Is mRNA the answer for all infectious diseases or has it just become the antidote for failing pharma companies?

Pharma companies are exploring using mRNA for prevention of other viral infections and making combined injections for multiple respiratory viruses at once. What could possibly go wrong?!

Why mRNA and not a traditional vaccine platform?

As Operation Warp Speed came online in 2020, pharma companies were jockeying for position to get their COVID-19 vaccine to the head of the line for emergency use authorization (EUA) by the FDA. As we all are now aware the mRNA genetic vaccines developed by Pfizer and Moderna won the race with Pfizer receiving EUA approval for its mRNA genetic vaccine on December 11, 2020.

I am often asked my opinion on why traditional vaccine platforms were not developed and mRNA was used instead to combat SARS-CoV-2?

One can only guess at the answer as to why mRNA was used instead of traditional, vetted, and trusted vaccine approaches. Based on my experience and knowledge of the field of vaccinology, I came up with two of my own suppositions to answer this question, one being that traditional vaccine approaches would not work to combat SARS-CoV-2.

We only need to look at vaccine development and testing for SARS-CoV-1 which emerged in 2003 for evidence of this. A study published in 2015 from none other than Ralph Baric’s group studying the potential of bat coronaviruses to infect humans also tested both monoclonal antibodies and various vaccine approaches to treat and prevent SARS infection.

"Evaluation of available SARS-based immune-therapeutic and prophylactic modalities revealed poor efficacy; both monoclonal antibody and vaccine approaches failed to neutralize and protect from infection with CoVs using the novel spike protein."

The authors tested double inactivated (DIV) SARS virus as a strategy for vaccination and showed,

"... that DIV could neutralize and protect young mice from challenge with a homologous virus; however, the vaccine failed to protect aged animals in which augmented immune pathology was also observed, indicating the possibility of the animals being harmed because of the vaccination." 

And....

"Notably, DIV vaccination resulted in robust immune pathology."

They also explored live attenuated virus vaccine and found,

"Together, the data suggest that SHC014-MA15 challenge may confer cross-protection against SARS-CoV through conserved epitopes, but the required dose induces pathogenesis and precludes use as an attenuated vaccine."

This clearly showed that there was evidence of harms being caused by vaccines for SARS and that vaccination was not a winning strategy.

Other than speed of manufacturing for mRNA, my best guess for turning to mRNA was because, if pharma companies could get the technology approved through EUA, that would save them millions of dollars in early development of the technology. Once mRNA was shown to work, then pharma companies could begin using it to combat all kinds of other infectious agents without the costly up front investment. As we have witnessed, Pfizer and Moderna have been able to run the largest public clinical trial at the expense of American taxpayers with raging success for their companies.

Source: https://www.fiercepharma.com/pharma/pfizer-moderna-will-rake-a-combined-93-billion-next-year-covid-19-sales-says-analytics-group

Welcome to the vaccine revolution!

Here we are just two years after the rollout of the COVID-19 mRNA and pharma companies are already exploring the use of mRNA for other virus infections such as HIV, influenza, and respiratory syncytial virus (RSV), to name a few, even though genetic vaccines have shown significant safety signals damaging, disabling and causing deaths of people who have received them.

Let’s explore the use of mRNA as a strategy for vaccination against RSV.

RSV, is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover in a week or two, but RSV can be serious, especially for infants and older adults. RSV infection contributes substantially to the global morbidity and mortality burden in children aged 0–60 months, particularly during the first 6 months of life. Each year in the US, approximately 60,000-120,000 older adults are hospitalized, and 6,000-10,000 of them die due to RSV infection.

Vaccine development for RSV was derailed after a trial of a candidate in 1966 led to two deaths and the hospitalization of 80% of the infants who received an inactivated version of the entire virus. Babies who got the vaccine ended up with more severe disease, not less, when they were exposed to RSV after vaccination because the vaccine induced the wrong type of immune response. This is the key to vaccine development, ensuring that a vaccine induces a protective immune response which will prevent infection and not just any response.

"There are some vaccines that came very easily, but developing a vaccine for RSV is very tricky," says Fernando Polack, of Johns Hopkins University.

To date, no vaccines have proven effective in preventing RSV infection.

But now Moderna is testing mRNA as a strategy for prevention of RSV infection in older adults.

Source: https://investors.modernatx.com/news/news-details/2023/Moderna-Granted-FDA-Breakthrough-Therapy-Designation-for-mRNA-1345-An-Investigational-Respiratory-Syncytial-Virus-RSV-Vaccine-Candidate/default.aspx

Stéphane Bancel, Chief Executive Officer of Moderna stated, "With this designation, we look forward to productive conversations with the FDA in the hopes of bringing our RSV vaccine candidate for older adults to the market safely and quickly. Moderna's mRNA platform has now demonstrated two positive Phase 3 infectious disease trial results and we continue to advance a portfolio of respiratory mRNA vaccines targeting the most serious diseases. We are grateful to the FDA for this designation."

I’m sure Moderna and its stockholders are very thankful to the FDA, given the agency has ignored all safety signals from their COVID-19 mRNA genetic vaccine as well. It’s important to keep in mind that not all viruses are amenable to vaccination and RSV may very well be one of those viruses. Time will tell if similar safety signals are reported with this mRNA RSV genetic vaccine.

Other pharma companies are also jumping on the mRNA genetic vaccine bandwagon.

CureVac, a global biopharmaceutical company, is developing a new class of “transformative medicines” based on mRNA. They recently announced positive data from ongoing Phase 1 clinical trials conducted in collaboration with GlaxoSmithKline (GSK) on joint COVID-19 and Flu mRNA vaccine development programs in older adults.

Source: https://www.curevac.com/en/curevac-announces-positive-data-in-older-adults-from-covid-19-and-flu-mrna-vaccine-development-programs/

“The exciting preliminary data seen among older adults for our COVID-19 and flu programs significantly add to the validation of our technology platform into this highly relevant and at-risk population,” said Franz-Werner Haas, Chief Executive Officer of CureVac. “The strong immune responses we observed in both indications further support our commitment to advancing to the next stage of product development in 2023.”

CureVac has several other mRNA-based prophylactic genetic vaccines in the pipeline for agents such as rabies, Lassa fever, yellow fever, rotavirus, malaria and of course a universal influenza vaccine.

This graphic is a compilation of mRNA genetic vaccines that are currently in development and the stages of testing for each. (Courtesy of Dr. Ingo Fricke)

In addition to genetic vaccines for HSV, VZV (chickenpox), Zika, HIV and Nipah virus, Moderna is also developing combination mRNA genetic vaccines in the following combinations: COVID+flu, flu+RSV, flu+COVID+RSV, pediatric hMPV+PIV3, and pediatric RSV+hMPV.

So, it looks like the COVID-19 mRNA genetic vaccines have opened the door wide open for the use of mRNA genetic vaccines for many other infectious disease agents. Since pharma companies produce too many “me-too” drugs and very few to no truly innovative drugs, mRNA genetic vaccines have become the go to “drug” of choice to cure everything. In reality mRNA has certainly been the cure to bring failing pharma companies back to life.