On the 9th November 2020 promising results from a vaccine candidate against Covid-19 were announced by Pfizer and its partner, the German company, BioNTech. They stated that their candidate vaccine (BNT162b2 (modRNA)) was “more than 90 percent effective in preventing Covid-19 in participants”.
Whilst there have been substantive funds poured into vaccine development in the UK, EU and USA, Pfizer were quick to clarify that they funded the research with their partner independent of governments’ support. In July, Pfizer negotiated a $1.95 billion deal with the US government’s Operation Warp Speed, the multiagency effort to rush a vaccine to market, to deliver 100 million doses of the vaccine. The arrangement is an advance-purchase agreement, meaning that the company will not be paid until they deliver the vaccines. Delivery itself appears to be a significant challenge as the Pfizer vaccine needs to be kept at minus 70 degrees Celsius (-94 F) or below.
A week later, the 16th November, Moderna presented similarly promising preliminary results. Moderna recruited 30,000 volunteers across the United States to participate in its trial. A quarter of the participants are 65 years or older. White people make up 63 percent of the volunteers; 20 percent are Hispanic; 10 percent are Black; and 4 percent are Asian Americans. The United States government provided $1 billion in support for the design and testing of the Moderna vaccine and an additional $1.5 billion in exchange for 100 million doses if the vaccine proved to be safe and effective. They have proposed that theirs requires less stringent temperature controls.
Data is thin on the duration of benefit and the effects in differing age groups and safety are a way off being clarified. Encouragingly, the Pfizer trial has not reported to date any severe “adverse events” in the 43,500 trial participants, Moderna has yet to release their findings. While most vaccine-associated severe reactions occur shortly after vaccination, it will be important that trial participants and those vaccinated following licensures are closely followed to ensure that the benefits of receiving the vaccine outweigh any risks.
Importantly, the data released by Pfizer on November the 9th and Moderna on the 16th were delivered in news releases, not a peer-reviewed medical journal. It is not conclusive evidence that the vaccines are safe and effective, and the initial finding of more than 90+ percent efficacy could change as the trials go on.
BioNTech and Moderna have purposed a technology that has never been approved for use in people until now. They take genetic material called messenger RNA and inject it into muscle cells, which treat it like instructions for building a protein, a protein found on the surface of the coronavirus. The proteins then modulate innate and adaptive immunogenicity and are believed to confer long-lasting protection against the virus.
Ten other vaccine makers are also conducting big Phase 3 trials, including efforts in Australia, Britain, China, India and Russia. More than 50 other candidates are in earlier stages of testing.
Phase 2 preliminary results data published in the Lancet on the 18th November 2020 on the single blind Oxford ChAdOx1 nCov-2019 vaccine study shows that it triggers a robust immune response in healthy adults aged 56-69 and people over 70.
Whilst further data needs to be examined, it appears to be a developing narrative, that the immune system responds to at least three triggers – non vaccine expose, vaccine trigger via lipid particle mRNA generation of immunity and adenovirus-vectored vaccine which contains a pathogen-specific transgene.
ChAdOx1 nCoV-19 is a replication-defective chimpanzee adenovirus-vectored vaccine expressing the full-length SARS-CoV-2 spike glycoprotein gene (GenBank accession number MN908947).
In a move to shore up public confidence around the novel development of the vaccine, and after criticism from outside researchers, Pfizer and other companies took the unusual step of releasing their trial blueprints, known as protocols, revealing typically secret details about how it was evaluating its vaccine. Public confidence in the drug companies’ findings and regulators rigour and independence will be critical in persuading populations to consider the merits and get vaccinated.
Pharmaceutical companies have had their reputations severely damaged due to multiple failures of policy (fraud) as well as medicines. Quite understandably there is anxiety about the proposed vaccination of billions of people. Albeit, initial >90% efficacy outcomes are likely to persuade people far more than the anticipated 40-50%.
There is precedent for a greater type of transparency. The large Recovery trial run by the University of Oxford, which helped determine that the steroid dexamethasone reduces deaths in patients with Covid-19, has published its trial protocol and statistical analysis plans, helping clinicians and the public understand the assistance it offers.
Nutrients and Immunity
What we can be relatively clear about, is that Immunity is a multifaceted phenomenon. The concept of the herd immunity threshold, which refers to the fraction of the population that needs to be immune to prevent an ongoing epidemic spread of an infection, has been a major focus of research and extensive discussion since the early days of the SARS-CoV-2 pandemic.
