India: Indigenous vaccine information

[Ronan Kelly]

: Zydus Cadila gets DCGI nod for trials on H1N1 vaccine

Drug maker Zydus Cadila on Monday said it has received approval from the Drug Controller General of India (DCGI) for conducting clinical trials for the swine flu (H1N1) vaccine. With this approval Zydus Cadila becomes the first Indian pharma company to commence multi-centric clinical trials of its vaccine, the Ahmedabad-based firm said in a statement to the BSE. In recent times, the pandemic H1N1 Influenza has claimed thousands of lives across the globe. ?With the vaccine in the market soon, we should be able to prevent further loss of lives to this infectious disease,? Zydus Cadila CMD Pankaj R Patel said. With the speedy completion of trials and the fast track approvals, the indigenous H1N1 vaccine is expected to hit the markets by April this year, the company said. According to the company, the demand for H1N1 vaccine in the country is estimated to touch 50 to 60 million doses in initial phase. Zydus Cadila's egg-based inactivated vaccine has been developed by the group's experts at its Vaccine Technology Centre in Ahmedabad.
http://www.financialexpress.com/news/Corporate-Notes/563352/

 

[Pathfinder]

Re: Zydus Cadila gets DCGI nod for trials on H1N1 vaccine

Re: Zydus Cadila gets DCGI nod for trials on H1N1 vaccine

Cadila Healthcare sets April date for the launch of H1N1 vaccine

Gopal Modi / DNA
Tuesday, January 5, 2010 2:05 IST

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Ahmedabad: Ahmedabad-based Cadila Healthcare Ltd could well be the first Indian company to launch the H1N1 vaccine in India. It expects to bring its vaccine in the market by April 2010.
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The Rs 3,000 crore turnover company commenced the clinical trials of its vaccine from Monday after a go-ahead signal from Drug Controller General of India (DCGI) for conducting clinical trials on humans.

With this development, Cadila Healthcare has outpaced many other pharma and biotech companies including Cadila Pharma, Serum Institute, Panacea Biotech and Bharat Biotech in getting approvals for conducting clinical trials.

Cadila Pharma, another Gujarat-based company, is also confident of getting DCGI approval for clinical trials soon.

The egg based, inactivated vaccine based on conventional technology, has been developed by the group?s experts at its Vaccine Technology Centre in Ahmedabad.

Pankaj Patel, CMD, Cadila Healthcare, said, ?The company plans to conduct the clinical trials in 10 centres in Ahmedabad, Bangalore, Pune and Jaipur. We expect to complete the trials by end of March 2010, after which we will send the study results to DCGI for approval. We expect DCGI approval by April 2010 and will ready to launch the vaccine in the same month.?

Patel didn?t comment on the sample size for the trials, but said, ?We will do as per World Health Organisation?s (WHO) guidelines. The first swine flu vaccine will be ready from the Vaccine Technology Centre near the manufacturing facility at Moraiya, Ahmedabad. To begin with, we will be ready with the infrastructure to produce 6 million dosages which we plan to double by the end of the current fiscal.?

The demand for H1N1 vaccine in India is estimated to touch 50 to 60 million doses in the initial phase.

The group had earlier received the WHO prequalification accreditation for its rabies vaccine, Lyssavac N - the Purified Duck Embryo Rabies Vaccine (PDEV). ?We are also working on vaccines for malaria and Human Papillomavirus - HPV and progress is satisfactory,? Patel said.

There are two types of H1N1 flu vaccines available in the market ? the intramuscular vaccines and intranasal vaccines. H1N1 flu vaccine market is estimated to be $676 million with the first lot of doses being commercialised in September 2009.

The market is expected to cross $7 billion by 2011.

http://www.dnaindia.com/money/repor...l-date-for-the-launch-of-h1n1-vaccine_1330954

 

[Ronan Kelly]

Re: Zydus Cadila gets DCGI nod for trials on H1N1 vaccine

Re: Zydus Cadila gets DCGI nod for trials on H1N1 vaccine

Blow to Cadila?s H1N1 vaccine plan

New Delhi, February 7
Cadila Pharmaceuticals? plan to indigenously develop Influenza A HINI (swine flu) vaccine in collaboration with US-based Novavax is likely to be delayed as the government has shown caution in giving go-ahead for the clinical trials.

