Opinion

Addressing mRNA vaccine safety, efficacy concerns – Young Scientists Network

Covid-19 jabs formulated without using actual virus, so there’s no risk of infection or contamination

Updated 5 years ago · Published on 02 Feb 2021 7:00AM

Addressing mRNA vaccine safety, efficacy concerns – Young Scientists Network
The mRNA has been studied for a long time in lab and clinical settings, and the Covid-19 mRNA vaccines that have been approved were built on these scientific advancements. – AFP pic, February 2, 2021

THERE have been concerns highlighted about the messenger RNA (mRNA) vaccine over the last few weeks. 

As young Malaysian scientists, we would like to delve into the science and technology behind mRNA vaccines in the hope that it will provide a more holistic understanding.

Like the general population, the scientific community was caught off guard by the sudden appearance of Covid-19. Among other initiatives, there was an urgent need for scientists to develop a vaccine to stop the spread of the virus. 

Although the pandemic is unprecedented, scientists and global public health experts have been preparing for large-scale outbreaks since the 1990s. The coronaviruses that caused the previous SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome) epidemics, and now the Covid-19 pandemic, are among the harmful viruses and bacteria that made the priority list in the 2016 World Health Organisation R&D Blueprint for Action to Prevent Epidemics.

Scientists have been researching various new technologies to enable the rapid production of effective vaccines against such harmful viruses and bacteria. The mRNA has been studied for a long time in laboratory and clinical settings, and the Covid-19 mRNA vaccines that have been approved were built on these scientific advancements. 

It is for this reason, along with the dedicated public and private funding for Covid-19 research, that these vaccines were rapidly developed to combat the pandemic (click here for the history of the mRNA vaccine).

These vaccines use molecules called mRNA that contain information to instruct the cells in our body to produce a small fraction of the virus, which then triggers an immune response, allowing the vaccinated person’s immune system to defend itself against a natural Covid-19 infection.

Unlike traditional vaccines, Covid-19 mRNA vaccines are formulated without using the actual Covid-19 virus – live or attenuated – which attests to the safety of these vaccines, as they themselves will not cause a Covid-19 infection. In addition, as no live sample of the virus is used in their manufacture, there is no risk of virus contamination.

In December last year, two Covid-19 vaccines were approved by the US Food and Drug Administration. As soon as these mRNA vaccines were approved, many people were concerned about their safety and efficacy.

While these concerns are genuine, there is a need to address several misconceptions underlying them with clear scientific facts and information. Many articles available to the public have already addressed the scientific basis of mRNA vaccines. We would like to highlight a few issues, and hopefully bring more clarity.

A vaccine usually takes years to develop. However, due to the urgency of the pandemic, massive resources were put in globally – in terms of both human capital and funding – and Covid-19 mRNA vaccines were made a priority internationally to speed up clearance for clinical trials. 

The availability of advanced, high-end technologies such as computer simulation also contributed to the expedited development of Covid-19 mRNA vaccines.

These vaccines have gone through rigorous laboratory and animal testing, followed by comprehensive human clinical trials. To ensure the vaccines’ safety and efficacy, the trials involved up to 10 times the usual number of participants, recruited from diverse age groups and ethnicities. 

To read about the clinical trials and the breakdown of their volunteers, click here and here. There have also been numerous research efforts, both ongoing and completed, on mRNA vaccines conducted by scientists globally. 

Despite the speed, the development process of these vaccines followed the stringent safety standards set by global regulatory bodies, and they were approved at each phase of clinical trials.

The side effects of vaccination, whether with traditional or mRNA vaccines, have been documented in depth, and can be found online. The side effects of Covid-19 mRNA vaccines have also been transparently reported on by manufacturers. 

It is known that some people who have received these vaccines commonly experienced soreness, a swollen arm, fever, and/or chills. However, these side effects are not long-term, they are not dangerous, and they have been documented to disappear in due time. 

With respect to the high-profile cases of deaths and more serious side effects reportedly after taking the Pfizer mRNA vaccine, there are explanations for most of these cases indicating that they are not related to the vaccination. Click here, here and here to read the explanations.

There has also been concern about the efficacy of Covid-19 vaccines, whether the live or attenuated vaccines, or mRNA vaccines, against newer variants of the virus circulating globally.

However, recent studies have shown that mRNA vaccines will remain effective in protecting against different Covid-19 variants because they were designed to target a part of the virus that is less susceptible to genetic changes.

Also, mRNA vaccines, and those made using the live or weakened virus, are designed to trigger a more complex and broad immune response to confer protection against the virus in different ways.

Therefore, the vaccines will still be able to trigger our immune system to fight against any mutated or new variants of the virus. Concurrently, scientists continue to closely monitor the appearance of new variants, while actively researching and preparing to produce new vaccines against potential variants, should the current list of vaccines be found ineffective in the future.

The safety and efficacy of Covid-19 vaccines is at the heart of every regulatory process, and this process cannot be compromised, to ensure that the long-term health of citizens remains optimal.

In Malaysia, the Special Committee on Covid-19 Vaccine Supply Access Guarantee has acquired the Pfizer vaccine (which currently has the highest reported efficacy) as part of a portfolio of vaccines for use by Malaysians. 

This portfolio will also include the AstraZeneca, Gamaleya, Sinovac and CanSino vaccines (depending on National Pharmaceutical Regulatory Agency approval).

The agency, which has been a World Health Organisation Collaborating Centre for Regulatory Control of Pharmaceuticals since 1996, recently reviewed the scientific documents submitted by Pfizer, and found that its vaccine meets international and national safety and efficacy requirements.

Our battle against Covid-19 is ultimately a shared one, and our goal remains the same – to protect lives and livelihoods. The public’s concern about the safety and efficacy of Covid-19 vaccines should be taken seriously and addressed with scientific truth if we want to win this battle. 

As scientists, we have shared some of the facts here, but more data surrounding the science behind mRNA vaccine technology can be found online. We hope that everyone will arm themselves with information from trustworthy resources.

We hope that this response, highlighting scientific evidence, reassures everyone that all stakeholders, including the scientific community, have gone beyond the norm in committing to extreme precautions and care in evaluating and ensuring the efficacy and safety of Covid-19 mRNA vaccines.

As scientists, ensuring that public health is protected through the use of safe and effective vaccines is among the core purposes of and primary motivations behind the development of any vaccine.

We also hope that the public will trust scientific evidence in the midst of this public health crisis. We cannot stress enough that a successful Covid-19 vaccination programme is vital in our quest to enjoy a pre-Covid-19 quality of life.

We can protect our loved ones better when we protect ourselves. We hope that adherence to public health precautions will still be part and parcel of life, even post-vaccination, until we achieve herd immunity. – The Vibes, February 2, 2021

Young Scientists Network-Academy of Sciences Malaysia was established as a platform to promote careers in science

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