Sunday, 3 July 2022

HALMED: Most Side Effects Not Serious, COVID Vaccine-death Link in Two Cases

ZAGREB, 3 July 2022 - The Agency for Medicinal Products and Medical Devices (HALMED) has published a report on side effects to medicines reported in 2021 which says a majority were not serious and that a link between COVID vaccines and deaths was established in two cases.

In 2021, HALMED received 9,966 reports of side effects of medicines and 6,613 reports of side effects to COVID vaccines.

Last year, 4.7 million vaccine doses were administered. An increase of 337% was registered in reports of side effects made by patients, who reported their suspicions just a little less than doctors.

A majority of the reported side effects to medicines and COVID vaccines were not classified as serious but as expected, mild and passing in a few days.

A link between COVID vaccines and deaths was established in two cases, one involving Vaxzevria (AstraZeneca) and the other Jcovden (Janssen).

For everything you need to know about coronavirus specific to Croatia, bookmark our dedicated section and select your preferred language if it isn't English.

Tuesday, 7 December 2021

Regulator Confirms First Vaccination-Related Fatality in Croatia

ZAGREB, 7 Dec, 2021 - After more than 2.2 million Croatians were vaccinated against COVID-19, the Croatian Agency for Medicinal Products and Medical Devices (HALMED) on Tuesday confirmed the first vaccination-related fatality, a 33-year-old man who died after vaccination with the AstraZeneca vaccine.

The causal relationship between vaccination and the side effects and fatal outcome was assessed as probable, and the man died of the thrombosis with thrombocytopenia syndrome, HALMED said.

So far no other cases of this side effect have been reported nor has any other reported fatal outcome been found to be related to vaccination.

The man in question died 12 days after vaccination with the AstraZeneca vaccine (Vaxzevria) and the report on the case was received in March 2021, after which extensive medical checks and analyses were conducted.

Based on reports filed with the European database of suspected adverse drug reactions, the European Medicines Agency (EMA) identified the said syndrome and established that it can occur very rarely if viral vector vaccines are applied.

EMA also determined that even though this very rare syndrome can occur, as can related risks from hospitalisation and fatal outcome, the overall benefit of the said vaccine in preventing COVID-19 by far outweighs the potential risks.

According to the latest information by EMA, by 14 October 2021, 624 reports of suspected thrombosis with thrombocytopenia were filed with the European database of suspected adverse drug reactions, and around 69 million doses of the AstraZeneca vaccine were administered in the EU by 29 October 2021.

In Croatia, 562,938 doses of the Vaxzevria vaccine were administered by 6 December 2021, and 1,584 reports of suspected side effects were filed. Most or 81% of the side effects reported so far were not serious, were mild or moderate and lasted several days.

For Croatia's latest news, CLICK HERE.

Thursday, 15 April 2021

Croatia to Extend Current Epidemiological Restrictions

ZAGREB, 15 April, 2021 - The head of the national COVID response team, Interior Minister Davor Božinović, said on Thursday that the epidemiological measures in force until midnight tonight would be extended, underscoring that the restrictions would not be tightened at the national level, but as necessary from county to county.

Speaking to the press after a meeting of the government's Scientific Advisory Council, Božinović said that meeting mostly focused on the current situation with the spread of coronavirus.

County response teams, he added, will adopt stricter measures depending on the epidemiological situation which at the moment will not be ramped up at the national level.

He said that the situation varies from county to county, adding that currently Primorje-Gorski Kotar has the strictest measures.

Vaccines no longer doubtful in Croatia 

Božinović announced that an additional 50 million doses of vaccines were arriving in the EU in the second quarter and he expressed hope that the number of doses for Croatia would not be brought into question.

He added that the experts had different opinions regarding school lessons but there is no reason now to change the decision for schools to go online as the number of those infected is not falling but actually increasing.

Asked what number would be required to ramp up restrictions according to the experts, Božinović said that some countries that introduced so-called traffic lights had tied their own hands in some situations.

"We are referring to trends here. We are monitoring the situation on a daily basis and applying measures on a county to county basis. I think that we won't refrain from that approach as it has shown to be correct so far," he underscored.

Croatia has not registered the experiences with AstraZeneca's vaccination like in other countries

As far as mistrust towards the AstraZeneca vaccine is concerned, Božinović said that reports by the HALMED medical agency and the Croatian Institute for Public Health "have not had any experiences that are being referred to in other countries."

However, it will be necessary to improve the trust in that vaccine through communication with the public, recalling that government members, including the Prime Minister, were inoculated with that vaccine.

