The biotech firm says its Phase 1 trial shows promising results.
By May 18, 2020, 5:04 pm ET
The headquarters of Moderna Therapeutics, which is developing a vaccine against the coronavirus disease (COVID-19), in Cambridge, Mass., May 18.
Photo: Brian Snyder/Reuters
Stock and oil prices climbed on Monday on news that a coronavirus vaccine candidate by biotech startup Moderna has shown promise in early clinical trials. Governments are starting to lift their lockdowns, but Americans and the rest of the world will need an effective vaccine—and maybe several—for a return to pre-virus normality.
It took 20 months for scientists to prepare a SARS vaccine for tests on humans, but private innovation is compressing the time-frame against Covid-19. Using rapid genetic sequencing and its nimble mRNA manufacturing platform, Moderna was able to develop and deliver a vaccine to the National Institutes of Health for clinical trials in late February.
Moderna’s mRNA vaccine gives cells a building manual to produce a particle that resembles the spike on the coronavirus. The goal is to induce an antibody response similar to the actual virus. Because the vaccine doesn’t utilize a pathogen particle, there are fewer safety risks. Production can also rapidly be scaled up using a standardized process.
The first phase of a clinical trial examining whether the vaccine is safe and causes an immune response began in mid-March. Forty-five healthy volunteers ages 18 to 55 received varying doses. Moderna reported on Monday that all participants who had received two doses developed antibody levels at or above levels of those seen in patients who have recovered from the virus.
This suggests that the vaccine could be effective, and none of the participants experienced severe side effects. Separately, Moderna reported that its vaccine “provided full protection against viral replication in the lungs” in mice infected with the coronavirus. On May 7, the Food and Drug Administration cleared the company to begin phase two of its trial with 600 participants including individuals over age 55 to determine whether they also muster a robust immune response.
On May 12 the FDA granted Moderna fast-track designation to begin the third phase of its trial to assess the vaccine’s efficacy in thousands of people, which is expected to begin in July. A vaccine could be made available for high-priority groups such as health-care workers as early as the fall if results show promise.
Historically only 16% of vaccines that begin clinical trials have been approved. But more than 100 vaccines are in development worldwide, and the Gates Foundation and the National Institutes of Health are investing heavily to accelerate those like Moderna’s with the most scientific potential based on early evidence.
Scaling up manufacturing will take time, but Moderna’s factory outside of Boston can produce 100 million doses a year and it is working with Swiss firm Lonza to increase capacity to up to one billion doses. Other drug manufacturers are also gearing up factories to churn out vaccines if their candidates show promise.
Johnson & Johnson plans to begin clinical trials in September and says it hopes that the first batches could be made available for emergency use early next year. Its Netherlands plant could produce 300 million doses annually. Pfizer is also testing several vaccine candidates and hopes to have 10 to 20 million doses ready for emergency use this fall.
The FDA could help by streamlining trial designs such as allowing manufacturers to increase participation in studies, or dose “arms,” with strong preliminary results. This wouldn’t compromise safety, and the death and destruction from the virus have removed some of the political obstacles to faster testing. Thirty-five House Democrats and Republicans last month wrote a letter urging the FDA to act more rapidly and nimbly.
Relaxing lockdowns and social-distancing mandates will also be needed since masses of people will have to be exposed to the virus for manufacturers to figure out if vaccines work. Until a vaccine is widely available, large gatherings may not occur, international travel will be limited, and millions of people will feel anxious about returning to pre-virus habits. This is why markets are cheering on Moderna, despite the uncertainties that remain, and Americans should be too.
By May 18, 2020, 5:04 pm ET
The headquarters of Moderna Therapeutics, which is developing a vaccine against the coronavirus disease (COVID-19), in Cambridge, Mass., May 18.Photo: Brian Snyder/Reuters
Stock and oil prices climbed on Monday on news that a coronavirus vaccine candidate by biotech startup Moderna has shown promise in early clinical trials. Governments are starting to lift their lockdowns, but Americans and the rest of the world will need an effective vaccine—and maybe several—for a return to pre-virus normality.
It took 20 months for scientists to prepare a SARS vaccine for tests on humans, but private innovation is compressing the time-frame against Covid-19. Using rapid genetic sequencing and its nimble mRNA manufacturing platform, Moderna was able to develop and deliver a vaccine to the National Institutes of Health for clinical trials in late February.
Moderna’s mRNA vaccine gives cells a building manual to produce a particle that resembles the spike on the coronavirus. The goal is to induce an antibody response similar to the actual virus. Because the vaccine doesn’t utilize a pathogen particle, there are fewer safety risks. Production can also rapidly be scaled up using a standardized process.
The first phase of a clinical trial examining whether the vaccine is safe and causes an immune response began in mid-March. Forty-five healthy volunteers ages 18 to 55 received varying doses. Moderna reported on Monday that all participants who had received two doses developed antibody levels at or above levels of those seen in patients who have recovered from the virus.
This suggests that the vaccine could be effective, and none of the participants experienced severe side effects. Separately, Moderna reported that its vaccine “provided full protection against viral replication in the lungs” in mice infected with the coronavirus. On May 7, the Food and Drug Administration cleared the company to begin phase two of its trial with 600 participants including individuals over age 55 to determine whether they also muster a robust immune response.
On May 12 the FDA granted Moderna fast-track designation to begin the third phase of its trial to assess the vaccine’s efficacy in thousands of people, which is expected to begin in July. A vaccine could be made available for high-priority groups such as health-care workers as early as the fall if results show promise.
Historically only 16% of vaccines that begin clinical trials have been approved. But more than 100 vaccines are in development worldwide, and the Gates Foundation and the National Institutes of Health are investing heavily to accelerate those like Moderna’s with the most scientific potential based on early evidence.
Scaling up manufacturing will take time, but Moderna’s factory outside of Boston can produce 100 million doses a year and it is working with Swiss firm Lonza to increase capacity to up to one billion doses. Other drug manufacturers are also gearing up factories to churn out vaccines if their candidates show promise.
Johnson & Johnson plans to begin clinical trials in September and says it hopes that the first batches could be made available for emergency use early next year. Its Netherlands plant could produce 300 million doses annually. Pfizer is also testing several vaccine candidates and hopes to have 10 to 20 million doses ready for emergency use this fall.
The FDA could help by streamlining trial designs such as allowing manufacturers to increase participation in studies, or dose “arms,” with strong preliminary results. This wouldn’t compromise safety, and the death and destruction from the virus have removed some of the political obstacles to faster testing. Thirty-five House Democrats and Republicans last month wrote a letter urging the FDA to act more rapidly and nimbly.
Relaxing lockdowns and social-distancing mandates will also be needed since masses of people will have to be exposed to the virus for manufacturers to figure out if vaccines work. Until a vaccine is widely available, large gatherings may not occur, international travel will be limited, and millions of people will feel anxious about returning to pre-virus habits. This is why markets are cheering on Moderna, despite the uncertainties that remain, and Americans should be too.
