A Covid-19 vaccine developed by the biotechnology company Moderna in partnership with the National Institutes of Health has been found to induce immune responses in all of the volunteers who received it in a Phase 1 study. These early results, published in the New England Journal of Medicine on Tuesday, showed that the vaccine worked to trigger an immune response with mild side effects — fatigue, chills, headache, muscle pain, pain at the injection site — becoming the first US vaccine candidate to publish results in a peer-reviewed medical journal. The vaccine is expected to begin later this month a large Phase 3 trial — the final trial stage before regulators consider whether to make the vaccine available.
Early results from Moderna coronavirus vaccine trial show participants developed antibodies against the virusModerna noted in a press release on Tuesday that, if all goes well in future studies, “the Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.”
Patient-Reported Data Can Help Monitor the Safety of Fast-Tracked Covid-19 Vaccines
The pharma industry is in a mad dash to bring a Covid-19 vaccine to market, ideally before 2020 slips into 2021. This represents a dramatic acceleration from standard development timelines, which historically have often lasted 10 to 15 years. More than 100 Covid-19 vaccines are currently in development, with 21 already being tested in human clinical trials. Regulatory agencies like the U.S. Food and Drug Administration are doing their part to accelerate the path to approval, allowing manufacturers to conduct animal studies in parallel with Phase 1 trials and outlining criteria for emergency authorization before full approval.
These efforts mean we could have a vaccine approved much sooner than was previously possible, which would be a powerful tool for resolving this health care crisis. Yet a race to the market means regulators will have a briefer period of experience with vaccine safety and effectiveness to evaluate when they are considering vaccines for approval.