Ministry admits proper guidelines not followed in vaccine trial

The Union Health Ministry has admitted that proper guidelines were not adhered to while carrying out trials of HPV vaccine among young girls in Andhra Pradesh.

Last Updated: Apr 29, 2010, 00:42 AM IST

New Delhi: The Union Health Ministry has
admitted that proper guidelines were not adhered to while
carrying out trials of HPV vaccine among young girls in Andhra
Pradesh.

The admission was made by the Secretary Department of
Health Research V M Katoch to the Parliamentary Standing
Committee on health, headed by Amar Singh.

When the committee drew the attention of the secretary
to the DCGI (Drug Controller General of India) guidelines
where under third phase trials of any drug or vaccine cannot
be conducted on children until a similar trial was held on
adults, Katoch admitted that the same was not adhered to in
the present case.

The committee said in a report that the secretary,
however, said the vaccine is supposed to be given before
sexual activity begins to protect against cancer and therefore
it was used on young girls aged 10-14 years.

Taking serious view of procedural and ethical lapses
on the part of the Ministry, the committee sought the matter
of allowing trial of the vaccine as also the approval for its
marketing in the country to be inquired into by a premier
investigating agency and to take further appropriate follow-up
action in the matter.

It also asked that the findings of the investigating
agency and the follow-up action taken in this regard may be
furnished to the committee at the earliest.

The committee said in the future, all guidelines and
norms should be adhered to before allowing trials of any drug
including vaccines on Indian population.

It also recommended that the DCGI should observe
optimum precautions and follow all norms and guidelines while
allowing marketing of any drug including the vaccines in the
Indian market.

The HPV vaccine trials in Andhra Pradesh and Gujarat
were stopped by the government following the death of six
children. The vaccines in question are Gardasil by MSD
Pharmaceuticals and Cervarix by GSK Pharmaceuticals.
The Phase III trials involved 14,019 in Andhra Pradesh
and 10,686 people in Gujarat.

Four of the six deaths occurred in Andhra, while the
other two occurred in Gujarat.

The vaccination drive was being conducted as part of a
study by an NGO `PATH` and was recommended by the Ethical
Committee and Advisory Groups at state and central government
levels.

-PTI

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