Teminology: Vaccine apartheid

Copyright © Françoise Herrmann

As the COVID-19 vaccination campaign picks up speed in the US, with a record 3 to 4 million vaccinations per day, issues of global access to COVID-19 vaccines and of vaccination campaign equity have arisen. Vaccine apartheid is the term that has been coined in reference to global inequity in vaccine distribution, and corollary access to COVID-19 vaccination. By way of comparison, for example, according to Médecins sans frontières/Doctors Without Borders, a country like Iraq has received 360,000 doses of the Astra Zaneca vaccine for a population of 40 million (Ebeid, O., 2021). 

According to the British scientific research journal Nature, the following threefold issue is at the root of the emerging global inequity of COVID-19 vaccine distribution: 1>COVID-19 vaccine production capacity, 2> the purchasing power of rich nations who have pre-ordered vaccines, and 3> patenting rights, which exclude the transfer of technologies beyond those few companies owners of the intellectual property (IP) rights, already producing the vaccines at full capacity, primarily in the West, China and Russia. In other words, patenting rights perceived as obstructing the supply of COVID-19 technologies, in response to an extremely urgent demand. In sum, whatever vaccine production exists, it is already largely earmarked for those (rich) countries, who have pre-ordered, compounded by the fact that patenting rights prevent production from being distributed elsewhere, among other facilities, for example in medium–income nations. A production that would cover local populations, and the population of the poorest nations, without facilities or any purchasing power. 

Thus, medium-income, and poor nations, not only have to wait for vaccines (perhaps till 2022 or 2023), they have to wait far longer than necessary, because production is prevented from happening elsewhere. In terms of numbers, poorer nations, making up to 80% of the world population, currently have access to less than one-third of the available COVID-19 vaccines (Nature Editorial, 2021). The World Trade Organization (WTO), is thus currently under the pressure of an India and South Africa-led coalition of 100 nations, with civil society support, demanding that intellectual property rights for COVID-19 vaccine technologies be temporarily lifted, at least until the pandemic is under control, so that production can be set up elsewhere than at the few facilities of the western world for the Pfizer, Moderna, Johnson & Johnson, and Astra Zaneca vaccines, as well as for the Sinopharm vaccine in  China and the Sputnik V vaccine in Russia. (The People's Vaccine, Global Justice now).

Such a dramatic situation, oblivious of the public health interest, is not altogether unfamiliar. With hindsight from the disastrous monopoly on antiretroviral therapies (ART) within the context of the AIDS pandemic, pharmaceutical companies, such as Moderna, have indeed waived enforcing their patenting rights against others making the COVID-19 vaccine till the end of the pandemic, and will grant licensing rights for the mRNA technology post-pandemic. A pledge that technically lifts the monopoly on pricing conferred by patenting rights, promoting the development of a new vaccination paradigm, while still falling short on the possibility of transferring vaccine know-how and manufacturing to the Third World, during the pandemic (Shore, 2020). However, considering the absence of electricity for 1.5 billion people in the Third World, the Moderna vaccine is also considered an unsuitable candidate vaccine for the Third World, primarily due to the low-temperature storage conditions and to the costs of a double-dose regimen (Curtis, 2020). Likewise, for the same reasons, the Pfizer vaccine is deemed even more significantly ill-suited for the Third World, considering the extreme cold storage conditions (-70 degrees Celsius) required for the costly double-dose regimen of the Pfizer vaccine (1). Thus, the small set of pharmaceutical companies, producing effective COVID-19 vaccines worldwide, and especially those deemed more suitable for the Third World  (e.g.; Astra Zaneca), are being specifically urged to live up to the spirit of solidarity that was put forward during the early phases of public funding for research and development of COVID-19 vaccine development (Ellman, 2021). An urgent request that often forcibly ends up as a desperate appeal to all rich countries and pharmaceutical companies implicated, for the purchase and donation of vaccines to poorer nations, not only in need of COVID-19 vaccines right now, but of the right vaccines (Nature Editorial, 2021).

