Drug makers are racing to create a solution to the pandemic pains and help those who have been disproportionately affected by coronavirus disease 2019 – even offering vaccine tests that included approximately 3,000 blacks to close the gap in health equity.
Although the participation of blacks compared to other ethnic groups was low in Moderna’s phase three clinical trials this fall, the overall results proved to be a success. Last month, biotech giant Moderna announced that its clinical trials for the novel coronavirus was 94.5% effective.
“These are obviously very exciting results,” said Dr. Anthony Fauci, the country’s top infectious disease specialist. “It’s just as good as it gets — 94.5% is truly outstanding.”
Moderna, one of the pioneers in mRNA technology, is a Massachusetts-based company that is on the road to major breakthroughs in vaccine development against coronavirus.
In fact, it was the second company to report positive results after pharmaceutical powerhouse Pfizer revealed its vaccine was over 90% effective in treating the virus.
However, Moderna’s vaccine trials experienced a delay in October after the company’s private contractors had limited success in enlisting enough Black volunteers.
The clinical trial, conducted in collaboration with Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases, included more than 30,000 volunteers in the US aged 18 and over.
There were approximately 7,000 volunteers over age 65. About 5,000 volunteers were under the age of 65 with high-risk diabetes, cardiac disease, and obesity. There were twice as many Hispanic volunteers than Blacks: 6,000 vs. 3000.
In a Press Release dated November 16th, 2020, Moderna said:
“Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.”
Several Blacks who participated in Moderna’s trial had cases of the disease before taking the vaccine. Many reports have found that Blacks were more likely to be victims of preexisting conditions that predispose them to the Coronavirus disease and were less likely to have access to health insurance and remote work that would limit exposure.
In addition, Blacks are three times more likely than whites to be infected by coronavirus, and Blacks are twice as likely to die from the virus according to various reports.
“The coronavirus disease epidemic that upended every aspect of American life has exposed the naked face of institutional and interpersonal racism,” says Marc H. Morial, President & CEO of the National Urban League.
There has been a long-standing mistrust of the healthcare system among blacks ever since the Tuskegee Syphilis Experiment began in 1932.
Black men, many who were sharecroppers who had never visited a doctor, enrolled in the Tuskegee project in exchange for free medical care. Unfortunately, hundreds of black men died from the disease because adequate treatment was withheld from them, causing unnecessary pain and suffering.
Moderna’s trial, known as the COVE study, involved 15,000 participants who were given a placebo, a shot of saline that has no effect. The other half of study participants were given the COVID-19 vaccine.
When the results were delivered for the participants who were given a placebo, reports showed that 90 of them developed COVID-19. The impacted participants included 12 Hispanics, four Blacks, and three Asians.
Eleven of the participants were severe cases of COVID-19, but the racial identity was not revealed. However, those 15,000 volunteers who were given the COVID-19 vaccine did not become severely ill and only five contracted the virus.
Moderna’s clinical trials may potentially move everyone a step closer to
the answers that are needed – aiming to provide immediate support to those most vulnerable to COVID-19 to “This is a pivotal moment in the development of our COVID-19 vaccine candidate,” said Stéphane Bancel, CEO of Moderna. “We have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease. This milestone is only possible because of the hard work and sacrifices of so many. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. They are an inspiration to us all.”
Moderna received $1 billion from the U.S. government’s Operation Warp Speed to help develop its mRNA vaccine and $1.5 billion for future distribution. The company aims to provide the U.S. government with 20 million doses by the end of the month although there is still uncertainty about the length of time that the protection from the vaccine would last.
On Monday, Moderna applied to the Food and Drug Administration to authorize the vaccine for emergency use, providing the possibility for the first shots to be given as early as December 21st if authorization is granted.
More than 64 million coronavirus cases have been confirmed globally with the U.S. accounting for over 20% (13.7 million) of the total cases, according to data from the Johns Hopkins Coronavirus Resource Center.
Unfortunately, death rates have been climbing as exposure spreads -- more than 270,000 U.S. and over 1.4 million global deaths have been reported.
