GRAND RAPIDS, Mich. — A health system in West Michigan is playing a key role in a COVID-19 vaccine candidate that expects to apply for emergency use authorization from the U.S. Food and Drug Administration by the end of the month.
Trial data published in the New England Journal of Medicine last Wednesday demonstrated Janssen Pharmaceutical Companies of Johnson & Johnson’s vaccine generated an immune response in most participants, with people only experiencing mild side effects, like fatigue, headache and fever.
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“It was a very encouraging study,” said Dr. Eric Achtyes, director of research at Cherry Health. “I think it’s very hopeful that we may have soon a third COVID vaccine that people could use here in the United States.”
The company also announced it expects “topline” Phase 3 data for its single-dose vaccine candidate to become available in late January, positioning Johnson & Johnson to apply for FDA approval shortly thereafter.
Cherry Health is a testing site for Johnson & Johnson’s phase three coronavirus trial.
Achtyes says the health system has signed up more than 400 people from West Michigan and is a top enrolling site.
The recently released data comes from Phase 1 and 2A. It includes 800 participants aged 18 to 55 years old and 65 and older. Analysis ended after 71 days, but people will be studied for a year after. Researchers found either one or two dose shots showed encouraging results.
“By day 29 after the single dose, 90 percent of the participants showed neutralizing antibodies, a neutralizing level of antibody response, which is terrific,” said Achtyes. “By day 57, 100 percent of those individuals showed neutralizing antibodies.”
“They found that the second dose was given 57 days after the first dose, and there was more than double the antibody response after that second administration. The idea there is that more robust immune response.”
Unlike other vaccines, Johnson & Johnson’s does not require ultra-cold storage.
The vaccine uses a weakened common cold virus to carry DNA into a person’s body, leading their cells to fight back. Achtyes says while it’s a newer mechanism to develop a vaccine, it has been used in other vaccines against things like Zika, Ebola and HIV, and tested in tens of thousands of people in those populations.
“The idea is that you’re essentially priming or teaching your immune system to recognize the spike protein of the SARS-CoV-2 virus,” said Achtyes. “Should you ever be exposed to the virus again, in the real world, walking around, talking to people, your immune system would react very quickly, hopefully before you would get sick at all, or if you did get sick, the illness would be less severe.”
According to Cherry Health, Johnson & Johnson plans to conduct a large-scale two-dose shot. The health system says it will begin recruiting people for it within the next two weeks.
In August, Johnson & Johnson announced it signed a contract with the U.S. government to provide 100 million doses of its vaccine if it won emergency use authorization.
Achtyes is eager for what’s ahead, considering data from West Michigan patients will be used in the emergency approval decision.
“I think this is the only way we’re going to get our communities rolling again, our businesses, our schools, is to get everybody vaccinated,” said Achtyes.