?We have not given approval (for clinical trials) to Cadila yet as they are using a new technology called virus like particles (VLP),? Drug Controller General of India Surinder Singh said.

"We are still studying the process... and it would take some more time before we decide on that," he added.

Last year, Cadila along with four other Indian companies, Zydus Cadila, Bharat Biotech, Panacea Biotech and Serum Institute, had applied for the health regulator's permission for conducting trials for vaccines in India.

All other Indian firms except Cadila Pharmaceuticals have got the permission and have started the clinical trials for the vaccine in India.

Singh said globally there was only one vaccine that used VLP technology. So, the company need to substantiate the new technology's credentials.

?We are still looking at data they gave us for the trials conducted in Mexico, but other Indian companies are using traditional methods to develop vaccines, it is already tested and certified ? so we need to be very cautious,? Singh said.

An email query sent to the company remained unanswered.

According to industry officials, it will take around at least another three months for the Indian firms to develop the vaccines and their shots will be available in the market by April this year.

For meeting immediate requirements, the government has already placed the order for 1.5 million doses of imported vaccines in the country.

Ahmedabad-based Cadila Pharmaceuticals is one of the largest privately held pharma companies in India. ? PTI
http://www.tribuneindia.com/2010/20100208/biz.htm#1

 

[Ronan Kelly]

Re: Zydus Cadila gets DCGI nod for trials on H1N1 vaccine

Re: Zydus Cadila gets DCGI nod for trials on H1N1 vaccine

Zydus applies for Phase II & III H1N1 vaccine trials


3 Mar 2010, 1836 hrs IST, Vishal Dutta, ET Bureau



AHMEDABAD: The race amongst Indian swine flu vaccine-makers seems to be moving to the next level with Cadila Healthcare Ltd, the Rs 2,900-crore
Zydus Group's listed entity, filing for the next phase of clinical trials after completing the first phase.

Talking to ET, Zydus Cadila CMD, Pankaj Patel said: "We have successfully completed our phase I trials and last week we have filed application with DCGI for phase II & III clinical trials". He said, he was hopeful of getting the requisite permission this month. Zydus conducted the first phase of trials for six weeks within Ahmedabad. "The vaccine was found to be effective, safe and well tolerated," said Mr Patel.

Last month, Serum Institute of India (SII) become the first Indian company to announce the success of phase?I human clinical trials for its swine flu (H1N1) vaccine. SII too will begin the next phase of clinical trials after obtaining the necessary permission from the DCGI.

Amongst the other players working on the development of indigenous H1N1 vaccines are Bharat Biotech and Panacea Biotech. Cadila Pharmaceuticals Ltd, another Ahmedabad-based pharma major, too is working on developing H1N1 vaccine using Virus Like Particles (VLP) technology.

Zydus now plans to conduct the Phase-II and Phase-III clinical trials in Ahmedabad, Bangalore, Jaipur and Pune. The company will be manufacturing the vaccine at its vaccine manufacturing facility at Moraiya, Gujarat. "We will initially be producing 5-6 lakh doses per month which will be doubled to 10 lakh doses per month in the next 6 months." he said.

The company earlier made an announcement during the third quarter in this fiscal year that it planned to launch the H1N1 vaccine in the Indian market by April 2010.
http://economictimes.indiatimes.com...I-H1N1-vaccine-trials/articleshow/5637678.cms

 

[Ronan Kelly]

Re: Zydus Cadila gets DCGI nod for trials on H1N1 vaccine

Re: Zydus Cadila gets DCGI nod for trials on H1N1 vaccine

H1N1 vaccine: Phases II, III human trials begin todayPost CommentLarger | Smaller Anuradha Mascarenhas
Tags : H1N1 vaccine, swine flu

Posted: Monday , Mar 08, 2010 at 0002 hrs
Pune:
The Serum Institute will enroll 300 people for the trial.


The Serum Institute of India will begin phase II and III human clinical trials of the nasal spray vaccine against the H1N1 virus at two sites in Pune and three other centres on Monday. The virus has claimed 201 lives in Pune itself.


