The public was understandably shocked and dismayed at the death of a healthy twelve year old child Peshala Hashani, from a Rubella vaccination, a routine preventive health measure. Naturally there was a public outcry demanding that an inquiry be held and those responsible be punished

The health administrators confused description of the child’s death as being due to an "allergic" reaction naturally led to the assumption that it was an occurrence which could have been prevented. The immediate response of the Health Minister and administrators to the public’s wrath, was to scapegoat the medical personnel who had administered the vaccine, especially as it was reported that the girl’s, mother had sent a letter that her child was prone to allergic reactions to food containing cow’s milk.

Frequency of Reactions

The Chief Epidemiologist, Dr. Paba Palahawadane defended the National Immunization Program, adding that the program was handled entirely by a trained staff. In her report, Aisha Edris , (28-3-09, Island ) quoted Dr. Sudath Peiris, his assistant, to have added that "during the 13-year history of the program, more than five million people have received the Rubella vaccination and not a single case of Anaphylactic shock, which is the most severe form of allergy, has been reported in the Government sector".

Quality of the Vaccine

He is also said to have indicated that the vaccines that were used were bought from Serum Institute of India, a WHO approved, highly reputable institution which has been supplying the program with vaccines since 2001, and that all the vaccines, once received, are stored at the Central Cold Stores at the Unit under "specific cold chain requirements".

Anaphylactic Reactions-Causes & mechanisms

Anaphylactic reactions are not always caused by allergy. The latter term, denotes a immunological mechanism for the reaction. They may also be due to non- immunological biological reactions called "anaphylactoid " reactions, They result from introduction into the body to foreign substances such as food and drugs, biologics, insect venom ,dyes, latex, and rarely avian (egg or chick tissue) based vaccines. Anaphylaxis may follow exercise (exercise induced anaphylaxis).. These reactions cause liberation into the tissues and circulation of chemicals producing symptoms and physical signs which are identical, irrespective of the causative mechanism. When severe anaphylaxis occurs once in a million times after a simple procedure, without a recognizable predisposing cause, one has to assume that it is due to a reaction which is " idiosyncratic" (unique to the individual).Hashani’s reaction was probably one of these.

Signs & Symptoms

Itching and cutaneous and mucous membrane swellings, vomiting, abdominal cramping are minor symptoms of the reaction, while vascular collapse { shock) and respiratory distress from laryngeal swelling are serious and may result in death.

According to the report by Aisha Edris mentioned above, Peshala "fainted immediately after the vaccination, and was rushed to the Matara Hospital. She had a weak heartbeat soon after the vaccination was administered. The reaction therefore appears to have been immediate and severe, and reactions such as this have a high mortality despite immediate and intensive treatment.

Could Harshini’s death have been prevented?

Milk allergy.

Peshala Hansani ‘s mothers letter stating her child was prone to allergic reactions to food containing cow’s milk has no direct relevance to Hashani’s reaction to the vaccine, as the latter does not contain cows milk protein

Most babies outgrow milk allergies by their second or third year, and there was no mention of Hashni being on a "milk free" diet or of having had symptoms which would suggest a serious reaction, previously.

Sensitivity to Vaccine continents

The constituents of the Rubella vaccine which are even remotely likely to cause an adverse reaction are the antibiotic neomycin which requires parenteral administration to produce a systemic reaction, and the stabilizer gelatin, a common constituent of many foods and "Jello". There was no suggestion that Hashani had previously reacted adversely to an injection or vaccination as the source of possible sensitization to neomycin. In a large survey of children with systemic reactions to MMR vaccine, sensitivity to Gelatin was not uncommon by allergy testing but none of these children had reactions to gelatin-containing foods .There seems to be no relation between systemic sensitivity to gelatin and sensitivity to gelatin in foods, and getting a history of sensitivity to gelatin in food is therefore of no relevance to systemic sensitivity, in this context.

Outdated vaccine

There was an accusation from some that the reaction was due to the vaccines being outdated or nearly so. An outdated vaccine, or an improperly stored vaccine may become ineffective but there is no evidence at all that it is more likely to produce adverse reactions.

The reactions in the other students

It was also reported that, around 27 other students were also admitted with symptoms of headache, feeling faint, numbness and fever" suggesting that these symptoms were also adverse reactions to the vaccine, when in fact these symptoms are common after the vaccine especially in young females.

Prediction of Reactions

The prediction of who is likely to have the rare anaphylactic reaction to the vaccine, has to rely predominantly on the history of a previous anaphylactic reaction to other causative agents such a foods or drugs etc., The predictive value of this information in regard to a reaction to a vaccine, is low, as is a history of Atopy ( hereditary proneness to allergic diseases). To cofuse things further, the public tends to regard any untoward reaction especially involving the skin and gastrointestinal tract, and feelings of giddiness headache and even fever as due to "allergy". Therefore, screening of those who might react to vaccine in large programs are ineffective, and prompt recognition and treatment after the reaction has occurred, is often the only option. Symptoms, usually occur within minutes in severe and fatal reactions, as they are reported to have done in Hashani’s case. Often, it is necessary to err on the side of treatment before the diagnosis is clear.

The health officers in charge of an immunization program must have special training and a detailed protocol to guide them, which Dr Sudath Peries said they had. However recognizing a severe reaction and implementing the protocol when one occurs, once in a million vaccinations, when hundreds are vaccinated a day, must need special attributes!!

In summary therefore an inquiry has to focus on whether Hashhani’s reaction to the vaccination could have been anticipated under the circumstances and more importantly whether it was recognized and treated when it occurred. The answer to the first question I believe is no. It is the second that needs enquiring into. The outcome may not have been different even if it was.

Before I finish I would appreciate the opportunity to comment on the peripheral actors in this tragic drama, who used it to give voice to their prejudices and fulfill their own agendas.

The GMOA did a disservice to itself as a responsible professional organization by, using the child’s death to bash the Minister and the Health administrators, without a clear knowledge of the facts, demanding that they resign. A political section of the GMOA, the All Ceylon Government Medical Officers’ Association (ACGMOA), attributed the child’s death to the ‘inferior quality’ of the Rubella vaccine which it said was nearly outdated, an assertion. which was subsequently proven to be wrong. They also categorized, unfairly, I believe, a health professional from Society of Registered and Assistant Medical Officers (SRAMO) as unqualified to run a vaccination program, before the facts were known..

Most responses from the public were from genuine outrage and sympathy for the child. So much so that one knowledgeable and frequent contributor to the Island went so far as to ask, quote: Peshala’s death: A murder?(Isl. Opinion,23-3-09) There were others, like the erudite ,distinctly right wing , anti-government, almost omniscient contributor to the Island, , who in a letter titled, "Health Minister  solely responsible",(Island,Opinion ,26-3-09) demanded his resignation. Letting his bias get the better of his judgment. he said, quote: "There are posters calling upon him to resign. He should or the President must dismiss him. Today there are no tenders that Ministers do not have a hand in. So if outdated or inferior drugs are imported the responsibility must lie fairly and squarely on the Minister"

I hold no brief for the Minister or the health administration, and I dare say that the general lack of confidence in their administrative competence and principled behavior is justified, their inactivity on the generic drug issue comes to my mind in this regard. However, to assume that their incompetence, and even malfeasance had contributed to the Hashani tragedy is unfair.

The writer is a fellow of the Amercan Academy of Allergy and Immunology and Instructor in Medicine and Attending Physician at the Cornell University Medical College and its Medical Center in New York City while being in the private practice of Allergy in Queens, NY. for 20 years. He was also Chief of Allergy at the Booth Memorial hospital and The Flushing Hospital in Queens, NY., for varying periods.