India: TN deaths put measles shot under lens

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Source: http://timesofindia.indiatimes.com/...sles_shot_under_lens_/articleshow/2977086.cms

TN deaths put measles shot under lens
24 Apr 2008, 0254 hrs IST,Kounteya Sinha,TNN

NEW DELHI: A new batch of measles vaccines, procured by the health ministry from Human Biologicals Institute, Hyderabad, is now under the scanner. Four infants died of complications after they were administered the vaccines at a primary health centre in Thiruvallur on Wednesday.

The injectible measles vaccine, which provides 85% protection, is administered only once ? when a child is nine-months-old. Unsure about what might have caused the deaths, the health ministry rushed a two-member team of experts headed by Pawan Murti of India's National Polio Surveillance programme (NPSP) to the spot.

Samples from various batches of the vaccine, procured by the Centre from HBI and allocated to Tamil Nadu for use in its routine immunization programme, have been sent to the Central Research Institute, Kasauli, for testing.

Officials told TOI that they want to check the vaccine's efficacy and safety in order to ascertain whether the deaths occurred due to a break in the cold chain or because the vaccines were contaminated.

Serum Institute in Pune has been India's staple supplier of measles vaccines. The ministry has been purchasing 350 lakh doses of the vaccine annually for its immunisation programme. However, in February, the ministry allowed HBI to supply 90 lakh doses because it cost around Rs 7 per dose in comparison to Serum's price of Rs 8 per dose and Rs 43 per vial (5 doses).

An official said, "According to protocol, a new company cannot be asked to supply more than 20% of the country's annual requirement for a particular vaccine initially. So HBI was asked to supply 90 lakh doses." He added, "We know the adverse effects vaccines can have if not used properly. Cases of toxic shock syndrome have been common. However, we don't know what caused the deaths in Thiruvallur. Vaccine samples used there have been sent to Kasauli."

According to experts, the measles vaccine can prove "notorious" and even "fatal" if not administered three hours after being prepared. "The vaccine has to be administered within three hours of reconstitution. The vaccine comes in a freeze-dried form and has to be mixed with a fluid before administering.

All through, it has to be kept in temperatures of 8-10 degree Celsius. If the procedure isn't followed, the vaccine can prove fatal," a ministry official said.

Dr Bir Singh, professor of community medicine at AIIMS, however, said, "There aren't reports of measles vaccine killing children because it went bad. At best, side effects have been reported and the vaccine has proved ineffective. However, vaccines which are exposed to heat or direct sunlight after reconstruction could cause anaphylactic reaction resulting in heart failure and respiratory trouble."

Measles has been a major cause of morbidity and mortality among children below 5 years of age in India. Recently, India also held the dubious distinction of exporting the measles virus to Australia. Around 84 people in six Australian states were affected. According to India's Central Bureau of Health Intelligence, in 2005, an estimated 52,500 children were affected by measles.

kounteya.sinha@timesgroup.com

 

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Re: India: TN deaths put measles shot under lens

Government stops supply of vaccine
PTI
Thursday, April 24, 2008 19:26 IST


Centre asks all state governments to stop use of measles vaccine manufactured by Indian Immunological Limited following death of four infants who were given vaccine shots in Tamil Nadu.
High-level team rushed to Tamil Nadu by the Centre to inquire into the death of infants after they were administered measles vaccine. :tiphat: http://www.dnaindia.com/report.asp?newsid=1161253

 

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Re: India: TN deaths put measles shot under lens

Source: http://timesofindia.indiatimes.com/Chennai/Tests_on_vaccines_to_take_2_weeks/articleshow/2984179.cms

Tests on vaccines to take 2 weeks
26 Apr 2008, 0445 hrs IST,TNN

NEW DELHI/CHENNAI: In his first interview after the tragic death of four infants shortly after being administered the measles vaccine in Tiruvallur district in Tamil Nadu, drug controller general of India Dr Surinder Singh told The Times of India: ?We will carry out tests on the samples picked up from the PHC and the manufacturer. Unfortunately, there is a fixed amount of time required to test vaccines. We can?t expedite the process."

