As two top-level independent committees probed a child’s death following a rubella vaccine shot, the vials are to be sent abroad for quality-testing.
Some of the rubella vaccine vials from Wariyapola will be sent for testing to a foreign laboratory, recognized by the WHO, in a country other than the country of manufacture which is India, explained Prof. Manouri Senanayake, Professor of Paediatrcis, Faculty of Medicine, University of Colombo who is heading the five-member Technical Committee set up to investigate all aspects of the rubella incident.
In the latest incident in the rubella saga, 12-year-old Asanthi Wasana Premathilake of Wariyapola died on October 12, while eight months earlier Peshala Hansini of Matara also succumbed after being administered the vaccine.
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| The vial containing the Rubella vaccine. The main picture shows only the date of expiry of the vaccine as November 2009, but not the date of manufacture. |
The report of the Technical Committee which began investigations immediately after Asanthi’s death is being compiled and will be released soon, stressed Prof. Senanayake, explaining that their inquiries covered a wide area. The other members of the committee are Chief JMO Colombo, Dr. Ananda Samarasekera; Consultant Immunologist of the Medical Research Institute, Dr. Rajiv de Silva; Senior Lecturer in Pharmacology, Medical Faculty, University of Colombo, Dr. Shalini Sri Renganathan; and Consultant Community Physician of the Epidemiology Unit, Dr. Sriyani Dissanayake.
It will not be a run-of-the-mill report, the Sunday Times understands, with an important large-scale study also being undertaken with both international and local expertise to assess the allergy status of the Sri Lankan population.
Asanthi died nearly 60 hours after being administered the rubella vaccine on October 10 at the Wariyapola MOH clinic. Although schoolgirls are given the vaccine in school, after the Matara death of Peshala in March, any child who is prone to allergies is asked to come to the nearest MOH clinic for the injection, it is learnt. Having been given the vaccine at the MOH clinic, Asanthi who developed adverse effects, was taken to the Wariyapola District Hospital and later transferred to the Kurunegala Teaching Hospital where she died on the evening of October 12.
The Technical Committee visited the Wariyapola MOH clinic and both the Wariyapola and Kurunegala Hospitals and interviewed doctors ranging from consultants to medical officers. They also spoke to the regional epidemiologist and other categories of staff, the Sunday Times understands.
“We visited the child’s home and spoke to the parents, other children as well as adult women who were immunized,” said Prof. Senanayake, adding that they took into their custody all documents including the autopsy report.
Tissue and blood specimens, including those taken ante-mortem (before death) are being analyzed, she said, explaining that the Ministry of Health had provided full cooperation and encouraged the committee in its bid to co-opt not only local but international experts for their views and advice.
The report from the second committee which is looking into the administrative aspects of the Wariyapola incident will come out this week, as soon as they interview the dead child’s parents, said the Director of the Drug Regulatory Authority, Dr. Hemantha Beneragama who is heading it.
“We have all the other interviews, but were awaiting the right time after the alms-giving in view of the sensitive nature of the issue, to talk to the parents,” he said, adding that his three-member committee is hoping to visit Wariyapola once again on Tuesday.
Meanwhile, a health source indicated that another inquiry is being conducted at provincial level while the Government Medical Officers’ Association (GMOA) called on the government to send samples of the present lot of vaccines to an accredited laboratory for analysis of all components not only the active ingredient.
The GMOA wants the continuation of the rubella vaccination programme as otherwise babies will be born with Congenital Rubella Syndrome, said Assistant Secretary Dr. Chandana Atapattu, pointing out, however, that since 1996 when it was first administered no serious adverse effects had been reported. “But this year Medical Officers of Health have reported to us that there are more allergic reactions compared to previous years,” he said.
The severe allergic reactions may not be due to the rubella virus which is the active ingredient in the vaccine, he says, but due to some other, even the gelatine used as a stabilizer. These incidents indicate there is something wrong with the product.
Rubella and the importance of immunization programmes
The immunization of girls and women between the ages 11-44 years against rubella began after there were many babies born with Congenital Rubella Syndrome (CRS) in 1994 and 1995, the Deputy Director-General of Public Health Dr. Palitha Mahipala said. Since then millions of doses have been administered in Sri Lanka.
Underlining the importance of the immunization programme begun over a hundred years ago in 1886, he said, smallpox which killed millions worldwide and hundreds of thousands in Sri Lanka was eradicated through vaccination.
The landmarks of the immunization programme in Sri Lanka include the last case of polio being reported way back as 1993, no cases of diphtheria being reported in 10 years, no cases of neonatal tetanus being reported in the last few years, only a very few cases of whooping cough being reported and the number of cases of measles being brought down. |
Why is the rubella vaccine important?
Although rubella or German measles is a mild febrile viral disease, if any pregnant mother contracts it especially during the first trimester, the impact on the foetus is devastating. Many mothers will have miscarriages or stillbirths but if the foetuses survive, 90% will get CRS.
Babies with CRS will be born with multiple birth defects and may have blindness, deafness, cardiac malformations, a small brain (microcephaly), mental retardation and behavioural problems. Those who survive the neonatal period, may face serious developmental disabilities and have an increased risk of developmental delays including autism, diabetes mellitus and thyroiditis, the Sunday Times learns.
There was a CRS epidemic in Sri Lanka during 1994-95, explains Dr. Mahipala, adding that 275 babies were born with the disease in 1994 and another 169 in the early part of 1995.
Under the EPI, Sri Lanka now administers the measles-rubella (MR) vaccine when a child is three years old and at around 13 years a rubella booster to gain life-long immunity.
Stringent guidelines followed
The strong message which came from all health sources was that there are stringent guidelines and testing procedures to ensure safety and efficacy when procuring vaccines for the Expanded Programme of Immunization (EPI).
The main condition set by the Epidemiology Unit when getting vaccines for the EPI is that the manufacturer has to be pre-qualified by the WHO, said Dr. Virginie Mallawaarachchi who is attached to the unit.
Pre-qualification status is granted to a manufacturer by the WHO after it undergoes rigorous screening and testing of samples, it is learnt. Even after that, when Sri Lanka imports a vaccine, a detailed dossier from the manufacturer (in this case the Serum Institute of Pune, India) which includes the manufacturing process of the vaccine from beginning to end is evaluated by many experts under a WHO formatted system. Control samples are also tested by the MRI’s National Control Lab (NCL) for vaccines which is mandated by Gazette notification and also recognized by the WHO, the Sunday Times understands.
However, the procedures do not end there. After the lot of vaccines is imported, the Epid Unit cannot use them until the NCL tests samples the shipment and issues a Lot Release Certificate in addition to a certificate from the government of the country of origin that the stock is of good quality.
“We are accountable. We will never compromise on quality,” assured NCL Head Dr. Omala Wimalaratne.
With regard to the Wariyapola incident, she said, that the NCL was quality-testing the vials from there while also making arrangements to send some vials to a WHO-recognized laboratory either in Australia or Europe for an independent quality report.
The quality-testing of the vaccine began soon after the adverse reaction was reported on October 10 while the child was still in hospital, it is learnt. When asked, Dr. Wimalaratne said there were no quality issues in the batch used in Matara in March and the WHO team which had independently investigated it had also come to the same conclusion. |
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