At the end of December, Biolik, a Kharkiv pharmaceutical company, submitted documents for the registration of the Russian vaccine in Ukraine. In fact, this is a preparatory stage for launching vaccine production in Ukraine (such an opportunity exists at the enterprise).
But the authorities said that Sputnik V could not be registered in our country, and allegedly for objective reasons.
"We cannot legally register a vaccine that does not have the qualifications of WHO and countries with strict regulatory policies: the United States, EU countries, Switzerland, Japan," said Mykhailo Radutsky, head of the parliamentary committee on the health of the nation.
In parallel, a big scandal is unfolding over the purchase of vaccines for budget funds. Arsen Zhumadilov, the head of the "Medical Procurement of Ukraine" State Enterprise accused Minister of Health Maksym Stepanov of setting the task too late to purchase the vaccine (only in December), although other countries have contracted billions of doses since spring, and now it will be extremely difficult to break through in this market... As of the end of December, Ukraine was only able to agree on the supply of the Chinese vaccine.
It is clear that the volumes of the drug that Ukraine can receive (8 million free doses through COVAX plus about 2 million doses of the Chinese vaccine) will not be enough for mass vaccination of the population. And there is virtually nowhere to buy additional lots since vaccines are already in short supply.
Biolik representatives noted: the launch of mass production is possible not earlier than the vaccine is registered in Ukraine. Recently there was information that the documents for registration have already been submitted.
"On December 30, 2020, Biolik Kharkiv company applied to the Ministry of Health of Ukraine and the State Expert Center of the Ministry of Health with an application for state registration of a medical product – the Sputnik V coronavirus vaccine to ensure vaccination of Ukrainian citizens with it," he said.
Medvedchuk also said that the transfer of the line for the production of Sputnik V could be completed in two weeks. Its production will take three to six months.
That is, if the Sputnik V vaccine were registered in Ukraine, in theory, it could begin to be produced and sold in Ukraine in the foreseeable future.
But, apparently, there will be no easy registration procedure.
Statements about why registration of the Russian vaccine is impossible in our country to have already been made by the head of the relevant parliamentary committee, Mykhailo Radutsky, and the chief sanitary doctor and deputy minister of health, Viktor Lyashko. It is noteworthy that none of them speaks about political reasons, they emphasize exclusively professional issues.
"Ukraine will use vaccines against Covid-19, which have successfully passed the third phase of clinical trials. Today there are already vaccines against Covid-19 that are allowed for use under special procedures (emergency use authorization). Based on this, Ukraine has decided on the possibility of registering vaccines registered in countries with strict regulatory policies (the USA, EU countries, Japan, - Ed.). I emphasize that only under the indicated conditions we will allow vaccines to be used. Therefore, all rumors and political statements about state registration in Ukraine of the Russian candidate vaccine are not corresponded to reality," chief sanitary doctor Viktor Lyashko said.
However, in this case, it is not clear why Ukraine has already signed a contract for the purchase of a Chinese vaccine that has not completed the third phase of trials, does not have WHO qualifications, and is not registered in countries with a strict regular policy.
Earlier, the head of the Mechnikov Institute of Microbiology and Immunology of the National Academy of Medical Sciences, Valeriy Menuhin, told Strana that the registration of the Russian vaccine in Ukraine is quite possible.
"There should be no problems with registration since Russian pharmaceutical legislation is even tougher than ours. But only if politics does not intervene," Minukhin said.
How vaccines are registered in Ukraine
It should be noted that the approaches to vaccines in Ukraine are different, depending on the funds for which they are purchased.
As indicated on the website of the Ministry of Health, only vaccines that are prequalified by WHO or approved by the US Food and Drug Administration (FDA) are actually purchased for state budget funds.
WHO prequalification includes:
- checking general manufacturing processes and quality control procedures;
- verification of consignments of vaccines;
- audit of production sites by WHO specialists;
- regular re-checks at regular intervals;
- targeted screening of vaccine batches that are supplied through UN agencies to monitor product compliance with specifications.
