ZAGREB, 19 March, 2021 - Health Minister Vili Beroš said on Thursday that Croatia had contacted two Chinese COVID-19 vaccine manufacturers and that talks were at at an initial stage, while Prime Minister Andrej Plenković said that the situation with AstraZeneca's vaccine proved that caution was important.

"We have established contact with manufacturers of the Chinese vaccine, or more precisely, with manufacturers of two types of Chinese vaccine. We have been given some preliminary information and talks will continue," Beroš told a press conference after a cabinet meeting.

He said that all important aspects of the vaccines needed to be discussed, such as safety, efficiency and quality.

Plenković said that the situation with AstraZeneca "is more than clear proof of how one needs to be cautious when placing a vaccine on the market."

"We are now talking about the credibility of a vaccine that has passed clearance and filters in America, the United Kingdom and the European Union. What would we do with vaccines that have none of these credentials? We have to take that into account," the prime minister warned.

Easter passes not discussed

As regards the deterioration in the epidemiological situation and possible passes for Easter, Plenković said that no one talked about such passes and that they were not an option.

He said that Croatia had now ordered more vaccine from Pfizer than from AstraZeneca, but added that at this point no one knew at what rate vaccines would be distributed from 1 May onward. "If a negative scenario happens with AstraZeneca, we are already in the process of ordering more vaccine from Pfizer to offset that."

He said he was confident that progress would be made on a corrective mechanism for vaccine distribution because "people understand that it is not countries that are responsible for this situation."

Asked if he was satisfied with how the EU handled vaccine procurement, Plenković said there was no doubt that the contracts could have been better written in terms of the pace of vaccine delivery. As for people's scepticism about the safety of vaccines, he said it was also important what the media said about them.

"We need to respect authorities on this matter, and our authorities are the World Health Organisation, the European Medicines Agency and the Croatian Agency for Medicines and Medicinal Devices. These are regulators. If a vast majority of professionals from a large number of countries think that this is all right, then we should use that for guidance. That's the most logical and best approach we can take," the prime minister said.

Additional encouragement to regional approach

The head of the national coronavirus response team, Interior Minister Davor Božinović, said that the team would unveil guidelines for the Adriatic counties on Friday as an additional encouragement to the county response teams because the incidence rate differed from county to county.

"We do not think it is time for horizontal measures, especially not in those counties, and there are more of them in the north of the country, where the epidemiological situation is good," Božinović said.

He noted that county response teams had been invited from the outset to propose tighter restrictions because their epidemiologists and professionals on the ground know where a coronavirus hotspot has emerged and what has caused it.

"This regional approach is not just an encouragement, but also a preparation for what is and what will become an integral part of the EU policy for the tourist season," Božinović said, calling for increased inspections of compliance with the restrictions in place and for self-discipline.

For more about COVID-19 in Croatia, follow TCN's dedicated page.

ZAGREB, 16 March, 2021 - Prime Minister Andrej Plenković said on Tuesday that Croatia would continue to administer the AstraZeneca COVID-19 vaccine despite the fact that some 20 countries have suspended vaccination due to blood clotting in some patients.

Although more and more countries are suspending the use of AstraZeneca, Croatia will wait for the opinion of the European Medicines Agency (EMA).

"The stand of professionals on this matter is that the benefits of vaccination outweigh any risks known to them at the moment," Plenković told the press in Daruvar. "None of them has pointed to us any risks which would lead to the conclusion that vaccination should stop."

Today Plenković took part in an online meeting with prime ministers Sebastian Kurz of Austria, Janez Janša of Slovenia, Boyko Borissov of Bulgaria, Andrej Babiš of the Czech Republic, and Arturs Karinš of Latvia.

The six EU member states will demand a corrective mechanism for vaccine distribution, Plenković said afterwards. "We agreed to jointly appeal for the creation of a corrective mechanism."

Thereby, he added, they wish to "compensate for the delay some countries have experienced due to the slower distribution of the AstraZeneca vaccine."

EMA will meet on Thursday to discuss the information gathered and decide if said vaccine has contributed to thromboembolism in people who have received it.

For more about vaccination in Croatia, follow TCN's dedicated page.

ZAGREB, 16 March, 2021 - The Koprivnica-Križevci County's COVID-19 crisis management team on Tuesday decided to suspend mass vaccination with AstraZeneca shots against COVID-19, which was set for Wednesday, 17 March, until the European Medicines Agency (EMA) decides on the matter at its meeting on 18 March.

The mass inoculation was to have been held in a hall in Sveti Petar Orehovec for the residents of that town as well as for residents of Gornja Reka and Kalnik.

However, in the meantime it has been decided to wait for the EMA's decision.

To date, 6,363 residents of this county in north Croatia have been inoculated against coronavirus with Pfizer, Moderna and AstraZeneca vaccines, and 1,961 have received both doses of the two-dose vaccine. There have been no reports of any serious side-effects.

