The scientist said the company has already created a DNA template for a vaccine prototype and plans to manufacture a batch of that prototype. In addition, it proposes to conduct a phase I clinical trial of a booster injection of that prototype vaccine that would test against a booster of the current vaccine.
“This will be an immunogenicity study where you look at the immune response. And those studies are much, much smaller than the giant efficacy studies,” Dormitzer said.
The scientist explained that in immunogenicity studies the immune response of each person can be observed, in such a way that this allows them to have much smaller and easier studies to carry out. It is not as definitive as the efficacy data, but it can be collected much more quickly.
The U.S. Food and Drug Administration (FDA) has yet to release a roadmap for how companies should design booster vaccine trials.
The results of a study revealed that the South African strain of the coronavirus could reduce the effectiveness of the vaccine produced by Pfizer and BioNTech, which only produces a third of the antibodies against that variant.
The research revealed that the vaccine neutralizes the virus, but there is no evidence from human trials that the variant reduces the protection of the vaccine. BioNTech and Pfizer in November 2020 reported that their vaccine demonstrated greater than 90% efficacy.
Tests in pregnant women
Pfizer Inc and BioNTech began an international study with 4,000 volunteers to evaluate the safety and efficacy of their COVID-19 vaccine in healthy pregnant women. Pregnant women are at higher risk of developing severe COVID-19, and many public health officials have recommended that some in high-risk professions receive the coronavirus vaccine even without proof that it is safe for them.
Last week, the U.S. National Institutes of Health called for greater inclusion of pregnant and lactating women in COVID-19 vaccine research.
Bioethicists, vaccines, and maternal health experts have argued for years that pregnant women should be included early in pandemic vaccine trials so they don’t have to wait long after a successful one emerges.
With information from ..