February 8, 2021 - News
P.J. Hoffmeyer MD
President SFITS
Research and investigations regarding the WHO declared COVID 19 pandemic, its causal virus and variants, and its impact on human health are ongoing. The consensus is that transmission of the virus is mainly airborne and through contact. Importantly, unlike many infections asymptomatic carriers may spread the virus. Undisputed prevention measures have gained worldwide acceptance and include social distancing, hand hygiene and wearing of appropriate face cover. Treatment is essentially supportive.
There are different types of tests on the market available globally. The PCR test is the most reliable but obtaining the result requires a delay of 24 hours. Antigenic tests have faster read-outs but are less reliable. Positivity of these tests signify that the subject is a potential spreader. Serological tests are only of public health interest insofar as they verify the presence of anti-bodies signifying an infection in the past. In many countries tests performed not less than 72 hours before entry are mandatory and may even be followed by a period of quarantine.
Different types of vaccines against COVID 19 have been generated in record time. Whether, and how effectively, they protect against variants of the virus, present and future, is still disputed. To this day vaccines are not freely available and this at least for the next six to twelve months. Furthermore, there is no evidence that vaccination prevents patients from remaining carriers and spreaders of the virus, so it must be accepted in light of current knowledge that vaccinated individuals may remain asymptomatic spreaders.
Concerning a vaccination passport and an obligation to vaccinate many voices (WHO, GAVI) caution against its use in the current situation. Legally a private organization or entity is free to issue such an obligation although it might be considered discriminatory. Introducing a mandatory vaccination for SFITS course participants would, at this time, countermand vaccination strategies established by regional or national health authorities and even provide incentives for fraud. Proof of vaccination is not proof of immunity. It should also be noted that Covid-19 “survivors” develop some form of immunity and therefore an immunity passport may have to be delivered.
The SFITS has decided to issue the following recommendation: From an ethical standpoint an obligation to display a vaccination certificate as a condition of participation to a SFITS event would only be acceptable if and when efficacious and safe vaccination was freely available at an affordable price.
In consequence, the adherence by all participants to mitigation measures such as physical distancing, face cover wearing in closed spaces, or outside if distancing is impossible, and frequent hand washing are essential and need to be made mandatory for all participants, independently of their personal vaccination or immunity status. Disinfection of instruments and surfaces will be necessary in case of hands-on activities and the premises must be adequately ventilated.
Pre-course testing (PCR) less than 72 hours prior may be made mandatory, this does not infringe on ethical principles as this may be required for other activities such as travel. The results of the test must be verifiable. If complete protection is the goal, it would be necessary to proceed with a first PCR test followed by a quarantine of 7 to 14 days then proceed with a second PCR test.
If and when vaccination becomes freely available vaccination passports might be required for attendance, as long as they can be verified and authenticated. However, until the pandemic is declared officially terminated mitigation measures will remain the standard.
The first patients developed symptoms of COrona VIrus Disease-19 (COVID-19) on December 1, 2019 in Wuhan, China after which rapid human-to-human transmission and intercontinental spread later ensued, being declared a pandemic by the WHO on March 11th 2020. As of February 1st 2021 there have been worldwide 103,569,867 cases and 2,238,898 deaths.
[Institute for Health Metrics and Evaluation : ihme@healthdata.org]
Transmission is dependent on viral load and is believed to occur essentially through droplets or aerosols originating from the upper respiratory tract. The droplets (>μ5m) and aerosol (<5μm) do not travel more than 1-2 m. The virus can survive on metallic, glass or plastic material for up to 72 hours. A fecal-oral transmission is also possible. These methods of transmission justify social distancing, face covers, frequent hand washing and adequate ventilation in closed areas. It is, as of yet, unclear whether vaccination stops transmission or whether it protects only from the development of severe disease, the vaccinated person remaining contagious. The same is true of patients having previously been affected by Covid.
[Harrison AG et al. Trends in Immunology, December 2020, Vol. 41, No. 12]
The virus causes symptoms in the upper respiratory tract (sinusitis, rhinitis, pharyngitis), the pulmonary system (cough, dyspnea, pneumonia, embolism), the central nervous system (headache, impaired consciousness, loss of smell/anosmia and taste/ageusia), muscular (myalgia, back pain) the skin (painful discolorations), digestive system (diarrhea, nausea, vomiting, abdominal pain), the cardio-vascular system (coagulation disorders, phlebitis, chest pain, arrhythmias) and systemic symptoms (fever, chills, fatigue, malaise, cytokine storm). In conclusion studies show that anosmia/ageusia, fever, and myalgia are the strongest predictors of positive tests while nose congestion and sore throat were, when in isolation, associated with negative tests.