Dr Prasad Kulkarni, director of clinical trials at the institute, told Newsline on Sunday that they had received the required approval from the Drug Controller General of India (DCGI). A total of 330 people in three age groups — paediatric, adult and elderly — will be enrolled for the trial. “Initially, the trial will begin at four centres; We will include two more later.”


The trial sites have been identified at Pune, Ahmedabad, Kolkata, Indore, Bangalore and Chennai. A private hospital and a medical college are taking part in the trial in Pune.


Explaining the procedure, an institute official said the vaccine, in the form of an inhalation mix, would be administered in each nostril in doses of 2.5 ml. “Here, the virus is live but weakened (attenuated). It produces immunity but does not cause disease. As it is given intra nasal, it mimics the natural route of infection. It grows in the nasopharynx and produces local immunity followed by systemic immunity.”


Once the intra nasal spray vaccine has been administered, the results will be tested in laboratories at the Serum Institute and National Institute of Virology.


The officials hope to submit the trial data to the DCGI by the second or third week of April.


Kulkarni said the results of the Phase I clinical trial of the injectable vaccine against the HINI virus would be submitted to the DCGI soon.


The Ahmedabad-based Zydus Cadila has also embarked upon the multi-centric Phase II and III clinical trials of the vaccine.


http://www.indianexpress.com/news/h1n1-vaccine-phases-ii-iii-human-trials-begin-today/587951/0

 

[Ronan Kelly]

Re: India: Indigenous vaccine information

Desi swine flu vaccine ready for commercial use by April-May
Rupali Mukherjee, TNN, Mar 9, 2010, 04.50am IST

Tags:Swine flu|Fluvac
NEW DELHI: Pune-based Serum India's swine flu vaccine 'Fluvac' will be ready for commercial use by April-May, subject to all regulatory clearances. The Pune-based company received the drug regulators go-ahead on March 5 to carry out advanced safety tests on the vaccine ?Phase II/III clinical trials crucial for its introduction in the market.

On Monday, it started clinical trials of nasal form of vaccine on 300 subjects at different locations around the country. After Ahmedabad-based Zydus Cadila, Serum Institute becomes the second company to have started Phase II/III trials, pushing it closer to the finishing line.

"The single dose vaccine will be available in two forms ?nasal spray and as an injectable. The inhalation vaccine uses a live virus, which will be administered to three age groups. Further trials will be carried out later to test safety of the injectable vaccine on another set of people", Serum Institute of India's executive director S Jadhav told TOI.

The age group on which these trials will be administered is 9-19 years, 20-48 years and 48 and above. A single dose of the vaccine developed with egg-based technology will be initially tested in four cities across the country. The vaccine developed by indigenous players will most likely be administered as a single dose, and priced around Rs 150-200, sources close to the development said. (H1N1 vaccine globally cost between $9-15)

http://timesofindia.indiatimes.com/...cial-use-by-April-May/articleshow/5661122.cms

 

[Ronan Kelly]

Re: India: Indigenous vaccine information

?Intra?Muscular H1N1 Vaccine Safe for Humans?
Times of India
13 March, 2010
By Umesh Isalkar
Pune, India

The intra?muscular H1N1 vaccine (injectible), as developed by Pune?based vaccine major Serum Institute of India (SII), passed the safety norms in the first phase of human trial on Friday.

Speaking to TOI on Friday, Prasad Kulkarni, additional medical director, SII, said, ?As per the safety?data analysis, the intra?muscular vaccine has been found to be safe for humans.?

Going by the present progress of the company?s two vaccines, the intra?nasal vaccine which has already entered the second/third and thus a final phase of human trial, is likely to be pressed into commercial use from the third week of April, said Kulkarni. The intranasal vaccine was found to be safe for humans in the first phase of trial completed on February 12.

The next phase of the intra?muscular vaccine will begin after obtaining the necessary permission from the Drug Controller General of India (DCGI) and will be aimed at evaluating immunogenicity ? antibody?producing capacity of the vaccine in humans, added Kulkarni.