Vaccines that are prequalified by WHO are registered in Ukraine according to a simplified procedure.
The rest of the immunobiological drugs, that is, those that are not purchased for budget money, but are imported by importers and sold through private clinics or pharmacies, must go through the standard registration procedure in Ukraine.
Registration is carried out by the State Expert Center of the Ministry of Health, and its features are spelled out in the Cabinet of Ministers Resolution No. 376. It, in particular, states that registration is carried out on the basis of an application and the results of an examination of registration materials carried out by the State Expert Center of the Ministry of Health.
If the drug is registered by the European Agency for Medicines, the state registration in Ukraine is carried out without examination, on the basis of an application, registration materials, including the agency's report.
State registration of a drug registered by the competent authority of the USA, Swiss Confederation, Japan, Australia, Canada - based on the application and conclusion of the State Expert Center after checking the documents for their authenticity. That is, the expertise of materials (including the results of clinical trials) is not carried out.
For drugs from other countries - a scheduled check. Also, Ukrainian experts must draw conclusions about the safety of vaccines and the specifics of their use in our country.
In April this year, changes were made to the decree, which will be valid until March 31, 2022. In particular, a clause has appeared that for state budget funds and for free distribution in medical institutions, drugs can be purchased that have passed state registration in the USA, Switzerland, Japan, Australia, Canada or the EU competent authority and are used in these countries, regardless of the country of origin.
The state registration of such drugs in Ukraine is carried out by the Ministry of Health on the basis of the statement and conclusions of the State Expert Center based on the results of checking documents for authenticity.
The applicant must provide the materials of the registration dossier (which were given for WHO prequalification or for registration in countries with a strict regular policy), materials on drug quality control methods, production technology data, and a copy of the official approval document for production issued in the country of origin, packaging labeling text.
At the same time, the deadline for checking registration documents is 7 days, and the examination is not carried out, that is, the goal is to confirm that the dossier is the same that was submitted for registration in other countries. Nobody conducts a detailed analysis of its content.
If we are talking about drugs from other countries, 30 working days are allotted for the examination of registration documents. Moreover, this is a full-fledged check of all materials on the drug. This timeline does not include the time required to obtain additional information or conduct laboratory tests. That is, the real terms can stretch for months.
In December, the Verkhovna Rada adopted draft No. 4314, which prescribes a reduction in the time for making a decision on clinical trials of vaccines in Ukraine and their registration to 5 days.
Initially, there was no clarification regarding the country of the vaccine manufacturer. But at the relevant committee they said that Russia could take advantage of the new law, therefore, changes were made to the text of the document. It is possible to conduct clinical trials and register vaccines according to a simplified procedure only for drugs registered in the USA, Great Britain, the Swiss Confederation, Japan, Australia, Canada, Israel, India, Mexico, Brazil, and the EU.
On December 24, the president signed the new law. That is, according to it in Ukraine, it is possible to use vaccines that have not passed all stages of clinical trials, and to carry out these trials directly in our country. But not Russian vaccines. As you can see, there are no Chinese vaccines on the list either.
The head of the National Medical Chamber and the "Ukrainian Scientific Center" Institute of Vaccines and Immunobiopreparations, Serhiy Kravchenko, calls the allegations of the impossibility of registering the Sputnik V vaccine in Ukraine "a lie."
"In February 2020, WHO defined the criteria for the development of a vaccine against COVID-19 and recommended that all countries move to the emergency registration procedure for vaccines in connection with a global pandemic, since the full procedure for clinical trials and registration takes 2-3-5 years, including phase IV 10 -12 years There are currently 8 emergency registration vaccines registered worldwide and none of these vaccines have yet completed Phase III clinical trials in full according to the published study design according to clinicaltrials.gov:
Pfizer-BioNTech-Fosun - Phase III is scheduled for completion in January 2023.