If the obscene cruelty of an unnecessary wait for medical technologies appears to be repeating within the context of the emerging vaccine apartheid of the COVID-19 pandemic, an even greater threat is seen lurking on the horizon. According to UNAIDS Executive Director Winnie Byanyima, vaccine apartheid for the poorest countries of the world not only prevents those countries from exiting the health and economic crisis brought about by the COV-2 pandemic, on a par with the rest of the world, vaccine apartheid also puts the rest of the planet at risk, canceling the possibility of eradication. Indeed, according to Byanyami: 

"The longer the virus is allowed to continue in a context of patchy immunity, the greater the chance of mutations that could render the vaccines we have and the vaccines some people in rich countries have already received, less effective or ineffective." (Byanyima, 2021)

In other words, for all who have survived to tell the tale of the year 2020, the COVID-19 pandemic clearly illustrates global interdependency, just in case such a dynamic might have previously appeared untenable. As Democracy Now! puts it succinctly: “If one person is unprotected, we are all unprotected.” (Goodman & Moynihan, 2020), a situation that vaccine apartheid might be in the process of amplifying. 

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(1) As of March 5, 2021 Rwanda is the only African country thus far with a Pfizer vaccination campaign, launched using special storage technology. Astra Zaneca, the vaccine generally known to be a more suited vaccine for the Third World, was also launched  in Rwanda (Uwiringiyimana, 2021).

References

Byanyima, W. (Feb. 18, 2021) UNAIDS -  A global vaccine apartheid is unfolding. People’s lives must come before profit. UNAIDS.   https://www.unaids.org/en/20210203_oped_guardian

Curtis, J. (Nov. 30, 2020) Coronavirus: Access to vaccines in developing countries. https://commonslibrary.parliament.uk/coronavirus-access-to-vaccines-in-developing-countries/

Ellman, T. Dr.  (Feb. 18, 2021) Southern Africa needs the right COVID-19 vaccines, at the right price – right now. Médecins sans frontiers (MSF)/Doctors Without Borders (DWB).   https://www.msf.org/msf-urges-rich-countries-share-appropriate-covid-19-vaccines-southern-africa

Ebeid, O. (March 31, 2021) Only vaccination will end the ferocious spread of COVID-19 in Iraq. Médecins sans frontiers (MSF)/Doctors Without Borders (DWB).   https://www.msf.org/iraq-only-vaccination-will-end-fast-spread-covid-19

Glenza, J. (March 31, 2021) Coronavirus: How wealthy nations are creating a vaccine apartheid. The Guardian.    https://www.theguardian.com/world/2021/mar/30/coronavirus-vaccine-distribution-global-disparity 

Global Justice Now! https://www.globaljustice.org.uk

Goodman, A & D. Moynihan (FEb. 25, 2021) Vaccine Apartheid: If One Person Is Unprotected, We Are All Unprotected.    https://www.democracynow.org/2021/2/25/vaccine_apartheid_if_one_person_is

O’Neill, J. (March 18, 2021) End vaccine apartheid by waiving patents and save us all from Covid-19. The Guardian.  https://www.theguardian.com/world/2021/mar/18/end-vaccine-apartheid-by-waiving-patents-and-save-us-all-from-covid-19

Shores, M. (November 2020) Breaking Down Moderna’s COVID-19 Patent Pledge: Why Did They Do It? https://www.ipwatchdog.com/2020/11/11/breaking-modernas-covid-19-patent-pledge/id=127224/

Staff (March 31, 20210 It’s time to consider a patent reprieve for COVID vaccines. Nature.   https://www.nature.com/articles/d41586-021-00863-w

Staff (March 21, 2021) Interview: Three questions on worrying COVID-19 surge in Papua New Guinea. Médecins sans frontiers (MSF)/Doctors Without Borders (DWB).   https://www.msf.org/png-health-system-verge-collapse-following-covid-19-surge An

Staff (March 25, 2021) COVID-19 support desperately needed as second wave overwhelms Yemen. Médecins sans frontiers (MSF)/Doctors Without Borders (DWB).   https://www.msf.org/covid-19-support-desperately-needed-second-wave-overwhelms-yemen

The People's Vaccine - https://peoplesvaccine.org/ 

Uwiringiyimana, C.  (March 5, 2021) Rwanda becomes first African nation to use Pfizer COVID-19 vaccine.    https://www.reuters.com/article/us-health-coronavirus-rwanda/rwanda-becomes-first-african-nation-to-use-pfizer-covid-19-vaccine-idUSKBN2AX1P1

Oh patents! In silico 3D-modeling for drug design

Copyright © Françoise Herrmann

Pharmaceutical R&D includes in vitro (test-tube), in vivo (live, animal or human) testing, and fairly recently in silico (computer) 3D-modeling of molecular interactions, for the design of vaccines and drugs.

