Tuesday, 9 March 2021

Government Authorises Health Minister Vili Beroš to Purchase Pfizer/BioNTech Vaccine

ZAGREB, 9 March, 2021 - The Croatian government on Monday adopted a conclusion authorising Health Minister Vili Beroš to sign an order for the procurement of the Pfizer Inc./BioNTech COVID-19 vaccine.

The conclusion was adopted in line with an agreement signed between the European Commission and Pfizer Inc./BioNTech Manufacturing GmbH on 17 February 2021.

The funds for the procurement of the vaccine will be secured by the Croatian Health Insurance Fund.

The EC has so far signed six agreements on the upfront purchase of vaccines against COVID-19 on behalf of EU member states. The February 17 agreement between the EC and Pfizer refers to the purchase of an additional 200 million doses.

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

Monday, 8 March 2021

Women Better Responded to COVID-19 Vaccine, Study Shows

ZAGREB, 8 March, 2021 - People who had recovered from COVID-19 had a considerably high level of antibodies after the first dose of vaccine, which did not increase after the second shot, so they most probably will not need a second dose, the director of the Hospital for Infectious Diseases in Zagreb, Alemka Markotić, said on Monday.

Speaking at a regular press conference given by the national COVID-19 response team, Markotić presented the results of a study conducted by the hospital among its staff. The results have also been requested by the European Medicines Agency.

Women responded better than men

All staff had statistically considerably higher immunoglobulin levels a month after the second dose of vaccine compared with the first dose. Women responded better and had higher levels than men, especially after the second dose. There was a slightly negative correlation with age, as elderly subjects had a weaker response, which was moderate, Markotić said.

After the second dose, there was a considerable rise in the level of antibodies. None of the staff fell ill after the vaccination, and no differences were established among staff in respect of their job at the hospital, she added.

So far 426 (55.3%) of the staff at the Hospital for Infectious Diseases have received two doses of the Pfizer vaccine. Eight of them developed allergic reactions after the first dose and were not administered a second dose.

Initial serological tests were done on 420 staff three weeks after the administration of the first dose and shortly before the second dose, while second serological tests were performed on 82 staff four weeks after the second dose.

The subjects were 344 women and 89 men. They included 321 health workers and 112 workers in the healthcare system who are not in as close contact with patients as health workers.

Women better responded to the vaccine after the first and second shots. There is a negative correlation between the level of antibodies and age, which was expected given that the immunology system becomes less responsive with ageing, Markotić said.

Monday, 8 March 2021

Epidemiologist: Roll-Out of Johnson & Johnson Vaccine to Start in Croatia in Early April

ZAGREB, 8 March, 2021 - The distribution of the Johnson & Johnson coronavirus single-dose vaccine can be expected in Croatia in early April, the head of Zagreb's Fran Mihaljević hospital for infectious diseases said on Sunday evening.

Asked by the commercial NOVA TV broadcaster whether Croatia is facing the third wave of the COVID-19 pandemic, the hospital's head, Dr. Alemka Markotić, said that the developments in Croatia's neighbourhood and in Europe "are being followed with the closest attention."

"The numbers are rapidly rising. Each country is trying to take care of its specific features and act accordingly," the doctor said adding that Croatia is currently among the countries that are faring best against COVID.

Markotić recalls that the European Centre for Disease Prevention and Control (ECDC) tried to give some common guidelines, however, everybody assessed that their respective countries had too many differences and specific features.

"(Anti-epidemic) measures are important, we should adhere to them so as to keep the things at bay," Markotić said, among other things.

She added that on Monday a team of Croatian researchers would present findings of a study about the efficacy of the second shot of two-dose vaccines. The research has been conducted in Croatia.

The findings show that a high antibody titer was produced by some organisms after the they received the second dose of the COVID vaccination, she said.

Thursday, 4 March 2021

Croatian PM Plenković: "Government More Than Ready to Procure Sputnik V Vaccine"

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.

Thursday, 4 March 2021

HALMED Confirms News That EMA Starts Review of Sputnik V

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.

