ICT

The Romanian anti-Covid vaccine, in the testing phase on guinea pigs

GEORGE MARINESCU (TRANSLATED BY COSMIN GHIDOVEANU)
English Section / 28 aprilie

The Romanian anti-Covid vaccine, in the testing phase on guinea pigs

Virgil Păunescu, coordinator of the project: "Our vaccine, based on cellular immunity, has a memory of at least 11 years"

The Orban government last year allocated 3.5 million lei for the

DECODE project, which concerns the Romanian anti-Covid 19 vaccine

Researchers in the medical sector have reached the animal testing phase of the Romanian Covid-19 vaccine, which according to the representatives in the field, create immunity for a period of 11 years. If Romania succeeds in getting that vaccine to market, it would reach the top in terms of the medical research. Unfortunately, the project has not been spared controversy, as in the last two months the Court of Auditors has conducted audits at the Pius Brânzeu County Clinical Emergency Hospital and at the OncoGen research center of Timişoara - involved in the development of the vaccine -, concerning the manner in which the budget allocated to the budget allocated for the making of the anti-Covid 19 serum.

The Romanian anti-Covid 19 vaccine seems to have reached a deadlock concerning the funds needed for ongoing research. The initially allocated amount is insufficient, and the making of the vaccine needs financing, says university professor Ph. D. Virgil Păunescu, coordinator of the Decode project (for the making of the Romanian anti-Covid 19 vaccine). According to him, 5 more million Euros would be needed to move to the testing phase. The specialist recently announced on his Facebook page: "Thanks to the efforts of our team, the OncoGen center is in negotiations with the European Bank of Investments (EIB) for financing the manufacturing facilities for Sars-Cov-2 vaccines in Romania.

OncoGen (in partnership with the Cantacuzino Institute) is the only research institute in Romania that has under development a candidate vaccine against Sars-Cov-2 recognized by the WHO and which can meet the EU grants financing terms for a factory. With a little help, Romania can once again have the ability to ensure its own vaccines (and not just for Sars-Cov-2)".

The announcement of the project's coordinator was publicized by Cristian Diaconescu, the president of the PMP, a political party of which Virgil Păunescu is the vice-president. On April 7, the leader of the PMP was making a call to prime-minister Florin Cîţu, concerning the need to allocate funds from the National Recovery and Resilience Plan (PNRR) "for the manufacturing of a vaccine against the virus, with an immunity period of 17 years".

Cristian Diaconescu said: "The European Investment Bank has expressed its intention to finance a factory in Romania to produce the anti-Covid vaccine developed by the OncoGen Timişoara institute. The financial institution would provide half of the funds needed for the construction of a factory and the full amount needed for the third phase of the clinical trial, which is also the most expensive. The other half could be financed using the loans that Romania will be able to access via the Resilience Plan. A study of the researchers at the National Allergies and Infectious diseases institute of the USA has confirmed that the activation of cellular immunity, which the Romanian anti-Covid vaccine relies on, is efficient in the fight against the virus.

The vice-president of the Popular Movement Party (Partidul Mişcarea Populară), Prof. Dr. Virgil Păunescu, who is researching this vaccine in Timişoara, claims that the immunity given by the serum lasts 17 years. He asked the Government to assign him an economic adviser to discuss this topic of overwhelming importance for Romania. The EIB provides full consultancy free of charge, from financing to commissioning the future plant. That would allow the production of 5-10 million doses within a short time, and the vaccination platform could be used for other diseases as well, not just SARS-Cov-2. All that is needed is a political decision".

The Romanian vaccine may ensure a long lasting cellular immunity

None of the vaccines that are being worked on right now are going to have the efficiency of the Romanian vaccine, because the technology of the OncoGen institute of Timişoara creates cellular immunity, that persists for 11 years, while the antibody-based immunity, used by the ones working on the vaccine, only protects for a few months, Virgil Păunescu was saying recently. "Romania could reach the peak of medical research if the anti-Covid vaccine were completed. The Romanian technology has a completely different approach, a fact which will ensure a protection for a long period. That is probably why the Romanian vaccine is being sabotaged in every possible way, but in particular by the people in the government, who are refusing to finance perhaps the country's most important project. We are waiting for funding and the more time goes by, the more the data that appears in the specialized materials shows that the vaccine we are working on has every chance of being the most successful one. All studies show that antibody-based immunity does not last long, and our vaccine, based on cellular immunity, extrapolating the data of those who have developed it to cancer, has a memory of at least 11 years.

Umoral immunity, the one which produces antibodies, only protects for a few months. Besides, Astra Zeneca has already announced that the future vaccine may be repeated after a year. Immunity has two components, one based on antibodies, in principle, and a cell-based component. In the case of cancer, for example, if one develops antibodies, they will die quickly, because the antibodies cannot kill tumoral cells. Cell immunity, in TBC, for instance, is very important, because the response is with cytotoxic T-lymphocites. Those destroy malfunctioning cells, either because those cells contain a virus and the virus is multiplying, or they have a tumor. That will work the same way in the case of Covid. (...) We have conducted an analysis of the 112 sequencings of various patients from across the world. The initial Wuhan variant isn't circulating in Romania anymore either, rather it's a new variant that is making the rounds all over the world and which produces a much greater viral load and has a higher contagion level. The replacement of the old variant happened over the course of a month, more specifically in April".

