It will happen when it happens - The vaccination entanglement in North Macedonia
The Government of the Republic of North Macedonia has agreed on 833,000 doses of the AstraZeneca vaccine through the COVAX system; 800 thousand doses of Pfizer and 200,000 doses of Sinofarm and Sputnik V (each). The latest news from the Government is that 500,000 Sinofarm doses will be also procured.
Although the WHO assessed these agreements as self-destructive, they were the channel through the countries provided early access to vaccines. The countries, among other things, have agreed on higher purchase prices, have exempted the producers from responsibility from side effects, without having a guarantee date for delivery of the vaccines. In our case, the information in the contracts is unknown. What is obvious is that the Government was late with the direct negotiations with the producers, in comparison with other countries. According to the official statements, the Government started the negotiations in December and sent a request for quote to Pfizer immediately following the authorization of the vaccine by EMA.
Unlike us, many countries concluded pre-agreements with these companies before our Government entered into negotiations with them. Serbia signed such an agreement in November and it was from this quantity that Serbia provided the first vaccines for North Macedonia. In addition to the Pfizer vaccines, additional doses of Sputnik V, again a donation from Serbia, arrived in the country at the end of March. While the Government has consistently insisted that will secure the vaccines directly with the producers, most of the vaccines available to North Macedonia came as a donation from Serbia. That is, 10 thousand doses more than those that arrived as a result of the agreements concluded by the Government with the COVAX mechanism and with the producers.
Uncertain vaccines, reduced trust in the institutions
The fact that North Macedonia, as a NATO member and a candidate country for membership in the European Union failed to procure vaccines in time, and the fact that the Macedonian citizens are going to Serbia for vaccination, can be considered a great failure for the government in its fight against the pandemic. Additionally, the public rumors that the government officials have been vaccinated and then denied by the Government, shows that even if it is fake news, it is easily digested by the citizens because the trust the citizens have in the institutions is quite shaky.
The issue of lack of trust in the institutions is not a new one and (especially) the health authorities are not helping in resolving the situation. First, there was a statement that a direct agreement was reached with Pfizer (30.12.2020), followed by the statement that the contract was finalized this morning (04.01.2021) and then, two weeks after, to be followed by a statement from the Minister of Health that “we will sign this agreement in a short time“ (16.01.2021). All of this leaves a definite doubt that there is something wrong in the whole situation.
A few more "announcements" followed, first that they are in the final stage of direct talks with Pfizer (27.01.2021), then that the draft of the contract should arrive “next week” (11.02.2021), after two weeks it was said that issues in the contract are finalized (26.02.2021). Following all this confusion, it is logical for the citizens to ask themselves if something may not be right.
A situation followed that raised doubts about the vaccination and immunization process as well as additional institutional mistrust – the procurement of the Chinese vaccine. After rumors surfaced that the Chinese government had returned the advance payment because the Macedonian Government has included a phantom company from Hong Kong, several statements followed denying or confirming these rumors. First the Prime Minister said that "a private company was used as an intermediary in the procurement of vaccines and that this was the reason for China to return the deposit, but denies any abuse."
Then the Ministry of Health stated that "Those speculations are not true. "Our country has a contract for 200,000 vaccines from Sinofarm, a Chinese manufacturer of vaccines against Covid-19. The vaccines will arrive in our country soon." Ultimately, the Minister of Defense gave a statement that still confirmed the initially announced speculation, saying that "we could have easily kept silent about the returned deposit but we wanted to be transparent" – this did not help to clarify things and led to even greater confusion among the people. Why any government would go through such procurement channels, and this definitely raises doubts again and undermines the trust in the institutions.
Doubt in the intentions of the Government
The situation is similar regarding the procurement of Sputnik V. In terms of the Russian vaccine, the Russian Embassy has issued several notifications on the availability for receiving this vaccine. The first notification was sent by the Embassy on 18 August 18 2020 to the Minister of Health, and on 25 September of the same year a letter was sent by the Russian Direct Investment Fund to the head of the National Immunization Committee, but without any response from our authorities.
This further demonstrates the frivolous approach by the Government to this key issue for tackling the pandemic. Has the Government "overestimated" its ability to procure vaccines or has it relied entirely on others without a plan B? Either way, both options are equally bad. The response of the authorities, that is, Minister, was that "they acted in accordance with the procedures for approval by the international regulatory bodies and the decisions were made on that basis.” Still, the compliance to the procedure is not improving the perception among the citizens that the vaccines are not being procured with the pace shown by the institutions.
Although the interest in vaccination does not seem sufficiently big, the number of just over 100 thousand citizens registered on the official website of the Ministry of Health for expression of interest for vaccination, this figure may be actually quite higher given the institutional distrust among the citizens.
What can we learn from other countries?
The lack of vaccines is not the only problem that the country faces in the process of vaccination of the population. The countries that have secured greater quantities of vaccines face the challenge of actually using them in full. The prime minister Zoran Zaev called our late procurement a potential ‘advantage’, although we had the opportunity to learn from the mistakes and challenges faced by other countries, but the stapes taken by the institutions so far convinced us that we have not learned enough.
Fear and skepticism
The mistrust and insecurity of the citizens to go for voluntary vaccination is a problem faced by the countries that already have (conditionally speaking) a sufficient quantities of vaccines. Besides France which has long faced anti-vaccination sentiment, Serbia is the closest example in supporting this claim. This country called for vaccination of citizens of the neighboring countries, while the majority of its citizens have not been vaccinated.
