Pfizer Inc has launched a new study involving adults over 65 years of age who have been vaccinated with its Coivid-19 vaccine that makes use of the company's 20-valent pneumococcal conjugate vaccine (20vPnC) candidate with a third dose of the Pfizer-BioNTech vaccine shot. This was announced by the company on Monday.
Pfizer said that this study has been initiated to test whether it is safe to administer a combination of the vaccines as well as the immune response that is developed following the addition of the pneumonia vaccine to the existing COVID-19 vaccine.
The company said that the vaccine candidate, 20vPnC, is being developed by it to help in protecting adults against 20 serotypes that are believed to be responsible for the majority of invasive pneumococcal disease and pneumonia.
600 adult participants will be included in this study and they would be selected from the late-stage COVID-19 vaccine study of the vaccine following the participants being administered their second dose of the Covid-19 vaccine at least six months prior to being recruited for the co-administration study.
Previous recommendations were to be administered the Covid-19 vaccines alone. After considering the previous experiences of administration of non-Covid-19 vaccines, recommendations that the Covid-19 vaccines and other vaccines can be administered simultaneously or on the same day were made by the United States Centers for Disease Control and Prevention.
A request for a priority review Pfizer's biologics license application for the investigational 20vPnC in adults over 18 years was accepted last December by the US Food and Drug Administration (FDA) and had set an action date for taking a decision in June.
On the other hand, the company's marketing authorization application for 20vPnC was accepted by the European Medicines Agency (EMA) two months later/
Pfizer’s 20vPnC vaccine candidate includes capsular polysaccharide conjugates for the 13 serotypes in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes that cause pneumococcal disease, and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis. Together, the 20 serotypes included in 20vPnC are responsible for a majority of currently circulating pneumococcal disease globally.
“At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us,” Pfizer noted.
(Source:www.usnews.com)
Pfizer said that this study has been initiated to test whether it is safe to administer a combination of the vaccines as well as the immune response that is developed following the addition of the pneumonia vaccine to the existing COVID-19 vaccine.
The company said that the vaccine candidate, 20vPnC, is being developed by it to help in protecting adults against 20 serotypes that are believed to be responsible for the majority of invasive pneumococcal disease and pneumonia.
600 adult participants will be included in this study and they would be selected from the late-stage COVID-19 vaccine study of the vaccine following the participants being administered their second dose of the Covid-19 vaccine at least six months prior to being recruited for the co-administration study.
Previous recommendations were to be administered the Covid-19 vaccines alone. After considering the previous experiences of administration of non-Covid-19 vaccines, recommendations that the Covid-19 vaccines and other vaccines can be administered simultaneously or on the same day were made by the United States Centers for Disease Control and Prevention.
A request for a priority review Pfizer's biologics license application for the investigational 20vPnC in adults over 18 years was accepted last December by the US Food and Drug Administration (FDA) and had set an action date for taking a decision in June.
On the other hand, the company's marketing authorization application for 20vPnC was accepted by the European Medicines Agency (EMA) two months later/
Pfizer’s 20vPnC vaccine candidate includes capsular polysaccharide conjugates for the 13 serotypes in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes that cause pneumococcal disease, and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis. Together, the 20 serotypes included in 20vPnC are responsible for a majority of currently circulating pneumococcal disease globally.
“At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us,” Pfizer noted.
(Source:www.usnews.com)
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