Head of the advocacy department at the 100 Percent Life Sergey Dmitriev has recently published an article about the problem with vaccination in Ukraine. The original article can be found here: https://life.pravda.com.ua/columns/2021/02/11/243902/
A translated version of the article is as below:
While the vaccination campaign is actively rolling out in the world and about 5 million doses of vaccines against COVID-19 are administered daily, Ukraine is still trying to sign at least some contracts for the supply of vaccines, waiting for the first deliveries from COVAX and enters into negotiations with Governments of foreign countries asking to share their surplus. People are not ready to be vaccinated and do not trust the vaccine purchased by the Ukrainian Government and National Anti-Corruption Bureau of Ukraine is launching an investigation regarding the corruption component in the only vaccine deal Ukraine’s managed to make. The risk groups prioritized by the MOH for receiving the vaccine do not comply with either the WHO recommendations or the national context. The vaccination process is not supported financially. This is the recipe for the complete failure of the campaign to immunize the Ukrainian population against COVID-19, to which Minister of Health Maksym Stepanov “successfully” has led the country.
“Ukraine should be among the first countries to be able to buy the vaccine. We need to think about this now. The whole world is lining up.” This statement of Volodymyr Zelenskyy was published on the President’s official website on July 25, 2020, and it provided optimistic forecasts for the timely immunization of Ukrainians against COVID-19. During the summer and fall, the head of the MOH also assured Ukrainians of active negotiations with international manufacturers, diplomats, etc., declaring Ukraine’s leadership role, timeliness, and effectiveness of state actions aimed at obtaining coronavirus vaccines as soon as the successful results of clinical trials of vaccine candidates were published.
As of February 12, 2021, according to Bloomberg, 159 million doses of the COVID-19 vaccine have been administered worldwide in 76 countries.
Thus, the vaccination campaign has been launched not only in such countries as Israel, the United States, and the United Kingdom but also in less wealthy countries, such as Morocco, Nepal, Egypt, Bangladesh, and others.
What about Ukraine? So far, only one agreement with the Chinese company Sinovac has been signed to supply 1.9 million vaccines to Ukraine. Meanwhile, Government still promises to sign a contract for the supply of AstraZeneca and Novavax vaccines (there are news about arrangements, confirmations of vaccine supply circulating on the internet, but still no official information about a contract singed) and it is still waiting for 3% of free vaccines to be provided to Ukraine from international COVAX initiative and making agreements with the governments of other countries to give their surpluses of vaccines to Ukraine. In parallel with these slow processes, the readiness of Ukrainians for vaccination is rapidly declining: while in November about 55% of the population were ready to be vaccinated under the condition of free immunization, according to the latest sociological research, this figure has dropped to 43%.
It should be noted that such an indicator of the vaccinated population is extremely insufficient to form so-called herd immunity because, according to the WHO, vaccination should cover at least 80% of people to protect the population from the transmission of such infectious diseases.
The question arises: what and when did it go wrong in Ukraine?
Unfortunately, the answer is simple and obvious: unacceptableinactivity and passivity of the Government. While most countries throughout the world have been concluding pre-order agreements for candidate vaccines since the spring and summer of last year (as of December, almost 7 billion doses were totally pre-ordered), Ukraine… has been just declaring its readiness to be among the first. When some countries (India, Bangladesh, and Egypt) prepared manufacturing facilities to produce licensed drugs and vaccines against COVID-19, they boastfully, long and loud talked in Ukraine about the semi-mystical Ukrainian vaccine nobody heard more about.
Thus, according to Bloomberg’s rating of contracts concluded by countries and the percentage of pre-ordered doses of vaccines per capita, Ukraine is at the bottom of the list (as of the end of January 2021 – 176th on the list), along with African and some Latin American countries. And The Economist Intelligence Unit‘s latest forecasts for Ukraine are extremely disappointing: mass access to the vaccine in the country will be possible only from 2023.
Let’s consider the main circumstances and problems Ukrainians face to have an access to immunization against COVID-19.
