Pfizer (NYSE:PFE) said its bivalent RSV vaccine candidate met a main goal of showing efficacy against severe disease but did not reach statistical success in the second main objective in a phase 3 trial in pregnant women who given the vaccine to help protect their infants from RSV disease after birth.
The phase 3 study, dubbed MATISSE, evaluated the bivalent RSV prefusion vaccine RSVpreF (PF-06928316) against placebo to test efficacy against medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI in infants born to healthy women vaccinated during pregnancy.
The study enrolled ~7.4K pregnant individuals who received RSVpreF or placebo during the late second to third trimester of their pregnancy.Pfizer said that an interim efficacy analysis met the success criterion for one main goal. The observed efficacy for severe MA-LRTI was 81.8% through the first 90 days of life, and efficacy of 69.4% was seen for infants over the six-month follow-up period.
The company noted that although the statistical success criterion was not met for the second primary goal, clinically meaningful efficacy was seen for MA-LRTI of 57.1% in infants from birth through the first 90 days of life. Meanwhile, efficacy for MA-LRTI of 51.3% was observed over the six-month follow up period.The vaccine was well-tolerated with no safety concerns for the individuals and their newborns, the company noted.
Pfizer said that at the recommendation of a Data Monitoring Committee (DMC), and in consultation with the U.S. Food and Drug Administration (FDA), the company has stopped enrollment in the study. Based on these results Pfizer plans to submit an application to the FDA by the end of 2022 seeking approval of the vaccine.
IF #PfizerLiedPeopleDied is trending, possibly it is time for Short, just thoughts.
The investments and idea published may not be suitable for all investors. If you have any doubts as to the merits of an investment, you should seek advice from independent financial advisor or other professionals to determine what may be best for your individual needs. We do not and cannot guarantee that your use of our APP and/or any of its features will generate profits. All opinions, news, reviews, research, analysis, prices, or other information contained on or provided via this site are provided on an “as is” basis as general market commentary and/or expressions of opinion only. Information may not be complete, accurate or up to date and may not be suitable for every individual, nor be a suitable basis for an investment decision. No representation, warranty, undertaking, assurance or guarantee (express or implied) is made or given as to the availability, adequacy, accuracy, completeness, reasonableness or appropriateness of any of the information or opinions provided or expressed on or through this site. There is no obligation to notify you of any corrections or modifications.
The phase 3 study, dubbed MATISSE, evaluated the bivalent RSV prefusion vaccine RSVpreF (PF-06928316) against placebo to test efficacy against medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI in infants born to healthy women vaccinated during pregnancy.
The study enrolled ~7.4K pregnant individuals who received RSVpreF or placebo during the late second to third trimester of their pregnancy.Pfizer said that an interim efficacy analysis met the success criterion for one main goal. The observed efficacy for severe MA-LRTI was 81.8% through the first 90 days of life, and efficacy of 69.4% was seen for infants over the six-month follow-up period.
The company noted that although the statistical success criterion was not met for the second primary goal, clinically meaningful efficacy was seen for MA-LRTI of 57.1% in infants from birth through the first 90 days of life. Meanwhile, efficacy for MA-LRTI of 51.3% was observed over the six-month follow up period.The vaccine was well-tolerated with no safety concerns for the individuals and their newborns, the company noted.
Pfizer said that at the recommendation of a Data Monitoring Committee (DMC), and in consultation with the U.S. Food and Drug Administration (FDA), the company has stopped enrollment in the study. Based on these results Pfizer plans to submit an application to the FDA by the end of 2022 seeking approval of the vaccine.
IF #PfizerLiedPeopleDied is trending, possibly it is time for Short, just thoughts.
The investments and idea published may not be suitable for all investors. If you have any doubts as to the merits of an investment, you should seek advice from independent financial advisor or other professionals to determine what may be best for your individual needs. We do not and cannot guarantee that your use of our APP and/or any of its features will generate profits. All opinions, news, reviews, research, analysis, prices, or other information contained on or provided via this site are provided on an “as is” basis as general market commentary and/or expressions of opinion only. Information may not be complete, accurate or up to date and may not be suitable for every individual, nor be a suitable basis for an investment decision. No representation, warranty, undertaking, assurance or guarantee (express or implied) is made or given as to the availability, adequacy, accuracy, completeness, reasonableness or appropriateness of any of the information or opinions provided or expressed on or through this site. There is no obligation to notify you of any corrections or modifications.