The herd immunity threshold is reached when an infected individual infects fewer than one other person, on average. For a novel infection for which there is no pre-existing immunity, herd immunity can be generated either through infection with the pathogen or through vaccination. The primary mechanisms for developing resistance and immune memory relies on the development of antibodies and T cells with existing viral familiarity and related cytotoxicity.
Although much remains to be understood regarding the immune response to SARS-CoV-2, and how vaccine-induced protective immunity may differ from natural immunity owing to the immune-evasion strategies of the virus, an improved understanding of the natural immune response will be instrumental in developing effective vaccine and therapeutic strategies. One of which we can easily integrate into our clinical care, namely the provision of adequate nutrients required to offer both natural and vaccine induced immune development, and safely.
Adequate and appropriate nutrition is required for all cells to function optimally and this includes the cells in the immune system. An “activated” immune system further increases the demand for energy during periods of infection, with greater basal energy expenditure during fever for example. Thus, ‘optimal nutrition’ for the best immunological outcomes should be nutrition and supplementation, which supports the functions of immune cells allowing them to initiate effective responses against pathogens but also to resolve the response rapidly when necessary and to avoid any underlying chronic inflammation.
The immune system’s demands for energy and nutrients can be met from exogenous sources i.e. the diet, or if dietary sources are inadequate, from endogenous sources such as body stores. Some micronutrients and dietary components have very specific roles in the development and maintenance of an effective immune system throughout the life course or in reducing chronic inflammation and can also be supplemented exogenously.
Healthy eating, exercise, sleep, stress management, vitamins, minerals, fatty acids, and other natural agents can help mitigate the seriousness of diseases and health conditions, and even protect and save lives. The distinction that needs to be made, though, is what good nutrition, lifestyle and supplements cannot do is to stop a virus or bacteria from infecting people but is an “essential component” of outcome determination.
In terms of determining nutrients that confer a benefit on vaccination (including those approved for Covid-19) it is necessary to draw on prior work, as there are no current vaccines to test against. As may be expected Vit D status has an impact on tolerisation, and may be of particular importance for older people. Zinc, A and E deficiencies have been noted to diminish benefits from vaccination in younger patients. Further work shows that Vitamin C, B vitamins, Copper, Selenium, Iron, Probiotics and EFAs are all required to ensure best response patterns to infection and vaccination.
To Vaccinate or Not
The WHO recognises that vaccine hesitancy is a global challenge, and is nothing new. As we are likely to be asked to consider multiple vaccine candidates in a short time frame, this uncertainty it is going to create natural barriers to public acceptance.
Where we are presently, is that whilst there are many factors yet to be qualified regarding immune generation via a vaccine, a healthy and adequate nutrient status is a clinical benefit not a risk. If you have family or friends looking to receive a vaccine, the message is clear, there is a better outcome from efficiency and reduction of risk in those people with suitable micronutrient status than in those without.
Microbes are big news, bigger than any other health related story for decades including Aids and Ebola. The Coronavirus (Sars-Cov-2 and Microbe No 1) has dominated popular, political, and scientific discourse for months.
The related pandemic as defined by the WHO on the 11 March 2020 is also challenging our bodies and minds in obvious and hidden ways. For, while protecting ourselves from unwanted exposure to the Sars-Cov-2 virus and limiting risk of infection, some people have begun to fear all microbes, regardless that many are beneficial for human health.
Humans, as we already know face rising rates of allergies, food intolerances, inflammation, auto-immune diseases, metabolic disorders and gut-brain conditions – negative health trends that are already entrenched in most societies and linked to a changing relationship with our various microbiomes and diet. Read the rest of this entry »
“Our ability to mitigate disease emergence is undermined by our poor understanding of the diversity and ecology of viral threats.”
Whilst the burden of non-communicable disease (NCD) dominates health and disease globally, its progress through the population is slow, providing opportunity to intervene, reverse and restore health in many cases.
Infectious disease rarely provides such a time related opportunity and depending on a variety of factors can induce rapid local, national or as we have all seen international responses, that we would never see regarding NCDs. For most of us, witnessing the political, economic and societal strains brought about by this recent event can promulgate anxiety, and varying opinions. Yet zoonotic infections on a global scale have been predicted for many years by infectious disease specialists (which has included Disease X), but mostly ignored by governments and the public. Read the rest of this entry »
The challenge for everyone either resisting or managing a SARS-CoV-2 related infection appears to centre around the ability to determine the validity of the data sets used, and those that are available.
Most people, until the last few months, have had very little personal experience with the use of testing for infectious diseases. Until the last few months in the UK most people were dealing with the adverse consequences of non-infectious diseases, the ones that dominated global health news until just recently.
