FDA approves second group B meningococcal vaccine
The US Food and Drug Administration (FDA) today approved Bexsero, a Novartis vaccine to prevent meningococcal disease caused by Neisseria meningitidis serogroup B in people 10 through 25 years, the second group B vaccine approved by the FDA.
In October the agency approved Wyeth's Trumenba, also for people 10 to 25 years old. Both group B vaccines had been fast-tracked after several serogroup B outbreaks of meningitis on college campuses. Two other vaccines previously approved for US use cover the A, C, Y, and W-135 serogroups.
Three studies evaluating Bexsero's effectiveness were conducted in Canada, Australia, Chile, and the United Kingdom in about 2,600 adolescents and young adults. Two doses of Bexsero produced antibodies to three different strains of serogroup B N meningitidis in 62% to 88% of study participants, the FDA said in a press release.
Safety trials involved about 5,000 US and international volunteers, with the most common side effects being pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue, and chills. In addition, safety was monitored in more than 15,000 people who received Bexsero in response to two university outbreaks of serogroup B meningococcal disease in the United States, the FDA said.
Jan 23 FDA news release
Oman reports 3rd MERS case, Saudi Arabia reports death
The World Health Organization (WHO) today confirmed Oman's third MERS-CoV case this year, in a man who had contact with one of the earlier patients, and Saudi Arabia reported the death of a previously reported MERS patient.
The Omani patient with MERS-CoV (Middle East respiratory syndrome coronavirus) is a 43-year-old from Dakhiliyah governorate in the north central part of the country. His case was identified through contact tracing and reported to the WHO on Jan 17 by Omani officials.
The man visited the country's fatal case-patient at home and participated in his funeral, the WHO said. The agency previously identified the previous patient as a 32-year-old man who died in an intensive care unit on Jan 7.
The recently reported patient was admitted to a hospital on Jan 16 and was discharged on Jan 19 but has not had symptoms. He has no preexisting disease and reported no exposure to other risk factors in the 2 weeks before a respiratory sample was taken.
The third Omani case reported this year is in a 31-year-old woman who lived with the man who died of MERS, the WHO reported last week. She was reported to be hospitalized in stable condition.
Jan 23 WHO statement
Jan 16 WHO report on MERS in Oman
In Saudi Arabia, the country's Ministry of Health (MOH) reported no new MERS-CoV cases after reporting seven in Riyadh in the preceding 5 days. The MOH did, however, report the death of an 80-year-old man in Riyadh whose case was first reported yesterday.
The agency also said that a 61-year-old man in Riyadh has recovered from MERS. Both men had preexisting conditions.
Jan 23 MOH update