Moderna nears full enrollment on COVID-19 vaccine trial

But study welcomes more African-American participants

Brigham & Women's among study sites for COVID-19 vaccine trial

BOSTON — He’s seen friends lose family members to Covid-19. He saw a cousin fall apart because so many in her community were dying. Anthony Shivers decided to be part of the solution he said, by signing up to participate in a Covid vaccine trial.

“You can’t wait. You have to engage with this,” he said. “You know the coronavirus isn’t waiting on us. So we really have to engage and be involved.”

Shivers got engaged with Moderna Therapeutics vaccine candidate, mRNA-1273, last July as the Cambridge company launched its Phase Three trial. He is one of 30,000 participants Moderna hopes to have enrolled by the end of this month.

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“Going 24 hours without a mask would just be lovely,” Shivers said. “Being able to travel somewhere. So it is really important that we all come together and really do this. Particularly the black community.”

Paulette Chandler, MD, heads up Community Engagement and Education for Covid vaccine trials at Brigham and Women’s Hospital, one of around 100 sites studying the Moderna product. She said it’s been challenging getting African-Americans to join the trial because of feelings of mistrust.

Yet, their participation -- like that of other ages, races and ethnicities -- is vital.

“It’s important that we have this diversity in the trial so we can analyze and see are there differences in the responses to the vaccine,” Chandler said.

Differences in vaccine response have been demonstrated before. In 2016, researchers at Dana-Farber Cancer Institute found that genes and ethnicity played a role in response to influenza A vaccination.

Chandler added there is still plenty of space left at the Brigham site if anyone wants to participate.

Shivers, like all participants, got two doses of either the vaccine or a salt-water solution -- what is known as a placebo. He has no idea which he got, and neither do investigators -- a standard way to minimize common biases in drug studies.

Moderna’s vaccine candidate differs from traditional vaccines in that it is not based on a live or weakened virus. Rather, it uses messenger RNA to coax the body’s immune system to create antibodies.

“There are vaccines that are protein-based, there are vaccines that are whole virus-based, where we take the whole organism,” said Lindsey Baden, MD, one of the principal investigators of Moderna’s vaccine candidate and an infectious disease specialist at Brigham and Women’s Hospital. “There are vaccines that use delivery systems like vectors, and then there are genetic vaccines which I think of in relation to DNA or RNA.”

Currently, numerous types of Covid-19 vaccines are in various stages of development, including one other mRNA candidate by Pfizer.

“What’s attractive about mRNA technology is the speed with which it can be developed because you just need to know the sequence of interest, which we knew back on January 13th,” Baden said.

One day before that, China shared the genetic sequence of Covid-19 with the world.

“All of these platforms are attractive,” he said. “All of the platforms being advanced are of great interest. My hope is they all will work. The question is how quickly can we develop them and assess if they work so we know to make the investment to go to scale.”

‘Scale’ would mean hundreds of millions of doses, initially -- and perhaps billions of doses in the end.

Baden would not put a date on when the Moderna vaccine might be ready for market -- or if it would ever be -- though he did say the trial was going well.

“The science will guide us,” he said. “We need to follow the science. If we short-circuit the scientific process we do that with great risk. There is a need to understand efficacy. There’s a need to understand safety.”

If there is any silver lining to the rising number of Covid cases across the country it could be this, he said:

“What influences the speed with which we get to an answer is the speed with which Covid is being transmitted in our community,” Baden said. “The more Covid that is spreading, the more opportunity, unfortunately, for all of us and the volunteers in this study to be exposed and therefore to see if the vaccine works.”

He added, “Sadly things are happening faster than any of us want because the transmission of Covid is out of control.”

Local doctor breaks down progress of Moderna vaccine

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