PART 4: The 4 Emerging Public Concerns About Aspects Of The Novel mRNA Vaccines
Human beings are creatures of habit. Familiarity brings some dependable level of comfort.
Many new technologies have faced some resistance to uptake. Pioneers who break barriers experience unexpected and unwanted resistance from the public.
Just to recap, in Part 1, I raised an alert about what seems to be emerging public hesitation to COVID-19 vaccination. In Part 2, I discussed the origins of vaccination as a concept. We also saw how smallpox was eventually eradicated through concerted vaccination efforts.
In Part 3, I presented the evolution of virus vaccine technologies that were a precursor to the development of the novel mRNA vaccines.
So, why are we witnessing unprecedented resistance to the COVID-19 vaccination efforts?
As we saw in Part 2 of this 4-part article series, in 1721 when inoculation was introduced to manage smallpox in Boston, people were not readily willing to have something enter their body if they felt unsure.
It is human to question, and the novel mRNA vaccines are no exception.
Fortunately, some brave souls among us are willing to go first and the rest of us will gladly follow once the coast is clear.
For the first time in the history of vaccinology, a naked RNA molecule has been used successfully to develop a vaccine. Both Moderna and Pfizer/BioNTech developed novel mRNA vaccines of impressive efficacy.
Much as we hail their effort in rapidly giving us these vaccines, people are also raising valid concerns that must be addressed.
It is only fair to the public and an obligation to the biotech corporations involved that they invest time and resources to explain their products in a way that will educate the skeptical public, and win their trust.
I?d like to take a moment to raise some of the most pressing concerns. But before that, I?ll put in a word about adverse vaccine reactions.
Vaccines are intended to produce active immunity to specific antigens. An adverse reaction is an undesirable side effect that occurs in some individuals after they are vaccinated. This phenomenon is not new. Adverse reactions have been documented in nearly all vaccines developed to date. The reasons for the negative reactions are varied but, normally, only a small number of people are affected.
According CDC, vaccine adverse reactions are classified as local, systemic, or allergic.
That said, it must be noted that vaccination is a practice that weighs public risks and benefits, and overwhelmingly favours the benefits.
Individuals prone to vaccine adverse reactions may receive alternative versions of vaccines (see Part 3 for details). Such options may sometimes not be as efficacious, but they trigger sufficient protective immunity.
Vaccines from the earlier generations are still being produced today. Some are preferred for persons with pre-existing medical conditions. For example, where the general population is given a live attenuated vaccine, vulnerable immunocompromized people will be given the inactivated version or a recombinant form.
So let's dive in and look at the emerging public concerns about aspects of the novel mRNA vaccines. I have summarized them into 4 categories.
1. The general public is concerned that there isn't enough safety data among different populations
A typical vaccine development cycle takes anything from 10 to 20 years from concept, pre-clinical and clinical trials. A rigorous product approval process follows before release for general use. The regulators then oversee its distribution to ensure continuing safety.
On the contrary, it took just 9 months for Moderna and Pfizer/BioNTech to declare success with their mRNA vaccines. The US Food and Drug Administration soon granted them emergency use authorization.
The speed with which these vaccines were developed was described as both impressive and "unprecedented".
As a scientist, I do appreciate that the technology used to create the novel vaccines is new. It may not necessarily follow the same path as the previous virus vaccine technologies. But the public must get credible explanations to have confidence that they are in safe hands.
There isn?t much safety data out there to rely on, and people are validly justified to be concerned.
I also do understand that we are in the middle of a pandemic and this is an emergency situation. But still, information is key in propping up the public?s trust to ensure the success of the new vaccines.
What I see here is a communication lapse. A missed opportunity.
2. The concerns of individuals with pre-existing conditions or the vulnerable: People prone to allergic reactions, the immunocompromized, pregnant women and infants
In the absence of long-term safety data, experts appear divided on what guidance to give to those with a history of severe allergic reactions.
An independent advisory committee to the CDC recommended caution about receiving the novel vaccines among persons with a history of severe allergic reactions to injectable medications.
