Novartis awaits pivotal Bexsero decisions in Canada and Europe

Bexsero has always carried high expectations at Novartis ($NVS). As the vaccine unit posted loss after loss in recent years, Novartis pitched the meningitis B vaccine to investors as the product that would usher in an era of consistent profitability. This has yet to happen, but the slow rollout of the vaccine continues.

Having already won approval in Australia and Europe, Novartis this week got the nod from Health Canada. Adding a third market is a boost for Novartis, but the size of the opportunity will only become clear after Canada decides whether to add the vaccine to its routine immunization program. The group tasked with making recommendations on new vaccines--the Canadian National Advisory Committee on Immunization--traditionally holds its first meeting of the year in February.

Novartis is also waiting on recommendations from immunization advisory panels in Europe, where it is yet to begin generating significant sales despite winning approval in January. In June, the United Kingdom Joint Committee on Vaccination and Immunisation (JCVI) reported routine vaccination is highly unlikely to be cost effective, but is now running further analyses incorporating new evidence. This week JCVI's Irish equivalent said it expects to make a decision next year, and gave an insight into its thinking.

Talking to The Irish Times, chairperson of the committee Dr. Kevin Connolly called the Bexsero ruling "one of the more difficult decisions" the board has faced. While meningitis B is a devastating bacteria, incidence is in decline and Bexsero is "quite an expensive vaccine," Connolly said. The falling prevalence of disease factored in the interim decision for the U.K., which has seen incidence of invasive meningococcal disease drop by one half in the past 10 years. A decade ago the case for Bexsero would have been much clearer.

The situation at Princeton University shows meningitis B is still a serious threat, though. Bexsero is yet to win FDA approval, but the agency has allowed the import of the vaccine for use on the campus. Vaccinations began this week, with the Associated Press reporting that 2,000 students received the vaccine on the first day of the campaign. A booster shot is planned for February. Jimmy van Thron was among those planning to receive the vaccine: "My mom's a pediatrician, and she told me to. So, gotta do what mom says."

- read the Health Canada news
- here's the Irish Times article
- check out the Associated Press report
- and Novartis's release