Within the context of the COVID-19 pandemic, all of the groundwork for the accelerated vaccine development, currently underway, was launched early. Indeed, it was as early as January 12, 2020, that Chinese Health authorities made public the complete sequencing of the new coronavirus (2019 n-CoV), or Wuhan virus, as it was then called, prior to being officially designated the SARS CoV-2 by the World Health Organization (CCDCP, 2020; CAS, 2020, Institut Pasteur in Shanghai, 2020). Sequenced at lightning speed, using Next Generation Sequencing (NGS) (Shang, Oct. 2020), the Chinese preemptive release of the SARS CoV-2 virus genomes, crucial to modern drug and vaccine development, included further research. Research, such as the description of the virus (a single-strand RNA virus, belonging to the Betacoraonavirus group), identification of the S-protein as critical for binding to the host cell receptor, therefore designated as the prime target of vaccine and drug treatments, and comparative data on both the suspected origin of the virus in bats, and transmission to humans, via the infected animals of the Huanan Seafood Wholesale Market, in Wuhan (Staff, CCDCP, Jan 2020; Shi, Oct. 2020).

In turn, the Chinese public release of genomic information prompted immediate and unprecedented scientific collaboration across frontiers. The collaboration to develop vaccine and drug candidates was both immediate and unprecedented, in the face of a documented emergency. Documented, because the genomic data, released from China, included supporting data on how robust the role of the viral S-protein in securing entry into human cells. An entry point where the virus could replicate, attacking the lungs and other organs of infected persons, prior to triggering massive inflammatory responses that were fatal, when they could not be prevented.  

Drug or vaccine development at the genomic level relies significantly on in silico 3D modeling, in view of supporting such queries as molecular dynamics simulating receptor molecule and substance; secondary, tertiary and quaternary protein structure prediction, binding site prediction, homology modeling for analyzing previously unknown protein function, protein threading (fold recognition) in protein modeling. In sum, programs supporting simulations for comparing nucleic acids, and the search for existing drugs and their targets, that might potentially be repurposed.  

One such patented in silico 3D-modeling system, used for enzyme modeling is called  Catalophore,™. This system was actually used in January 2020 by Innnophore, an Austrian company, specialized in enzyme discovery, to search for already designed protease inhibitors that could also bind to the SARS CoV-2, and be repurposed as an effective antiviral treatment for COVID-19 (Gruber, C & G. Steinkellner, Jan 23, 2020; Wang, 2020).  

The technology used for this purpose, embodied in the Catalophore™ enzyme modeling system, is patented in the US utility patent application US2015302142A1, titled Determining novel enzymatic functionalities using three-dimensional point clouds representing physicochemical properties of protein cavities.

Below, the January 2020 Catalophore™ modeling of the SARS CoV-2 protease point clouds, showing favored cavities where ligands could bind for inhibiting CoV-2 protease activity, thus deactivating virus replication. [Innophore, Jan 23, 2020]. In turn, the Innophore emergency response team searched their point cloud databases for proteins with similar physicochemical configurations and known protease inhibitors to see if any of them could also bind to the SARS CoV-2 protease. Lopinavir, a previously approved HIV protease inhibitor, was then identified as the best match for inhibiting the SARS CoV-2 protease (Gruber & Steinkellner, Jan 23, 2020).  

With FDA authorization granted last week for emergency use of the Pfizer-BioNTech BNT162b2 vaccine, and the upcoming review, on Dec. 17th, 2020, of the Moderna mRNA-1273 vaccine, the concerted emergency response of scientists worldwide for the development of treatments and vaccines, able to halt the spread of  COVID -19, offers the glimpse of a real triumph. In other words, hope exists for effective prevention of the spread of COVID-19, at the conclusion of very grim news for the year 2020, and unspeakable statistics of the human toll. 

