The COVID-19 marathon, in reality it’s more of relay.

By Lisa Short

You could be forgiven for waking each morning to feeling overwhelmed that overnight you’ve missed a month’s worth of information about medical advances, vaccine development, infection and death rate statistics, lockdown, easing of lockdown, political and scientific bantering, alternative therapies and all things in between. You’d be right!  To ease the burden here’s a summary of some of the major developments.

A COVID-19 Vaccine

Globally, vaccine FOMO has now emerging as a key bargaining chip in pandemic diplomacy, with China, United States and United Kingdom flexing their investment muscles and intent to share, often dependent on the political mood of some of the most volatile world leaders in history. The UK Government has largely turned a nationalised marathon into a relay by handing the baton to Gavi when it holds the Global Vaccine Summit on 4^th June 2020 aimed at mobilising resources to expedite vaccine development with equitable access.

The vaccine teams with the leader’s baton

• There are 124 candidate vaccines in development globally
• 10 vaccines designed to prevent COVID-19 are already being tested in people, and another 114 are in development.
• A landscape list can be found at WHO or GAVI
• Earliest expectation of vaccine for use is end of the year or January 2021
• A vaccine will be a valuable tool in assisting in the reduction of spread of COVID-19.

CanSino [Beijing Institute of Biotechnology] 

• Ad5-nCoV is a weakened common cold virus (adenovirus) genetically engineered to produce the COVID-19 spike protein.
• Is at Phase 2 trial

Sinovac [Beijing China]

• CoronaVac consists of a chemically inactivated version of the SARS-CoV-2 virus. This is a very traditional method of creating vaccines and one that historically has proved successful.
• Is at Phase 2 trial which has already been found to protect monkeys from being infected with the coronavirus.
• Discussing Phase 3 trials to take place in UK
• Building a commercial vaccine production plant to manufacture up to 100 million doses of the vaccine per year.

Moderna [National Institute of Allergy and Infectious Diseases (NIAID) USA]

• LNP-encapsulated mRNA vaccine works on the principle of having the immune system recognise the spike proteins the coronavirus uses to enter people’s bodies. It encodes the instructions for making a spike protein into a RNA molecule that can be injected into patients.
• Is at Phase 2 trial

Oxford University/AstraZeneca  [United Kingdom]

• A candidate vaccine, ChAdOx1 nCoV-19, is made from the ChAdOx1 virus, a weakened version of a common cold virus (called adenovirus) that causes infections in chimpanzees, genetically modified so that it is impossible for it to replicate in humans Genetic material used to make the spike glycoprotein, the protein that the coronavirus uses to penetrate people’s cells and gain entry to their bodies, is added to ChAdOx1. Researchers hope to make the body recognize and develop immunity to these spike proteins, therefore preventing the SARS-CoV-2 virus from entering people’s bodies.
• In Phase 2 trial
• Phase 3 planned

Ibuprofen as a Treatment for COVID-19 Respiratory Complications

• A pioneering trial called LIBERATE as a collaboration between London’s Guy’s & St Thomas’ NHS Foundation Trust, King’s College London and the pharmaceutical organisation the SEEK Group has commenced in early June.
• The trial is using a type of Ibuprofen called Flarin which has a separate composition than the standard version to protect the stomach
• Researchers believe the anti-inflammatory properties of the drug could treat severe respiratory distress syndrome, in hospital admissions, by reducing inflammation of blood vessels and subsequent blood clotting.
• This is a good example of how scientific information has evolved during this pandemic as more knowledge is developed. Initially at the onset of the pandemic, there were concerns that ibuprofen would aggravate the infection, but this has since been withdrawn. For simple symptomatic relief of fever, paracetamol is still the preferred option as it has less impact on the stomach.

Malaria Drug Hydroxychloroquine

• The controversial drug Hydroxychloroquine has been tested and reviewed as a treatment for COVID-19 and does NOT save lives and is NOT a treatment for COVID-19.
• The drug has immediately been removed from the University of Oxford’s UK’s Recovery trial, which ran one the world’s largest trials shows on the drug of 11,000 patients with Covid-19.
• The trial results showed 25.7% of people taking hydroxychloroquine had died after 28 days. This compared with 23.5% who were given standard hospital treatment.

Madagascar’s artemisia-based tonic Covid Organics

• There is as yet, no evidence Covid Organics is a cure for COVID-19. 

