When the National Institutes of Health and biotechnology company Moderna released initial promising results of a vaccine for COVID-19, biochemist Nicole Woitowich read the study with disappointment.
The research, published in the New England Journal of Medicine in mid-July, had a glaring oversight, she said. While both men and women participated in the trial, the data related to adverse drug effects were not analyzed by sex. This means the clinical community right now has no way of knowing if men or women responded differently to various vaccine dosages. The adverse effects from the experimental vaccine were mild or moderate and included chills, nausea and fever.
The NIH along with HHS’ Office of Biomedical Advanced Research and Development Authority are funding the Moderna trial. The other major vaccine trial underway in the U.S. from drugmaker Pfizer and biotechnology company BioNTech also hasn’t analyzed data by sex in their published results, although the findings haven’t been peer-reviewed yet.
Woitowich, associate director of the Women’s Health Research Institute at Northwestern University in Chicago, said the absence of analysis by sex in the COVID-19 vaccine trials thus far is concerning as there are high hopes for an effective vaccine that can be brought to market quickly.
“If we are going to be developing treatments and vaccines that will be given to the global population, then it’s important that these experiments driving these treatments and vaccines are rigorous, and they are analyzing and reporting the data by sex. We know there are sex differences,” Woitowich said.
Men are more likely to die from coronavirus-related symptoms and suffer negative outcomes compared with women. There are also studies finding women respond better to influenza vaccines and have a stronger immune response. Understanding how men and women respond to the COVID-19 vaccine will be critical to determining the appropriate dosages and ways to avoid adverse effects.
“I don’t want to make this a women’s health issue—it benefits all people if we analyze data by sex,” Woitowich said.
In an email, the NIH’s National Institute of Allergy and Infectious Diseases said the initial results released in the New England Journal of Medicine represent phase one of the trial, which had only 45 participants, and “was not designed to understand differences among sexes” but rather how the participants who met the inclusion criteria responded to the vaccine.