H1N1 patient's death in Pune sparks warning

[Ronan Kelly]

H1N1 patient's death in Pune sparks warning
Umesh Isalkar, TNN, Aug 27, 2010, 12.01am IST

PUNE: If one is suffering from cold, cough, fever, diarrhoea or sore throat basically any upper respiratory illness or even an attack of asthma he/she should not take the H1N1 vaccine, said Sharad Agarkhedkar, president of the city chapter of Indian Medical Association (IMA), here on Thursday.

The IMA warning comes following the death of an H1N1 patient on August 24, 10 days after he was administered an intra-nasal vaccine in a private hospital.

Bhupendra Thakur (35) of Bhairoba Nallah in Pune Camp, was administered a dose of Nasovac, produced by the Pune-based Serum Institute of India, on August 14, the victim's brother, Rajnikant Thakur, told TOI.

"Bhupendra was suffering from cold and cough since the first week of August, so we thought he should be given the vaccine as a precautionary measure. We purchased Nasovac from a medical store in Pune Camp and took him to a private hospital, where he was administered the nasal drops by a doctor. His condition worsened and he was taken to the Sassoon hospital on August 17, where he tested positive for the H1N1 flu. He was put on the ventilator, but he succumbed to the flu," Rajnikant said.

Agarkhedkar said the death of Thakur could send wrong signals to the community at large. "The vaccine should not be blamed for his death. The timing of the vaccine was wrong as the patient already had symptoms of swine flu," he said.

"It is very important to understand that when the swine flu virus enters a human body, it takes a minimum of one day to a maximum of eight days for the disease to develop fully. When a person is in incubation period, he/she doesn't show any symptoms. Hence, if the person starts showing symptoms within seven days of vaccination, it is important to consult a doctor to verify the cause of the fever," said Agarkhedkar.

"We have seen cases wherein we had to give Tamiflu even after vaccination. The antibodies produced by the vaccine start appearing from the eighth day onwards, and reach sufficient amount needed to fight the disease within three weeks. During this period, the person has to take all the precautions like washing hands, using sanitisers and keeping a safe distance from sick people," he said.

Agarkhedkar advised people against buying the vaccine themselves because temperatures between two and eight degree centigrade are needed to preserve it.

"Similarly, doctors should ask patients about their medical history, present illness, pregnancy, egg-related allergies, lactation, status of diabetes (whether controlled or uncontrolled). Inquiries should also be made about whether there is any cancer patients on chemotherapy in the family as the chances of transmitting the vaccine induced virus to such immunocompromised patient is quite likely," added Agarkhedkar.

When contacted by TOI, Prasad Kulkarni, additional director, Serum Institute of India, said, "Nasovac is safe. Around 11 lakh doses of the vaccine have been distributed in the last one-and-a-half months and no serious adverse reaction has been reported. As far as the death of Thakur is concerned, it is amply clear that he was already suffering from swine flu."

http://timesofindia.indiatimes.com/city/pune/H1N1-patients-death-in-Pune-sparks-warning/articleshow/6442274.cms#ixzz0xkZ38Eyc

see also http://www.flutrackers.com/forum/sho...=124573&page=9 (264 and 265)

[tetano]

Re: H1N1 patient's death in Pune sparks warning

It was the faulty treatment given by this unnamed doctor to the 35-year-old patient, Bhupendra Thakur, that had led to his death.

Thakur had died because of the swine flu and not because of the vaccine. The vaccine is an attenuated virus and has no affect on aggravating the situation at all.

As Thakur already had swine flu symptoms like cold and cough (as mentioned in the report) before he took the vaccine, the concerned doctor should have treated him and given him Tamiflu instead,? said Dr Cyrus Poonawalla.

The chairman, Poonawalla Group, which includes Serum Institute of India - developers of the swine flu vaccine.

Poonawalla was reacting to Pune Mirror?s story (?Engineer dies after taking H1N1 vaccine?, page one, August 25) which detailed how Thakur, an engineer, had been administered the vaccine - produced by Poonawalla?s Serum Institute ? at the Fatima Convent Sahyadri Clinic, where he had gone for treatment for cold and cough. Soon after, Thakur developed complications and died of swine flu at Sassoon General Hospital on Tuesday night.

On Thursday, a highly concerned Dr Cyrus Poonawalla - his son and executive director (Operations) for Serum Institute, Adar, had launched the vaccine with much fanfare on July 14 this year, claiming almost no side-effects ? met Pune Mirror reporters at his office on Ambedkar Road, opposite the National Institute of Virology.

Serum has invested about Rs 50 crore in a facility in Pune, with the capacity of producing about 50 million doses of Nasovac. At the time of the launch, Poonwalla had hoped to sell about 20 million doses in the first year in India.

Cyrus Poonawalla, however, effectively negated the statement given to Mirror on Wednesday by Dr S A Sangle, associate professor of Medicine, Sassoon General hospital, in which she had said that the intake of Nasovac by someone already suffering from cold and cough is harmful, and may aggravate his or her infection. Poonawalla said that the vaccine cannot worsen or aggravate any disease.

?A person already suffering from cold, cough or fever should not take the vaccine, as it will be no use to him, but it will definitly not aggravate his condition. Nasovac is known to be harmless, as seen through the hundreds and thousands of people who have been administered the vaccine. There were no complaints of any serious reactions,? Poonawalla said.

Referring to Thakur?s case, he added, ?It was a mistake on the part of the doctor to administer the vaccine to Thakur. As Thakur already had swine flu symptoms, the doctor should have rather treated him or given him Tamiflu or other supportive antibiotics to help the patient recover.?

?There are some factors involved, though. The vaccine only becomes effective after three weeks from the day it had been administered. During these three weeks, one may get swine flu if the H1N1 virus enters the body - the vaccine will be ineffective. Again, people who are allergic to eggs should not take the vaccine.

This is mentioned on the vaccine?s packaging. All details and concerned questions are provided on the website www.seruminstitute.com. We have held quite a few meetings with doctors, wherein we have made them aware about the vaccine. It is the responsibility of the concerned doctor to take a call, depending on the situation.?

Dr Prasad Kulkarni, additional medical director, Serum Institute, who was also present, said, ?In the last one month, around 10 lakh people have been vaccinated and there were no complaints of serious reactions. This vaccine can never aggravate one?s disease.

In Thakur?s case, as the virus was already inside him before he was administered the vaccine, his condition getting worse was natural course of the disease. It was just a conincidence that Thakur had taken the vaccine.

However, pregnant women are generally not given this vaccine. But again, if a pregnant woman is in a situation where people around her are already infected with swine flu, then she may have to given the vaccine to save her.

Basically, it is the doctor who has to take a call. Everyone should consult a doctor before taking any medicine. The vaccine is not supposed to sold over the counter, and has to be administered only by a registered medical practitioner.?

Dr Rajeev Dhere, senior director (Vaccine Production), said, ?Around 11 lakh people have been vaccinated till now and there have been no complaints.

We are conducting a post-marketing surveillance of the vaccine. Around 3,000 of our own staff were administered the vaccine before we introduced it in the open market. Different people have different queries and concerns regarding the vaccine.

All answers are mentioned on our website. Everyone has to remember that it takes atleast three weeks for the vaccine to generate immunity in the body. The only side effect may be a mild cold or fever, which disappears in a day or two?

http://www.punemirror.in/article/62/2010082720100827044538417b8496aac/%E2%80%98Techie-died-of-H1N1-not-our-vaccine%E2%80%99.html