The issue of barriers to access to vaccination in Ukraine was widely analyzed in a study conducted by experts of 100 Percent Life in cooperation with the Committee of Medical and Pharmaceutical Law and Bioethics of Ukrainian National Bar Association in January this year. Details of the report in Ukrainian can be found here. Let’s focus on the key points.
First, despite all the declarations made by the Ministry and the President, Ukraine did not (and still does not, in part) had a regulatory framework for the procurement, import, and organization of the vaccination process. Secondly, a certain confrontation between the MOH and the State Enterprise “Medical Procurement of Ukraine” (which is the officially established procurement agency in Ukraine) played an important role and set our state back for at least a month in terms of negotiations and the conclusion of agreements with vaccine companies.
Thus, only on December 16 (when the vaccination campaign was already rolled out in the USA, Israel, and Europe), the Cabinet of Ministers finally authorized the SE “Medical Procurement of Ukraine” to carry out the relevant activities (negotiation, the conclusion of agreements to buy vaccines). On December 30, the only vaccine approved by Minister Stepanov with a rather strange justification was the Chinese Sinovac’s vaccine, although the MOH announced active negotiations with other leading development companies in October. In particular, according to an official announcement posted on the MOH website on October 15, the Ministry also held talks with such global companies as Pfizer, Moderna, and AstraZeneca, which, unlike the Chinese manufacturer, completed clinical trials of drugs at the end of December, and the US, UK and EU regulators even approved their vaccines for use.
Instead, the MOH concluded the first contract 1) to buy a not yet fully tested vaccine, 2) using the Ukrainian private company Lekhim as an intermediary in this process (whose role is still a mystery, as well as the mechanism of introduction in this scheme) 3) considering that a vaccine price is one of the most expensive prices in the world – almost $ 18 per dose. Was it possible to buy a cheaper vaccine for Ukraine? Obviously, yes – because at the end of December 2020, SE “Medical Procurement of Ukraine” was in the final stages of negotiations with other manufacturers that offer more affordable prices, but the Ministry of Health simply did not agree to sign contracts with them. We could assume that the Chinese vaccine could be a good option considering it’s availability in terms of lower demand for it – therefore the Ministry of Health chose the vaccine which can be delivered to Ukraine the soonest. However, this is very much unlikely, since recently Lekhim adressed a request to the procurement agency to postpone the date of the first delivery of the Sinovac vaccine till April.
Meanwhile, in continuation of the large-scale public response caused by the above-described events, National Anti-Corruption Bureau of Ukraine is opening a proceeding on this procurement. This whole situation clearly looks semi-surreal – because given the level of attention to these processes, their social significance and already existing failure of the Ministry of Health to ensure proper access to vaccines through the timely conclusion of relevant agreements, any abuses, schemes and machinations in these processes seem to have no chance for existence. But the reality remains quite dissappointing.
Then, only in January, the process of amending the legislation on the registration of medicines, which would allow the import and use of vaccines against COVID-19 in Ukraine, actually began. The Law of Ukraine “On Medicinal Products” was amended in a hurry, without sufficient finalization and discussion with the public – and these amendments were made only on January 29.
For reference: because COVID-19 vaccines are being developed rather rapidly, the manufacturer cannot provide a complete list of clinical trial documents, as it is required by regular drug registration process; therefore, in Europe and other countries, there are the Emergency Use Authorization or Emergency Use Listing procedures for such cases, which simplify the authorization process introducing less requirements to the documents the applicant is obliged to provide as well as some different measures of medicines quality control assurance.
According to the original version of the draft law, the MOH could authorize the use of any vaccine that is at any stage of clinical trials (even initial) and has previous positive results of such trials. However, international experience in using such a procedure limits emergency use only to those drugs that are in the final (third) stage of studies because only these medicines can really demonstrate sufficient efficacy and safety.