?The phase?I trial of the intramuscular vaccine was a randomised, double?blind, single?dose safety study, in which a total of 50 volunteers, males and females, aged between 18 and 49 years participated. The 30?day?long phase?I trial on humans was conducted by clinical research organisation (CRO) in Ahemadabad,? said Kulkarni.

The next phase of human clinical trial of the injectible vaccine will be multi?centric across India. It will be conducted in 10 hospitals in Pune, Indore, Bangalore, Kolkata, Chennai, Ludhiana, Lucknow and Ahmedabad. ?The immunogenecity data generated after 21 days will be evaluated and submitted to the DCGI,? said Kulkarni.

Volunteers from the age groups of 3 to 17 years, 18 to 49 years and 50 years and onwards will participate in this phase, which is aimed at evaluating resistance?producing capacity of the vaccine, said Kulkarni.

Commenting on the progress of its intra?nasal vaccine against the Swine Flu, Kulkarni said, ?The phase two/three study is going on. So far, more than 120 people have been administered the intra?nasal vaccine at Ahmedabad, Pune, Indore and Bangalore. We hope that by early next week, we will complete the recruitment of 330 more volunteers. This is going to be the final phase. If the DCGI finds the data satisfactory, a licence will be issued to manufacture the vaccine on commercial basis.?
http://pune.aarogya.com/index.php/news-and-update/intra-muscular-h1n1-vaccine-safe-for-humans

 

[Ronan Kelly]

Re: India: Indigenous vaccine information

Indigenous vaccine for H1N1 by mid-May



Special Correspondent

CHENNAI: An indigenous vaccine for H1N1 will be available in the market from mid-May, Union Health Secretary Sujatha Rao has said.

The Union government is working out the costing, but it will eventually depend on ?demand and supply,? Dr. Rao told reporters on the sidelines of the International Conference on Health Systems Strengthening (ICONHSS 2010). ?It will definitely be much cheaper than if we import the vaccine. Three or four Indian pharmaceutical companies will manufacture the vaccine and distribute it throughout the country.?

Already the vaccine has been sent to frontline health workers to protect them in their line of duty, she said.

http://www.hindu.com/2010/05/08/stories/2010050863091000.htm

 

[Ronan Kelly]

Re: India: Indigenous vaccine information

Zydus gets DCGI nod to market H1N1 vaccine

BS Reporter / Mumbai/ Ahmedabad May 13, 2010, 0:01 IST



Ahmedabad-based pharma major, Zydus Cadila, has recieved an approval from the Drug Controller General of India (DCGI) to market H1N1 (swine flu) vaccines in the country. The vaccine will be marketed under the brand name VaxiFlu-S.

"With this, the company will become the first Indian pharma company to launch the vaccine," the company said in a release.

VaxiFlu-S will be marketed by Vaxxicare, a division of the group that focuses on preventives. The company has also set up a dedicated taskforce to market the vaccine.

"With the vaccine in the market soon, we would be better prepared with an affordable therapy and prevent further loss of lives to this infectious disease. The launch of VaxiFlu-S gives added thrust to our objective of emerging as a strong player in the area of preventives," said Pankaj R Patel, chairman and managing director, Zydus Cadila.

The egg-based, inactivated vaccine based on conventional technology has been developed by the group's researchers at its Vaccine Technology Centre (VTC) in Ahmedabad.

VTC further plans to develop a wide spectrum of vaccines against bacterial, viral and protozoal infections.
http://www.business-standard.com/india/news/zydus-gets-dcgi-nod-to-market-h1n1-vaccine/394614/

 

[Ronan Kelly]

Re: India: Indigenous vaccine information

Indian-made swine flu vaccine found safe after trial
UNI
Friday, May 21, 2010 AT 10:58 PM (IST)
Tags: Swine Flu, Swine Flue-Pune, Serum Institute, H1N1
PUNE: After a clinical trial at the Serum Institute of India Limited, the indigenous H1N1 vaccine has been found safe, and a licence for mass production is likely to be given by mid-June, after a report prepared by scientists is reviewed by the Drug Controller General of India.



Dr Prasad Kulkarni, incharge of the clinical trial for the H1N1 Vaccine, today told UNI that the first part of the phase II and III trial had been completed.