Virgil Păunescu has expressed his disappointment that neither the Orban government, nor the Cîţu government have allocated that amount from the state budget, and instead have preferred allocating money for other purposes, instead of prioritizing the production of the Romanian anti-Covid vaccine.

However, just a few days later, through the head of his political party, the coordinator of the project called upon the support which the Government can grant for the completion of the negotiations with the representatives of the European Investment Bank, in order for the financing of the Romanian anti-Covid vaccine to continue.

The Cantacuzino Institute: "We are currently experimenting on lab rats"

While project coordinator Virgil Păunescu claims that the Romanian vaccine will provide long term immunity, researchers from the Cantacuzino Institute claim that the results cannot be evaluated yet, because animal experimentation is still ongoing.

"The research project conducted in partnership with the County Emergency Clinical Hospital of Timişoara for the development of a vaccine against the SARS-Cov-2 virus is ongoing. The team of researchers of the National Medical-Military Research and Development Institute Cantacuzino is currently conducting tests on animals. These include the potential toxic effect that the inoculated antigens may have on the animals. The results obtained so far cannot be assessed because the experiments need to be finalized and interpreted", it is stated in the response formulated by the representatives of the Cantacuzino Institute to the inquiry addressed by the BURSA newspaper.

The same document states that the initial budget has not been supplemented, but it is not stated whether there is a need for additional funding to complete the research for the making of the Romanian anti-Covid 19 vaccine.

George Marinescu

....

The funding of the Romanian vaccine - verified by the Court of Auditors

The Court of Auditors has completed the audits performed over the last two months (February 1st - April 2nd 2021) at the County Clinical Emergency Hospital Pius Brânzeu and at the OncoGen the research center of Timişoara. The financial audit concerns the amounts received from the state budget by the Timişoara-based hospital, amounts which were also used by the OncoGen research center which is a division of the aforementioned hospital.

When it comes to OncoGen the amount is 3.5 million lei, amount allocated last year from the state budget to finance the Decode project, aimed at developing the Romanian anti-Covid 19 vaccine. According to the representatives of the Communications, Public Image and Public Relations Department, of the Court of Auditors, "after completing the financial audit and the subsequent procedures (ed. note: - requests for clarification, related responses, the issuing of a decision, and any challenges of said decision), the report concerning the audit of the Oncogen center will be published on the website of the public institution". The quoted sources told BURSA that the report would be published at the earliest in the next 30 days.

Cristian Brehui, head of Department of the Timiş Chamber of Accounts, told us: "I don't know any details concerning the financial audit activity conducted at the Pius Brânzeu Emergency County Clinical Hospital of Timişoara, because there was a team that conducted investigations over there, and its activity ended on April 2nd. The team members have drafted the document with the findings of the investigation and they will send it to the appropriate entity, which is entitled to raise objections within 15 days. Following that period, within a maximum of 15 days the Chamber of Accounts issues the decision, which the audited entity is allowed to challenge. If such a challenge is submitted, it will be resolved by a commission of the Court of Auditors, at the central level. If the decision is not challenged, the report in question will be made available to anyone interested at the end of May or the beginning of June, based on the law 544/2001.We are not going to post it on the website, it will be mentioned in the annual report which will be published in the beginning of next year".

UEFISCDI: "The activities performed are in line with the proposal in the project"

The Decode project concerning the development of a peptidic prophylactic vaccine for Covid-19 based on epitopes recognized by the immune system is financed by the Government, via the state budget, through the Executive Unit for the Financing of Higher Education, Research, Development and Innovation (UEFISCDI). Financing contract no. 11Sol/2020 was signed last year in April - during the state of emergency - and the final deadline by which OnconGen has to deliver the first Romanian anti-Covid-19 vaccine is December 5, 2021. According to the specific objectives of the Decode project the vaccine has no side-effects.

Concerning this project, the Executive Unit for the Financing of Higher Education, Research, Development and Innovation replied and told us that the value of the Decode project is 3.5 million lei and will remain unchanged.

"The financing procedure of the UEFISCDI does not allow the supplementing of a project's budget past the initially contracted limit. At the end of 2020, the project was monitored by experts from the Ministry of Healthcare and they have agreed that the activities conducted are in line with the proposal in the project", a response sent by the institution in question to BURSA states.

The representatives of the County Emergency Hospital Pius Brânzeu of Timişoara told us the same thing: "The Decode project conducted by SCJUPBT through the OncoGen center, in collaboration with the Cantacuzino Institute, is within the contractual parameters contracted of the agreement signed with the financing unit. So far, the funds of the project have not been increased. At this stage of research, the results of the study are encouraging, according to the OncoGen heads of the project".

That same document does not mention the deadline by which the first Romanian vaccine will be ready, but it states that all studies are "made within the funding limits for the project".

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