The survey of the Ministry of Health showed that, in contrast to several developed countries, 68% of health professionals expressed interest in vaccination. However, the data for the entire population show opposite results. The MCMS research showed that the majority (58%) of the citizens would not like to be vaccinated. That is, 40.9% said they would never vaccinate themselves while 17% said it was somewhat unlikely. The new data collected after the commencement of the vaccination show that 50% of the people would like to get vaccinated. However, there is a significant 34% of people who would not like to be vaccinated while 16% do not know or did not answer.
Several factors may cause the citizens to be hesitant in their decision to be vaccinated. In addition to the indicated reasons, we also have the vaccine safety, the fear of side effects and concern that the clinical trials and studies are taking place way too fast. It was exactly those isolated but prominent news of side effects that prompted the European governments to put pressure on the public to stop the use of AstraZeneca without prior recommendation by EMA. In addition, the online misinformation distorts the citizens' perceptions and may reduce the interest in vaccination.
Non-transparent approach in the vaccine approval
The Agency for Drugs and Medical Devices MALMED, which is the institution responsible for approval of the vaccines in the country, in addition to effective implementation and supervision of the regulations and their approximation to EU standards, has the task to "inform the professional and general public." The Agency has never directly informed about its work regarding the process and criteria it uses to approve the vaccines for use. MALMED, according to the vaccination strategy, should receive reports by citizens on side effects through its website, which is available only in Macedonian and this shows that the Agency is not ready to respond to the tasks for which it is responsible towards all the citizens.
During the process of vaccines procurement, the Minister of Health, Venko Filipche initially pointed out at that, "we will follow the decisions of the FDA and EMA“ for the Covid-19 vaccines, same as for other medical preparations. Just 10 days later, as the Sinofarm vaccine was still under consideration in the EMA, the documents from their national agencies were a sufficient for its approval. In the case of Sputnik V, it was not explained what makes this vaccine safe. For comparison, EMA publishes on its website the authorization data and information related to all approved vaccines and for the vaccines pending approval, as well as explanation about the checks on AstraZeneca for side effects. In North Macedonia, the Ministry of Health has created a special website where it provides information about the safety, efficacy and side effects of each of the vaccines. The data available on this website is scarce and are not sufficient to provide a clear answer to the dilemmas that citizens may have about each of the vaccines.
AstraZeneca: safe or not?
The mantra that "all the vaccines we have procured are safe" has been cancelled by the decision to suspend vaccination of citizens under the age of 60 with AstraZeneca, following the example of Germany and Canada. In fact, the decisions adopted by the Governments of EU member states to suspend AstraZeneca was the reason for a drastic reduction in trust in this vaccine in Europe. The decisions of the institutions in such situations are really difficult, hence the decision to invoke a precautionary principle should be evidence-based and it is equally important that they are transparent. Hasty and unsubstantiated decisions to suspend a vaccine may initiate anti-vaccine movements and increase the skepticism about other Covid-19 vaccines.
In our case, this decision came only two days after the Minister of Health supported the decision of the citizens to be vaccinated in Serbia with this vaccine. So far no information can be found about the reasons for this decision on the websites of the ministry nor on the website of MALMED, including instructions on what the people who have already been vaccinated should do. The silence and the delayed informing of the citizens creates panic and the likelihood of use of irrelevant sources which can easily become the first instance of informing of the concerned citizens.
A fight without restrictive measures
The vaccination is the best way to fight Covid-19. However, starting of the vaccination process does not mean the end of the pandemic. In fact, the European countries where most of the population has been vaccinated there are still more restrictive measures in place for prevention of the spread of the virus compared to North Macedonia.
The number of new cases and deaths significantly increased in the past period and the epidemiological situation in the country is critical. However, the Commission for Infectious Diseases did not recommend further restricting or shutting down restaurants – a measure used in European countries. All these things raised raising the dilemma health or the economy is the first priority in this pandemic.
The shortage of vaccines in the country and the skepticism of the citizens do not inspire confidence that in the near future we will be able to use the "best weapon" against Covid-19. What is important is that with the start of the vaccination should not raise a false optimism that the virus will disappear immediately after the majority of citizens are vaccinated. The vaccination process so far may be confusing and non-transparent, but that does not mean it should continue in that manner.
This blog is published as part of the regional blogging initiative “Tales from the Region”, led by Res Publica and the Institute of Communication Studies, in partnership with Macropolis (Greece),
Lupiga (Croatia), Sbunker (Kosovo), Ne Davimo Beograd (Serbia), Analiziraj (Bosnia and Herzegovina), and Pcnen (Montenegro).
*Stefan Ristovski works as a researcher in EPI since December 2019. He finished his Master degree at the European Economic studies program [business specialization] at the College of Europe in Bruges, Belgium. He finished his Bachelor degree at the Faculty of Economics in Skopje. In EPI, Stefan works on monitoring the accession process of North Macedonia in the European Union and sectorial policies. So far, he has written several bulletins on the situation with COVID-19 in Central and Eastern Europe. Before working in EPI, Stefan worked in EuroEvents – Market Research Institute on projects concerning compliance with regulations and transparency, and cross-border health care with a focus on the European acquis.
*Angel Mojsovski works as a researcher at the European Policy Institute (EPI). During his four years at EPI, Mojsovski worked as a project assistant and researcher on several projects dedicated to human rights, minority rights, with a particular focus on social rights. Mojsovski is a graduate political scientist at the Faculty of Law "Iustinianus Primus". Topics of interest are issues in the field of social policy.