Vaccines, convalescent plasma, and monoclonal antibodies for covid-19BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m2722 (Published 09 July 2020) Cite this as: BMJ 2020;370:m2722
All rapid responses
I read with interest the editorial on vaccines and passive immunity (1), which ‘injected’ a note of caution in the expectations of the public. Professor Sewell et al give the triple warnings of vaccines being less effective in those with greatest need (ie older age groups), having likely short term protective immunity or even injurious effect, and the need for careful timing of treatments such as convalescent plasma to avoid progression to a overactive immune-inflammatory response (cytokine storm) with consequent severe organ damage in those predisposed.
While intensive research for effective and safe vaccines continues, in addition to public health measures, we should search widely for ways to ameliorate the underlying pathological processes at an early stage in those affected. Mast cells are known to be the main source of cytokine release that leads to lung damage in SARS-Co-V2. Mast cell stabilisers together with mediator blockers may therefore help to ameliorate the pro-inflammatory effects of covid-19.
Mast cells are the sentinels lining mucosal and connective tissues throughout the body, including the respiratory tract, being located at the junction point of the host and external environment at places of entry of antigen. They are heterogeneous, multifunctional immune master-cells containing an exceptionally large number of granules which store preformed and other inflammatory mediators and equally have a large number of interactions. Their physiological functions include regulation of vasodilation, vascular homeostasis, innate and adaptive immune responses, angiogenesis, and venom detoxification. On activation, mast cells release preformed histamine, proteases, (chymase, tryptase, and carboxypeptidase A type), and later, proinflammatory cytokines including IL-1, IL-6, leukotrienes and TNF α
In the respiratory tract, the immune response to mast cell activation results in airway constriction, increased mucous production, rhinorrhoea, fever and cough. Mast cell degranulation increases vascular permeability and local oedema, which can obstruct nasal airways and lead to congestion. There is increased production of mucus and its accumulation may block off the sinuses and result in a bacterial infection.
Mast cell stabilisers and mediator blockers, such as antihistamines and anti-leukotrienes, are widely used in allergic conditions and mast cell disorders, which may have similar respiratory symptoms, and are therefore logical substances to consider in the fight against SARS-CoV-2. (2)
Mast cell stabilisers include Vitamin D (3), ketotifen (also an antihistamine), sodium cromoglycate, quercetin, luteolin. Vitamin C also has a role in mast cell stabilisation. These could be trialled individually or in combination at an early stage of infection in a patient with moderate symptoms or on admission to assess effect on the subsequent course.
1. Vaccines, convalescent plasma, and monoclonal antibodies for covid-19 https://www.bmj.com/content/370/bmj.m2722
2. Mast cell stabilisers, leukotriene antagonists and antihistamines: A rapid review of the evidence for their use in COVID-19 https://www.cebm.net/covid-19/mast-cell-stabilisers-leukotriene-antagoni...
3. Quercetin and Vitamin C: An Experimental, Synergistic Therapy for the Prevention and Treatment of SARS-CoV-2 Related Disease (COVID-19) https://www.frontiersin.org/articles/10.3389/fimmu.2020.01451/full
Competing interests: No competing interests
COVID-19 Pandemic, vaccines, vaccinations and antibody therapies: The paradox of making haste slowly with cautious optimism
The ‘Unprecedented Ragingly Devastating 21st Century Scourge’ continues to ‘Task and Challenge’ the ‘Global Capacity/ Preparedness’ to ‘Weather the Storm’ [1-6]! The deployed ‘Global Armoury’ for the ‘COVID-19 Pandemic’ is increasingly undermined by the ‘Rapidly Dynamically Transmuting Pandemic Specifics’ which have necessitated the ‘Deluge of COVID-19 Research Outpourings’ but which, unfortunately with STRICT ADHERENCE to ‘Best Research Standards’, are largely reported as ‘COVID-19 Research Waste’ [7-10]!! While some ‘Communications’ call for OVERLOOKING the ‘Time-tested Research Standards’ [11-14], others advocate STRICTLY UPHOLDING ‘Conventional Research Standards’ to eclipse the enlargement, and possible reduction, of extant ‘COVID-19 Infodemic’ [15,16]!! The level of ‘Politics’ polluting the ‘Science-Facts-Evidence’ of ‘COVID-19 Pandemic’/ ‘COVID-19 Research’ has the POTENTIALITY of assuming ‘Pandemic Proportions’ !! Some ‘Issues’ will be disposed concerning Vaccines, Vaccinations and Antibody Therapies for ‘SARS-CoV-2’ and ‘COVID-19’.