The people who get vaccinated with vaccines registered in Croatia and the EU will have protection from getting seriously sick, which could eventually result in death, the team said.

For more about vaccatinations in Croatia, follow TCN's dedicated page.

ZAGREB, 15 March, 2021 - Prime Minister Andrej Plenković said on Monday that a coordinated stance by the European Medicines Agency (EMA) regarding the AstraZeneca vaccine should be known tomorrow, after several countries have temporarily suspended administering the vaccine due to the emergence of certain side effects.

"Our stance is that a sound test has to be conducted to determine if there are any reasons, based on the findings so far, for Croatia also to go in that direction. From what the experts are telling me, there are no such indications for the time being. Tomorrow, we will probably see a coordinated stance by EMA, which as far as I understand, will proceed cautiously, that is, continue testing the vaccine itself and continue with consultations with the company regarding any possible consequences of the vaccination," Plenković said ahead of a joint meeting of the Croatian Democratic Union (HDZ) Presidency and National Council.

He added that the director of Croatia's HALMED drug regulator, Siniša Tomić, today participated in EMA meetings which discussed what to do next considering the emergence of several side effects that have been reported throughout Europe.

In reference to the procurement of the Russian Sputnik V vaccine, Plenković said that Croatia would wait for it to be approved and that the EMA had launched the relevant procedure. In the meantime, we will obtain additional information and test the vaccine, he added.

Asked who made the decision on how many doses of a vaccine Croatia would order, Plenković said that the procurement of vaccines was launched in the summer before reports that AstraZeneca had had certain problems with clinical trials.

"The vaccine that at the time was way ahead in terms of testing and the fact that it could be finished and its approval sought was AstraZeneca's and we, like the majority of other countries, immediately ordered the largest quantity of that vaccine. Then we ordered the Pfizer, Moderna and Johnson and Johnson vaccines. Croatia ordered a total of 8.7 million doses," said Plenković, adding that no one could have known that problems would emerge in vaccine production when the initial orders were made.

Asked whether anyone would be held responsible for the poor estimate in procuring vaccines, he said that for the entire time the aim had been to protect citizens, which was why more doses had been ordered than Croatia needed.

"The problem has emerged because one company, from which we ordered the biggest quantity... now has a problem in delivering the vaccine to the entire European Union. If that problem didn't exist, the rate of inoculation in Croatia would be very high," he explained.

Asked why Croatia didn't order the largest quantity of the Pfizer vaccine, which was the option many countries used, he said that only a few countries did that and that Croatia's decision was based on an expert opinion at the time.

"Croatia has a population of four million people and can immunise a maximum 3.4 million, and how could it justify buying 20 million doses?" "We did everything that was logical and correct based on the information that was available at the time and as time is moving on, we are looking for other solutions, just like everyone else," he said.

He added that it was necessary to find a corrective mechanism to redistribute the vaccines.

As far as continuing inoculation with the AstraZeneca vaccine in Croatia is concerned, Plenković said that the experts would decide on that. "As far as I understand, EMA's stance is that when the risk and benefits are taken into account, at the moment it is better to be vaccinated," said Plenković.

With regard to the European initiative for a vaccination certificate, Plenković said that the European Commission would release its proposal on Wednesday and that that would enable free movement and the tourism season.

For more about vaccinations in Croatia, follow TCN's dedicated page.

ZAGREB, 13 March 2021 - The head of Croatia's Agency for Medicinal Products and Medical Services (HALMED), Siniša Tomić, said on Saturday that according to preliminary data he did not believe that there was a connection between the death of a 91-year-old woman and her inoculation with AstraZeneca vaccine against COVID.

The HALMED regulator and the Croatian Institute of Public Health (HZJZ) are supposed to adopt their joint conclusion on this matter next week; he told the national broadcaster HTV on Saturday evening.

HALMED is looking into a 7 March report of a fatal pulmonary embolism in the 91-year-old woman three days after receiving a shot of AstraZeneca.

According to Tomić, this case will also be on the agenda of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA).

Tomić said that to date, 14 reports had been submitted in Croatia about side effects with death outcome after inoculations against coronavirus. In nine cases, the reports were sent after the inoculation with the Pfizer vaccine and in five with AstraZeneca.

In six cases, it has been ruled out that the death might be associated with inoculation. In two cases, this relationship does not seem probable, and in another six cases, the authorities are waiting for more supporting documents.

To read more about Coronavirus in Croatia, follow TCN's dedicated page.

March 12, 2021 - Dr. Nataša Ban Toskić revealed that 30% of Croats refused AstraZeneca vaccination on Friday.

Index.hr reports that after ten countries announced in the last two days that they are temporarily suspendeding the AstraZeneca vaccination, several people in Croatia refused to be vaccinated with the same vaccine. 

"Approximately 30 percent of people in the whole of Croatia, as I heard from colleagues from all over the country, today refused to come to the scheduled appointment for a vaccination with AstraZeneca. What I heard from colleagues and what I saw in my office is that people were very scared of it. Some of the patients scheduled for today canceled their vaccination, and those we offered it to after they canceled also refused to be vaccinated with AstraZeneca," said Dr. Nataša Ban Toskić, President of the Coordination of Croatian Family Medicine, for Index.

