Moderna Inc announced on Thursday that it has completed enrollment of 30,000 volunteers for the final stage of its coronavirus vaccine trial.
Additionally, the Massachusetts-based company says its group is more diverse and that more than 5,000 volunteers have already received their second of two jabs.
The reveal indicates that the company is not far from applying for emergency use authorization (EUA) with the US Food and Drug Administration (FDA).
Earlier this week, Moderna said it will know if its experimental shot is effective at preventing people from contracting the disease by November and, if results are positive, it will submit for approval with the FDA.
Moderna Inc announced on Thursday that it completed its goal of enrolling 30,000 volunteers in its coronavirus vaccine trial. Pictured: Atlanta resident Norman Hulme, 65, prepares to have his blood drawn as part of Moderna’s COVID-19 vaccine trial in Atlanta, Georgia, May 4
Of the participants, more than 25,000 have received the second of two jabs, 37% are minorities, and 42% are those at high risk of severe illness. Pictured: A sign marks the headquarters of Moderna Therapeutics in Cambridge, Massachusetts, May 2020
In September, the company announced it was slowing enrollment to recruit more minorities including blacks, Hispanics and Native Americans, after falling short.
Now, the drugmaker says that 37 percent of all participants are people of color.
What’s more, 42 percent of volunteers are people at high-risk of falling seriously ill from COVID-19 due to underlying health problems or age.
Upon news of the completed enrollment, Moderna shares rose by 4.4 percent on Thursday morning, according to Bloomberg.
On Tuesday, CEO Stéphane Bancel, speaking at The Wall Street Journal‘s annual Tech Live conference, said the company is waiting for interim results of its late-stage clinical trial.
Provided the results are positive, Moderna could apply for EUA by late November and may receive approval from the FDA by December.
This timeline is about the same as that of rival drugmaker Pfizer Inc, which announced last week it would also likely apply for EUA next month.
‘Unlike sometimes when you make a recipe at home, if you miss one ingredient, you might decide to still go ahead and make your meal, but in our case we cannot do that,’ Bancel said, according to The Journal.
‘We need all the ingredients to be there on time to be able to make a lot of vaccine. If one ingredient is missing, we cannot make a vaccine.’
Moderna’s vaccine was developed in partnership with the National Institutes of Health.
It uses part of the pathogen’s genetic code called messenger RNA, or mRNA, to get the body to recognize the coronavirus and attack it if a person becomes infected.
The candidate, called mRNA-1273, works by tricking the body into producing some of the viral proteins, which the immune system then recognizes and builds a defensive response against.
For the trial, one group is given the vaccine and another group is given the placebo.
Researchers will then wait until 53 participants contract the virus and develop symptoms, reported The Journal.
If the number of people infected is significantly higher in the placebo group, then the jab is considered effective.
The first term analysis is expected in November but Bancel said ‘it’s hard to predict exactly which week because it depends on the cases, the number of people getting sick,’ according to the Journal.
However, if the first analysis, does not show the efficacy of the vaccine, a second analysis will occur, and researchers will wait until 106 people have been infected with COVID-19.
This would delay results until December and receiving FDA approval until early next year.
In August, the federal government signed a $1.5 billion contract with Moderna, placing an order 100 million doses for the US – enough for 50 million people.
The Journal reports that Bancel expects Moderna to produce about 20 million doses by the end of 2020 and at least 500 million doses next year.
There are 10 companies around the world currently testing vaccine candidates, and Moderna is one of four in the US.
Pfizer has stated it expects to submit for EUA next month while the remaining two, AstraZeneca Plc and Johnson & Johnson – both currently paused – have stated their submissions are expected later this year.
