Biotechnology company Moderna Inc said that analysis of interim data from the early stage human trials of its Covid-19 vaccine candidate RNA-1273 reaffirmed positive findings announced about two months ago.

“Results from participants in the initial dose cohorts who received both vaccinations and were evaluated at pre-specified timepoints reaffirm the positive interim data assessment announced on May 18th and show mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2,” the company said.

The analysis of this open-label Phase 1 study has been published in The New England Journal of Medicine . The interim analysis evaluated a two-dose vaccination schedule of mRNA-1273 given 28 days apart across three dose levels (25, 100, 250 µg) in 45 healthy adult participants ages 18-55 years, and reports results through 57 days, the company explained.

The study is led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).

“These Phase 1 data demonstrate that vaccination with mRNA-1273 elicits a robust immune response across all dose levels and clearly support the choice of 100 µg in a prime and boost regimen as the optimal dose for the Phase 3 study,” said Chief Medical Officer of Moderna. “We look forward to beginning our Phase 3 study of mRNA-1273 this month to demonstrate our vaccine’s ability to significantly reduce the risk of COVID-19 disease.”

Phase III trials on about 30,000 people is expected to get underway from July 27.

Other companies and their trials

The development comes just days after a Russian news agency reported that Russia had completed trials and had a safe Covid-19 vaccine in place. In fact, volunteers on whom the vaccine was tested are to be discharged today and on July 20, the report said. China’s Sinovac has also said it was in late-stage trials in Brazil.

Over 150 vaccines are under development from different companies across the world and those in a more advanced stage include the Oxford University’s vaccine candidate, being co-developed by AstraZeneca; a candidate from CanSino Biological Inc/Beijing Institute of Biotechnology and another from Inovio Pharmaceuticals/ International Vaccine Institute. India’s Zydus Cadila, Bharat Biotech, Panacea Biotec and Serum Institute (in a production and marketing alliance with AstraZeneca) are also in the fray.

Moderna’s candidate

The mRNA-1273, the company said, was generally safe and well-tolerated, with no serious adverse events reported through Day 57. Adverse events (AEs) were generally transient and mild to moderate in severity.

Explaining how it works, the company said mRNA-1273 induced binding antibodies to the full-length SARS-CoV-2 Spike protein (S) in all participants after the first vaccination, with all participants recovering by Day 15. Dose dependency increases in binding titers were seen across the three dose levels, and between prime and boost vaccinations within the dose cohorts, the company said.

Evaluation of the durability of immune responses is ongoing, and participants will be followed for one year after the second vaccination, with scheduled blood collections throughout that period. Studies were also on among a small elderly group and the data will be published separately, the company indicated. Given the increased morbidity and mortality of Covid-19 in older and elderly adults, additional evidence for the potential of a vaccine to protect this population is an urgent priority, the company said.

Phase III

The protocol for the Phase III trial has been reviewed by the US Food and Drug Administration and is aligned to recent FDA guidance on clinical trial design for Covid-19 vaccine studies. The randomised, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants at the 100 µg dose level in the US. The primary endpoint will be the prevention of symptomatic Covid-19 disease.

Moderna has completed manufacture of vaccine required to start the Phase 3 study. With the Phase 3 dose being finalised at 100 μg, the company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to one billion doses per year, beginning in 2021 from the its internal US manufacturing site and strategic collaboration with Lonza, the company said.

Moderna also has a collaboration with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana. In addition to this, it has an alliance with ROVI for large-scale, commercial fill-finish manufacturing of mRNA-1273 for supply to markets outside of the US, starting in early 2021 at ROVI’s facility in Madrid, Spain, it added.

 

 

 

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