Wednesday, 3 March 2021

Health Minister Beroš Calls on Russian Side to Expedite Delivery of Vaccine Documentation

ZAGREB, 3 March, 2021 - Health Minister Vili Beroš said on Wednesday that during his talks with a Russian delegation 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.

"The meeting yesterday with the Russian ambassador does not indicate that we are abandoning the European Commission's common procurement but is rather a sign that we are looking for complementary methods that will be in line with the EC and Croatian regulations," the minister told a news conference.

He said that it was possible to obtain the vaccine without the approval of the European Medicines Agency and that the analysis by HALMED would take some time, but that he was talking about days and weeks, not months.

Yesterday's meeting was held at the proposal of the Russian ambassador, it was pleasant, constructive and friendly and focused on possibilities of obtaining the vaccine, Beroš said.

It was stressed that procuring the vaccine from Russia was a possibility and that it had to be in line with EU and Croatian regulations, Beroš said.

He noted that the Foreign and European Affairs Ministry has sent a note to the Russian Embassy specifying the 11 documents HALMED needed in order to be able to evaluate the safety of the vaccine.

"I thank our Russian friends for their efforts to help us in the fight against the pandemic because vaccination, along with restrictions, is the main weapon in preventing the spread of the infection," he said.

He noted that it had already been said that HALMED could evaluate the efficacy of the vaccine without the approval of the European Medicines Agency if so requested by Croatian health authorities, in order to secure emergency vaccine imports.

"I believe it is a legitimate government effort to ensure for citizens everything that science can offer, but the main criterion must be safety, efficacy and quality," he stressed.

As for the debt to drug wholesalers, which have limited drug deliveries to hospitals because of their debts, Beroš said that it was a problem that had persisted for decades and that it should be dealt with through a reform of the health system as well as talks with drug wholesalers.

He said the government would do its best to secure an unobstructed supply of drugs for citizens and that it would hold talks with drug wholesalers.

The Croatian health system is financially unsustainable and the crisis year 2020 accentuated the negative financial effects due to an increase in health spending as well as the cost of procuring the COVID-19 vaccine, which amounted to more than two billion kuna last year, said Beroš.

Thursday, 11 February 2021

PM: AstraZeneca Vaccine Protects Elderly from Death, Ventilators, Graver Symptoms

ZAGREB, 11 February, 2021 - Prime Minister Andrej Plenković said on Thursday the AstraZeneca COVID-19 vaccine protected the elderly against death, ventilators and more serious symptoms, and that therefore there were no obstacles to administering it to people over 65.

Speaking at a cabinet meeting, he said that this morning he spoke with representatives of pensioner unions and associations which demand that people over 65 are not given the AstraZeneca vaccine.

Plenković told the public, notably older people, that all three COVID vaccines, Pfizer's, Moderna's and AstraZeneca's, "are 100% effective against death, against situations on ventilators and more serious symptoms."

He said that according to the information at the government's disposal, there were no obstacles to people over 65 receiving the AstraZeneca vaccine.

"We believe that in these circumstances as many people as possible whose health is at risk, whose health is fragile, who are older, to whom coronavirus can cause major health damage in a short time, should be vaccinated."

Plenković said additional studies and trials would confirm that the AstraZeneca vaccine was equally effective in reducing the number of COVID deaths in Croatia.

The number of new infections keeps falling

Speaking of the epidemic, he said the decrease in new infections was continuing, as confirmed by this week's numbers.

Today Croatia is third in the EU by the weekly average of confirmed cases per million inhabitants and has the fifth largest two-week decrease in COVID deaths, he added.

"We are in the winter months and a strong cold wave has been announced, the British virus strain has been identified, so many European countries, which have much stricter measures, are extending or further restricting them."

Plenković said there were indications that vaccine deliveries would step up and that greater quantities could be expected by the end of March.

Croatia has received about 150,000 doses, another 600,000 are expected by the end of March, so it will be possible to vaccinate a markedly larger number of people, he added.

It is important that the Health Ministry, the Croatian Institute of Public Health, hospitals and general practitioners ensure mass vaccination, he said.