Infectious disease specialists it seems were wheeled out for short term fearful and nerve-wracking infectious agents such as Ebola and SARS, but then disappeared to their labs or areas of investigation. Read the rest of this entry »
As we progress on the pandemic learning curve, with immunology, or at least versions of it occupying centre stage. It is becoming clear that science studies provide supporters of science with better arguments to combat critics, by showing that the strength of scientific conclusions arises because credible experts use comprehensive bodies of evidence to arrive at consensus judgments about whether a theory should be retained or rejected in favour of a new one. It is, however, difficult to feel completely secure in judgements, when data sets continue to evolve and capture periods of focus.
These consensus judgments are what have enabled the astounding levels of success that have revolutionised our lives for the better. It is the preponderance of evidence that is relevant in making such judgments, not one, or even a few results. Read the rest of this entry »
There is a seasonal change to weather patterns that is reflected in the behaviour and responses to biological challenges within us. Physical, psychological, and metabolic, including immune rhythms are all circadian in their functionality and as such have related shifts in their capability and responsiveness at different times of the year and at different latitudes.
In most cases these are of little consequence, after all we have a substantive level of redundancy built into all our integrative systems, each one operating to support the other to minimise entropy or dysfunction.
However, managing these systems requires a high level of biological autonomy and feedback loops, that in turn rely on the internal and external environment to provide cues and support. Much like our immune system does in its evolution as it seeks to protect us. By now you are probably less interested in antibodies than a few weeks ago, but they remain a viable part of our overall immune defence and reflect exposure of various antigens and so can confer long term protection. Read the rest of this entry »
In an era when trust in just about every institution is waning, the confidence held by the public in researchers and politicians to validate the safety and efficacy of a Covid-19 vaccine is not unsurprisingly, under scrutiny.
Concerns about vaccine safety already exist and should not be dismissed simply as ignorant or “anti-science.” It is quite reasonable that public health scientists and people offered the vaccine want to have a high consistency in analysis and safety data and significant comfort in efficacy vs risk. For if the global population is to be offered a vaccine, or vaccines, even a small percentage of adverse reactions or a limited protective response will negate any viable uptake, potentially extending the period before natural herd immunity can confer some sense of control for years.
Because the beneficial impact of vaccines requires widespread public acceptance to achieve population-level immunity, as well as individual immune systems capable of responding appropriately, vaccination policies from their earliest days have been subject to political and ideological debate, pitting individual rights against public health, referred to as vaccine hesitancy. Read the rest of this entry »
There is an old saying that we have seen which is very applicable to a number of positions held by various groups:
‘You can’t reason someone out of a position they didn’t reason themselves into’.
What do we mean?
Obviously, ongoing challenges across all aspects of comprehension with the Covid-19 pandemic has spurred numerous opinion pieces (including our own), polarised groups into entrenched positions and created a tsunami of conspiracy theories, and a small number of potential clinical interventions (so far), some of which appear to be viable, safe and effective, others less so. Read the rest of this entry »
It is a matter of ongoing review that different countries have experienced different levels of infection with SARS-Cov-2. Some had had very low rates to date with a similarly adjusted associated loss of life and others such as the USA, UK and India have had high levels of infection and associated loss of life.
The results of the new study, published (July 21 2020) in JAMA Internal Medicine suggest that, despite the rising numbers, the infection rate suggested to be necessary for herd immunity has yet to be reached. However, the data indicates that many of these people likely had no symptoms or mild illness and may have had no idea that they were infected. The authors indicate that as many as 40% have been without symptoms while the symptoms brought on by the disease can be highly variable.
Existing immune competence, viral load and other elements previously discussed are suggested as reasons for such a high asymptomatic level and the related number needed to be exposed to determine the gradual collapse in new cases is accordingly adjustable. Read the rest of this entry »
Whilst the subject of viral disease is by virtue of the time span since Jan 2020 somewhat overcovered in musings as well as science reviews, each month brings new clarity on the intersecting health and economic risks of a global pandemic.
The SARS-Cov-2 virus is a recognised threat to billions of people around the world, with the risk being compounded for people who live in overcrowded homes, who don’t have access to safe drinking water or nutritious food and are obese. Other risk factors are also relevant but being overweight, according to one of the largest UK studies on the Covid-19 mortality rate to date from Glasgow University, found that as a patient’s Body Mass Index (BMI) increases, so does their risk of having a severe case of the virus. Obesity is a chronic inflammatory disease and it starts with an inflammation in adipose tissue, or body fat. Researchers have proposed there may be a link between this inflammation and an immune system response in Covid-19 patients ultimately manifesting in the terminal induction of the “cytokine storm”. Read the rest of this entry »