COVID-19 Vaccine

A vaccine is a weakened or killed pathogen or part of a pathogen that, when injected into the body, stimulates related antibody production (Vaccines, 2020). This results in a primary response to the epitopes of the modified immunogen and generates immunity by inducing the production of a large amount of B and T memory cells (Mak, 2014). Vaccination is therefore the clinical application of immunisation, designed to artificially help the body defend itself against a pathogenic threat (Vaccines, 2020).

There are numerous vaccine trials currently active, all attempting to find a suitable vaccine to prevent infection with the coronavirus of 2019. A variety of companies are racing to be the first to develop their vaccine. This results in fast tracking of the vaccine development process, leading to possible neglect of safety checks. The most well known current trials for COVID-19 include:

· Moderna Therapeutics

o Current phase: Exploratory

o Method: mRNA-1273 (synthetic strand of RNA) administration may trigger the immune system to produce antibodies (Garde, 2020).

· CanSino Biologics

o Current phase: Exploratory (planned clinical trial approved in China)

o Method: Snippet of coronavirus genetic code is taken and is entwined with that of a harmless virus. This is administered and exposes the patient to the novel virus and spurs the production of antibodies (Garde, 2020).

· Arcturus Therapeutics

o Current phase: Preclinical

o Methods: Engineered RNA that has been edited to encode for proteins that will protect against infection (Garde, 2020).

· BioNTech

o Current phase: Preclinical (clinical phase planned to begin in April 2020)

o Method: mRNA vaccine (Garde, 2020).

· CureVac

o Current phase: Preclinical (animal testing to begin in April 2020)

o Method: Man-made mRNA that will trigger the production of proteins that will prevent the infection (Garde, 2020).

· Johnson & Johnson

o Current phase: Preclinical (human trials to begin in November 2020)

o Method: Deactivated version of the virus administered to produce immunogenicity (Garde, 2020).

· Sanofi

o Current phase: Preclinical (human trial in 6 months)

o Method: Mixing RNA of coronavirus with that of a harmless virus leading to a chimera that will prime the immune system (Garde, 2020).

· Seattle Trial

o Current phase: Clinical (Writer, 2020)

o Method: Genetic material from the “spikes” of the coronavirus, which are receptors used to attach to and gain entry into a cell, administered into the body and then producing an immune response (Ahmed, 2020).

The process of vaccine development is supposed to be a strictly governed process, with stages that are essential for keeping new vaccines safe and efficient. As shown in these trials not all the stages have been followed, as the development of vaccines has been fast tracked. CanSino Biologics, BioNTech, Johnson & Johnson, and Sanofi all plan on omitting the preclinical stage of their trials, following the example of the Seattle Trial, therefore neglecting the important information about the vaccine’s safety and immunogenicity in a live subject. The Investigational New Drug (IND) application, that needs to have been submitted and approved by the Food and Drug Safety Administration (FDA) before clinical trials begin, is not completed and the clinical trials proceed without this important safety regulation (Offit, 2018).

Each stage of these trials has also been fast tracked. The exploratory stage of the trial is supposed to last for 2 – 4 years (CDC, 2020; Offit, 2018) and this has been reduced to a few months. The preclinical stage, the stage that these companies are omitting, is vital enough to warrant being allocated at least 1 – 2 years for completion (Offit, 2018). Typical vaccine development can take up to 15 – 20 years if the process is done thoroughly (Writer, 2020) and the reason that the process is long, strictly enforced and governed is simple – safety. Moderna Therapeutics themselves have stated that the human trial is about ensuring the vaccine is not toxic, going so far as to offer participant $1,100 for their acceptance of the risk of participation (Schreiber, 2020). The National Institute of Allergy and Infectious Diseases has also expressed their concern that the vaccine could cause an “immune enhancement”, which would result in the vaccinee getting much sicker if they did contract the already deadly virus (Allan, 2020). It is worrying that we may need to rely on a poorly tested, possibly toxic vaccine to fight this pandemic. It will be up to each individual to decide if taking the vaccine is worth the risk of its adverse effects, or if the risk of not taking it is worth the risk of COVID-19.

References

Allan, A., 2020. Why The Push For A Quick Coronavirus Vaccine Could Backfire. [online] POLITICO. Available at: <https://www.politico.com/news/2020/03/20/why-the-push-for-a-quick-coronavirus-vaccine-could-backfire-139854> [Accessed 2 April 2020].

Ahmed, I., 2020. US Just Started The First Human Trial Of A Vaccine For The New Coronavirus. [online] ScienceAlert. Available at: <https://www.sciencealert.com/us-begins-first-human-trial-of-coronavirus-vaccine> [Accessed 27 March 2020].

Cdc.gov. 2020. Vaccine Testing And Approval Process | CDC. [online] Available at: <https://www.cdc.gov/vaccines/basics/test-approve.html> [Accessed 26 March 2020].

Garde, D., 2020. An Updated Guide To The Coronavirus Drugs And Vaccines In Development. [online] STAT. Available at: <https://www.statnews.com/2020/03/19/an-updated-guide-to-the-coronavirus-drugs-and-vaccines-in-development/> [Accessed 27 March 2020].

Mak, T., 2014. Primer To The Immune Response. 2nd ed. Elsevier, p.Chapter 14.

Offit, P., 2018. Vaccine Development, Testing, And Regulation. [online] Historyofvaccines.org. Available at: <https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation> [Accessed 27 March 2020].

Pokhrel, P., 2020. Differences Between Primary And Secondary Immune Response. [online] Microbiology Notes. Available at: <https://microbiologynotes.com/differences-between-primary-and-secondary-immune-response/> [Accessed 26 March 2020].

PublicHealth.org. 2020. How Vaccines Work | Publichealth.Org. [online] Available at: <https://www.publichealth.org/public-awareness/understanding-vaccines/vaccines-work/> [Accessed 26 March 2020].

Schreiber, M., 2020. The Risky Race For A Quick Coronavirus Vaccine. [online] The New Republic. Available at: <https://newrepublic.com/article/156932/risky-race-quick-coronavirus-vaccine> [Accessed 2 April 2020].

Writer, N., 2020. Researchers Fast-Track Coronavirus Vaccine By Skipping Key Animal Testing First. [online] livescience.com. Available at: <https://www.livescience.com/coronavirus-vaccine-trial-no-animal-testing.html> [Accessed 27 March 2020].

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