Monday, 1 February 2021

Croatia Will Get Russian Vaccine If It Asks for It, Says Ambassador

ZAGREB, 1 February, 2021 - Croatia will get the Russian COVID-19 vaccine if it asks for it, Russian Ambassador Andrey Nesterenko said in an interview with the Monday issue of the Večernji List daily.

EU countries, including Croatia, have been having difficulty obtaining pre-ordered vaccines and Russia is willing to provide 100 million doses in the second quarter, as confirmed to the daily by Ambassador Nesterenko.

Even though Croatia has still not officially asked Russia for the vaccine, Nesterenko says that the head of a research group at Zagreb's Ruđer Bošković Institute, Dragomira Meichen, is Croatia's representative on the international scientific council for the Sputnik V vaccine and that the platform for consultations with Croatian experts already exists.

Sputnik V has a number of advantages that greatly simplify the delivery of the vaccine worldwide - it is stored at temperatures ranging from 2 to 8 degrees Celsius, which makes it possible to keep it in an ordinary refrigerator, and the price per dose is less than US$ 10, which makes the vaccine affordable for many countries, the diplomat said.

The ambassador also said that the Russian vaccine could play an important role in the fight against the pandemic and be used in UN missions.

UN Secretary-General António Guterres has therefore expressed hope that the World Health Organisation would approve the vaccine as soon as possible, the diplomat said.

He noted that Russia had so far received orders for the purchase of 1.2 billion doses of the vaccine from more than 50 countries.

Nesterenko added that the vaccine was being actively used in Russia, with vaccination conducted not only in hospitals but also in shopping malls and other venues. He added that a centre for the vaccination of foreign nationals had been opened in Moscow and that some of the foreign ambassadors serving in Russia had been vaccinated with Sputnik V.

Monday, 25 January 2021

Plenković: Vaccine Diplomacy Has Turned Into Vaccine Hijacking

ZAGREB, 25 January, 2021 - Prime Minister Andrej Plenković said on Monday that the COVID vaccine diplomacy was turning into vaccine hijacking, adding that a joint EU lawsuit against vaccine manufacturers is possible if they do not meet contract obligations.

Speaking to the press, Plenković said that the European Council adopted a firm stance on Thursday that the deadline should be respected.

Some countries are paying more per dose than what the EU paid, he said, adding that that is not part of the agreement.

The prime minister said that Croatia had not yet turned towards other vaccines because the agreement was that we EU member states do not contact the manufacturers themselves.

"Once that happens, there is no joint agreement. The joint agreement must ensure that the entire at-risk population is covered by the summer, that is most important," he said.

Italy is preparing a lawsuit against Pfizer, and Plenković thinks that will be a joint activity at the EU level, adding that the Commission signed the agreement "on our behalf."

Asked whether the European Union will enter into new negotiations with the manufacturers and offer a higher price, like some countries are doing, he said he did not see the logic behind such a move.

"They should be paying penalties to us and not vice versa," the prime minister said.

I think we will provide doses for second shot

The prime minister thinks that Croatia will provide the doses necessary to administer the second shot to people who have been vaccinated. "You've heard the epidemiologists, the deadline is 21 days... There will be no danger that someone who received the first shot doesn't receive the second one in time," he said.

As for politicians, he said there were fewer than a hundred at the national level that had been vaccinated, adding that the government has concluded that it is good to vaccinate ministers who have not been infected with coronavirus.

Asked about the relaxation of epidemiological measures and the possibility that cafes and restaurant reopen in February, Plenković said that those matters were discussed in yesterday's meeting.

At the EU level, there is currently great caution due to the new strains of the virus. The vaccination dynamic has changed due to delivery slowing down, which is another reason for caution, he said.

"The figures are encouraging, the situation is more favourable than usual, but those are not ideal circumstances," the prime minister said.

"After yesterday's discussion we think that the situation is challenging," Plenković said.

Asked whether children will return to schools at the beginning of February, he said that the national COVID-19 crisis management team would explain everything at its press conference today.