''The vaccine has been found to be safe and there are no serious side effects. We are now analysing the data prior to the phase III of the trial,'' Kulkarni said.



The vaccine will be priced at Rs 150 per unit and will be available in a syringe and delivered by a pump like mechanism atop the syringe.



A total of 330 people of 3 age groups-- paediatric, adult and elderly, had been enrolled for the trial at various sites in Pune, Ahmedabad, Kolkata, Indore and Bangalore. The indigenous vaccine, in the form of an inhalation mix, was administered to each nostril in doses of 2.5 ml. The virus remains alive, but weakened. It produces immunity but does not cause the disease.



''The immunological tests were carried out by the National Institue of Virology (NIV) and Serum Institute,'' Kulkarni said.



In Maharashtra, there had been a total of 7100 cases of H1N1 virus and 462 deaths. Nearly 50 per cent of the case are from Pune, which had also registered 234 deaths, said Pune health officials.

http://www.sakaaltimes.com/SakaalTimesBeta/20100521/4748922277212513790.htm

 

[Arkanoid Legent]

H1N1 vaccine in June

H1N1 vaccine in June

Four Union health ministry-funded H1N1 vaccines ? three injecting and one nasal pray ? will hit the market in June this year, one year after H1N1 was declared a pandemic on June 11. The US and China had H1N1 vaccines ready in September 2009 and started vaccinations within a month.

Since India could not make its own vaccines in time, it had to import vaccines from Sanofi Pastuer, which arrived in February 2010. By then, the worst of the H1N1 ? which has infected 31,904 and caused 1,527 deaths in India ? was over.

(Read more, link)

 

[Ronan Kelly]

Re: India: Indigenous vaccine information

Indian H1N1 vaccines to be launched on Thursday

Indo-Asian News Service
New Delhi, June 02, 2010
First Published: 19:38 IST(2/6/2010)
Last Updated: 19:39 IST(2/6/2010)

Almost a year after H1N1 was declared a pandemic, India will launch four indigenous vaccines for the influenza on Thursday, sources in the health ministry said on Wednesday.

The sources said the four vaccines -- three injections and one nasal spray -- will be launched Thursday by Health Minister Ghulam Nabi Azad. The vaccines are expected to cost between Rs.150 to Rs.200.

The first death due to H1N1 flu was reported in May last year (Ro's note: First case in May, first fatality in August) and the casualties from the flu stood at 1,531 as of May 31, 2010. Nearly 31,934 people have been affected by the H1N1 flu in the country so far.

Indian vaccines for H1N1 come much after the US and China launched their vaccines. India had to import the vaccine to meet the domestic demand at the peak of the pandemic.

"We did not have the basic facility as this was the first time a vaccine for a flu was being manufactured, this is why it took so long," a senior official from the health ministry said.

Though the number of new infections has come down rapidly over the past couple of months, health ministry figures pointed that nearly 30 new cases of the flu were confirmed during the last week and four deaths were reported during this period.

Of the deaths, three were in Maharashtra while one was in Kerala. The highest number of 21 cases were reported from Maharashtra last week.

http://www.hindustantimes.com/Indian-H1N1-vaccines-to-be-launched-on-Thursday/Article1-552244.aspx

 

[Ronan Kelly]

Re: India: Indigenous vaccine information

MUCH AWAITED H1N1 VACCINE LAUNCHED IN CITY
Reporter
Friday, June 18, 2010 AT 12:00 AM (IST)
Tags: H1N1, swine flu, vaccine, medice, Pune, monsoon, health
The much awaited vaccine for H1N1 novel virus, which rocked the city last monsoon, was finally commercially launched in the city on Thursday, with the chemists selling 500 dosages of the vaccine on first day of its launch.



The vaccine has been developed by pharmaceutical company Zydus Cadila. The vaccine contains 10 dosages of 0.5 ml each in one pack. It costs Rs 391.



?The first day of H1N1 vaccine launch on Thursday had a reasonable response. We sold 500 dosages from across the city. In monetary terms the overall business was of around Rs 18,000,? Coordinator of Chemists Association, Pune District, Mahendra Pitalia told Sakal Times.



