Vaccine shows promise as cases soar
Moderna trial studied in Houston is second to report high efficacy
Drugmaker Moderna said Monday its coronavirus vaccine provided strong protection in early trial results, the second company in a week to report its candidate looks to be highly effective in preventing COVID-19.
The Moderna vaccine demonstrated 94.5 percent efficacy in a study that so far has enrolled 30,000 participants, including about 1,150 at Houston-area sites. The report comes a week after Pfizer said its vaccine prevented illness in more than 90 percent of participants.
“These are very hopeful signs in a very dark year,” said Dr. Hana El Sahly, a Baylor College ofMedicine professor of molecular
virology and microbiology and a primary investigator of the national Moderna trial. “We now have two sets of data, from two separate clinical trials, showing roughly the same degree of efficacy. Given the similarity of the vaccines, that gives validity to such efficacy.”
El Sahly said she was almost in disbelief when she saw the Pfizer results, just based on her experience with other vaccines for other respiratory diseases. The norm for the flu vaccine, for example, is about 50 percent efficacy, she said.
El Sahly said the Pfizer news made her hopeful the Moderna results would be similar.
The vaccines offer the best hope against a pandemic that has infected nearly 55 million people worldwide, including more than 1 million in Texas. The death toll is over 247,000 in the U.S. and1.3 million globally.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the report “a really strong step forward to where we want to be” and projected that there will be “doses of the vaccines available for individuals in the higher risk category from both companies by the end of December.” The institute co-developed the vaccine with Moderna.
Both Moderna and Pfizer reported their preliminary findings in news releases, not academic journals. Both plan to apply for the Food and Drug Administration’s emergency authorization within weeks to begin deploying the vaccines, initially to health care providers.
Any rollout of the two vaccines, assuming the FDA grants emergency approval, will be limited and rationed. By year’s end, Moderna said, it’ll have 20 million doses for the U.S., and Pfizer
and German partner BioNTech say they’ll have 50 million doses for the world.
‘Ecstatic’ reaction
Among the Moderna trial’s Houston participants was Christene Kimmel, an administrator with Rice University’s James A. Baker III Institute for Public Policy. She said shewas “ecstatic” to see the 94.5 percent efficacy figure.
“It makes my participation in the trial even more worthwhile,” Kimmel said. “I look forward to the day when I can take my children to get the vaccine. They asked today if I’d give them the vaccine when they sawthe news, and I said absolutely. I want us to get back to a place where we can hug each other, go to the rodeo.”
Kimmel thinks she was among
trial participants that got the vaccine rather than a placebo because of symptoms she developed after the second shot — a low- grade fever, headache, muscle aches and chills. She said they were easily managed with Advil, then went away after 24 hours.
Kimmel participated in the trial through the houstonfightscovid.com campaign, which recruited about 800 people in the Houston area at the Texas Center for Drug Development, an independent study clinic. Another 271 enrolled at Baylor and 83 enrolled at a League City site of the University of Texas Medical Branch at Galveston.
Both vaccines use the same new technology, an approach that injects part of the virus’ ge
netic code in order to provoke an immune response. The approach, being deployed for vaccines in development for other infections and cancers but never before approved or marketed, is appealing because it isn’t made from the virus and thus can’t result in the disease like vaccines made from live viruses occasionally can.
The analysis of the Moderna vaccine data, conducted by an independent data and safety monitoring board appointed by the National Institutes of Health, was based on the development of COVID-19 symptoms in the first 95 trial participants. Ninety of the cases were in people who received a placebo instead of the vaccine. Only five had received the vaccine.
The 95 included 11 severe COVID-19 cases. All those occurred in people who received the placebo.
There were a few differences in the design of the Moderna and Pfizer trials: Moderna’s required two symptoms of disease, in addition to a positive test, for the case to be counted as COVID-19; Pfizer required only one symptom, in addition to a positive test. Also, Moderna waited 14 days after the second injection before assessing cases, compared with Pfizer’s seven.
Moderna’s big advantage over Pfizer’s vaccine is the storage requirement. Moderna’s requires refrigeration at only about 25 degrees Fahrenheit, a temperature easily reached by most freezers. Pfizer’s requires storage at minus 94 degrees Fahrenheit, supplied by specialized freezers available only at academic medical centers.
Another vaccine in trial
The Moderna findings were reported the same day that a vaccine created by Baylor scientists at Texas Children’s Hospital’s Center for Vaccine Development began human trials in India. The vaccine is expected to be widely deployed in economically developing nations if it proves effective.
The team produced the vaccine after Chinese scientists posted the virus’ genetic sequence in mid-January, using the same method it did for a 2016 vaccine against severe acute respiratory syndrome, known as SARS, the coronavirus that circulated in 2002-2003. That vaccine worked in animal models but was never tested in humans.
Some 1.2 billion doses of the vaccine will be manufactured by India’s Biological E. Limited, which partnered with the Baylor team in a licensing deal over the summer.