More than 200 NJ volunteers joined COVID trials; researchers 'ecstatic' at positive results
For a doctor who has treated scores of critically ill COVID patients and now leads one of the study sites for Moderna’s vaccine, this week’s announcement from the Cambridge biotech company that its vaccine was more than 90% effective couldn’t have come at a better time.
“Ecstatic” is how Dr. Bindu Balani, the study’s principal investigator at Hackensack University Medical Center and an infectious disease specialist, described her reaction. Touched both professionally and personally by the disease’s spread in New Jersey, she and her team “really wanted to help bring this pandemic under control.”
Like others around the state and across the nation, the Hackensack hospital now faces a rising second wave of coronavirus patients that has the potential to exceed even last spring’s tsunami. More than 2,320 COVID-positive patients were hospitalized in New Jersey on Tuesday — the highest number since May 30.
Seeing the news about the Moderna vaccine success “gave me a second wind,” said Balani, who also treated New Jersey’s first patient hospitalized with COVID in March.
Fifty researchers and more than 200 clinical-trial participants in New Jersey helped make possible the breakthrough announced Monday by Moderna. I was one of the study participants at Hackensack, and I, too, was thrilled at the news.
I received two shots, four weeks apart, as part of the trial. After developing a mild reaction following the second shot — a sore arm, a fever of 100.3 degrees and fatigue that lasted a single day — my hunch is that I received the vaccine candidate. But I haven’t been told, and I don’t know for sure.
Moderna’s announcement, coming soon after Pfizer’s that its vaccine was 90% effective, brightened my hope that there will be an end to the worry that any stray encounter may lead to a potentially deadly disease. Not to mention that the future may one day again include visits to far-flung family, shared hugs, guests for dinner, and a ride by public transportation to a theater performance in the city.
But for now, I’m still wearing a mask.
At Rutgers' New Jersey Medical School in Newark, where 57 volunteers received injections in Moderna’s clinical trial at University Hospital, Dr. Shobha Swaminathan, its principal investigator, said she found the data “extremely encouraging.” Like most people, she learned about the results at about 7 a.m. Monday.
It felt historic to contribute to a vaccine study at such a critical juncture in the pandemic, she said. But no single vaccine will be sufficient to inoculate the world’s population, or most of it. Multiple vaccines, with additional research, will be needed.
Vaccines are studied through trials that compare an equal number of participants who receive an injection of the vaccine candidate with those who receive a placebo, in this case, salt water. Aside from the pharmacy employees who prepare the syringes and the nurse who injects it, neither the researchers nor the participants know who receives the vaccine or the placebo.
“We strove to provide opportunities for study participants from the community we serve, which is mostly communities of color,” Swaminathan said. Moderna’s goal was to mirror the American population.
Of its total enrollees, 63% are white, 20% Latinx or Hispanic, and 10% Black. A quarter are older than 65. The vaccine was not tested on anyone younger than 18.
Moderna reported that 95 of its 30,000 participants developed symptomatic cases of COVID in the data it submitted to a separate safety and monitoring board. Appointed by the National Institutes of Health, that board has a level of independence intended to give the public confidence in the transparency and scientific integrity of the vaccine study.
The board “unblinded” the data from Moderna to learn how many of the 95 participants diagnosed with COVID received the vaccine candidate and how many received the placebo.
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It turned out that only five had received the vaccine — strong evidence of its efficacy. In addition, all of the 11 people with severe COVID-19 illness among the 95 had received the placebo.
Fifteen of those who got sick were over 65 years old, Moderna reported, and 20 were Black, Latinx, Asian American or multiracial.
The New Jersey investigators, Balani and Swaminathan, declined to reveal whether any of the participants at their research sites were diagnosed with COVID-19 or to give any demographic details about the participants they enrolled.
The vaccine also appears to be safe so far. “The majority of adverse events were mild or moderate in severity,” Moderna reported. Basically, they were like mine, or included headaches and muscle and joint pain.
A Rutgers-Eagleton poll conducted before the presidential election — and before the recent announcements by Pfizer and Moderna about their vaccine — found that between 36% and 47% of New Jerseyans said they would “probably” or “definitely” not get a vaccine.
“It is likely that public opinion on immunization will continue to shift and evolve,” said Ashley Koning, the poll’s director, “but right now, a large portion of New Jerseyans are still wary.”
Before either company can ask the federal Food and Drug Administration for an Emergency Use Authorization, safety data for two months after the second shot must be obtained for a majority of participants. Then, for full approval, months or years of safety data will be required.
The research will continue.
My commitment to the study is for 25 months — a full two years after the second shot. Whether I will be given the vaccine, if it is authorized and it turns out I received a placebo, remains to be seen. I am allowed to withdraw from the study at any time, so I could get it that way.
But sticking with it will also help answer some other important questions.
For example, “we really need to know how long this immunity is going to be durable for,” Balani said. By returning periodically to give blood samples, participants like me can help scientists determine how long the protection lasts.
That way we'll know whether this will be a once-a-year or once-in-a-lifetime shot.
Lindy Washburn is a senior health care reporter for NorthJersey.com. To keep up-to-date about how changes in the medical world affect the health of you and your family, please subscribe or activate your digital account today.