We wish to comment on importance of HPV vaccination and the recent
decision of the Government to suspend two studies on HPV vaccine on
account of alleged deaths, sending alarm signals to pediatricians.
HPV vaccination is for primary prevention
(serotype-specific, with limited cross-protection) of carcinoma of uterine
cervix (CaCx). Both bivalent (Cervarix) and quadrivalent (Gardasil)
vaccines are licensed and in clinical use in India. Risk of HPV infection
and consequent CaCx is not necessarily predicated by one’s sexual
promiscuity. Any heterosexual woman has risk because of her partner’s
private life, past or present. Those who will abstain from sex in
adulthood cannot be predicted. Therefore vaccine is proposed for all girls
without considering future sex-life. Both vaccines are safe from serious
adverse reactions. Secondary CaCx prevention is through periodic screening
(for HPV infection or cytological/visual lesion) and appropriate treatment
of early stages. Since current vaccines will prevent only 70-80% CaCx,
both interventions are essential. India does not have CaCx prevention
program; this is perceived by many to indicate lack of need. Had the need
existed, they trust that Government would surely have initiated control.
Truth is, our Government has no programs for controlling innumerable
preventable diseases. Treatment costs of serious illnesses pull many
families below poverty line; hence, disease-prevention is also poverty
alleviation(1). Unfortunately some health professionals themselves lobby
against disease-prevention giving the Government a convenient alibi(2).
Being very expensive (including 10% as taxes), some
suspect that HPV vaccination is solely for profit of the vaccine
makers/marketers. Had there been a CaCx prevention program and the
Government purchased vaccine in bulk, or if Indian manufacturers are
encouraged/enabled to manu-facture vaccine, the cost will drop
substantially. The gross economic loss on account of CaCx has to be
assessed before cost-benefit, and financial benefit to national economy
can be understood.
Will vaccination protect against CaCx? Science is
predictive. If HPV infection is prevented, CaCx caused by it will be
prevented. How long will protection last? The documented attrition rate of
antibody indicates that protection will last decades. It is unscientific
to wait until after longevity is documented before vaccine is used. We
guess that the unlikely worst-case situation may require a booster.
The two HPV vaccination projects were approved by all
required agencies. One is for operational feasibility of school-based and
community-based vaccination, in Khammam district (Andhra Pradesh, Gardasil)
and Vadodara (Gujarat, Cervarix), conducted by the State Governments in
collaboration with Indian Council of Medical Research (ICMR) and PATH (a
US based not-for-profit non-governmental organization). No bio-logical
outcome is measured; hence it is not a clinical trial. The second is a
multi-centric clinical trial to investigate immunogenic efficacy of 2
doses (6 months apart) compared to conventional 3 doses (at 0-2-6 months)
of Gardasil. If successful, it will lead to 33% cost-reduction. There was
allegations in the media of vaccine-caused death of 4 girls in Khammam and
the Union Government suspended both studies and initiated enquiry (which
is under process as we write this) into the safety of both vaccines. Both
vaccines continue in clinical use; suspending clinical trial while
allowing clinical use is illogical. The causes of death had been
scrutinized by the State Government and reported to ICMR and Drugs
Controller General of India; all were satisfied that no death was
vaccine-related. We understand that there is an unusually high frequency
of death among girls in this community, which is what deserves immediate
enquiry and remedial interventions.
The death of a 14-year old British girl shortly after
receiving HPV Vaccine, evoked considerable media attention across the
world. The necropsy studies showed that she had malignant tumor affecting
her heart and lungs(3). The vaccine was not her cause of death. In
summary, we state that HPV vaccines are safe, and, effective against
serotype-specific CaCx. We request the Government to take disease-control
seriously, and to include CaCx among those targeted for control. The role
of immunization in preventing diseases has been time-tested, and it is
important that science prevails over misguidance. When vaccine is
available against a disease, its non-utilization becomes a risk factor of
that disease. Epidemiology, economics and ethics demand that health
professions and Government join hands to alleviate the misery caused by
innumerable infectious diseases including CaCx.
1. Berman P, Ahuja R, Bhandari R. The impoverishing
effect of health care payments in India: New methodology and findings.
Economic Political Weekly 2010; 45: 65-71.
2. Puliyel JM, Madhavi Y. Vaccines: Policy for pubic
good or private profit. Indian J Med Res 2008; 127: 1-3.
3. Woods K. MHRA’s first year safety review of HPV
program. Vaccine letter October 2009 and a summary of the Drug Safety
Update Bulletin on 7 October 2009. Available from http://www.mhra. gov.uk/Safetyinformation/Generalsafety
HPVvaccine/index.htm. Accessed From on 10th May 2010.