References

Chinese Academy of Sciences (CAS). https://english.cas.cn/

Chinese Center for Disease Control and Prevention (CCDCP).   http://www.chinacdc.cn/en/

Chinese Center for Disease Control and Prevention (CCDCP) - COVID-19.   http://www.chinacdc.cn/en/COVID19/

CCDCP - Staff (Jan, 23, 2020) Study reveals how novel coronavirus infects humans.   http://www.china.org.cn/china/2020-01/23/content_75643109.htm

Chinese Center for Disease Control (Wuhan satellite).   https://www.natureindex.com/institution-outputs/china/wuhan-center-for-disease-prevention-and-control/52ae6a29140ba06f3d000003 

Gruber, C and G. Steinkellner (Jan. 23, 2020) Coronavirus COVID-19, formerly called Wuhan coronavirus and 2019-nCoV: What we can find out on a structural bioinformatics level.  (Austria)   https://innophore.com/2019-ncov/

Innophore (company website) https://innophore.com/

Institut Pasteur of Shanghai - Chinese Academy of Sciences.   http://english.shanghaipasteur.cas.cn/

Karlin-Smith, S. (Jan. 29, 2020) U.S. officials praise Chinese transparency on virus — up to a point.   https://www.politico.com/news/2020/01/29/officials-praise-china-transparency-virus-108926

SARS CoV-2 – Wikipedia   https://en.wikipedia.org/wiki/Severe_acute_respiratory_syndrome_coronavirus_2

Shang, Y. (October 2020) Next-generation sequencing in  SARS CoV- 2 identification. http://www.chinacdc.cn/en/COVID19/202011/P020201119531938682677.pdf

Shi, W. (October 2020) Genetic sequencing reveals natural origin, early spread and infectomes of SARSCoV-2 in China.      http://www.chinacdc.cn/en/COVID19/202011/P020201119531353047965.pdf

Wang, J. (2020) Fast Identification of Possible Drug Treatment of Coronavirus Disease-19 (COVID-19) through Computational Drug Repurposing Study  - J. Chem. Inf. Model. 2020, 60, 6, 3277–3286  https://pubs.acs.org/doi/10.1021/acs.jcim.0c00179#

WHO COVID -19 Timeline  (Archived). https://www.who.int/news/item/27-04-2020-who-timeline---covid-19

WHO (Jan 12, 2020) Novel Coronavirus – China. https://www.who.int/csr/don/12-january-2020-novel-coronavirus-china/en

Wuhan Institute of Virology http://english.whiov.cas.cn/                  

FDA Advisory Committee-recommended! The Pfizer-BioNTech COVID-19 vaccine

 Copyright © Françoise Herrmann

On December 10, 2020, the US Federal Drug Administration (FDA) Vaccine Advisory Committee recommended an Emergency Use Authorization (EUA) for the COVID-19 BNT162b2 vaccine, developed and manufactured by Pfizer-BioNTech, in Germany. Thus, the BNT162b2 vaccine has cleared a major hurdle to become the first, long-awaited, FDA-authorized vaccine in the US, designed for the prevention of COVID-19, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).  A virus that has infected, to date, close to 70 million people worldwide (1.5 million in the US), claiming more than 1.5 million lives worldwide (close to 300 thousand in the US) (WHO Dashboard; JohnHopkins CoV Resource Center). A virus, now raging a second time, that is also paralyzing world economies.

The FDA Vaccine Advisory Committee recommendation comes exactly one week after the United Kingdom authorized the same vaccine for a mass vaccination campaign, on December 3^rd; and one day after authorization in Canada, on December 9^th. The votes, recommending emergency vaccine use in the US, cast by 17 of the 23 expert scientists on the FDA Vaccine Advisory Committee, kickstarts the FDA authorization process. A process that escalates the Advisory Committee recommendation to the FDA Commissioner, Stephen Hall, who has to sign off on the authorization for emergency use, before US Marshal-escorted shipments of the vaccine, from Germany to every US State, can begin, and Operation Warp Speed kicks off. Vaccinations would then be administered approximately 96 hours, following FDA authorization (Smith & Rahhal, Dec 10, 2020).

