Could an innovative mRNA-based vaccine win the race for a Covid-19 vaccine?

GlobalData Healthcare 1 May 2020 (Last Updated September 4th, 2020 07:48)

Could an innovative mRNA-based vaccine win the race for a Covid-19 vaccine?

Messenger RNA (mRNA)-based vaccine technology, an innovative approach, is emerging as one of the frontrunners among the technologies being exploited to develop a vaccine for Covid-19. Eighteen mRNA-based vaccine candidates are in development globally for Covid-19, according to GlobalData’s Pharma Intelligence Center Drugs Database (Table 1). Information related to these innovative vaccines can now be extracted using the Molecule Type mRNA vaccine filter which is available in several databases in the Pharma Intelligence Center.

RNA vaccines offer several advantages over conventional vaccines, particularly when responding to a pandemic threat. While conventional vaccines, developed with an attenuated or inactivated disease-causing pathogen or using proteins made by the pathogen (antigens), require long production times and have limited production capacity, RNA vaccines work by introducing an mRNA sequence that encodes the disease-specific antigen to trigger the body’s immune system. As such, a major advantage of RNA vaccines is that RNA can be produced rapidly and cheaply in the laboratory, offering the potential to scale up production to meet the demands of a pandemic. Other advantages include enhanced immunogenicity and better safety profile compared to classical and other types of vaccines, as has been proven in clinical trials.

Over 150 Covid-19 vaccines are currently under development by biopharmaceutical companies and research organisations around the world. Nine of them are in clinical trials. SinoVac biotech’s inactivated SARS-CoV-2 vaccine and University of Oxford’s ChAdOx1-nCov19, a recombinant viral vector vaccine, have progressed ahead of others to Phase I/II studies. Vaccines and drugs in development for Covid-19 can be tracked on GlobalData’s Coronavirus Disease 2019 (Covid-19) dashboard.

Covid-19 mRNA-based vaccine candidates have indeed shown fast progress. Moderna, which specialises in developing therapies based on mRNA molecules, was the first company to test a vaccine against SARS-CoV-2 in humans. Moderna’s mRNA-1273 is expected to enter a Phase II study in Q2 2020 depending on the outcome of the Phase I study, which was initiated in March. On 17 April 2020 the company announced that it had received a $483M contract from the US Biomedical Advanced Research and Development Authority (BARDA), which will fund the development and scale-up of mRNA-1273 through to FDA licensure. This announcement saw the company’s shares jump as much as 21%. In an effort to enable large scale production for the pandemic response, the company has already begun expanding its current manufacturing facility. Moderna’s CEO said: “We believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021 if the vaccine candidate is successful in the clinic.”

Germany-based BioNTech and New York-based Pfizer’s BNT162 vaccine candidates are not far behind mRNA-1273. The companies received approval from the regulatory authority on 22 April 2020 to start Phase I/II clinical studies for its BNT162 vaccine program in Germany. They will test four BNT162 vaccine candidates in 200 healthy volunteers to determine the optimal dose for further studies, as well as to evaluate the safety and immunogenicity of the vaccine. It is the first approved clinical trial of a Covid-19 vaccine in Germany. Trials will also be conducted in the US, where approval is expected shortly. BioNTech said it plans to produce the vaccine for the clinical trials at its manufacturing facilities in Europe in collaboration with contract manufacturer Polymun GmbH. BioNTech is collaborating with Fosun Pharma to develop BNT162 in China.

Seven other preclinical stage mRNA vaccine candidates are in the pipeline for Covid-19 (Table 1). Of these, Stemirna Therapeutics’, Imperial College London’s, Curevac’s, and Arcturus Therapeutics’ vaccine candidates are expected to enter clinical trials in the summer.

RNA platform technology appears to be promising, although no RNA vaccine has been approved to date. With the worldwide Covid-19 death toll crossing over 200,000 and infections over three million as of 30 April 2020, it remains to be seen which will succeed in the race for a Covid-19 vaccine.