Intended for healthcare professionals

Rapid response to:


Antivaccine lobby resists introduction of Hib vaccine in India

BMJ 2010; 340 doi: (Published 29 June 2010) Cite this as: BMJ 2010;340:c3508

Rapid Response:

'Sudden Deaths' after Pentavalent vaccination: Is the vaccine really safe?

I am a member of the group that filed the petition against the
Pentavalent vaccine in the Delhi High Court. I could not sign the earlier
letter to the BMJ as I was out of the country. I write to endorse that
letter and also to provide new data on the deaths following Pentavalent
vaccination in Asia; in Pakistan and Bhutan. There have been 3 deaths in
Pakistan and 8 deaths in Bhutan following Pentavalent vaccination, besides
the deaths in Sri Lanka.

According to an expert on the committee investigating the Pakistan
deaths, one child died within half an hour of receiving the vaccine and 2
others died within 12 to 14 hours. No alternate cause of death was found
for any of the deaths but the experts misleadingly suggest that ‘two cases
were diagnosed as Sudden Infant Death Syndrome (SIDS) but we (the experts)
were not sure of the third case’ (1). Yet in no case was the vaccine
blamed for the deaths.

The 'expert report' on the 8 deaths in Bhutan is not available in the
public domain as far as we can ascertain. A WHO spokesperson is reported
to have said the cause of death in Bhutan was not vaccination, but they
were due to a three other causes namely ‘sudden death, convulsions and
meningitis’ (2).

It seems that no effort has been made to follow the WHO protocol for
classification of adverse events following immunization (AEFI) in Pakistan
or Bhutan. All the cases of sudden death following vaccination would have
been classified as ‘Very likely’ or ‘Probably’ related to the vaccine if
the standard AEFI classification were employed. This large cluster of
‘sudden death’ in Asia, following immunization with Pentavalent vaccine
needs to be investigated dispassionately before more lives are lost.

S K Mittal MD

Formerly Professor and Head of Department of Pediatrics,
Maulana Azad Medical College,
Delhi, India.


1. Mansoor F. Introduction of the pentavalent vaccine into RI in
India- is it relevent in SEA Region? TechNet 21. Accessed on 22/7/10

2. Choden T. WHO declares the vaccine safe. Bhutan Times 30/5/2010
Accessed on 22/7/10

Competing interests:
None declared

Competing interests: No competing interests

23 July 2010
S. K. Mittal
Chairman Department of Pediatrics
Pushpanjali Crossway Hospital, Gaziabad, NCR.