The Pfizer-BioNtech COVID-19 vaccine is a nucleoside-modified messenger ribonucleic acid (modRNA) type vaccine (FDA - Pfizer-BioNTech). This means that to produce the vaccine an mRNA strand was modified to code for the coronavirus spike glyco-protein (S). The spike viral glycoprotein S is the red tentacle-like glycoprotein, represented on the surface the SARS coronavirus-2, that gives the virus its unique profile (see image). Once engineered, and covered with protective lipid nanoparticle (NP) carriers, the modRNA strands are then injected into the human body, where the message to produce (harmless) glyco-protein spikes is delivered within human cells. The production of spike glyco-proteins is then believed to trigger an immune response, where the human body creates antibodies against the (harmless) intruding glyco-protein spikes. Antibodies, which will then circulate, ready to mount an attack, in case a person is actually infected with the SARS coronavirus 2, since the antibodies will be able to recognize the glyco-protein spikes, attached to the surface of the (dangerous ) virus, for the purposes of binding to the virus and preventing its replication (extrapolated from Weintraub & Padilla, June 21 2020).

The Pfizer-BioNTech vaccine is supplied in a multi-dose (5-dose) vial stored at extremely low temperature, between -80°C to -60°C (- 112°F to -76°F)].  Once thawed and diluted into five, 0.3 mL, doses, the vaccine has to be injected within 6 hours. Thus, the vaccine’s temperature storage requirements make it difficult to transport and deliver, not to mention almost impossible to use in Third World countries where facilities for such extremely cold storage might not be readily available. The vaccine is otherwise administered as a series of two, 30 µg (0.3 mL) doses, via intramuscular injection, 21 days apart (FDA - Pfizer-BioNTech). Another FDA Advisory Committee recommended that vaccinations in the US begin with health care workers, the elderly in nursing homes, and the staff taking care of them.  

Different sorts of bio-engineering technologies are invoked in the Pfizer-BioNTech vaccine. The Lipid nanoparticle (NP) carrier technology for the modRNA strands is, for example, recited in the following US utility patent applications and patents, granted to BioNtech.

• US2020/0155671 – Particles comprising a shell with RNA.
• US2018/0263907 - Lipid Particle Formulations for Delivery of RNA and Water-Soluble Therapeutically Effective Compounds to a Target Cell.
• US2017/0273907 – Stable formulations of lipids and liposomes.
• US10576146 – Particles comprising a shell with RNA.
• US10485884 – RNA formulation for immunotherapy.
• US9950065 – Particle comprising a shell with RNA.

References

FDA Briefing Document  - Pfizer-BioNTech COVID-19 Vaccine (Dec. 10, 2020).   https://www.fda.gov/media/144245/download

John Hopkins CoV Resource Center.     https://coronavirus.jhu.edu/map.html

Smith, J, and N. RAhhal (Dec 10, 2020) FDA panel votes to give emergency approval to Pfizer's coronavirus vaccine - but the shot won't ship to Americans until the agency signs off and a final verdict could take DAYS. DailyMail.com.      https://www.dailymail.co.uk/news/article-9039119/  

Weintraub, K.  and R. Padilla (June 21, 2020) Vaccines are not all created equal: A variety of ways to stop the virus that causes COVID-19.      https://www.usatoday.com/in-depth/news/health/2020/06/21/different-technologies-developing-vaccine-against-covid-19/5318458002/

WHO  Coronavirus Disease (COVID 19) Dashboard.   https://covid19.who.int/?gclid=CjwKCAiAq8f-BRBtEiwAGr3DgTBY2t_njp3yW4kHF--UtD3vhq5bCvzrTIAjtppWIC9P-J5FRvmtQhoCI-EQAvD_BwE

Oh, patents! Z-Mapp

Copyright © Françoise Herrmann

According to the WHO (World Health Organization) Ebola virus disease Updates in West Africa, 

“Between Aug, 19 and Aug. 20, 2014, a total of 142 new cases of Ebola virus disease (laboratory-confirmed, probable and suspected) and 77 deaths were reported from Guinea, Liberia, Nigeria and Sierra Leone” (WHO1 – GAR1). 

As of Aug 20, 2014, according to the same WHO Global Alert and Response (GAR) page, there were 1427 deaths and 2617 cases reported. Ebola virus has a case fatality rate of up to 90%. It is one of the world’s most virulent diseases. The current survival rate in this epidemic is 47%. (WHO2-GAR)

The question that arises almost immediately is whether there is a cure for this deadly disease, and/or for preventing it from spreading any further, both locally in the villages or crowded cities of the infected areas, and internationally across borders and continents -- to Europe and the rest of the world.  Indeed the extraordinary measures of isolation that were taken to bring home for treatment two infected American missionaries,  Dr Kent Brantly and Nancy Writebol, who both survived the disease, serve to further highlight the issue of treatment and access to it.

