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Moderna’s Work on a COVID-19 Vaccine Candidate. Photo: Theconversation

Current status of Moderna vaccine

As more and more countries record the biggest single-day spikes in COVID-19 cases, the world is still grappling with the increasing terror of the novel coronavirus. The total number of infections worldwide has reached almost 5 million, including 3,24,000 fatalities. In between the growing death toll and the rate at which the infection is spreading, the medical staff are working day and night and toiling on front lines of the pandemic.

Even though experts across the globe are working round the clock to develop a potential vaccine, it is important to note that the development of a vaccine is a long process that goes through several stages of clinical trials. When a vaccine is injected in the body, it trains the body’s immune system to fight a particular pathogen. As of now, there are over 100 potential vaccines worldwide in different stages of development and the results of the US-based Moderna Therapeutics has been promising, as reported by Timesofindia.

About mRNA-1273

mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH.

The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing, according to Moderna.

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Coronavirus Vaccine. Photo: EPR

On May 12, the FDA granted mRNA-1273 Fast Track designation. On May 29, the first participants in each age cohort: healthy adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of mRNA-1273. On July 8, the Phase 2 study completed enrollment.

The Phase 3 COVE study of mRNA-1273, being conducted in collaboration with the NIH and BARDA, began on July 27; enrollment is on track to complete in September. Results from a non-human primate preclinical viral challenge study evaluating mRNA-1273 were recently published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of mRNA-1273 was published in The New England Journal of Medicine.

The advantage of RNA-based vaccine

One of the biggest advantages of using RNA-based vaccines is its rapid manufacturing rate which can prove to be a game-changer, especially in the face of current COVID-19 pandemic. They are also usually safer to use as they do not carry weakened viruses in them.

As of now, Moderna’s mRNA-1273 vaccine has become the first vaccine candidate to develop protective antibodies against the virus and stimulated the immune system to fight it. The findings come from a small early trial conducted in the month of March where 8 people out of the 45 subjects showed positive immune system response and developed protective antibodies against the virus. All the 8 people received 100 microgram dose of the vaccine and developed minor side effects including redness, chills and soreness where the injection was given. The symptoms were said to subside within a day.

mRNA vaccines are fully synthetic, so once a target antigen’s sequence is known, a vaccine can be produced quickly, and the same infrastructure can be used to produce other mRNA vaccines that contain a different sequence, explained Norbert Pardi, PhD, research assistant professor, Department of Medicine, University of Pennsylvania. In contrast, vaccines that carry proteins to stimulate the immune system have additional steps that include cell line and purification procedures, which can make manufacturing more of a challenge, Pardi said.

The second wave of Covid-19 cases is now affecting many countries, and the increasing number of patients emphasises the growing need to bring a prophylactic vaccine to market. Moderna is set to be the winner in the race for a Covid-19 vaccine, with the highest recorded forecast peak sales and millions of doses already ordered by both the US and Canadian governments. However, key questions surrounding Moderna’s ability to deliver the hundreds of millions of doses necessary to treat this global pandemic and its unfamiliar mRNA vaccine casts doubt on the company’s potential victory. The Covid-19 vaccine race is far from over, and competitors such as BioNTech and Inovio still have a chance to beat Moderna to the finish line.

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