A month after public health experts had raised concerns over deaths of infants following the use of pentavalent vaccine, the Union ministry of health and family welfare has declared that the vaccine is "safe".
The pentavalent vaccine (PV) is a combination of DPT vaccine and two more vaccines, against Haemophilus influenzae type b (Hib) and Hepatitis B.
Starting December 2011, PV was introduced into India's immunisation programme, to replace DPT vaccine in a staged manner, with a view to adding protection against Hib and Hepatitis B, without increasing the number of injections given to infants.
This March, in an article published in the medical journal of Dr DY Patil University, experts had stated that the pentavalent vaccine had led to double the deaths of children (soon after vaccination) as compared to the DPT (Diphtheria, tetanus, and pertussis) vaccine.
However, the Union ministry of health and family welfare has said this is not the case. According to the results of an independent study—conducted by International Clinical Epidemiology Network, in partnership with the Centre and the state departments of health and family welfare in Tamil Nadu and Kerala—the vaccine is safe, Union Minister for Health and Family Welfare Ashwini Kumar Choubey told the Lok Sabha in response to a question on the subject.
In his response, the minister said the study tracked 30,688 infants who received three primary doses of pentavalent vaccine at 1.5 months, 2.5 months, 3.5 months. The results have demonstrated that "there is no increase in death and hospitalisation rates reported in the first week after vaccination, as compared to fourth week after vaccination".
In his reply, the minister also added that there was an increase in the number of adverse events following immunisation (AEFI), including deaths, every year.
But it was because of "better reporting" and a strong surveillance system. The surveillance system "encourages reporting of any death, hospitalisation, clusters, disabilities, etc. following vaccination".
However, he added that according to surveillance data, there has been no spike in deaths following immunisation in 2017, as compared to the previous two years. "As per reports available (as on March 3, 2018), 355 AEFI deaths were reported in 2017, compared to 345 deaths in 2016 and 311 deaths in 2015," the minister stated in his response.