[Lan FY, Filler R, Mathew S, Buley J, Iliaki E, Bruno-Murtha LA, Osgood R, Christophi CA, Fernandez-Montero A, Kales SN. COVID-19 symptoms predictive of healthcare workers’ SARS-CoV-2 PCR results. PLoS One. 2020 Jun 26;15(6):e0235460. doi: 10.1371/journal.pone.0235460. PMID: 32589687; PMCID: PMC7319316]
Treatment is essentially symptomatic including oxygen supplementation, antivirals, monoclonal antibodies, prophylactic anticoagulants, anti-inflammatories and cortisone. Tests and trials for the introduction of new medications are ongoing.
[NIH Covid-19 Treatment guidelines]
The incidence of Covid-19 leading to hospitalization increases with age. Patients aged 0-50 years of age make up 23% of the total of hospitalized patients and patients over 70 make up 50 % of hospitalized patients. Mortality of hospitalized patients reaches 16% with Covid-19 compared to 5.8% of mortality in patients hospitalized with influenza. These figures rise significantly in the face of comorbidities (Hypertension, obesity, diabetes).
[Piroth L, Cottenet J, Mariet AS, Bonniaud P, Blot M, Tubert-Bitter P, Quantin C. Comparison of the characteristics, morbidity, and mortality of COVID-19 and seasonal influenza: a nationwide, population-based retrospective cohort study. Lancet Respir Med. 2020 Dec 17:S2213-2600(20)30527-0. doi: 10.1016/S2213-2600(20)30527-0. Epub ahead of print. PMID: 33341155; PMCID: PMC7832247]
SARS-CoV-2 of the family Coronaviridae are lipidic membrane enveloped, positive-sense single-stranded RNA viruses. NB: The lipidic membrane makes the virus particularly sensitive to the solvant action of soap and hydroalcoholic solutions. Its genome comprises 14 open reading frames (ORFs), two-thirds of which encode 16 nonstructural proteins (nsp 1–16) that make up the replicase complex. The remaining one-third encodes nine accessory proteins (ORF) and four structural proteins: spike (S), envelope (E), membrane (M), and nucleocapsid (N), of which Spike mediates SARS-CoV entry into host cells by fixing itself to the ACE receptor on the host cell membrane.
Mutant coronavirus variants are many (Spanish variant: 20A.EU1; UK variant : B117; South African variant : B1351; Brazil variant : P1 and P2; California variant B1426 etc.) and some are more contagious because the mutation alters the Covid-19 spike protein and which improves its ability to bind to a receptor found on the surface of human cells called ACE2. This allows the virus to penetrate the cell and to create havoc. Viral mutations and infectivity evolve rapidly and new mutations are described almost daily.
The virus is destroyed by the immune system (Antibody production and T-cell lymphocytes) which is boosted by the vaccines. The vaccines, although all are effective to some degree, may not be as efficacious against the new variants. The mRNA vaccines seem more effective generally against all variants compared to the other types of vaccines.
[Harrison AG et al. Trends in Immunology, December 2020, Vol. 41, No. 12; Korber et al., 2020, Cell 182, 812–827 August 20, 2020 https://doi.org/10.1016/j.cell.2020.06.043]
These tests determine whether one is infected with the new coronavirus or not and studies show that these tests are more than 90% reliable. The test is performed with a nose and throat swab and the result is usually available after 24 to 48 hrs. The test determines the presence or absence of viral genetic material. There is a charge for this test if it is done for non-medical reasons (Travel, attending a course etc.).
[Böger B, Fachi MM, Vilhena RO, Cobre AF, Tonin FS, Pontarolo R. Systematic review with meta-analysis of the accuracy of diagnostic tests for COVID-19. Am J Infect Control. 2021 Jan;49(1):21-29. doi: 10.1016/j.ajic.2020.07.011. Epub 2020 Jul 10. PMID: 32659413; PMCID: PMC7350782.]
To ascertain that an individual is Covid free certain countries require a negative PCR test followed by 7 to 14 days of quarantine and a second negative PCR before entry.
[https://www.bag.admin.ch]
Rapid antigen tests yield a result within 15 to 20 minutes. Like PCR tests, they determine whether one is infected with the new coronavirus. The tests detect specific viral proteins such as the spike prorein— known as antigens — on the surface of the virus. The test is done by means of a nose and throat swab. Some companies are developing saliva tests for home testing. This type of test can be performed as a precautionary measure (i.e. course attendance). However, they are less sensitive than PCR tests and an infected person with a small viral load may have a false negative result.
[https://www.bag.admin.ch]
Serological tests are used to detect antibodies in the blood, for example antibodies against a protein of the coronavirus, such as the spike protein. Antibodies indicate that the tested person has been in contact with the virus. This test is not indicated as a precautionary measure as the current status of the person concerning presence or absence of the virus is not established.