"It is important for the overall public to realise that the pandemic has affected all four corners of the earth and that we will come out of this situation when an adequate solution is applied in all the countries affected by COVID," Božinović underlined, adding that it was important for the vaccine to be available everywhere.

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

Tuesday, 16 March 2021

PM Andrej Plenković: EMA's Stance on AstraZeneca Vaccine to be Known Tomorrow

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.

Monday, 15 March 2021

Croatian Agency for Medicinal Products and Devices Inspecting Documentation on Russian Vaccine

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.

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

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.

Wednesday, 3 March 2021

Health Minister Beroš: "By This Morning 36,013 People Registered to be Vaccinated"

ZAGREB, 3 March 2021 - By this morning 36,013 people have registered online to be vaccinated, which indicates that citizens have recognised that vaccination is an unavoidable step in the fight against the coronavirus epidemic, Health Minister Vili Beroš said on Wednesday.

More than 50% of those who registered for vaccination were from Zagreb, followed by Split-Dalmatia and Primorje-Gorski Kotar counties. There were also 948 phone calls by people interested in getting vaccinated, Beroš told a regular press conference by the national COVID response team.

The head of the Croatian Institute of Public Health (HZJZ) Krunoslav Capak underscored that in the first three days of this week there were 11.7% more new cases of coronavirus compared to the same period last week.

The share of positive cases among those tested is 10.2% while in the past seven days that was 7.9% and in the past 14 days that share was 7.2%.

Croatia ranks 3rd in the European Union with regard to the incidence rate, with Germany and Denmark recording lower incidence rates while the Czech Republic has the highest rate.

The HALMED medicines agency has received 1,186 reports of side effects - 891 to the Pfizer vaccine, 222 to AstraZeneca and 71 to the Moderna vaccine.

Asked why fairs are not allowed, Capak said that that was being considered and added that it was not the same to have a farmers' market fair in downtown Zagreb and the usual village fairs where pigs are roasted on the spit and the festivities continue until late into the night.

The head of the response team, Interior Minister Davor Božinović, said that measures were being relaxed gradually. He added that the measure to limit the number of people at funerals to 25 had brought about results.

There are some deviations and we are trying to respond to that in situations of funerals or some other organised event. Anyone organising such an event needs to do everything they can to keep it under control, said Božinović.

He added that as far as spontaneous gatherings like those in Zagreb are concerned, he recalled that a decision was adopted yesterday which is not repressive but rather preventative and that messages are being sent that large gatherings are not a good idea.

Monday, 21 December 2020

Effective Vaccine Whose Benefits Outweigh Possible Risks Available

ZAGREB, Dec 21, 2020 - The director of Croatia's Agency for Medicinal Products and Medical Devices (HALMED) said on Monday the European Medicines Agency's approval of the first COVID-19 vaccine confirmed that all Croatian citizens could be sure to have access to an effective vaccine whose benefits outweighed possible risks.

Earlier today, EMA recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent COVID-19 in people from 16 years of age.

EMA’s human medicines committee has completed its rigorous evaluation of Comirnaty, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available, HALMED said in a press release.

HALMED evaluators have participated in this procedure from the start as members of EMA's scientific commissions and working groups, Tomic said. "After the vaccine is put on the market, we will continue to intensively monitor the efficacy and safety of its application together with the Croatian Institute of Public Health and other regulators in the European Union."

EMA's scientific opinion will be submitted to the European Commission that will decide by tomorrow at the latest to grant marketing authorisation, which will be valid in all EU and European Economic Area member states, including Croatia.

The Comirnaty clinical trial involved around 44,000 people and showed a 95% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine, HALMED said.

The trial also showed around 95% efficacy in the participants at risk of severe COVID-19, including those with asthma, chronic lung disease, diabetes, high blood pressure or a body mass index ≥ 30 kg/m2. 

Comirnaty is given as two injections at least 21 days apart. The most common side effects were usually mild or moderate and got better within a few days after vaccination.

As Comirnaty is recommended for a conditional marketing authorisation, the company that markets it will continue to provide results from the main trial, which is ongoing for two years. This trial and additional studies will provide information on how long protection lasts, how well the vaccine prevents severe COVID-19, how well it protects immunocompromised people, children and pregnant women, and whether it prevents asymptomatic cases.

The company will also carry out studies to provide additional assurance on the pharmaceutical quality of the vaccine as the manufacturing continues to be scaled up. Comirnaty will be closely monitored and subject to several activities that apply specifically to COVID-19 vaccines.

Although large numbers of people have received COVID-19 vaccines in clinical trials, certain side effects may only emerge when millions of people are vaccinated, HALMED said.