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Reports US

US stock market daily report (April 07, 2014, Monday)

April 8, 2014, Tuesday, 04:48 GMT | 23:48 EST | 08:18 IST | 10:48 SGT
Contributed by Millennium Traders


College campuses have reported an increase in outbreaks of Meningitis, specifically the strain known as “serogroup B” or “MenB”. During 2012 in the United States, according to the Centers for Disease Control and Prevention (CDC), 160 of the 500 cases of meningococcal disease were caused by MenB. The MenB strain, although uncommon in the USA, can be very serious and potentially deadly.

To address this critical public health concern, the Food and Drug Administration has been working closely with CDC in order for CDC to make an unapproved MenB vaccine available as quickly as possible to universities where CDC determined outbreaks had occurred. While there are approved vaccines licensed in the USA to prevent meningitis, none include the MenB strain. The action from the FDA is being accomplished under their expanded access program for investigational or unapproved products. When other options are not available to treat or prevent serious or immediately life-threatening conditions, the program allows the use of unapproved drugs or vaccines.

The FDA continues to work closely with pharmaceutical companies working toward development and approval of MenB vaccines for the USA. Approval of potential vaccines require an extensive process that requires submission of a Biologics License Application by a manufacturer. A detailed review of data supporting the safety and effectiveness of a vaccine is performed by medical and scientific staff with the FDA. The staff are then responsible for inspecting the quality of the manufacturing process. The evaluation of each submission includes a careful assessment of benefits versus risks, to the health of the public. Serious consideration is given to weigh out the potential usefulness of a preventative vaccine against any unintended side effects.

The FDA has been able to make innovative and effective new treatment options available to patients faster, to address serious conditions related to MenB. Regulatory tools available to the FDA include accelerated approval, breakthrough therapy designation, fast-track program and priority review. Laws in the USA generally prohibit the FDA from disclosing the existence of pending applications however, Novartis AG (NVS-NYSE) gave the FDA permission to disclose that the pharmaceutical giant plans to submit a BLA for Bexsero (serogroup B meningococcal vaccine) for review, during Q2 of 2014.

In a statement on March 20, 2014 from Pfizer Inc. (PFE-NYSE), the pharmaceutical company acknowledged receiving breakthrough designation from the FDA for their vaccine for serogroup meningococcal B vaccine and intends to submit an application for review by mid-2014.