Pfizer stock responds well to developments, trading at PFE +0.22% to $46.25 premarket on September 15.
Pfizer (NYSE:PFE) will be seeking FDA approval given the Pan-meningococcal vaccine is superior to Trumenba, and GSKs Menveo is in testing. Pfizer (NYSE:PFE) said that its pentavalent meningococcal vaccination (MenABCWY), which met the primary and secondary goals of a phase 3 trial in healthy individuals aged 10 to 25 years, was as effective as its own meningococcal illness vaccine, Trumenba, and GSKs (NYSE:GSK) Menveo.
Any illness brought on by the Neisseria meningitidis bacteria is referred to as a meningococcal disease. According to the U.S. CDC, these disorders include blood infections and meningitis, which affect the lining of the brain and spinal cord. They are frequently fatal.
In a press release on September 15, Pfizer stated that the MenACWY and MenB vaccines are currently licensed separately and that no one vaccination is available to help protect against the five serogroups–serogroups A, B, C, W, and Y–which cause the majority of invasive meningococcal illness.
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Menveo is licensed for MenACWY, and Trumenba is for meningitis B. In the trial, participants either got two doses of MenABCWY or two doses of Trumenba with one dose of Menveo, two approved vaccinations. The business reported that in comparison to two doses of Trumenba and one dosage of Menveo, data indicated non-inferiority for all five serogroups following two doses of MenABCWY. In addition, Pfizer claimed that a single dose of MenABCWY compared to a single dose of Menveo fulfilled the non-inferiority criteria for serogroups A, C, W, and Y.
The proportion of patients who had immune responses that were four times greater following either one or two doses of MenABCWY for serogroups A, C, W, and Y was observed to be higher among individuals who had not previously received a meningococcal vaccine than after one dose of Menveo, the company noted.
According to Pfizer, more individuals showed a 4-fold increase in immune responses to all four serogroup B strains after receiving two doses of MenABCWY than after receiving two doses of Trumenba. According to the manufacturer, MenABCWY was well accepted and had a safety profile similar to that of approved vaccinations.
Pfizer stock upbeat on new developments
In order to get the vaccine approved, Pfizer intends to submit a biologics license application to the American Food and Drug Administration in Q4 2022. If licensed, MenABCWY would offer the most comprehensive serogroup coverage of any meningococcal vaccine and aid in streamlining the meningococcal vaccination schedule.
PFE +0.22% to $46.25 premarket on September 15
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Author: Jowi Kwasu
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