At the time when this article was written, there were over 62 million Covid-19 cases confirmed worldwide, including more than 1.4 million deaths. The world is now eagerly awaiting for vaccines that can help fight the pandemic, with hopes of returning to life as we previously knew it.
The world is eager for Covid-19 vaccines, with hopes of resuming normal life soon.
That hope now seems to come closer every day. On 28th November 2020, Prime Minister Tan Sri Muhyiddin Yassin announced that Malaysians are likely to have access to Covid-19 vaccines from as early as January 2021 and that the government had signed an early purchase agreement with pharmaceutical giant Pfizer to gain supplies of the vaccine1.
While we often hear that the Covid-19 vaccine is still under development in different types, and also heard of a phenomenon known as “vaccine hesitancy”, it is necessary for the public to understand the scientific makeup of the vaccine.
Dr S. Geetha Subramaniam, Associate Professor, Faculty of Health and Life Sciences (FHLS), INTI International University.
As such, we talked to Dr S. Geetha Subramaniam, Associate Professor; and Ms Lalita Ambigai Sivasamugham, Senior Lecturer, both currently with the Faculty of Health and Life Sciences (FHLS) at INTI International University and who specialise in Biotechnology, Microbiology and Immunology. These experienced academicians and researchers weighed in with their insights on the upcoming vaccinations.
According to them, vaccination schedules are used worldwide and are developed usually after years of research and continuous studies. Carefully developed vaccinations provide protection against infectious diseases such as diphtheria, measles, mumps and pertussis that could, if left untreated, result in serious illness and fatality.
Unfortunately, several factors including the growing popularity of anti-vaccination propaganda, isolated cases of adverse reactions, immunization resistance, religious prohibitions and pseudoscientific beliefs, and the rapid spread of misinformation via social media have fuelled the global problem of “vaccine hesitancy”.
“This phenomenon has caused increasing deaths globally among children over the past few years, with the recent death being reported in February this year in Malaysia when a 2-year-old boy in Johor Bahru died of diphtheria, a vaccine-preventable disease (VPD). For whatever reason, this boy was not vaccinated against this disease2,” pointed out Lalita, who specialises in microbiology and virology, and has been lecturing at INTI for more than 15 years.
Lalita further debunked other false beliefs, “Isolated cases of adverse reactions against a particular vaccine, especially when sensationalised over social media, must be thoroughly investigated by parents before they conclude that it could also be harmful to their children. After all, refusing to vaccinate children puts them and others at risk, leading to the spread of preventable diseases.”
Ms Lalita Ambigai Sivasamugham, Senior Lecturer, Faculty of Health and Life Sciences (FHLS), INTI International University.
Speaking as a specialist in medical biotechnology and microbes, Dr Geetha assures the public that: “Vaccines are developed under stringent regulations to ensure their safety and effectiveness. It generally takes 12 to 14 years for a vaccine to be developed from the bench to the shelf3. There are three stages in vaccine development which are exploratory, pre-clinical and clinical development4. Each must meet the stringent standards required before a vaccine can be released.”
Expanding on these stages, Dr Geetha shared that the exploratory stage starts with the identification of a potential target macromolecule in a pathogen that induces a strong immune response. This long process often has more than 1000 potential vaccine candidates with usually only one being successful enough for manufacturing.
“This is followed by rigorous testing of the formulated vaccine preparation that could be either a DNA vaccine, subunit vaccine, whole virus vaccine, vector vaccine and mRNA vaccine, which are analysed in vitro (outside the body) or in vivo (inside the body),” she continued.
The third stage, pre-clinical testing, which includes testing the vaccine on animals, is carried out before testing is done with humans.
“There must be sufficient data with the details of the development and vaccine production which are adequate to justify the progression of the vaccine candidate/s to clinical studies in humans5,” affirmed Dr Geetha, who holds a PhD in Medical Sciences from University Malaya, and served as an internal auditor for ISO/IEC 17025:2008 for a biosciences company before she joined INTI about seven years ago.
Besides serving as a bioscience lecturer, Dr Geetha is also the Lead Auditor for ISO 45001:2018 at INTI International University.
“Throughout the Covid-19 pandemic, we have kept our students abreast with the current biotechnological innovations in response to the pandemic. We incorporated this new information into our lecture and tutorial sessions,” stated Dr Geetha, explaining that these recent events were timely in expanding the understanding of students who study INTI’s Bachelor of Biotechnology (Hons) degree.
“Medical Biotechnology, Microbiology and Immunology are the three subjects in which we have incorporated new information to improve the students’ understanding of this pathogen that has devastated the entire world,” remarked Dr Geetha.
Recently, the world has seen very promising reports of two vaccines against the coronavirus; one by Moderna and the other by Pfizer and BioNTech. Both use mRNA vaccines to elicit immune responses against the spike (S) protein of the coronavirus. Initially, 20 vaccines were developed on a fast track with clinical trial phases starting in May 2020. However, the death of a 28-year-old man due to Covid 19 during the trial phase of the vaccine developed by AstraZeneca and Oxford University has raised a global concern on the safety of these vaccines6.
“Public acceptance of vaccines and their sufficient availability in the market are some of the challenges in the potential distribution of the Covid-19 vaccine,” admitted Dr Geetha.
Both Dr Geetha and Ms Lalita opined that the severity of the disease and its disruption to everyday life had put the vaccine development on a fast track.
“We must remember that we are dealing with a novel virus, one the world has not encountered before. Hence, it will take a while for us to know the full biological properties of the virus, its epidemiology, how our body elicits specific immune responses against it, the mutation rates of the virus, and the ability of the virus to undergo recombination,” Dr Geetha elaborated further.
“Although some reports are suggesting the possible use of the mRNA vaccine by the end of 2020, the exact timeframe will depend on the comprehensive report of the data garnered from the clinical trials,” said Lalita.
Going back to the basics of vaccine development, both Dr Geetha and Ms Lalita concluded that even when the Covid-19 vaccine reaches the public, it needs to be monitored continuously over the years through post-marketing and medical surveillance, to identify any adverse reactions that may be reported in patients using the vaccine.
1 Vaccines for 6.4mil M’sians next year, The Star, 28 Nov 2020.
2 https://www.nst.com.my/news/nation/2019/02/463016/unvaccinated-jb-boy-dies-suspected-diphtheria
3 Dr Khushroo Shroff, the Executive Director of Pfizer Vaccines Research and Development.
4 https://www.cdc.gov/vaccines/basics/test-approve.html
5 https://www.who.int/biologicals/publications/clinical_guidelines_ecbs_2001.pdf?ua=1
6 https://www.bbc.com/news/world-latin-america-54634518