For life to return to normal, the world needs a COVID-19 vaccine — possibly a few of them.
Over the past month, several companies have announced promising early results for COVID-19 vaccines. But before a vaccine can be approved by the Food & Drug Administration, mass produced and distributed, it needs to be tested on tens of thousands of volunteers — some of whom will be from North Texas.
Last week, two major vaccine makers, Pfizer and Moderna, began recruiting volunteers in Dallas-Fort Worth. Both companies are part of the government’s Operation Warp Speed, a project that has poured more than $8 billion toward the goal of delivering a safe and effective vaccine by January 2021.
“The speed is historic,” said Jason McLellan, a UT-Austin researcher who helped design components of both vaccines.
The companies will each recruit 30,000 volunteers across the country and internationally, including hundreds in North Texas. Trial volunteers, who are eligible to be paid for their participation, will be randomly selected to receive either the vaccine or a placebo.
Dr. Anthony Fauci, the nation’s top infectious disease expert, on Friday told a House panel investigating the country’s response to the pandemic that 250,000 people have signed up for trials online. Not all who volunteer, however, will be eligible.
While early results for both vaccine candidates look promising, scientists won’t know until at least the fall whether or not the vaccines are safe and if they can prevent serious illness.
Both vaccines are based on new technology. Traditional vaccines, said McLellan, “do not ask the body to do very much.”
Most inject small amounts of live or dead virus to induce an immune response.
The Moderna and Pfizer vaccines use bits of genetic material called mRNA to stimulate cells to produce multiple copies of a coronavirus protein. Those proteins then trigger an immune response.
“The advantage of mRNA vaccines is they can be made very quickly, because it’s not very difficult to make a piece of mRNA,” said Peter Hotez , dean of the National School of Tropical Medicine at the Baylor College of Medicine in Houston. “The disadvantage is that it’s an unproven technology. There’s never been a human vaccine licensed with this technology.”
While the White House hopes to have solid data on both vaccines by October, experts say it’s unclear if that deadline can be met. Infection rates are leveling off across the country, and scientists need enough volunteers to become infected so that they can compare hospitalization rates and symptom severity in the placebo and treatment groups.
Yet people who sign up for trials, especially medical workers, are typically savvy about staying in good health avoiding unnecessary risks, said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College in New York City.
Texas is a desirable spot for a vaccine trial because the rate of community spread remains high, experts said.
Pfizer, which is recruiting volunteers through Fort Worth-based Ventavia Research Group, is looking for healthy volunteers between the ages of 18 and 85. Those who participate will receive two injections, 21 days apart. They will not know whether they received the actual two-dose vaccine or a placebo.
Pfizer is especially interested in testing the vaccine on those who are at high risk of exposure to the coronavirus, such as healthcare workers, first responders and grocery store employees.
Mercedes Livingston, chief operating officer for Ventavia Research Group, said those interested will need to pass an initial screening to find out if they’re eligible. Along with the injections, the study will require several follow up appointments over the coming months, including blood draws.
Moderna is also looking for healthy adults, especially those whose professions put them at high risk for developing COVID-19. The company is working with Global Medical Research in Dallas and Benchmark Research in Fort Worth to recruit volunteers. Eleven other research groups in Texas are also assisting in the Moderna vaccine trials.
In earlier trials, volunteers with both Moderna and Pfizer experienced mostly mild to moderate side effects including fatigue, chills, headaches, muscle aches, fever, and pain where the vaccine was injected, according to data released by the companies.
Hotez cautions that even if a vaccine becomes available by the middle of next year, which he thinks is possible, it may not put an end to the COVID-19 crisis.
“Americans don’t have realistic expectations on what we can expect from these vaccines,” he said. “Hopefully, some of these vaccines would prevent the infection. However it’s also possible that some may be just partially protective. In that case, we’d still need to have ongoing public health control measures, like masks and contact tracing.”
The Moderna and Pfizer vaccines are two of seven candidates in the government’s Operation Warp Speed portfolio, and more trials will be launching in North Texas in coming months.
“You need to have several shots on goal,” said Dr. Robert Gottlieb, who runs clinical trials at Baylor Scott & White Health. “We don’t have the luxury of seeing if one therapy is effective before deciding whether to pursue a second therapy. It may be that they’re all effective, and it may be none of them are effective, but we need to do this all in parallel at the same time and in a timely fashion.”
How to get involved
Those interested in participating in the Ventavia Research Group study can call 817-348-0228 or visit ventaviaresearch.com to find out if they’re eligible and to receive more information.
Those interested in Benchmark Research study can call 817-238-7254 or go to benchmarkresearch.net for more details.
More details on local studies are available at www.coronaviruspreventionnetwork.org.