The first participants aged 65 and older have received vaccinations in a new study assessing coadministration of a pneumococcal jab along with a COVID-19 booster shot, Pfizer announced on Monday. Trial investigators are aiming to study the safety and resulting immune response, following participants up to six months post-vaccination.
The trial involves 600 adults recruited from the company’s prior late-stage COVID-19 vaccine trial. Participants must receive both COVID-19 vaccines at least six months before joining the new study, Pfizer said in a statement. Participants were randomly assigned to one of the following groups:
- Pneumococcal vaccine and a third dose of Pfizer’s COVID-19 vaccine
- Pneumococcal vaccine and a placebo
- Third dose of Pfizer’s COVID-19 vaccine and a placebo
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In vaccine makers’ late-stage clinical trials, participants were prohibited from getting vaccines 14 days before to 14 days after receiving their COVID-19 vaccine, Dr. Greg Poland, professor of medicine and infectious diseases at the Mayo Clinic and director of the Mayo Vaccine Research Group, told Fox News.
“Now that we have real-world effectiveness studies, the issue has been, that’s very disruptive given how many people, because of the pandemic, are behind on their immunization status, particularly kids and older adults,” Poland explained. “So these are studies are designed to look at the safety and any interference with the efficacy of the COVID vaccine when you coadminister it, in other words in one arm you get the COVID vaccine, in the other arm you get your pneumococcal vaccine.”
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Poland says coadministration is defined as at least 1 inch apart, though investigators typically prefer to coadminister vaccines in different limbs to avoid confusing any local reactions. Sometimes vaccine recipients develop a skin rash following vaccination, so coadministration in one arm may make it difficult to distinguish between potential reactions.
Pfizer didn’t immediately return a request for comment.
According to the Department of Health and Human Services, pneumococcal disease is caused by a common type of germ, spread through coughs or sneezes. Resulting illness is usually mild but can cause larger issues like ear, lung, blood or brain infections. While everyone needs pneumococcal vaccines, it’s especially important for babies, adults over 65 and people with weakened immune systems and underlying health conditions, HHS says. Potential side effects post-vaccination include a sore arm or fever, usually resolving in several days.