The announcement from biotechnology company Moderna on Nov. 16 that its Phase 3 trials of the mRNA-1273 COVID-19 vaccine candidate returned a 94.5 percent efficacy rate was greeted by worldwide acclaim and hope, with two Indian Americans in California even more overjoyed, having experienced it up close and personal.
A week ago, competitor Pfizer Inc. announced its own vaccine looked 90% effective — news that puts both companies on track to seek permission within weeks for emergency use in the U.S., AP reported.
The National Institutes of Health helped create the vaccine Moderna is manufacturing, and NIH’s director, Dr. Francis Collins, said the two companies’ parallel results give scientists “a lot of confidence that we’re on the path towards having effective vaccines.”
The Moderna study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the NIH, and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, a Moderna press release said.
Among the volunteers in the study were Indian Americans Satish and Lilam Shah, both seniors over the age of 65 and in general good health, of Elk Grove, California, near Sacramento.
Satish Shah told India-West that he and his wife began looking for solutions to combat the virus when the pandemic began to spread throughout the U.S. in March. In their searches, they found Moderna and immediately expressed interest in volunteering for the trials.
In Phase 2 at the time, Moderna didn’t have a site in California at the time, but let the Shahs know they would consider them for the Phase 3 trials.
Shah said he and his wife were qualified in July when that phase began in Sacramento. They received their first shots on Aug. 4.
“We didn’t have any reactions, no pain at the site of the injection. We were well briefed about side effects and symptoms to look for and of course keep following CDC guidelines of wearing masks, social distancing and washing hands often,” Satish Shah explained to India-West.
He said they were told that half the participants received the actual vaccine and the other half was administered a placebo.
“The nurses or doctors at the lab site don’t know who gets what because it is called a Double-Blind study. Our second shot was given to us 28 days later on Aug. 31. We were entering weekly status of our health in an app on our phone,” Shah elaborated of the study.
“After our second shot, (Satish) started feeling feverish and my temperature was up to 102. Lilam did not show any effect. The lab doctor and our primary care doctor both suggested to start with Tylenol or Motrin to control fever,” Satish explained, in the days following the shots.
“Along with 102 fever, (Satish) had headaches, body aches. It lasted for two days and everything was under control,” Satish said. “Our lab nurse said that it looks like (Satish) has received the actual vaccine shot. Lilam didn’t have any reaction at all after the second shot. So, we are assuming that she may have received the placebo.”
The Shahs received COVID-19 testing after each shot and each test turned up negative, they said.
In addition to taking part in the trials themselves, they also launched a call-to-action campaign on social media, went on local news telecasts and wrote a letter to President Donald Trump to get more volunteers.
Moderna in its press release added that the primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine.
“We are extremely happy to hear that Moderna’s vaccine was found 95 percent effective and we both played a part in its testing and still continue to report each week via their online app,” Satish Shah told India-West.
“We always felt that being part of the vaccine trial will benefit us personally, our family and friends and humanity in general. We feel it is all Americans’ social responsibility to volunteer wherever we can and help fellow human beings,” Shah added.
As more cases accrue leading up to the final analysis, Moderna expects the point estimate for vaccine efficacy may change. It plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, 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,” Moderna CEO Stéphane Bancel said in a statement.
“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,” Bancel added.
Moderna next intends to submit for an Emergency Use Authorization with the U.S. Food and Drug Administration in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data. The company also plans to submit applications for authorizations to global regulatory agencies.
Moderna is working with the U.S. Centers for Disease Control and Prevention, Operation Warp Speed and McKesson, a COVID-19 vaccine distributor contracted by the U.S. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations.
By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. The company remains on track to manufacture 500 million to 1 billion doses globally in 2021, it said.
More information about Moderna’s work on mRNA-1273 can be found by visiting www.modernatx.com/COVID19.