Therefore, 100 Percent Life sent comments and recommendations to the relevant Committee on Public Health in Ukrainian Parliament to amend the draft, in particular, to expand the list of requirements for the vaccine or to limit the possibility of granting such use similar to the existing drug file authentication procedure in Ukraine: when such authorization is issued by a country with Stringent Regulatory Authorities (SRA)- the United States, Switzerland, Japan, Australia, Canada or the EU. Namely, if an authorization for use is issued in at least one of these countries, the MOH authorizes this drug for its use in Ukraine under a simplified procedure.
Unfortunately, despite the partial improvement of the proposed norms and the implementation of a similar procedure to recognize the authenticity of another country’s authorisation, the process proposed in the law has a lot of flaws. Despite the need for a rapid response by the state, it is clear that such changes to the legislation should not be made hastily, but considering the capabilities of the national expert institution and the specifics of the situation with vaccines against COVID-19, and there was time to do it smoothly at least since fall when the necessity of such changes was quite obvious.
However, it should be noted that despite the amendments to the law, a number of regulations on the procedure of pharmacovigilance, import control, etc. are still not finalized and may create barriers to vaccination. So the question is: even if the vaccines are physically delivered to Ukraine, will it be possible to start using them, will the batch of vaccines not be “quarantined” at the border, how will the conditions of their transportation and storage be controlled?
Another issue is the implementation of a vaccination program. On December 24, the MOH approved the Roadmap for vaccination from COVID-19 in Ukraine in 2021-2022. The document defines the target indicators of vaccination of Ukrainians during 2021, the main risk groups that have the right to priority vaccination and its stages, as well as the general concept of the immunization campaign against COVID-19. It is worth noting that both the document itself has a number of inconsistencies and a mechanism of its implementation, in our opinion, is virtually absent now.
First, the document sets a target to vaccinate 50% of the population during 2021. At the same time, according to the research cited by the Ministry in developing the Roadmap, at least 70% of the population (29,212,946 people) should be vaccinated to prevent epidemics (we remind that the WHO determined higher rates to form collective immunity). Therefore, the target of 50% for the whole year seems illogical because such coverage will not ensure the development of collective immunity and respectively undermines the effectiveness of vaccination in the country as a whole.
Second, the Roadmap provides official statistics on COVID-19 morbidity and mortality rates in Ukraine for 2020. In particular, the document states that the largest number of deaths from complications caused by COVID-19 was registered among people aged 60-69 (31.1%), in second place – the group aged 70-79 (28, 3%). Besides, 81.6% of people who died from COVID-19 had a history of comorbidities (cardiovascular, diabetes, neoplasms, kidney, liver, lung, and neurological diseases, malignancies, immunodeficiencies, etc.).
According to the latest results of the study of the effectiveness of coronavirus vaccines, their main action is aimed at preventing severe disease and reducing mortality, so it is the most expedient to immunize primarily people aged 60+, as well as people with comorbidities that increase the risk of death (which complies with WHO recommendations). Instead, according to the stages of the vaccination campaign set by the MOH, people aged 60 to 64, as well as people with comorbidities, will be fourth in line and all employees of law enforcement agencies (regardless of their age and health) – this is almost 600,000 people – should be vaccinated within the third stage. At the same time, according to the vaccination schedule approved and published by the Cabinet of Ministers on January 29, state security agencies will be vaccinated even earlier than the 65-69 age groups. Immunization of the highest mortality groups aged 65-69 and 60-64 is scheduled for mid-summer and late fall, respectively. The MOH plans to vaccinate people with comorbidities at the end of the year. It is rather difficult to understand the logic of this approach to prioritizing risk groups for primary vaccination.
After all, even according to the MOH scenario, the campaign to vaccinate the population of Ukraine against COVID-19 looks a bit illusory. As mentioned above, receiving the vaccine is a voluntary decision of every person. Given the fact that we do not have a register of patients and actual assessments of the need for vaccination, and negative attitude of the population majority to vaccination (considering many anti-vaccination ideas, and the delayed information policy of the MOH on this issue), it is unclear how this process will be implemented. If, for example, in the second stage there are people who do not will to be vaccinated, can persons from the third stage category have access to the vaccine, or will these vaccines simply be expired in warehouses? Will people have the right to choose a vaccine that will be provided free of charge? How will re-vaccination be monitored (most vaccines are designed for two doses)? This is quite difficult to understand now. For example, in some regions, doctors now personally call patients to make lists of people who will be vaccinated. But this is definitely not an effective example how to organize such a process.