The first positive H1N1 novel case was detected a year ago in the Hyderabad. School girl The first casualty of H1N1 for India was reported in Pune city on August 7, 2009. Since then more than 230 people have died due to the H1N1. In Maharashtra, total death till May 31 was 466. Next highest is Gujarat with 306 deaths, Rajasthan 198 and Karnataka 169.



Called as VaxiFlu-S, this vaccine should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of the vaccine, or who has had a life-threatening reaction to previous influenza vaccinations. This is because the vaccine contains highly concentrated, inactivated influenza virus, which has been grown in the embryo of chicken eggs



The decision to give VaxiFlu-S should be based on careful consideration of the potential benefits and risks. Prior to administration of any dose of VaxiFlu-S, the healthcare provider should review the patient?s prior immunization history for possible adverse events, to determine the existence of any contraindication to immunization with the vaccine.



Appropriate medical treatment and supervision must be available to manage possible reactions following administration of the vaccine. ?We have received 5000 packs of the vaccine. It has been stockpiled by the chemists, who have the confidence of getting patients needing the vaccine. The sale flow is there. There are good amount of dosages available for use in case of emergency,? Pitalia said.
http://www.sakaaltimes.com/SakaalTimesBeta/20100618/4881394474366183233.htm

 

[Ronan Kelly]

Re: India: Indigenous vaccine information

Swine flu shot for risk groupsJune 21st, 2010
DC Correspondent

Hyderabad, June 20: The government is awaiting the Centre?s approval to vaccinate high-risk groups against swine flu, following a return of the infection in the state.

One person died of swine flu in Visakhapatnam, and four cases of swine flu have been reported in the capital since June 1. The inclement weather has only added to the problem, since the virus thrives in cool weather.

Pregnant women, children and the aged are considered to be highly vulnerable to swine flu infection. Pregnant women are six times more prone to the disease than normal people. In Kerala, where 16 swine flu deaths were reported, nine of the victims were pregnant women.

The Centre has provided 80,400 units of swine flu vaccine. Of these 69,000 units have been distributed to health workers, said Dr K. Subhakar, state coordinator of Swine Flu Nodal Centre.

The state government has obtained permission from the Centre to vaccinate health workers.The vaccine is effective for a year but it has side-effects too.

Health officials have sounded an alert as the onset of monsoon is believed to be the reason behind the fresh cases. The authorities are on high alert in areas bordering Karnataka and Maharashtra, where several swine flu cases were reported during the last few days.
http://www.deccanchronicle.com/hyderabad/swine-flu-shot-risk-groups-392

 

[Ronan Kelly]

Re: India: Indigenous vaccine information

'Give my kid any flu vaccine, doc'
By: Alifiya Khan Date: 2010-06-24 Place: Pune

Paediatricians at pains to explain to jittery parents they must wait a few days more for Serum Institute of India's child-friendly vaccine

Parents in the city are queuing up at paediatricians begging them to vaccinate their children against swine flu since a few children tested positive for the virus recently, but the doctors are asking them to wait a few days more.

The reason is the Serum Institute of India's intra-nasal vaccine that can be administered to children is yet to be introduced in the market.

Schools and rains
With school starting again, parents started pressing the panic button after a couple of children tested positive for the H1N1 virus some days ago. Last year during the monsoon, children passing on the virus at school had been a major cause of swine flu spreading in the city.

The preventive vaccine for H1N1 currently available in the market can be administered only to those above 16 years of age.

The nasal vaccine on its way &#148; it is expected to hit the market by next month &#148; can be taken by anyone over three years of age.

"Though I get at least seven to eight queries a day, I have been able to give the vaccine only to three students who were above 16 years of age," said Dr Dilip Sarda, former president of the Indian Medical Association. "Now, that schools have reopened, parents are worried that children may contract swine flu as kids interact with each other at a close range in classrooms. This fear is driving parents to rush to doctors asking for vaccination for their children."

Some parents have even asked doctors to give their children any vaccine for regular influenza, despite knowing that it is ineffective against H1N1, said Dr Sharad Agarkhedkar, head of paediatric department at D Y Patil Medical College.

"Parents have approached me and asked me to give anything that's available," said Agarkhedkar. "But I have asked them to wait for a week, till the nasal vaccine arrives in the market."