[https://www.bag.admin.ch]
Inactivated or weakened virus vaccines, which use a form of the virus that has been inactivated or weakened so it doesn’t cause disease, but still generates an immune response. Sinovac, Sinopharm (China), Bharat (India)
Protein-based vaccines, which use harmless fragments of proteins or protein shells that mimic the COVID-19 virus to safely generate an immune response. Novavax (USA); Sanofi GSK (France)
Viral vector vaccines, which use an virus that has been genetically engineered so that it can’t cause disease, but produces coronavirus proteins to safely generate an immune response. Astra-Zeneca- Oxford (UK-Sweden); Janssen (USA); Pasteur (France); Spoutnik V (Russia)
RNA and DNA vaccines, a cutting-edge approach that uses lipid nanoparticle-formulated, nucleoside-modified mRNA vaccines encoding the prefusion spike glycoprotein of SARS-CoV-2, the protein that itself safely prompts an immune response to the virus that causes COVID-19. Pfizer- BioNtech (USA); Moderna (USA); Curevac (USA)
However, it must be emphasized that vaccination does not equal guaranteed immunization:
[https://www.who.int/news-room/q-a-detail/coronavirus-disease-(covid-19)-vaccines; https://www.cdc.gov/]
The goals of testing and vaccination are diverse:
Testing is a public health measure that aims to reduce the spread of the disease by identifying and isolating infected persons thereby reducing overall contagion.
Vaccines act at two levels: At the individual level, by affording protection to individuals from the effects of the disease, and at the societal level by promoting herd immunity to the population, thus bringing transmission to an end.
Testing (PCR or Antigenic) as a precautionary measure has become widely available and although involving a financial burden, the asymptomatic individual may choose to be tested or not. Furthermore, in any given individual a negative test is only as good as that individual’s next test. It should also be taken into account that there are very few contraindications, medical or otherwise to being tested and testing gives reliable results.
The goals of vaccination are: Reduce the number of severe cases of the disease and the number of deaths; Ensure that the provision of healthcare can be maintained; Reduce the negative health, psychological, social and economic impacts of the coronavirus pandemic. Vaccination certainly affords individual protection against severe manifestations of Covid-19 however, issues persist. At this time the availability of vaccines is scarce in the world. This is due to production and distribution difficulties. Currently, vaccine is not freely available and therefore individuals cannot obtain the vaccine unless they are in an “at risk” category as determined by the authorities of the countries and regions. This situation will change although there are no certainties as to when this will occur. Therefore, vaccination should not be declared mandatory for any given activity (travel or attending events) until vaccines become freely available and are left up to the decision of an individual. Also, vaccination does not, in the current state of knowledge, prevent transmission if the individual is an asymptomatic carrier.
[www.foph-coronavirus.ch/vaccination]
Concerning a vaccination passport many voices (WHO, GAVI) caution against its use in the current situation. At the present time, WHO recommends to not introduce requirements of proof of vaccination or immunity for international travel as a condition of entry as there are still critical unknowns regarding the efficacy of vaccination in reducing transmission and limited availability of vaccines. Proof of vaccination should not exempt international travelers from complying with other travel risk reduction measures.
Immunity passports are considered today as unethical and impractical, pointing to uncertainties relating to COVID-19, immunity, issues with testing, perverse incentives, doubtful economic benefits, privacy concerns, and the risk of discriminatory effects.
The vaccine passport will be ethically acceptable when there comes about timely access to vaccination for everyone. Introducing a mandatory vaccination for SFITS course participants would, at this time, countermand vaccination strategies established by regional or national health authorities and even provide incentives for fraud.
[Bloom BR, Nowak GJ, Orenstein W. N Engl J Med 2020; 383:2202-2204 ; Gupta R, Morain SR. J Med Ethics 2020;0:1–5. doi:10.1136/medethics-2020-106850]
Administrative issues are related to vaccination passports such as the certification and validation of such passports issued by relevant authorities. Amongst others, solutions may be found with the CommonPass Platform built up by the Common Trust Network. However, data protection and privacy issues remain unsolved at this time.
[Common Trust Network]
The goal of the SFITS strategy needs to be clearly defined. It should be considered that the goal is the protection of participants as a group and the avoidance of cluster creation. This SFITS strategy must be based on guidelines adhering to scientific and ethical principles and must be applied to all participants regardless of function or age. The strategy must be in accordance with local regulations.
Responsibility and liability issues are of major importance and must be addressed.
In consequence, the adherence by all participants to mitigation measures such as physical distancing, face cover wearing in closed spaces or outside if distancing is impossible and frequent hand washing or hand disinfection are essential and need to be made mandatory. Disinfection of instruments and surfaces will be necessary in case of hands-on events and premises need to be well ventilated.
Pre-course testing (PCR or Antigenic) less than 72 hours prior may be made mandatory, this does not infringe on ethical principles as this may be required for other activities such as travel. The results of the test must be verifiable. (If complete protection is the goal it would be necessary to proceed with a first PCR test then quarantine 7 to 14 days then proceed with a second PCR test).
If and when vaccination becomes freely available vaccination certificates/passports might be required for attendance, as long as they can be verified and authenticated. However, until the pandemic is declared officially terminated mitigation measures will remain a necessity.