The ‘COVID-19 Pandemic Devastations’ are due to ‘Lethality’ and ‘Transmissibility’ of ‘SARS-CoV-2’ against which ‘Global Interventions’ are directed! These reflect ‘Pathogenicity’ and ‘Immunogenicity-Antigenicity’ of the ‘Novel Coronavirus’! Some ‘Anti-COVID-19 Pharmaceuticals’ are directed against ‘SARS-CoV-2 Lethality’ to influence the ‘Clinical Outcomes’ for ‘Persons Contracting the SARS-CoV-2’ and are currently in various ‘Stages and Phases of Clinical Trials’: ‘Anti-COVID 19 Drugs, Vaccines and Antibody Therapies’!! These ‘Anti-COVID-19 Pharmaceuticals’ are expected to also influence ‘SARS-CoV-2 Transmissibility’ altering the ability of ‘Transmission’ by ‘Persons who Contract SARS-CoV-2’!! These ‘Anti-COVID-19 Pharmaceuticals’ are still largely in ‘Clinical Trials’ requiring STRICT ADHERENCE to ‘Best Research Standards’ COMPLETELY DEVOID of ‘Worrisome Politics’!! The WHO has recommended that ‘Politics’ should be ‘Quarantined’ in the ‘COVID-19 Pandemic’!!!
The ‘SARS-CoV-2 Transmissibility’ can also be altered by ‘Anti-COVID-19 Pharmaceuticals’ still largely in ‘Clinical Trials’ and ‘Anti-COVID-19 Non-Pharmaceutical Interventions (NPIs)’! The latter are the ‘Interventions that Work and still also in the Works’ and should attract proportionately more ‘Research-Development Investments’ but currently not so; ‘Interventional Inequity’ [10,18]!! The NPIs are part of the ‘COVID-19 Mitigation Methods’ [19-27]!!! This current ‘Communication’ addresses ‘Anti-COVID-19 Pharmaceuticals’ still largely in ‘Clinical Trials’ and, hence, the World MUST ‘MAKE HASTE SLOWLY’ with demonstrable ‘CAUTIOUS OPTIMISM’ kowtowing to the ‘Best Research Standards’ and AVOIDING ‘Dangerous Politics’; The ‘Uncertainties and Unknowns’ concerning the ‘Pharmaceuticals’ are legion!!! The ‘Anti-COVI-19 Drugs’ are not discussed in this ‘Communication’.
The ‘Non-Drugs Anti-COVID-19 Pharmaceuticals’ are bifid concerning their ‘Domain of Action’: ‘Active Immunity’ and ‘Passive Immunity’! For ‘Active Immunity’, several ‘Candidate Vaccines’ are in different ‘Phases of Clinical Trials’ [28,29]! Many such ‘COVID-19 Candidate Vaccines’ target the ‘Receptor Binding Domain (RBD)’ Region of the ‘Viral Spike Protein’ required for ‘Cell Invasion’ by binding to the ‘ACE 2 Receptor’ on the Human Cell Membrane ! There are several ‘Issues in the Works’ concerning this ‘Vaccine-Target Approach’: Do they induce ‘Neutralizing Antibodies’ sufficiently blocking the ‘ACE 2 Receptors’, ‘Antibody Production Determinants’, ‘Antibody Production Response Time’, ‘Antibody Span/ Reinfection-Reactivation’, ‘Antibody Presence/ Level’ equivalent to ‘Immunity/ Protection’, ‘T Cell Role’ etc? The ‘Implications’ of ‘SARS-CoV-2 Genetic-Genomic Diversity’/ ‘Viral Recombination Capacity’ need exploration re: ‘Vaccine-Target Approach’ ! The ‘RBD of the Spike Protein’ is relatively conserved with some ‘Mutations’ but very ‘Substantial Mutations’ possibly affect ‘Vaccine Effectiveness’ [31-33]!! ‘Lessons from Previous Epidemics-Pandemics’ are instructive re: sustained ‘Interest and Impetus’ for ‘Candidate Vaccines Research Enterprise’ with waning of the ‘Pandemic Numbers’ !! From previous experience, ‘Big Company Investments’ dwindle with ‘Victory over the Pandemic’ with abandonment of ‘Further Candidate Vaccines Research-Production Commitments’!! Additionally, the efforts to produce ‘Coronavirus Vaccines’ against SARS and MERS were unsuccessful  and ‘Vaccines against Other RNA Viruses’ were also not successful with some even causing ‘Disease Exacerbations’ from ‘Antibody-Dependent Enhancement (ADE)’ !! The ‘SARS-CoV-2 Genetic-Genomic Diversity’ begets ‘Vaccine Production Precursor Diversity’: Whole Virus, Viral Genetic Sequence, Viral Proteins etc!!!