- Moderna-NIAID - Completion of Phase III is scheduled for October 2022.
- AstraZeneca-Oxford - several studies are being carried out simultaneously, the completion of phase III is planned: September 2021, December 2021, February 2023.
Sinovac Biotech - several studies are being carried out at the same time, the completion of the III phase is planned: May 2021, April 2021, September 2021, October 2021.
Sinopharm-WIB - several studies are being carried out at the same time, the completion of phase III is planned: July 2021, September 2021, September 2022.
Sinopharm-BIB - several studies are being carried out at the same time, the completion of the III phase is planned: September 2021, December 2021.
CanSino-BIB - several studies are being carried out at the same time, the completion of the III phase is planned: July 2021, January 2022.
Sputnik V - several studies are being conducted at the same time, the completion of phase III is planned: April 2021, May 2021, September 2021, December 2021," Kravchenko wrote on his Facebook page.
"The Russian vaccine in terms of the dossier is not much different from the Chinese one, which Ukraine decided to purchase. In both cases, the interim results of clinical trials were not published, the vaccines did not pass the third phase of trials, the reports on vaccines are not available to the public (which have been made publicly available, for example, and Modena) That is, the "opacity" is the same.
Moreover, the situation is the same as the Astra Zeneca vaccine. Other vaccines also have questions.
Nevertheless, countries register them and vaccinate people. The UK, for example, also made a controversial decision - to increase the interval between the first and second dose to three months (instead of 3-4 weeks), although, for example, in the United States, the intervals were not changed.
That is, now countries are making non-standard decisions because on the one hand there is evidence-based medicine and the registration process, on the other, the challenges of the epidemic and a real threat to the health and life of people.
The UK, USA, Russia, China – did not wait for WHO. And Ukraine could do the same, but it is necessary to make a collective decision and bear collective responsibility for it, because today manufacturers are unlikely to give guarantees on the safety of the vaccine against Covid," Kateryna Amosova, a well-known doctor, Doctor of Medical Sciences, notes.
But at the same time, there are no direct prohibitions on the registration of vaccines (if they are not purchased with budgetary funds) from any country in the world in domestic legislation.
That is, formally, you can submit documents and register any drug – even from Russia, even from China. But only for a longer procedure.
And at this stage, if they wish, they can "hack to death" the drug, stating, for example, that an incomplete package of documents has been provided or there are no materials on all stages of research.
The purchase of vaccines missed
The situation is complicated by the fact that we, in fact, have nothing to choose from. Ukraine, according to preliminary agreements, can count on only 10 million doses of vaccine (8 million from COVAX and 2 million from China), which will be enough to vaccinate 5 million people, while for herd immunity at least 20 million need to be vaccinated, or even better – 30 million.
But where to get this amount of vaccine given the global shortage is an open question.
Zhumadilov said that only on December 10, the Ministry of Health authorized the State Enterprise to purchase vaccines, while the issue had to be dealt with since spring.
"As of the morning of December 28, the state enterprise received a response only on one supplier, with whom they entered into an agreement," Zhumadilov said.
He also accused Stepanov of having ordered to conclude a contract with the Chinese at a price one dollar higher than it could have been negotiated.
"I do not plan to play along with Minister Stepanov in his incompetent attempts to negotiate," said the General Director of the State Enterprise, declaring virtually open war on the minister.
Note that Stepanov, judging by Zhumadilov's statement, accuses him of the failure of vaccine purchases.
One way or another, but the result is obvious: due to the fact that Ukraine missed the time when it was necessary to conclude contracts, the supply of vaccines to our country is very problematic.
And in this sense, the possibility of producing a Russian vaccine in Kharkiv appears in a new light.
True, it is unlikely that now any reasons in favor of her registration will outweigh the political motives for which the authorities do not want to allow her presence in Ukraine. At least that's how it looks at this moment. But it is possible that the position will change if the problem with vaccination becomes extremely acute.