The World Health Organization has decided to block Canada’s COVID-19 vaccine, COVIFENZ®. This is the first such decision in history. Controversial to such an extent that it strongly touched the medical community. Especially since the preparation is highly effective, it is also cheap to produce and easy to store. What went wrong? For MedTvoiLokony, explains Prof. Krzysztof Filipiak.
Professor COVIFENZ® is the first ever vaccine in modern times that has been blocked by the World Health Organization (WHO) for non-medical reasons. What does such a blockage mean? If there has been a global blockade, is it not possible for the preparation to be used by European or American regulatory agencies, such as the FDA or EMA?
It is indeed a unique situation in which a well-studied, effective, biotechnologically interesting vaccine against COVID-19, in an ongoing pandemic, is a priori, for ideological reasons, rejected by the WHO. But let’s put the facts in order. It is a vaccine developed and manufactured by the company Medicago, whose minority shareholder is the tobacco company Philip Morris.
Szczepionkę opracowano w Kanadzie, w kraju o wysokiej jakości procesów badawczych i rejestracyjnych, bez problemu zarejestrowano więc ją pod handlową nazwą COVIFENZ® w tym kraju. WHO nie jest organem rejestrującym leki czy szczepionki, wydaje jedynie swoje własne rekomendacje. Decyzja WHO nie powinna zatem formalnie wpływać na inne agencje rejestrujące na świecie, ale rzeczywiście wprowadziła wielu z nas w konsternację.
Why was the vaccine blocked by the WHO? Was it really the fact that the minority shareholder of the company producing the preparation is one of the global tobacco companies? Is that a valid argument?
The WHO argues that there is no way for it to proceed, recommend, or even devote itself to scientific research – including vaccine development – in which the tobacco industry is involved. The trouble is, this vaccine is a joint venture between the Canadian biotechnology company Medicago and the global pharmaceutical company GSK. And the tobacco concern – a minority shareholder of Medicago – has more and more innovations to reduce the harmful effects of tobacco products on health compared to continuing to smoke cigarettes.
Chodzi m.in. o systemy podgrzewania tytoniu, które doczekały się autoryzacji ze strony amerykańskiej FDA, czyli Agencji Leków i Żywności i zostały ocenione jako produkty emitujące znacząco mniej toksyn, w tym karcynogenów, w porównaniu z papierosami, a przez to mogące też ograniczać ryzyka zdrowotne wśród osob palących. Widzimy też, że ten koncern inwestuje środki w obszary kompletnie niezwiązane z produkcją papierosów – jak choćby produkcja biofarmaceutyków.
And finally, the most paradoxical part of this story is that it is the experiences of such companies that can push the fight against this or the next pandemic forward. The COVIFENZ® vaccine itself is produced biotechnologically in the leaves of nicotina benthamiana – a tobacco plant, an ideal transgenic plant, and therefore one in which valuable drugs, proteins and necessary elements of vaccines can be produced in the future.
Czy rzeczywiście tytoń może mieć takie zasługi dla medycyny?
As a physician, I would like the great fields of tobacco cultivation to become the driving force behind the production of drugs and not the production of cigarettes in the future. Let us explain that the so-called Transgenic plants are simply plants that have been genetically modified to become the source of the necessary antibodies, vaccines, and hormones. By the way, tobacco has been a silent hero in reports of the search for not only COVID-19 vaccines, but also drugs for the SARS-CoV-2 virus.
Let me mention, for example, griffitsin – a substance obtained from red sea algae of the genus Griffithsia. It has a strong inhibitory effect on HIV entry into cells. It has also been noticed that it has a multidirectional antagonistic effect against many viral glycoproteins, including those characteristic of coronaviruses. Griffitsin binds to the S protein of the SARS-CoV-2 virus and has antiviral activity against the Ebola virus. For several years, there has been an easily available, genetically modified tobacco that produces griffitsin, so that we do not have to obtain it from sea algae. Do you already understand why the “know-how” of the big tobacco producers is becoming crucial for the advancement of medicine in some of its areas?
It’s hard to disagree with that. Then let’s talk about the COVIFENZ® vaccine itself. What do we know about her? What is its effectiveness, has it passed clinical trials and is it as safe as preparations against COVID-19, which have already been approved for use and are administered to citizens of many countries around the world?
I trust Canadian registration authorities to a similar degree as the US FDA, EU, European EMA or, for example, Australian and UK registration authorities. These are all countries that attach great importance to the proper testing, effectiveness and safety of registered products. In Canada, COVIFENZ® vaccine was registered in February 2022 for general preventive use, in two doses, for people between 18 and 64 years of age. In the conducted clinical trials, it was estimated that it has 71 percent. effectiveness in the prevention of symptomatic COVID-19 and 100%. effectiveness in preventing the severe course of COVID-19.
Admittedly, it was studied in times when the Alpha, Gamma and Delta mutants were dominant, but now – when Omikron is dominant – another large clinical trial with this vaccine is underway. And the aforementioned technology – “growing the vaccine” in the leaves of a tobacco plant – cheap, efficient, capable of producing a vaccine that is widely available and easy to produce, especially for the still unvaccinated, poorer regions of the world. Let us emphasize it again: the paradox of the WHO’s decision is that an organization that aims to ensure access to universal health and bridge the gap between countries is discrediting this vaccine for ideological reasons!