The usual scenario in connection to patented drugs and access to treatment is one of prohibitive costs, and the monopolies associated with the marketing and production of the drugs. For example, this is the well documented case of antiretroviral drugs for the treatment of Aids (Chneiweiss, 2013).  However, the availability of treatment for Edola virus disease is different in important ways that highlight a different set of ethical issues in the access to patented treatments.

The issue here pertains to a patented drug referred to as Z-Mapp, which is still in the pre-clinical stages of testing. This means that the drug, developed by Mapp Biopharmaceuticals Inc., with the support of the United States government (CDC and DoD), has only been tested in the laboratory, on animals or in test tubes, and has not yet completed the full cycle of clinical testing with humans required for assessing safety and effectiveness of the drug. A process required prior to obtaining authorization to market a drug, and specified in the provisions of US Federal Regulations Title 45, Part 46 on The Protection of human subjects, or equivalent European legislation, such as for example, France’s Code de la Santé Publique, Livre 1er, Titre II pertaining to biomedical research.,  

Who cares?  What other options beyond the miraculous are there for those people infected with the Ebola virus? If the two US missionaries survived the Ebola virus infection to return home to their families, virus free, after treatment with this experimental Z-Mapp drug, then this is already human cllinical testing with grand scale control…Well, that’s the gist of it, minus  roll-out issues. [CDC –Ebola Hemorrhagic Fever]

 Indeed the decision to make this Investigational New  Drug (IND) available under specific conditions within the context of this Ebola outbreak was unanimously approved by the WHO on August 11, 2014 [WHO3- Ethical Committee Report]. So that in a rare, and perhaps ground-breaking instance, communication finally completed in real time, between all the parties involved in the process of developing the drugs and those subjects and patients, for whom the drugs are intended in the first place – our not-so-distant neighbors in a globally connected world --infected with the Ebola virus.

Z-Mapp is patented in US2013149300 titled MONOCLONAL ANTIBODIES WITH ALTERED AFFINITIES FOR HUMAN FCyRI, FCyRIIIa, AND C1q PROTEINS. According to the patent 

specifications, the drug is designed for: 

" the prevention or treatment of human diseases including but not limited to infectious diseases (including Respiratory Syncytial virus, Ebola virus, Influenza virus), cancer (including breast cancer and B cell lymphoma) and inflammatory diseases (including rheumatoid arthritis and Alzheimer's)."

The abstract for Z-Mapp patent US2013149300 is included below as well as an image of this dreadful virus.

Disclosed herein are GNGN and G1/G2 antibodies that recognize and bind various FcRs and C1q. Also disclosed herein are glycan-optiminzed antibodies, predominantly of the GNGN or G1/G2 glycoform, with enhanced Fcgamma receptor binding achieved through CHO, Nicotiana benthamiana and yeast manufacturing systems. Nucleic acids encoding these antibodies, as well as expression vectors and host cells including these nucleic acids are also disclosed herein. Methods and pharmaceutical compositions including the monoclonal antibodies are provided herein for the prevention and/or therapeutic treatment of viral infections, cancers and inflammatory diseases.

References

WHO 1– Global Alert and Response (GAR) – Ebola Virus disease updates – West Africa

http://www.who.int/csr/don/2014_08_22_ebola/en/ 

WHO 2- Global Alert and Response  (GAR) – Ebola virus disease

http://www.who.int/csr/disease/ebola/en/

Chneiweiss, H. (2003) Sur les rivages de la misère : Épisode 1 : Le marché des médicaments essentiels. M/S – Médecine Sciences,  vol 19(8&9), pp. 892-894.

WHO 3– Ethical considerations for the use of unregistered interventions for Ebola Virus disease

http://apps.who.int/iris/bitstream/10665/130997/1/WHO_HIS_KER_GHE_14.1_eng.pdf?ua=1

CDC – Ebola Hemorrhagic Fever

http://www.cdc.gov/vhf/ebola/outbreaks/guinea/qa-experimental-treatments.html

US Federal Regulations –Title 45 – Part 46 on the protection of human subjects

http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf

Code de la Santé Publique – Première Partie, Chapt. 1^er, Titre II – Recherches biomédicales

http://www.recherchecliniquepariscentre.fr/wp-content/uploads/2012/06/0-Code-de-la-sant%C3%A9-publique.pdf 

Aug. 24, 2014 3:32 am - SFO CA 37.62 … 6.0 on the Richter magnitude scale and no stopping the earth from quaking

Pharmaceutical patents - MDR-TB*

Copyright © Françoise Herrmann

* MDR-TB means Multiple-drug resistant tuberculosis. 

