Moderna's Next-Gen Vaccine Outperforms Against SARS-CoV-2

Moderna has announced a significant milestone in the fight against COVID-19, revealing that its next-generation vaccine, mRNA1283, has met primary endpoints in its Phase 3 clinical trial. This vaccine has demonstrated a superior immune response against SARS-CoV-2 when compared to its predecessor, mRNA-1273.222.

"We are excited to announce our fourth infectious disease vaccine program with positive Phase 3 data, further validating our robust mRNA platform," said Stéphane Bancel, CEO, Moderna. In the NEXTCOVE Phase 3 pivotal trial (NCT05815498), mRNA-1283 exhibited a heightened immune response against both the original SARS-CoV-2 virus strains and the Omicron BA.4/BA.5 variants compared to mRNA-1273.222, as reported by Moderna.

Notably, this advantage was particularly pronounced in participants aged 65 and above, a demographic at elevated risk because of severe COVID-19 outcomes. "mRNA-1283 is a critical component of our combination vaccine against flu and COVID-19, mRNA-1083, and this milestone gives us confidence in our ability to bring this much needed vaccine to market," added Bancel.

The trial, encompassing approximately 11,400 individuals aged 12 and older in the United States, United Kingdom, and Canada, followed a randomized, observer-blind, active-controlled design. The safety profile of mRNA-1283 mirrored that of Moderna's authorized COVID-19 vaccines, reassuringly consistent across diverse populations.

Among the solicited adverse events, injection site pain emerged as the most common local reaction, while headache, fatigue, myalgia, and chills were the prevailing systemic symptoms reported. The storage, shelf life, and pre-filled syringe format of mRNA-1283 offer potential advantages, alleviating logistical burdens for healthcare providers and potentially expanding access to new healthcare settings.

Detailed insights into the Phase 3 trial data for mRNA-1283 will be unveiled during Moderna's Vaccines Day event on March. 27, 2024, and subsequently presented at upcoming scientific conferences.

COVID-19 Nowadays

In May 2023, the World Health Organization (WHO) declared the conclusion of the COVID-19 pandemic. Nonetheless, the subject remains a top priority in the realm of research. “Despite the initial waves subsiding, we must not assume that everything is resolved. Research and ongoing studies continue to shed light on the virus and vaccines,” said Marlene Llópiz-Áviles, Global Oversight Director, PPD, to MBN.

The outlook ahead is filled with uncertainty due to the ongoing evolution of the COVID-19 situation and the ongoing need for innovative strategies to tackle it effectively, according to Rodrigo Romero, Coordinator, Mexican Association of Vaccinology. “Initial concerns lie in securing reliable manufacturing, while secondary concerns involve governments' willingness to invest. A third concern is public engagement. While some expected an increased drive toward vaccination following the pandemic, there is now a sense of vaccine fatigue, with people averse to discussions surrounding vaccines,” explained Romero.