The principal investigator of an ongoing clinical trial of Pfizer-BioNTech’s COVID-19 mRNA vaccine said UMass Medical School plans to enroll about 100 participants from its first Pfizer trial in a vaccine booster study by the end of June. The booster would be given approximately six months after the participants were given the second vaccination with the original vaccine.
“The vaccine has apparently been shown to be incredibly effective for six months,” said Robert Finberg, MD, distinguished medical professor and member of Gov’s COVID-19 advisory group. Baker. “The question is what happens after that? So this will be a Phase III study with 10,000 people around the world and they will be randomized to either get a placebo or a third shot of the same vaccine that they had two doses of.
According to Dr. Finberg, the researchers will study cases of COVID-19 in two groups, those ages 16 to 55 and adults over 55 years of age.
With more than 150 cases in Massachusetts reported earlier this spring of the Delta variant, which was first discovered in India and is considered more transmissible and potentially more serious than previous strains, it is important to keep control of the mutant virus.
“So far, it’s good. It looks like we’re not seeing any breakthrough cases with the Delta variant,” said Finberg. “The question is, how long does the vaccine last? And the other question is, do we have to develop another vaccine in the future? “
In the clinical study, only a booster dose of the same type and manufacturer, in this case Pfizer-BioNTech, will be used as starting doses for the participants. However, Finberg said the National Institutes of Health and scientists in the UK are investigating whether the manufacturer or type of COVID-19 vaccines might differ between a person’s doses.
Pfizer-BioNTech and Moderna vaccines insert messenger RNA (mRNA) from the virus, a series of instructions for making proteins that are inserted into a cell’s cytoplasm. The cell then converts this mRNA into a viral protein and activates an immune response. Both vaccines are given in two syringes.
The Johnson & Johnson vaccine differs slightly in that it involves a single dose of a modified adenovirus to deliver a small piece of DNA to the cell that makes the spike protein. After the cells make the spike protein, the body makes antibodies and T cells to protect itself from the invader.
Maryland-based biotech company Novavax recently announced that it is seeking approval from the US Food and Drug Administration for a fourth vaccine after clinical studies showed it was also safe and highly effective. The two-dose vaccine “is a more conventional, nanoparticle-delivered protein vaccine and it would be easy to administer and store, so that’s good news again,” said Finberg.
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