Szczepionkę relatywnie tanią w produkcji i łatwą w dystrybucji, z uwagi na przystępne warunki jej przechowywania w porównaniu z innymi szczepionkami. Ta kanadyjska szczepionka ma potencjał, by trafić do państw o niższym PKB. Czy szczepionka jest dobrze przebadana? W badaniach III fazy wzięło udział ponad 24 tys. osób w Kanadzie, USA, Wielkiej Brytanii, Meksyku, Argentynie i Brazylii.
How exactly does this vaccine work? After all, COVIFENZ® differs significantly from other preparations against COVID-19. This is the first plant-based vaccine against SARS-CoV-2. How is plant vaccine different from mRNA or vector preparations?
The effect of plant breeding tobacco in this case is recombinant viral spike protein, but not the genetic material of the virus, so there is no possibility of disease transmission after administration of such a plant vaccine. In very simple terms, certain bacteria are introduced with viral genes that produce certain viral proteins, the bacteria are introduced into a plant that begins to produce these proteins in its leaves. And then just harvesting the leaves, extracting the proteins from the leaves, and preparing the vaccines. We get a ready antigen – a protein recognized by our immune system, a bit like in classic vaccines.
WHO rekomenduje do użytku nie tylko te znane w Polsce szczepionki przeciwko COVID-19, ale też chiński Sinovac® czy rosyjski Sputnik®. Czy te preparaty są lepsze i bardziej pewne niż COVIFENZ®?
Na pewno nie. I to kolejna kwestia, która tak zszokowała nas w decyzji WHO. Jestem tylko skromnym lekarzem, profesorem medycyny i nie w mojej gestii leży rozważanie przyczyn pozamedycznych tej decyzji. Wiem jednak, że wszędzie tam, gdzie podejmujemy decyzję z powodów ideologicznych, medycyna cierpi. A wielu ekspertów już teraz zwraca uwagę, że ta zaskakująca decyzja WHO wpisuje się także w coś, co możemy określić rodzajem «dyplomacji szczepionkowej». WHO, zamiast iść śladem Kanady, woli iść śladem Chin czy Rosji. Chińskie czy rosyjskie szczepionki przeciwko COVID-19 – nadal niezarejestrowane w Unii Europejskiej czy USA – wydają się mieć niższą skuteczność, publikowane badania budzą kontrowersje świata naukowego, ale nie WHO. Jako naukowca rani mnie również zasłanianie się «bioetycznymi» argumentami o częściowym udziale koncernu tytoniowego w opracowaniu tych szczepionek.
This is like saying that all the scientific research on COVIFENZ® vaccine should be thrown into the trash, because what matters is who is the shareholder in the company, not whether and how the preparation works. According to WHO, this argument is enough to bury several years of scientific work and the medical documentation behind this vaccine. Such an argument is also difficult to accept from a scientific point of view.
Finally, I will ask again about the consequences of the WHO blocking the vaccine. What about countries that have already registered or pre-purchased the preparation, such as Canada? Will it no longer be possible to administer this preparation in this country?
Again, the WHO is not a registration authority. Its recommendations have no legal consequences. Canada will be able to use this vaccine, other countries will take their own, I hope that will differ from the position of WHO. But the consequences of this decision are already visible. For example, the vaccine, following this WHO recommendation, will not be made available to developing countries under the COVAX program. Let us remind you that the global COVAX initiative is extremely important, and it is under the patronage of WHO and UNICEF.
COVAX started distributing vaccines against COVID-19 as early as February 2021, and after six months it has delivered 200 million vaccines to nearly 140 countries. Regardless of the fact that the plans were bigger, and the poor countries are still less fragmented, it can be concluded that if COVAX had not worked, the differences would have been even more pronounced. The first countries to benefit from COVAX vaccines were the poorest countries: Ghana and Côte d’Ivoire. In Europe, Moldova took advantage of this program and we can already see that it was a particularly good decision, as this country is currently facing a humanitarian crisis due to Ukrainian refugees. Bosnia and Herzegovina was the second European beneficiary of the COVAX program. In South America, the COVAX program benefited, among others, from Uruguay and Venezuela, plunging into poverty and economic crisis. So, on the one hand, the WHO is alarming that there is a lack of vaccines for poorer countries, patrons the COVAX program, but does not allow the Canadian vaccine that could go to such countries.
Summing up, are you disappointed with the WHO decision?
Not only disappointed, but also very sad. I will repeat once again – it is unfortunate when ideology inhibits medicine and saving human health and life. This is not the first time in the COVID-19 pandemic, experts from many countries do not agree with WHO’s recommendations. Let me remind you of such an episode – at the beginning of the COVID-19 pandemic, when, apart from remdesivir, we had no other antiviral drugs for SARS-CoV-2 infections, the WHO issued a recommendation not to use this drug. But it is registered in the European Union, has been given and is even still recommended in the Polish COVID-19 guidelines, even in their latest version from February 2022.
As you can see, the recommendations and recommendations of WHO experts do not translate into decisions of registration agencies or recommendations for action. Such decisions only undermine the authority of the WHO. Should I reject an effective, safe, cheap Canadian vaccine just because the tobacco company was a minority investor ?! We need an open scientific discussion on this matter. Free from prejudices and stereotypes, and based on data.
There will be no progress in science if we are unable to discuss the results of scientific research or allow it for purely ideological reasons. From this perspective, the WHO’s decision is not so much about a vaccine as it is about science as such. I am saying this with pain, especially in the current geopolitical situation. The world is polarizing before our eyes. WHO sees no problems with questionable or Chinese vaccines, rejects the well-tested Canadian vaccine. And would the Editor prefer to be vaccinated with Sputnik®?