Intended for healthcare professionals

Rapid response to:


Do we need a new approach to making vaccine recommendations?

BMJ 2015; 350 doi: (Published 30 January 2015) Cite this as: BMJ 2015;350:h308

Rapid Response:

With some confusion, I have followed the news about Bexsero, the new group B meningococcus vaccine and am now grateful to Natasha Crowcroft and her Canadian colleagues for clarifying some of the questions at issue. They suggest: 1) There is much uncertainty about vaccine effectiveness...2) There are serious concerns about vaccine safety...3) Even if effectiveness is proved the number of lives saved will be small...4) The vaccine is expensive...5) Lobbying has played a substantial role in its approval in Europe, Australia, Canada, and now the U.S. (FDA news release 1/23/15)....6) Including it in vaccine schedules will not be cost-effective and may threaten uptake of truly life-saving vaccines, as well as support for non-vaccine programs important for preventing morbidity and mortality

Group B meningococcal disease is rare, but adverse effects of Bexsero are not. There were 5 cases of Kawasaki Disease in 4340 trial infants; this is 115 KD cases per 100,000 infants, about 10 times the background incidence of KD in the U.S. More than one-third of infants had high fever the day of vaccination, including 8 who had seizures; this is nearly 3 times the seizure rate with the old DTwP vaccine and 5-6 times the seizure rate with DTaP/IPV/Hib vaccine (Lancet 381:785 & 825, 2013. JAMA 307:573 & 614, 2012).

Crowcroft refer to the public loss of confidence in vaccines and vaccine experts; they suggest a need for greater transparency and higher ethical standards for decision-making. They cite the tensions between individual benefit from vaccines vs. population benefit; between clinicians and public health professionals; between governments and industry; and between advocates for children and other members of society....Somewhat blandly they state, "Technical and economic considerations currently dominate ethical ones" where vaccine policies are concerned. Similar issues were raised more obliquely regarding the activities of the Advisory Committee on Immunization Practice (ACIP) in the U.S. (Schwartz & Mahmoud, NEJM 371:1953--Nov. 20, 2014).

Over a 40 year pediatric career I supervised or administered over a million doses of various vaccines. Sometime after 1990 I became aware of the commercial, as opposed to the humanitarian motives driving vaccine programs, and the tendency for manufacturers and officialdom to exaggerate the benefits of vaccines while paying little attention to rare but serious adverse effects.....I very much appreciate Dr. Crowcroft and her colleagues' analysis of the Bexsero controversy and its application to general concerns about vaccine policies.

Competing interests: No competing interests

01 February 2015
Allan S. Cunningham
Retired pediatrician
Cooperstown NY 13326 USA