# 1 Reboot and Re-focus :The Compound Eye in a new avatar.
CBD- COP 15, Xenotransplantation, & Vaccine mixology
Welcome Note: -
Welcome old and new subscribers. This is the new version of the health and life-science policy newsletter started by Shambhavi Naik. We have new contributors on board. They are Priyal Lyncia D’Almeida, Harshit Kukreja, and Ruturaj Gowaikar. We will also be expanding our coverage to include Health systems and climate & environmental issues as well.
Happy reading..
Convention on Biodiversity (CBD)-a stepchild of the Earth Summit of 1992.
-Ruturaj Gowaikar
Background..
The Conference of the Parties (COP26) on Climate Change Conference that concluded in Glasgow saw the presence of Heads of States and good media coverage. But another COP, the COP 16 of The Convention on Biological Diversity (CBD-COP16) that took place a few weeks ago in Kunming in China wasn’t graced by Heads of States or extensive media coverage.
Along with conservation of biodiversity, the CBD, deals with the fair and equitable sharing of benefits from the use of nature, and the safe transport, handling and labelling of Living Modified Organisms. The CBD isn’t a stand-alone international legally binding treaty between 196 signatory countries. It is in fact, part of three treaties signed in 1992 at the Earth Summit that gave rise to the Rio Declaration on Environment and Development.
Other conventions that came into existence were the UNFCCC (UN Framework Convention on Climate Change) and UNCCD (UN Convention to Combat Desertification). The UNFCCC is the more glamorous of the two, due to various reasons, the main being involvement of financing mechanisms from the initial meetings and inclusion of the global business community in the discourse surrounding climate change.
These three treaties have gone their separate ways with development of ancillary protocols, funding mechanisms and meetings. But these three treaties can’t be implemented in silos. The relation between preserving and/or improving the global biodiversity and arresting desertification and climate change are apparent. This piece covers in brief the broad aspects that the latest convention i.e. CBD-COP15, tried to address and the overall messaging of the meeting.
The meeting..
The Chinese city of Kunming played host, with the Chinese minister for ecology and environment, Li Ganjie, presiding over the meeting. The theme of the meeting was Ecological Civilization. A term originally coined by Xi Jingping in 2018 to express his ideological framework for the country’s environmental policies, laws and education. But in the context of this meeting it can be taken as a call to nations to maintain ecological continuity across generations to ensure a ‘Shared Future for All Life on Earth.’
CBD- COP15 included meetings of parties to three international agreements: the CBD and two subsidiary protocols, namely the Cartagena Protocol, and Nagoya Protocol.
The main agenda was to come-up with a zero draft for the “Post-2020 Global Biodiversity Framework”. The tricky issue of benefit sharing related to digital information on genetic sequences, without needing physical access to genetic resources was also on the agenda.
Novel features of this COP were participation of the global business community to address the issue of poor coherent funding mechanisms and involvement of local and sub-national governments as stakeholders.
The outcome of this meeting was the Kunming Declaration, containing 17 commitments agreed by more than 100 governments that attended COP15. Specific targets for the commitments will be negotiated at the follow up meeting, to be held in Geneva, Switzerland in January 2022. After which the post-2020 global biodiversity framework is due to be adopted at part two of the Biodiversity Conference in May 2022.
Challenges still plague this treaty with lack of robust funding mechanism, reluctance of the United States of America to ratify the treaty, and no efforts to couple all the three treaties of the 1992 Earth summit. Earnest action by the global community on the post-2020 global biodiversity framework is imperative lest this framework suffers a similar fate as the Aichi targets .
First animal organ kidney successfully transplanted into a human recipient.
-Harshit Kukreja
First animal organ kidney successfully transplanted into a human recipient
Last month, in the NYU Langone Hospital, a major step was taken towards alleviating the shortage of transplant organs. A pig kidney was transplanted into a human. The process, known as Xenotransplantation, or a heterologous transplant, is the transplantation of living cells, tissues or organs from one species to another.
The organ was attached to a comatose patient and was observed for 54 hours. The kidney functioned normally and all key indicators were comparable to that of a transplanted human kidney. The donor was maintained on a ventilator for 54 hours while doctors studied the kidney’s function and watched for signs of rejection.
The kidney was obtained from a pig genetically engineered by United Therapeutics.
The gene which is responsible for a rapid antibody-mediated rejection of pig organs by the human body was “knocked out” in the donor pig. Along with the pig's kidney, its thymus gland was also transplanted to stave off novel immune responses to the pig kidney.
