last week and 20% this week, we were able to allow hospitality establishments to reopen and sport trainings to resume, he added.

Underscoring that that was a step towards a more normal way of life, Plenković called for caution so that the trend of a decreasing number of patients in hospitals, patients on ventilators and deaths could be maintained.

Since there are infection hotspots in some counties, county COVID response teams are implementing stricter measures in agreement with the national COVID-19 crisis management team in order to curb a possible new spread of the epidemic, he said.

As for activities following the 29 December earthquake, the prime minister said that work on completing damage assessment was intensified so that it could be completed and so the government could apply for money from the European Solidarity Fund through the Ministry for Regional Development and EU Funds.

ZAGREB, 4 March, 2021 - Croatia's Agency for Medicinal Products and Medical Services (HALMED) reported on Thursday that the European Union's vaccine watchdog had started a review of the Russian-made Sputnik V COVID-19 vaccine.

HALMED recalls that Sputnik V jab was developed by the Russian Gamaleya Research Institute of Epidemiology and Microbiology.

The European Medicines Agency (EMA) said in a statement on Thursday that the rolling review is based on results from laboratory studies and clinical studies in adults.

The Russian vaccine has been deployed in 40 countries worldwide, including European nations Serbia, Montenegro, Moldova, and Hungary. Slovakia received its first shipment of 200,000 doses over the weekend, the Euronews said on its website.

The EMA has so far approved three vaccines for use across the bloc. These were developed by Pfizer/BioNTech, AstraZeneca/Oxford University, and Moderna. It is currently evaluating the jab by Johnson & Johnson and is expected to give its approval in mid-March.

On Wednesday, Croatian Health Minister Vili Beroš said he had held talks with a Russian delegation on Tuesday on Sputnik V vaccines.

He said that during the meeting he had called for expediting the delivery of documentation on the Russian COVID-19 vaccine so that Croatia's HALMED regulator could evaluate the vaccine's safety and efficiency.

February 15, 2021 - Spokesman of the Embassy of the Russian Federation in Croatia, Matvey Sidorov, spoke about the possibility of the Sputnik V vaccine in Croatia. 

The spokesman of the Embassy of the Russian Federation in Croatia, Matvey Sidorov, was a guest of New Day on N1. He spoke about the Russian vaccine Sputnik V and the possible delivery of that vaccine to Croatia.

Sidorov did not want to talk about the meeting between Prime Minister Plenković and the Russian ambassador before the government announced them.

"Sputnik V was on the table, and the Russian ambassador conveyed good intentions. We spoke about possibilities and details," he said.

He also cited the example of a European Union member state that already uses the Sputnik V vaccine.

"We have such an example; it is Hungary. An agreement was concluded on January 22, and on February 1, the vaccine arrived in Hungary," Sidorov said.

The number of vaccines is a complex and logistical issue, Sidorov said, stating that it is a matter that the appropriate people in the departments could solve.

“Palestine got the vaccine in three weeks, but it was through Israel. Two weeks is the normal approximate speed of delivery, but this should be resolved between the Russian manufacturer and the appropriate body in the Republic of Croatia according to your vaccination plan," said Sidorov.

He reiterated that they are always ready to help.

"We will not use it as a geopolitical benefit. We want to vaccinate the whole world as soon as possible. We also consider an agreement on the production of Russian vaccines in other countries possible," Sidorov added.

Sidorov noted that Russia had not set any conditions on the table for importing vaccines and thinks that there will be no such conditions.

Sidorov said 2.5 million citizens were vaccinated in Russia last week, and now there are just about 3 million people.

“Mass free vaccinations started on January 18. There are several mobile centers in Moscow and other major cities. Every citizen of Russia or foreign citizen who has a residence in Russia can be vaccinated," he explained.

No one has yet been vaccinated at the Embassy of the Russian Federation in Zagreb.

"It would take at least three weeks to go to Russia. That is why we are waiting for Sputnik V in Croatia. We cannot be vaccinated on the territory of the Republic of Croatia without the appropriate permits from state bodies," Sidorov said.

He recalled a study in the medical journal The Lancet that reported that the Sputnik V vaccine's effectiveness was 91.8 percent.

“We find it quite effective, at the level of any other vaccine in the world. We are confident about this vaccine," Sidorov said.

Asked why the Russian vaccine has not yet been approved in the European Union, he replied: “I can't say. We have sent a request to the European Medicines Agency, and we are waiting for an official response from them. We are ready for that. I don't really know why it's not going in that direction."

The number of vaccine doses delivered would depend entirely on the relevant bodies' ideas and plans in Croatia.

"As we agree, so it will be. I do not see any limit on the number of doses. I don't see any obstacles to a large number of doses," said Sidorov.

He once again noted that the quantity would depend on Croatia's official requirements.

"We are always ready for dialogue. Our embassy is ready to do it as soon as possible and deliver it," he concluded.

Illustration by Little Shiva

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