She states that even before this temporary vaccination suspension in other countries, patients had many questions about AstraZeneca, but that they were still vaccinated in the end.

"They had doubts, but they would still come. Today they refused en masse. There is a difficult situation in practice. Normally, people are confused and scared; our umbrella institutions should better communicate the AstraZeneca vaccine to the public and patients. I am thinking of HALMED, HZJZ, the Ministry of Health, and HZZO.

These institutions should publish concrete information on the situation with this vaccine in several media and several times," explained Dr. Ban Toskić.

He states that family doctors have been put in a rather awkward position.

"We don't have the information of which vaccine we will get, when and in what quantity it will arrive, and that puts us in a rather awkward position because we are on the first line of communication with patients. There is a danger that we are the only ones to bear the consequences of angry patients' lawsuits because we as vaccinators are the only responsible person if something happens to patients. At the same time, we do not influence which vaccine we get. We must adhere to official guidelines; we cannot now refuse to be vaccinated with AstraZeneca based on other countries' decisions.

We are in a problematic situation because if we do not vaccinate patients with the vaccine we received, then we are guilty, and if we vaccinate them, we can be guilty again. It would be extremely fair to the patients and us to intensively inform the public about the new situation with AstraZeneca," believes Dr. Ban Toskić.

He also states that the problem is that in most counties, there are no mobile vaccination teams for immobile and immobile patients.

They are especially concerned, he says, with the information that doctors will have to go to homes on their own and vaccinate patients.

"This is out of the question in these circumstances. There is no chance that the vaccinator comes alone and risks an unfavorable outcome. We need to have teams equipped in case of an allergic reaction to provide first aid to the patient immediately. 

Also, it is imperative to follow the rules of cold transport and transfer the vaccine in the refrigerator. This can only be done by a mobile team, not by an individual going with their purse on public transport or in their car without a refrigerator. And what if an adverse event occurs then, then accuse the doctor of not adequately transporting the vaccine? There are a lot of problems here. Honestly, it is unbelievable that to date, no mobile teams have been established in all cities and counties. Vaccination has been going on for three months now," Dr. Ban Toskić told Index.

Dr. Tanja Pekez said that she would see how the vaccination situation would develop next week, but that so far, everything was going well in her office.

"So far, it's been good, considering that the nurse and I have put in a lot of time and effort. For the first 42 patients, the nurse and I spent 8 hours determining who would be called. We called them all, and we referred calls to reserve patients because some of those invited canceled, then the vaccination started. As for the further situation with the vaccination, no one can know how things will go because everything has become a matter of politics. Britain picked up a huge amount of vaccines, then the explosion of a vaccine factory in India. Then there is the issue of Russian and possibly Chinese vaccines entering the European market. So, the predictions about vaccination are more in the domain of politics, and that should have been predicted by politicians, not only in Croatia but in the whole EU, and coordinated," Dr. Pekez told Index. 

She also states that patients became more interested in vaccination after the media published information about who got vaccinated. Still, she does not know how things will turn out after the latest events in the EU.

"In the end, I would like to add that because of the mental health of young people and the middle generation, we should have vaccinated them first so that we would have more freedom of movement. And we should finally start sanctioning inappropriate behavior," she added.

Recall, nine European countries and Thailand have suspended AstraZeneca vaccination because there have been several cases of blood clotting problems after vaccination and two deaths in Italy and one each in Denmark and Austria.

Denmark, Norway, and Iceland have temporarily suspended AstraZeneca vaccination, while Italy and Austria have stopped using certain vaccine batches as a precaution. Suspensions in Italy and Austria include different series of vaccines - in Austria, it is the ABV5300 series, and in Italy, the ABV2856. Estonia, Latvia, Lithuania, and Luxembourg have suspended the use of the series that Austria has also suspended. Thailand has also announced that it is suspending AstraZeneca vaccination.

At a press conference on Friday, Krunoslav Capak, head of the CNIPH, commented on the situation with AstraZeneca.

"As you know, Austria, followed by several EU countries, has decided to suspend vaccination with AstraZeneca temporarily. Sixteen EU countries have received a vaccine of the same series as Austria. Their decision is a precaution due to thromboembolic events. If they are found not to be related to vaccination, vaccination will continue. As for Croatia, we did not get that series, but we are vaccinating with another series. We did not have groupings of thromboembolic events. So we decided to continue vaccinating with AstraZeneca. In Croatia, the incidence of thromboembolic events is 61 per 100,000; there are slightly more than one per week with a fatal outcome. They are happening in Croatia as well," Capak said.

Alemka Markotić said that it would be imperative for Croatia to preserve the Institute of Immunology and get involved in vaccine production.

To read more about COVID-19 in Croatia, follow TCN's dedicated page.