The kidney was attached to the blood vessels in the upper leg, outside the abdomen, and covered with a protective shield for observation and kidney tissue sampling over the 54 hours of study. Key indicators such as urine production and creatinine levels were normal and equivalent to what is seen from a human kidney. Throughout the procedure and subsequent observation period, no signs of rejection were detected. The results of the study have not yet been published.
Pigs are used in most research in xenotransplantation, among other reasons because of the right size of their organs. Cow's organs are too large, while those from a goat are too small.
Pig's organs are also not without any issues. Ranging from inflammation inside the pig organ post-removal to human antibody and T-cell responses to the foreign organ.
The supply of organs has not kept pace with the growing demand. This is a step in the direction for a potentially unlimited supply of organs and saving countless lives.
However, the process carries a significant risk of Xenozoonosis(i.e. animal pathogens into humans) especially when xenograft is put into an immunosuppressed human. This could lead to newer pathogens infecting humans and possibly creating havoc.
Xenotransplantation poses a lot of ethical conundrums which need some thought on our part. Do we consider the animals that are raised for organ harvesting to be only human incubators? Is killing a primate more serious than killing a pig? Why do we consider a bunch of human foetal cells to have more rights than a fully grown animal?
This research could also be halted before it even properly takes off. The government may over-regulate and research may downright be banned in some places such as how Genetically Modified crops face a lot of regulatory hurdles. Regulation will have to answer questions such as are these organs to be governed by the same laws will regulate Genetically Modified Organisms(GMO), how do you manage risks posed by xenozoonosis.
Read More:
1. https://nyulangone.org/news/progress-xenotransplantation-opens-door-new-supply-critically-needed-organs
2. https://www.economist.com/science-and-technology/2021/10/20/a-pig-kidney-has-been-successfully-transplanted-into-a-human-for-the-first-time
Vaccine Mixology
-Priyal Lyncia D’Almeida
The conversation of booster doses has been happening around the world since August when US President Joe Biden promised booster shots to all adults. The Centres for Disease Control and Prevention (CDC) recommended booster shots for the Covid vaccine in October 2021. The idea behind administering booster shots was to extend the efficacy of the vaccine. The Food and Drug Administration (FDA) has authorised the administration of Pfizer-BioNTech, Moderna, and Johnson and Johnson. It has also authorised the "mix and match" strategy wherein an individual can choose to switch vaccines during the booster dose.
This decision comes after the results of a government-funded study were given to a group of experts that advise the FDA. The study showed that individuals who were administered with a single shot of Johnson and Johnson's and a Moderna booster shot had a 76-fold increase in their antibody levels in 15 days. Whereas, individuals who were administered with an additional dosage of Johnson and Johnson's only showed a fourfold increase in their antibody levels. The study also revealed that a booster shot of the Pfizer-BioNTech vaccine also elevated the antibody levels in individuals with Johnson and Johnson's vaccine. However, the elevated antibody levels were not from the latter were lesser than the former.
It is, however, important to note that these are short-term results from studies that were conducted on a small group of participants. Only one indicator of immunological response in the form of antibody levels was calculated as part of the initial findings. Another crucial indicator of vaccine efficacy is the levels of immune cells that are primed to combat the coronavirus which was not measured. Even while the evidence on mixing and matching dosages is limited, several researchers who have vehemently condemned the Biden administration's booster dose policy have stated that the vaccine providers should be given some discretion as the campaign expands as the mix-and-match has definitely shown a potent response than multiple doses of a single vaccine.
Convenience is another reason why experts approve of the mix-and-match strategy. The primary objective of states is to get most of the population vaccinated as soon as possible. This implies that if your primary and secondary dose is either Pfizer or Johnson and Johnson's and the only vaccine available locally is Moderna, you can take that injection without any delay.
Currently, based on the CDC guidelines, the booster doses are being administered only to people who are 65 years and older, people who live in high-risk settings, and people with underlying medical conditions. Currently, 36 countries around the world are administering booster shots to their population.
While the US has employed mix-and-match for booster policy, India has been working on undertaking studies on mix-and-match to speed up the vaccination drive in India. In July 2021, the Drugs Controller General of India (DGCI) had approved the trial for a mix-and-match study. This study involved the administration of one-shot each of Covishield and Covaxin to complete the course of vaccination. The DGCI granted CMC-Vellore the permission to conduct this study on 300 healthy individuals where they were administered with both the COVID-19 vaccines. The results are still awaited.
Given the fact that India is still behind in its goals to vaccinate its entire adult population by December 2021, approval of a mix-and-match strategy after a thorough review of scientific studies could potentially help us in speeding up the vaccination drive. However, it is too soon to draw any conclusions considering no concrete evidence has been found for Covaxin and Covishield mix-and-match strategy yet. Conducting regulated scientific studies on the mix-and-match and making an informed decision is the only way forward.