To facilitate access to vaccination, the Roadmap in each region provides for the establishment of mobile teams which include a doctor, up to two healthcare workers (nurse assistants), and a record keepers to report according to approved forms. According to the MOH, 572 mobile teams (23 per region on average) will be required for vaccination against COVID-19. Some of these teams have already been created. It should be also understood that the work of such teams requires significant funding. However, there is virtually no regulatory framework to ensure their functioning, as well as to provide vaccination services in general.
The state budget of Ukraine currently stipulates an additional separate article “Vaccination of the population against acute respiratory disease COVID-19 caused by the SARS-CoV-2 coronavirus” allocating UAH 2.6 billion above the budget expenditures of the Ministry of Health, but there are not any normative act that provides for details how this item in the budget can be applied. The program of state guarantees for health care in 2020 and the first quarter of 2021 does not provide any additional packages for vaccination of the population against COVID-19. The existing Specification for the provision of medical services, in the area of primary health care, provides for the payment of vaccination services exclusively according to the Schedule of preventive vaccinations and does not provide for the provision of vaccination services from COVID-19. So it is also unclear how the vaccination campaign will be funded and what the allocation of funds will look like.
Meanwhile, Ukraine plans to receive a new loan from the World Bank in the amount of USD 90 million in the framework of the “Emergency Response to COVID-19 and Vaccination in Ukraine” project. At the same time, if the target – 10 million people at risk is vaccinated – is achieved, Ukraine will be able to receive compensation of USD 30 million. Given that it is loan funds, the question arises as to the advisability of obtaining such a loan because when there is no adequate planning and efficient use of national budget funds, how will this loan use be justified and determined?
The choice of the Chinese Sinovac’s vaccine with a price of UAH 504 per dose (USD 17.8) is a clear example of irrational use of budget funds to buy the vaccine against COVID-19. As mentioned earlier, this is one of the most expensive vaccines available today. For comparison, let’s consider the prices of other vaccines for governments, which were previously posted on Twitter by the State Secretary for the Budget and Consumer Protection of Belgium Eva De Bleeker:
As we can see, in case of buying another vaccine, even one of the most advanced – such as BioNTech/Phizer – the purchase of a similar batch (1.9 million doses) of the vaccine could potentially save about 11 million dollars! This is an incredible amount in the Ukrainian healthcare budget.
Given the situation, it appears that attracting additional loan funds from the World Bank will only contribute to the further irrationality of the Ukrainian government’s decisions to respond to the COVID-19 pandemic and instead will only become a significant burden on the national health care system.
In retrospect: while vaccinations are actively carrying out in other countries, in Ukraine there are still more questions than answers. However, in such times as the pandemic, public health becomes a component of national security. And under these conditions, it is extremely important not only the proactivity of the government but also the openness of state bodies. Silencing and ignoring problems, inactivity, and reassuring that the situation is under control, when it is not true, is a road to nowhere. It is very important for the MOH to start a more open policy, ensure effective communication, and openly declare existing problems. This will create an opportunity to attract additional support, the reaction of patient-led organizations, donors, etc. 100 Percent Life has extensive experience in providing access to treatment for people living with HIV; we are adapting this expertise to COVID-19 and ready to support the state in the fight against the pandemic. Unfortunately, today we do not see that the MOH is interested and ready for a normal dialogue – all issues are resolved and all scenarios are written behind closed doors and we only have to respond to its decisions (or lack of them). We would very much welcome the change of the situation and then we can finally consolidate our efforts and effectively coordinate all the necessary actions to bring this pandemic to an end.