• On 22 April, Rajoelinalaunched Covid-Organics, an artemisia-based herbal drink developed by the Malagasy Institute of Applied Research to allegedly prevent and cure COVID-19.
• The tonic was tested onfewer than 20 patients. Data from the study has not been made available.
• On 23 April the National Academy of Medicine of Madagascar (Anamem) released a statement that the effectiveness of Covid-Organics in preventing and treating Covid-19 had not been adequately tested.
• WHO recognises that traditional, complementary and alternative medicine has many benefits and Africa has a long history of traditional medicine and practitioners that play an important role in providing care to populations. Africans deserve to use medicines tested to the same standards as people in the rest of the world. If therapies are derived from traditional practice and are natural, establishing their efficacy and safety through rigorous clinical trials is critical.

• WHO is working with Africa and Madagascar for medicinal plants such as Artemisia annua that are being considered as possible treatments for COVID-19 to be rigorously tested for efficacy and adverse side effects.

The Scientific Advisory Group for Emergencies [SAGE]

There is only one government appointed SAGE  for the United Kingdom for reputable and credible information and who provides scientific evidence to the Government from its various expert groups.

Other breakaway and informal groups have taken on similar names and are not government authorised.

Role:
SAGE is responsible for ensuring that timely and coordinated scientific advice is made available to decision makers to support UK cross-government decisions in the Cabinet Office Briefing Room (COBR). The advice provided by SAGE does not represent official government policy.
Important:
Science is an evolution of thinking and discovery based on what is known at any point in time. Science does not have all the answers and nor do all scientists agree. Different perspectives and approaches are based on interpretation and research and all scientists expect their work to be peer reviewed and collectively over time to arrive at the best known conclusion. It is not infallible. Science and advice changes as we learn more. Wanting all the answers, regardless of how urgent it is, is not the same as having them or knowing them or even being able to discover them.

The vaccination race for COVID-19: A marathon update.

by Lisa Short

The development of a safe, effective and widely available Vaccine for COVID-19 as a tool which can contribute to the control of its spread and ultimately enable lifting of social and economic restrictions that have crippled globalisation has been called a race against time by many of the leading scientific communities around the world¹. In reality it is more of a marathon with over 120 vaccines proposed across the world and 6 currently in clinical trial, another about to start and just on 70 in pre-evaluation stages². The incredible speed and resources attributed to achieve this marathon start must be recognised in association with the time it would normally take a vaccine to reach this stage which can be 2 to 4 years³. 

The unprecedented public health emergency created as a result of COVID-19 is clear. What is still not clear is the conclusive source and the origin of the virus, how it transferred from its host [also not conclusive] and why the world wasn’t prepared with robust pandemic planning on the back of a flu like pandemic being known as the greatest single global threat for more than 10 years. These issues do not change the fact that conducting research and vaccination development even under these trying times is still linked to “a moral obligation to learn as much as possible, as quickly as possible”¹. Patience as they say is a virtue, but with the global catastrophic impact of COVID-19 it is also in very short supply. The CSIRO states this is a very complex task, and ‘we really are pushing our science to the limits of global knowledge’⁷.

Some of the Scientific Challenges

Scientists face are overcoming a number of key challenges in this marathon of Olympic proportions, under extreme pressure of demand by a world wanting life as the once expected it to be.

The first relates to how the virus that causes COVID-19, SARS-CoV-2 gains entry into the cells of a person.  This entry door occurs via the angiotensin converting enzyme (ACE)-2 receptor. Put simply the virus attaches itself to a particular enzyme that converts a protein in the blood and enters much like a guest to an uninvited party. However, the real problem occurs when it comes to testing a proposed vaccine, because the two animals usually involved in the trial process – rats and mice – lack the ACE-2 receptors that virus attaches to.

Another challenge to be overcome of vaccine development in general lies in identifying a standardised neutralising antibody titre, which is designed to test whether being vaccinated against an infection will neutralise exogenous exposure to a virus, and thus offer seroprotection. And in that mix of ‘challenge’ is that the virus being tested hasn’t gone through generic change. In the case of SARS-CoV-2 there has been evolution, but fortunately not in the manner in which it enters cells through the ACE-2 receptors. 

Who’s winning the marathon and where are the other runners placed?

US based company Moderna, based in Massachusetts, is the current front runner leading Phase 1 trials in conjunction with the National Institute of Allergy and Infectious Diseases. On 18^th May 2020 Moderna released the first findings of its trial for mRNA-1273 the first SARS-CoV-2  vaccine to be tested in people. Findings indicate the vaccine seems to be safe, and stimulated an immune response against the virus where antibodies were generated in the trial volunteers, and were also able to stop the virus from replicating in human cells in the laboratory. The levels of antibodies in the blood of the trial volunteers were similar to those previously detected in recovered COVID-19 patients. These successes pave the way for the larger Phase 2 and Phase 3 [July] stages of the vaccine development. Tal Zaks of Moderna has cautiously indicated said that if these stages go well, the vaccine could be widely available by the end of this year or early next year.