According to Dr Singh, the tests will take a minimum of two weeks to complete. "Both a vaccine potency test and an abnormal toxicity test, which have to be conducted on mice and guinea pigs, will take a week. A sterility test to check for contamination will take 14 days. We will also check for the vaccine?s moisture content and Ph levels. We will randomly pick up samples from HBI."

On what could have caused the deaths, Dr Singh said, "A bad vaccine is highly unlikely because they were tested at CDL, Kasauli, before being released and their expiry date was 2010. They also had the vaccine vile monitors, which would change colour if the vaccine had gone bad."

"A human error looks most likely. Contamination of the needle used could be a possibility. Three children dying within an hour of being vaccinated is a direct result of an anaphylactic shock - a severe, acute, potentially lethal systemic allergic reaction. Such a reaction following a measles vaccination is rare and occurs in 1 out of every 10 lakh cases."

"The syringe might have been dipped in other chemicals like adrenalin or muscle relaxants and then reused to vaccinate the children. In such a case, it can kill instantly," Dr Singh added. Experts said the deaths could also have taken place because the vaccine, after being reconstituted, was kept out in the open, causing bacterial growth and contamination.

 

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Re: India: TN deaths put measles shot under lens

Source: http://timesofindia.indiatimes.com/...ome_killed_TN_kids/rssarticleshow/2997007.cms

Toxic shock syndrome killed TN kids
30 Apr 2008, 0308 hrs IST,Kounteya Sinha,TNN

NEW DELHI: Toxic shock syndrome (TSS) killed the four children in Tamil Nadu after they were administered measles vaccine on April 23, a fact finding team has concluded.

The health ministry?s five-member expert group, headed by additional director general Shiv Lal, said in its report that "clinical and epidemiological investigations" of the deaths revealed that all four children died of TSS, which usually occurs when the vaccine is contaminated.

The committee, however, said the conclusion would have to be corroborated with the findings of the Central Drug Laboratory, Kasauli, which is presently testing 20 vaccine samples picked up from the fatal site in Tiruvallur and those lying with Human Biologicals Institute in Hyderabad.

The seven-page report was prepared by Lal along with Safdarjung hospital?s R N Salhan, advisor to the drug controller general Charanjeet Sokhey, NIV Pune's Nitin Wadekar and joint director of NICD Uma Chawla. It was submitted to director general of health services (DGHS) R K Srivastava and health secretary Naresh Dayal on Monday.

The report also confirmed that disposable syringes were used to vaccinate the children. Speaking to TOI, Lal said, "Our observations are on the basis of a clinical and epidemiological investigation. TSS is an agent specific reaction. However, only toxic tests being done at CDL Kasauli and the post-mortem report can corroborate our conclusion."

According to Lal, all the four children died within 15 minutes of being vaccinated.

"The children became unconscious, with drooping head and frothy mouth. Their eyeballs were rolling and the death occurred suddenly. During our investigations, we met all the people who were related to the case ? health workers who administered the vaccine, health inspectors, anganwadi members, parents of the children who died, local police, district hospital officials and state health department?s principal secretary."

Sources said the ministry was planning to call a meeting over the report soon. Health minister A Ramadoss said, "The final report will reach the ministry in 10 days."

TOI had reported a day before the team handed over the report that the public health centre's cold chain system, which was used to store the vaccines, was not at fault.

 

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Re: India: TN deaths put measles shot under lens

Source: http://www.hindu.com/thehindu/holnus/004200805151966.htm

Govt. lab gives clean chit to Tamil Nadu measles vaccine

New Delhi (PTI): The measles vaccine administered to children in Tamil Nadu has been given a clean chit by a government laboratory and human error at the local level could possibly have resulted in the death of four infants last month.

Samples of the vaccine had been sent to the Central Drugs Laboratory at Kasauli in Himachal Pradesh, following the death of the children who had developed complications after receiving the vaccine and had died shortly after. The report, which the laboratory has submitted to the Union Health Ministry, has given a clean chit to the vaccine, saying it is completely safe for use, a senior ministry official told PTI.

The official said the report points to a scenario where human error at the local level while administering the vaccine could have led to the tragedy. The report will be forwarded to the Department of Family Welfare, which will take further necessary action, including issuing directives to the state government.