The committee also noted that persons with HIV infection, other immunocompromizing conditions, or who take immunosuppressive medications or therapies could still receive the novel COVID-19 vaccine, unless otherwise contraindicated. However they warned that they didn't have sufficient data to establish safety and efficacy of the novel vaccines in these groups.
While it may be too early to know how the allergic and immunocompromized may react to the novel mRNA vaccines, their concerns must also be addressed expeditiously.
There is also no data on the safety of the novel COVID-19 vaccines in pregnant women or breastfeeding mothers. The thinking at the moment is that there would be no risk to the breastfeeding infant since mRNA vaccines are not considered live virus vaccines.
3. The concerns of molecular biologists and geneticists
Several scientists have raised technical concerns about the design of the mRNA molecules that created the vaccines.
Coming from a biotech background myself, I acknowledge the need for intellectual property protection. It secures future earnings for research and development efforts.
However, molecular biologists and geneticists are seeking clarification that will assure them that once administered, the vaccines will perform as designed: express the viral proteins they encode to trigger an immune response, have a short half-life or "survival" time and will not have any retro-transposon tendencies.
Retro-transposons are RNA molecules that have structural features that enable them to be reverse-transcribed into double-stranded DNA that can then be inserted randomly and permanently in the host?s genome.
There must be some level of disclosure to this community of scientists to assure them that the novel mRNA vaccines do not carry such retro-transposon tendency.
4. The concerns about the stability of the novel mRNA vaccines in transit and distribution
Slightly less than half of the world?s population dwells in rural or remote locations. Most of these people live in developing countries.
Both the Moderna and Pfizer/BioNTech vaccines are RNA-based and require frozen preservation.
I?ll first address the concerns of the vaccines being RNA-based.
RNA is a very unstable molecule. If you've ever worked with RNA in the lab you?ll understand the many challenges and frustrations of keeping this molecule intact.
RNA is prone to rapid degradation by enzymes called ribonucleases (RNases). These enzymes are abundantly present in the environment. They are also among the most difficult to inactivate when compared to other enzymes.
RNA molecules are vulnerable to RNase degradation at temperatures higher than -94F (-70C). This explains why Pfizer/BioNTech have indicated that their vaccine requires storage at -94F (-70C).
During distribution especially to rural or remote locations, will there be quality control checks to ensure that the mRNA vaccines will arrive in the intact form? It will be unfortunate if an empty lipid nanoparticle placebo is administered to people because the mRNA in it degraded in transit.
This brings me to the second concern about the vaccines requiring a distribution chain that guarantees ultra low temperature preservation.
The kinds of freezers that can maintain ultra low storage temperatures at -94F (-70C) are mostly located in research institutions. They are certainly not readily available in most remote or resource-limited settings.
To overcome this challenge there must be a distribution network that is well supplied with holding facilities and dry shippers that will be used to transport the vaccines either in liquid nitrogen or on dry ice. Both of these will need to be replenished frequently due to evaporation loss, thus creating a tertiary problem of refilling limitations.
Can majority of the world?s population access these vaccines?
In conclusion, there?s hope on the horizon. Vaccines have brought back hope in a year that was hit by the COVID-19 pandemic.
I am cautiously optimistic. Cautious because I don't have all the information I need to make an informed judgment. I have faith in the science and the data released thus far.
At the end of the day, each one of us will have to make a personal choice between COVID-19 and taking the available vaccines.
As we move into the future and look forward to reining in the pandemic in 2021 or maybe 2022, I am optimistic. COVID-19 is a shared human problem that must be eradicated from the planet.
The sixth generation vaccines offer so much promise. They will open up new drug development opportunities. I expect to see a lot of testing on a plethora of other communicable infections.
Moving forward, more players need to come to the table to implement better communication strategies. The public is demanding more transparency.
If you want to review all the 4 articles, follow the links below:
PART 2: Origins of Vaccination
PART 3: Generations of Vaccines
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