 

On March 24 2014, the world celebrated World TB Day, an international health campaign launched by WHO (the World Health Organization) designed both to raise awareness about tuberculosis, and to reach the estimated 3 million people worldwide who are infected each year, and left untreated [WHO (2)].

 

TB is second only to HIV as the greatest killer due to an infectious agent [WHO (1)]. Every year about 9 million people are infected, 1.8 million die, and only 6 million will get treatment. The highest incidence of new TB cases occurs in Asia and sub-Saharan Africa.

 

Tuberculosis is a deadly bacterial and highly infectious disease that spreads from person to person through air. It is primarily an infection of the lungs, but it can also infect other organs. TB is preventable, treatable and curable. The two most potent standard treatments for TB are isoniazid and rifampin [CDC].

 

Due to a combination of factors, including but not limited to: how long the same two standard drug treatments have existed; time-consuming and antiquated sputum smear microscopy testing; poor, interrupted or incomplete treatments, overcrowded prison systems, and very low socio-economic conditions, an MDR-TB (multiple drug resistant- TB) epidemic now exists in conjunction with non-resistant TB strains [PIP]. Resistance occurs when the disease no longer responds to either of the two standard treatments plus any fluoroquinolone treatments. The estimated number of persons suffering from MDR-TB in 2012 was 450,000 [WHO (2)]. And contrary to beliefs, TB is estimated to infect 1 million children each year, 30,000 of which are infected with MDR-TB [PIP].

 

Accordingly, and thanks to the dissemination and availability of such epidemiological data, patenting activity related to tuberculosis exists and includes: inventions for cost-effective; fast and alternative methods of diagnosis of both TB and MDR-TB; and inventions disclosing new formulations for the treatment of TB and MDR-TB, including child-friendly diagnostic tools and formulations, since children cannot be tested via the traditional (and century old) methods of  sputum smear microscopy when they are very small, and the injection treatment options are also not well tolerated.  

 

The following are examples of this patenting activity (excluding sample Russian, Ukrainian, China and Taiwan patents since only the titles and abstracts of these patents are translated):

 

US2013095489 - Process for detection of multidrug resistant tuberculosis using real-time PCR and high resolution melt analysis 

WO201313247 – Real tme PCR detection.of M.Tuberculosis, resistant/susceptible to rifampicin and/or isoniazid. 

WO2013180779 – Methods of using isoniazid for the diagnosis of lung infections 

WO2014014434 – Preparation for the treatment of tuberculosis 

US2013150415 – Rationally improved isoniazid and ethionamide derivatives 

WO2012103119 – Compositions of the administering rifalazil and other anti-tuberculosis agents in unit dosage form for oral administration 

WO 2012044140 - Anti-tuberculosis preparation in tablet form and process for preparing same

US2011207684 – New low side effect pharmaceutical composition containing isoniazid

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The extent to which these patented discoveries are used to avert the spread of this hydra-headed epidemic and to reach their target populations -- in the most destitute areas of a globally connected world – is as much a question of public health policies as it is a political and economic issue of human rights and access to healthcare and health technologies.

 

 Thanks to the tireless efforts of dedicated organizations such as Partners in Health and Médecins sans frontiers / Doctors without borders, among many others, the prevention, treatment and ultimate eradication of TB, at the very least, continues to appear on the health technology agenda of pharmaceutical companies.

 

References

CDC -  Multi-drug resistant tuberculosis (MDR-TB)

http://www.cdc.gov/tb/publications/factsheets/drtb/mdrtb.htm

PIP – Partners in Health

http://www.pih.org/blog/mdr-tb-in-children-a-qa-with-pihs-dr.-mercedes-becerra

WHO (1) Tuberculosis – WHO Factsheet No. 104

http://www.who.int/mediacentre/factsheets/fs104/en/

WHO (2) World TB Day – Reach the 3 million

http://www.who.int/campaigns/tb-day/2014/en/