Concerning ‘Anti-COVID-19 Pharmaceuticals’ and ‘Passive Immunity’, there are ‘Bifid Possibilities’: ‘Convalescent Plasma Antibodies in Clinical Trials’  and ‘Monoclonal Antibodies in Clinical Trials’ [38,39]! The success with ‘Convalescent Blood’ for ‘Ebola Virus Disease’ in 2014 is instructive/ ‘Driving Impetus’ for the ‘Convalescent Plasma Trials’ !! Still ‘Unresolved Issues’ with ‘Convalescent Plasma Antibodies’: ‘Many Antibodies’ with some ‘Non-Neutralizing’, ‘Non-Viral Spike Protein Targeted’, ‘Optimal Administration Time’ and possible ‘Antibody-Dependent Enhancement (ADE)’/ ‘Worsening Disease’; ‘T Cells from Recovered Patients’? For ‘Monoclonal Antibodies’, again, ‘Bifid Approach’: ‘Humanized Monoclonal Antibodies’ from ‘B Cells from Recovered COVID-19 Patients’ and ‘Laboratory-based Genetically Engineered Monoclonal Antibodies’ [41,42]!! ‘Monoclonal Antibodies’ are beneficial: ‘Single Neutralizing Antibodies’ more specific to ‘Target Sites’ compared with ‘Convalescent Plasma’! The ‘COVID-19’ induces ‘Immune Dysregulation’ with very ‘High Antibody Levels-Immune Hyperactivity’ in Severe Disease [43,44] making ‘Optimal Time for Antibody Administration’ an ‘Unresolved Issue’ re: Possible ‘Antibody-Dependent Enhancement’! This applies to ‘Convalescent Plasma’ and ‘Monoclonal Antibodies’!! Outstanding ‘Issues’: ‘Cross-Neutralizations’, ‘Clonal Expansions’, ‘Somatic Hypermutation (SHM)’ etc [45,46]!!!
Another ‘Issue in the Works’ is ‘Vaccination’ even after ‘Successful Candidate Vaccines Research’! The ‘Issues’: Mass Production, Supply Chain Variables, Distribution and ‘Inverse Equity Hypothesis’ with worsening ‘Vaccines Access-Health Inequalities’; Those most in need possibly are the least to receive the critically needed ‘Interventions’!! Another ‘Issue for the Works’’: ‘VIP Triad’ even when there is ‘Vaccination’! Does ‘Vaccination’ necessarily result in ‘Immunization’ and does this necessarily result in ‘Protection’? For example, the ‘Elderly Population’ who experience ’More Severe COVID-19’ are reported with poor ‘Immune Response’ to ‘COVID-19 Candidate Vaccines’ from ‘Immune Senescence’ !! Would this necessitate ‘Frequent/ Multiple Vaccinations’ or ‘Vaccine Adjuvants’? An evolving ‘Unimaginable Issue’ is ‘Compromised Public Trust’ on the ‘COVID-19 Candidate Vaccines Trials’ because of the ‘Frightening Reported Progress Speed’ which is conjectured will most likely breach ‘Conventional Research Standards and Integrity’!! The ‘Public Acceptance of Vaccination’ is now seriously questioned!! This will likely affect Vaccination Coverege, Population Antibody Levels and Herd Immunity!!! The dangerous influence of ‘Politics and Political Pressure’ over ‘Science, Facts and Evidence’ concerning ‘COVID-19 Pandemic’ is, once again, brought to the fore !!