Friday, 22 January 2021

Health Official Says Not Satisfied With Pace of Vaccine Delivery

ZAGREB, 22 January, 2021 - Croatian Public Health Institute (HZJZ) director Krunoslav Capak said on Friday that he was not satisfied with the pace of COVID-19 vaccine delivery and that the vaccination plan would have to be changed because less than planned supplies were being delivered.

"We are not satisfied with the delivery, it is far below what we agreed. What makes the situation more difficult is that at the beginning we were given larger quantities of the vaccine and in the meantime they have decreased," Capak said at a news conference of the national coronavirus crisis management team.

"We will manage to vaccinate everyone who has been given the first dose of the vaccine but new vaccinations will have to be suspended as we do not have new vaccine supplies to begin administering the Pfizer vaccine," Capak said.

He added that Pfizer had reduced its deliveries for the next month by 30%.

Moderna, too, has changed the amount of the vaccine to be delivered, the delivery is a week late and it was promised that 11,000 doses would be delivered after February 1, he said.

"We must change the vaccination schedule because at the moment we do not have enough of the Pfizer vaccine to increase the number of people to be vaccinated but are keeping it for the second round of vaccination," he said.

The AstraZeneca vaccine is expected to be registered on 29 January, its fast distribution has been promised and additional quantities, promised after the 29 December earthquake, are expected from the EU.

Capak says that the rate of inoculation of the population depends on vaccine deliveries but that with greater quantities of the AstraZeneca vaccine and all the other vaccines, it is possible to achieve a high rate of inoculation of the general population by summer.

He said that the epidemiological situation in the country had improved but that there was a danger of new virus strains and that one should also take into account the situation in the earthquake-hit Sisak-Moslavina County when considering possible relaxation of restrictions.

He said that compared to the previous week, there was a 21% drop in the number of new infections. The incidence is highest in Sisak-Moslavina County, which has a rate of 428 infections per 100,000 people, and it is lowest in Istria, with 114.5 new infections per 100,000 people.

The share of new infections in the tests done is 12.3%, which puts Croatia in 13th place in the EU. So far 64,951 people have been vaccinated, and in Sisak-Moslavina County 5,863 have been vaccinated, said Capak.

Markotić: New virus mutations put us where we were a year ago

The head of Zagreb's Dr Fran Mihaljević hospital for infectious diseases, Alemka Markotić, said that the third variant of the virus originated in Brazil and that it differed from the strains in Great Britain and South Africa.

It seems this virus could partly bypass the response of antibodies in persons who have developed immunity either because they got infected or were vaccinated, and that can also affect serological testing, she warned.

The entire EU is agreed that virus genome sequencing should be stepped up, she said, warning that coronavirus was prone to mutation and sought new ways to spread.

As for possible relaxation of anti-epidemic measures, she called for caution, citing the winter season, which facilitated the spread of the virus.

Even though vaccines seem to be effective against the strain from Great Britain, one should follow new mutations and adapt diagnostic tests to the new variants, she said.

The European Commission believes that the new variants of the virus put us back where we were a year ago when it appeared. Everyone hopes that the existing vaccines and tests will be appropriate for new variants but we have to be extremely cautious to prevent them from spreading, Markotić said.

Božinović: Measures to be defined at meeting on Sunday 

The head of the national coronavirus crisis management team, Minister of the Interior Davor Božinović, declined to comment on the possible relaxation of epidemiological restrictions, saying that members of the coronavirus crisis management team and government ministers would meet on Sunday to discuss the topic.

He stressed that there was no draft for the relaxation of restrictions in the hospitality sector, an issue raised in recent days by the national hospitality sector association.

Božinović confirmed that inspections had been stepped up in ski resorts and spas and that so far 99 fines had been collected for failure to wear a face mask and 853 warnings had been issued.

He also said that the EU was ready to provide financial assistance for virus genome sequencing in the member-states.

"The European Commission wants the member-countries to sequence at least five percent of positive COVID-19 tests. We must step up our efforts to prevent potential damage from new strains," said Božinović.

Earlier in the day, the team said that in the last 24 hours, 643 new coronavirus infections had been confirmed and 32 people had died of the consequences of the coronavirus infection.

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