WASHINGTON — The drugmaker Pfizer on Monday announced it has started enrolling fully vaccinated individuals to study its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate with a third dose of the Pfizer-BioNTech COVID-19 shot.
In a press release, Pfizer said the 20vPnC vaccine is for the "prevention of invasive disease and pneumonia caused by 20 serotypes of Streptococcus pneumoniae in the vaccine in adults ages 18 years and older."
The company said it is enrolling 600 subjects 65 and older to receive the immunizations. The objective of the trial is to test if both vaccines are safe when they are co-administered, with a follow-up six months after vaccination. The second goal is to describe immune responses produced by each of the vaccines.
The individuals tested for the vaccine will be from the third phase of the Pfizer-BioNTech COVID-19 vaccine trial and will have received their second dose of the vaccine at least six months before entering the coadministration study.
Pfizer said all of the subjects are being randomized into three groups, one with the 20vPnC plus Pfizer-BioNTech COVID-19 vaccine booster, which is a third dose of the Pfizer-BioNTech COVID-19 Vaccine, another group will receive a placebo while the third group is given a Pfizer-BioNTech COVID-19 vaccine booster plus a placebo.
In December 2020, the U.S. Food and Drug Administration accepted a priority review of Pfizer's biologics license application for the investigational 20vPnC in adults over 18 and set an action date for a decision in June. The European Medicines Agency (EMA) in February of this year accepted for review the marketing authorization application for 20vPnC for adults ages 18 years and older.
The FDA has already authorized the use of the Pfizer-BioNTech COVID-19 vaccine back in December under the Emergency Use Authorization.
Dr. Anthony Fauci says vaccinated Americans would “not necessarily” need to get booster shots this fall for further protection from COVID-19.
Fauci, the nation’s leading infectious disease expert, told CBS “This Morning” on Friday that scientists would be tracking data on the virus and possible variants. He says it was still “possible” an additional shot would be needed later this year to ward off possible infection.
Fauci also urged Americans to continue to follow CDC guidelines. He stressed those who haven't been fully vaccinated still need to wear masks even if they are largely spending time with people who have been inoculated.
The Associated Press contributed to this report.