This ‘Communication’ is a ‘Contribution’ to the extant ‘Anti-COVID-19 Pharmaceuticals Conversations’ as they concern ‘Candidate Vaccines’, ‘Vaccinations’ and ‘Antibody Therapies’ (‘Convalescent Plasma’ and ‘Monoclonal Antibodies’) with a ‘Clarion Call’ to ‘MAKE HASTE SLOWLY’ with ‘CAUTIOUS OPTIMISM’!
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24. Eregie C.O. COVID-19 Pandemic and face mask use: Limitless matters for extant conversation. https://www.bmj.com/content/369/bmj.m2030/rr-0 of 11th June 2020
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Professor Charles Osayande Eregie,
MBBS, FWACP, FMCPaed, FRCPCH (UK), Cert. ORT (Oxford), MSc (Religious Education),
Professor of Child Health and Neonatology, University of Benin, Benin City, Nigeria.
Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria.
UNICEF-Trained BFHI Master Trainer,
ICDC-Trained in Code Implementation,
*Technical Expert/ Consultant on the FMOH-UNICEF-NAFDAC Code Implementation Project in Nigeria.
*No Competing Interests.
Competing interests: No competing interests
The ongoing pandemic of Coronavirus disease-2019 (COVID-19) has threatened millions of lives globally. An effective vaccine against COVID-19 is need of the hour. India has been a hub for vaccine productions and Indian pharmaceutical companies have contributed immensely to the vaccine related projects running all over the world. Indian companies have also been pioneers in starting working on COVID-19 vaccine and finishing preclinical trials1. Recently, two indigenous COVID-19 vaccines, Covaxin by Bharat Biotech and ZyCoV-D by Zydus, Cadila, have got regulatory approval to enter Phase I/II human clinical trials1. COVID-19 cases are surging fast in India, hence the commencement of the clinical trials for the vaccine has raised great hope and brought a sense of relief in the common people. However, as any proposed viral vaccine may have important safety risks for the clinical trial participants, and subsequent users, related issues have now come to the fore.
It has been a global understanding among medical institutions and research organizations that sticking to the guidelines set by World Health Organization (WHO) for human clinical trials for any vaccine is a must2, and any haste in that may be risky. Also, keeping to the standard ethical principles in selecting clinical trial participants, following up for the adverse effects, taking due care of their safety, and eligible scrutiny of the trial results are the mandatory concerns which cannot be overlooked. It is also necessary that the health centres chosen for the vaccine trial should have prior experience in running clinical trials2.
Surprisingly, Indian Council of Medical Research (ICMR), the top medical research regulatory body of the country, has asked participating health centres for setting a target completing all three phase clinical trials for Covaxin until 15th August, 20203,4. Covaxin has been developed in partnership with ICMR’s National Institute of Virology (NIV). The hastened approach by the regulatory body has astonished medical experts, biological scientists, and scientific organizations of the country 4 . However, later, the regulatory body has clarified on the issue and said that it was only an attempt to fast track the process, and any deadline has not been fixed. The organization has also assured that the quality of the vaccine and participant’s safety will not be compromised5. We hope that, hereafter the standard operative procedures will be followed and participants’ safety will remain a priority for the COVID-19 vaccine clinical trials in the country.
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2. WHO Expert Committee on Biological Standardization Sixty-seventh report /Guidelines on clinical evaluation of vaccines: regulatory expectations. https://www.who.int/biologicals/expert_committee/WHO_TRS_1004_web_Annex_...
3. Bharat Biotech ICMR [Internet]. [cited 2020 Jul 6];Available from: https://www.scribd.com/document/467859231/Bharat-Biotech-ICMR#download&f...
4. India’s Foremost Science Academy Calls ICMR’s August 15 Vaccine Deadline “Unfeasible” [Internet]. [cited 2020 Jul 6];Available from: https://thewire.in/science/indian-academy-of-sciences-covid-19-vaccine-i...
5. ICMR press release, July 4, 2020. [cited 2020 Jul 6];Available from: https://www.icmr.gov.in/pdf/press_realease_files/ICMR_Press_Release_0407...
Competing interests: No competing interests