Running second in the marathon is the University of Oxford. It has found its recent trial was not  effective in stopping six rhesus macaque monkeys from becoming infected with the coronavirus. albeit none of the vaccinated monkeys developed pneumonia. This is good news in that it suggests the trial may offer some protection against severe symptoms of COVID-19⁴. The progress of this trail continues, for the Oxford vaccine candidate just three months after the genetic sequence of the coronavirus was released for study.

In Australia the Coalition for Epidemic Preparedness Innovations (CEPI), which has funded four consortia one of which is led by The University of Queensland (UQ) in conjunction with the CSIRO are looking to move to Phase 1 dosing in June 2020. This follows Melbourne researchers from the Doherty Institute mapping immune responses from one of Australia’s first novel COVID-19 patients, showing the body’s ability to fight the virus and recover from the infection⁷.

Congratulations and accolades must go to the University of Queensland (UQ) who in 3 weeks created this vaccine candidate for SARS-CoV-2 , in part because of excellence in pre-existing knowledge and research.

Other universities including the Imperial College London and companies like Johnson & Johnson, Pfizer and GSK (GlaxoSmithKline) are discussing starting phase one trials in September 2020.

Vaccine Manufacture

Once efficacy and safety is finalised the race to the finish line must also include the final impetus to ensure the world has sufficient facilities to produce the vaccine. Pharmaceutical company AstraZeneca has announced it will develop, manufacture and distribute the successful  vaccine around the world. However, to do this they will need to ensure scaled production without critically affecting the supply of other vital vaccines. Oxford Biomedica and Cobra Biologics are conducting similar approaches to scaling their capacity.

In this regard the he UK government is powering ahead launching a vaccine taskforce to coordinate scale-up efforts and has funded a £14 million industry-led vaccine manufacturing group with a fast-tracked a £65 million Vaccines Manufacturing and Innovation Centre (VMIC). Australia to the contrary lacks the physical facility capacity to produce the vaccine numbers required and may need to look to overseas to conduct the task.

Other Interesting Developments 

No Olympic marathon would ever be complete without a few surprise delights and contributing factors. The development of treatments for COVID-19 will occur quicker than a vaccine, mainly because they are based on what scientists and medical staff already know.  For these reasons scientists from the United Kingdom have called for wider screening of existing drugs to see if they might work against SARS-CoV-2. Many of these being developed and the drugs already approved for use fall into a group of drugs called antivirals and target virus’s in people who already have an infection. Healthline¹⁰ publishes a good account of those approved already for use or under consideration.

Cardiff University in Wales has also led the world in antibody transfusion treatments for severe COVID-19 symptoms. Through transfusion of antibodies from plasma patients can increase their capacity to fight the infection themselves.

In another research paper produced in Canada on 2 May 2020, by the University of British Columbia it has been observed that by the time SARS-CoV-2 was first detected in late 2019, it was already pre-adapted to human transmission and there is a lack of definitive evidence to verify or rule out adaptation of the virus  in an intermediate host species¹¹.

What does all this mean?

There is still so much we don’t know about SARS-CoV-2, including its origin, source and exact time of appearance in humans. We do know it’s very new to its human host and for that reason only we don’t know yet how it will behave. A vaccine is still at best months away. Whilst a lot of criticism has been directed globally at the World Health Organisation and governments around the world in their responses to the management of the pandemic, and even in their pandemic preparedness, rightly or wrongly it will take a globally collaborative approach  to develop a vaccine and treatments for COVID-19. Political banter does not achieve this end goal. Working together in the fastest and most efficient way does. Concurrently, new processes and infrastructures that develop ways for the people of the world to live, work, travel and enjoy life with resilience to any pandemic are paramount.

LISA SHORT

🌎Top 100 B2B Thought Leaders in the World to follow in 2020 🌍

Strategist in Design Ecosystem Thinking, Education, Business, Leadership & Technology

Bachelor Training & Development, Dip. T&A Systems
BA (Economics, Fin. Mgt.) Dip. Ed. Adv. Dip. OHS, Grad. Cert. Sc.

¹   Royal Australian College of General Practitioners

²    World Health Organisation

³    The History of Vaccines: College of Physicians Philadelphia

⁴   New Scientist Update 18 May 2020

⁵   Centre for Infectious Disease & Research Policy

⁶   CSIRO

⁷   NatureMedicine

⁸   The Conversation

⁹   Cardiff University

¹⁰ Healthline

¹¹ University of British Columbia