The Cambridge vaccine, Massachusetts-based Modern Inc., generated antibodies similar to those seen in people who have recovered from COVID-19 in a voluntary study given either a low or medium dose.
Ted S. Warren | AP
Modern shares rose sharply after the company said its potential vaccine to prevent Covid-1
Moderna’s share rose by more than 16% in the post-trade news.
All 45 patients produced neutralizing antibodies, which researchers believe is important for building immunity, and provided more promising data that the vaccine may provide some protection against coronavirus. In the study, each participant received a dose of 25, 100 or 250 micrograms, with 15 people in each dose group. Participants received two doses of the potential vaccine.
After two vaccinations, the vaccine elicited a “robust” immune response in all participants in all dose cohorts, Moderna said. The company said that the levels of neutralizing antibodies in patients in the high-dose group were four times higher than in recovered Covid-19 patients.
“These phase 1 data show that vaccination with mRNA-1273 elicits a robust immune response across all dose levels and clearly supports the choice of 100 μg in a first-class and boost regimen as the optimal dose for the phase 3 study,” said Modernes’ medical director. Tal Zaks, said in a statement. “We look forward to launching our Phase 3 study of mRNA-1273 this month to demonstrate our vaccine’s ability to significantly reduce the risk of COVID-19 disease.”
In May, the company had released preliminary information from its early phase version, but it lacked all the information and there had not yet been a peer review.
Modern said the vaccine was generally well tolerated, but more than half of the participants reported mild or moderate symptoms such as fatigue, muscle aches or pain at the injection site.
Evaluation of the sustainability of immune responses is ongoing, says Moderna, and the participants will be followed for one year after the second vaccination.
The effort from Moderna is one of several working on a potential vaccine against Covid-19, which has infected more than 13 million people and killed at least 573,200 worldwide as of Tuesday, according to data compiled by Johns Hopkins University. More than 100 vaccines are being developed globally, according to the World Health Organization.
Earlier Tuesday, Moderna announced that it would begin its late phase study for its vaccine on July 27. The study will register 30,000 participants across 87 locations, according to ClinicalTrials.gov. Participants in the experimental arm will receive a 100 microgram dose of the potential vaccine on the first day and another 29 days later. Some patients will also receive a placebo.
Modern experimental vaccines contain genetic material called messenger RNA, or mRNA. MRNA is a genetic code that tells cells what to build – in this case an antigen that can induce an immune response against the virus. It became the first candidate to take part in a Phase 1 human trial in March.
Researchers are still learning about important aspects of the virus, including how the immune system reacts when a person is exposed. The answers, they say, could have important implications for vaccine development, including how quickly it can be distributed to the general public.
The United States aims to deliver 300 million doses of a Covid-19 vaccine by early 2021.
Dr. Anthony Fauci, the country’s best expert on infectious diseases, has often haggled over Modern’s potential vaccine.
On Monday, he said he is “cautiously optimistic” scientists will be able to create at least one safe and effective vaccine by the end of the year or early 2021.