Meanwhile, an advanced study called spectroscopy, which could have determined the exact cause of the deaths, is not available at the Kasauli laboratory, the sources said. The Centre had ordered halt to use of the vaccine supplied by a Hyderabad-based company across the country even as the state government suspended the vaccination drive alarmed by the death of the children.

An order of 90 lakh units of vaccine had been placed with the company, which is a wholly owned subsidiary of the National Dairy Development Board, out of which it had supplied 45 lakh units.

Regional

 

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Re: India: TN deaths put measles shot under lens

Source:http://www.chennaionline.com/colnew...4242-422B-B6B8-7755B1B951B2}&CATEGORYNAME=CHN

Cause for infants death only after investigation: Ramadoss

Chennai, May 17 :The exact reason for the death of four infants, who died after administration of measles vaccine at Thiruvalluvar district of Tamil Nadu last month, would be known only after the investigation was over, Union Minister for Health Anbumani Ramadoss said here today.

Talking to newspersons, he said the investigation was still on and the final report expected in one or two weeks. ''The preliminary report said the vaccine samples sent for testing at CRI Kasauli in Himachal Pradesh showed they were of high standard quality,'' he added.

The vaccine was provided by Human Biological Institute, Hyderabad.

Dr Anbumani said whether there was any discrepency in storing the vaccine or whether it was not administered properly, would be known only after the final investigation report was received.

He also ruled out the possibility of the dilutant provided by Serum Institute causing the deaths.

Published: Saturday, May 17, 2008

 

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Re: India: TN deaths put measles shot under lens

Source: http://www.flutrackers.com/forum/newreply.php?do=newreply&noquote=1&p=157582

Ramadoss admits some syringes in TN had rusted
18 May 2008, 0045 hrs IST,Kounteya Sinha,TNN

NEW DELHI: Union health minister A Ramadoss formally admitted on Saturday that some of the auto-disabled syringes sent to Tamil Nadu for their immunization programme, was indeed rusted.

He said, "Some of the needles were found to be rusted. Around 100 samples are being sent to Central Drug Laboratory in Kolkata for testing. Formal reports are expected in a week's time."

The state?s immunization programme has recently been in news for all the wrong reasons.

After the measles vaccine, the auto-disabled (AD) syringes are now under the scanner in Tamil Nadu.

The state?s immunization programme faced a fresh setback with the state health minister M R K Panneerselvam suspending the use of all AD syringes, under the brand name BD Solo Shot, used to vaccinate children.

According to Panneerselvam, needles of some of the syringes in Trichy had rusted while some of them had dust inside the cylinder. Using them could cause harmful reactions in children.

In a letter to health secretary Naresh Dayal, dated May 9, TN health secretary V K Subburaj said syringes supplied by the Centre on December 15 for the immunisation programme in Trichy were found to be defective and some of the needles were rusted.

"102 such defective AD syringes with expiry date of November, 2011, have been located. All district officers have been instructed to check their AD syringe stock," Subburaj wrote.

Following the complaint, health minister A Ramadoss on Friday rushed drug controller general Dr Surinder Singh to TN to pick up samples of the syringes in question for testing.

Speaking to TOI, Ramadoss said, "AD syringes are vital to run a safe immunisation programme in India. Before it?s initiation three years ago in the RI programme, 64% of injections used in India were unsafe mainly due to reused needles. We have not received a single complaint with AD syringes earlier. In fact, we are on our way to introduce its sole use in all government hospitals."

Dr Singh, who reached Chennai on Friday morning, told TOI that the team?s first move would be to trace the areas where this batch of syringes had been dispatched.

He told TOI, "Even though chances of AD syringe needles being rusty were remote we found some of the needles which were made of pure stainless steel to be rusted. We have studied the distribution patterns of this batch before samples are picked up. Our probe will see whether the needles were made of substandard material, which caused it to rust, if at all."

Officials said India uses 150 million AD syringes in its immunisation programme annually, 80% of which is supplied by Becton Dickinson India. The batch under question in TN were syringes procured from Spain.

Ram Sharma, managing director of BD India, said there was no question of the syringes being defective.

"The AD syringe facility in Fraga, Spain, has been WHO qualified to supply to all immunization programmes. BD SoloShot have been used in governmental immunization programmes the world over. Till date, BD has supplied over 5 billion syringes globally for immunisation through UNICEF."