Dr Sanjay Bafna, head of paediatric department at the Jehangir Hospital, said that the anxiety among parents was owing to the high number of deaths among children last monsoon.

"With the onset of the monsoon, cases of cough and cold have increased," he said. "In the past few months, people had forgotten about swine flu, but suddenly they have started calling on us again because schools have reopened."

http://www.mid-day.com/news/2010/jun/240610-Swine-Flu-Vaccine-Pune-Serum-Institute-of-India.htm

 

[Ronan Kelly]

Re: India: Indigenous vaccine information

Swine flu vaccine ?Nasovac? nasal spray now available
Posted by Shiva Remala on July 6, 2010

Swine flu has become a problem again in this monsoon over 16 swine flu deaths took place in India in the span of just seven days. Coastal states of the country, Kerala and Tamil Nadu especially hit with swine flu this year big time.

Swine flu vaccine Nasovac has hit the stores today, it?s a powder form vaccine, in which you need add the water that?s given along with the medicine.

Swine flu nasal spray costs around Rs. 200 and will be available in stores from today.

Nasovac swine flu spray has been tested, and it gave satisfactory results in clinical trials too. It doesn?t carry serious side effects. Anyone who is above the age of 3 are eligible to take swine flu vaccine.

Swine flu vaccine was released in India before a month, but it?s an injectable H1N1 vaccine.

Despite having developed an indigenous swine flu vaccine, several death cases have been reported across the country.

Swine flu samples are hitting the hospitals in huge number, and the government is taking all necessary spread to control the epidemic in this season.


http://www.znews24.com/swine-flu-vaccine-‘nasovac’-nasal-spray-now-available.html

 

[Ronan Kelly]

Re: India: Indigenous vaccine information

Serum Institute offers H1N1 vaccine
Special Correspondent

PHOTO: PAUL NORONHA AFFORDABLE: Adar Poonawalla (left), Executive Director, Serum Institute of India, with his wife Natasha Poonawalla at the launch of H1N1 vaccine Nasovac in Mumbai on Wednesday.
Serum Institute of India (SRI), the largest vaccine manufacturer in India, has launched an indigenously developed intra-nasal vaccine, Nasovac, for prevention of H1N1 (swine flu) infections. The single dose vaccine, fitted at the top of a syringe, is to be sniffed once in each nostril making it a painless prevention mode.

Along with a needle prick-free benefit, Nasovac has a superior efficacy profile based on its administration through the respiratory route ? it mimics the path followed by the virus to enter the body.

The vaccine is approved by the Drug Controller General of India (DCGI) for usage by any individual above three years of age, except pregnant women.

According to Dr. Cyrus Poonawalla, Chairman, Serum Institute of India, ?the philosophy at Serum Institute always has been about providing quality vaccines at affordable prices.?

Speaking to The Hindu, Mansoor Ahmed, Marketing Director, said, ?The product will be available across the country in the next few days. It is priced at Rs. 158 per dose and available in the 5-vial pack for Rs. 790.

?As of now, we have the capacity to make 50 million doses. But this can be scaled up in the coming months to 150 million or even 200 million doses if needed. As of now, we are only concentrating on the Indian market and will address the export market later.''

Adar Poonawalla, Executive Director, said ?We now have capabilities, in collaboration with global healthcare agencies, to respond with affordable preventive vaccines for pandemic healthcare emergencies anywhere around the world.?
http://www.thehindu.com/business/article515726.ece

 

[Ronan Kelly]

Re: India: Indigenous vaccine information

H1N1 vaccine out in city
TNN, Jul 26, 2010, 01.07am IST

BANGALORE: Nasovac -- indigenous intra-nasal vaccine to fight swine flu (H1N1) is finally out in Bangalore. Lokayukta Justice Santosh Hegde administered the first dose to a five-year-old at Isha Diagnostics on Sunday.

The vaccine is priced at Rs 250 and it takes just two puffs in each nostrils to avert the deadly H1N1 virus. "The vaccine is free from side effects and can be administered to anybody, except pregnant women and children below three years. To be on the safer side, we recommend that the vaccine be taken every year and it's safe,'' say consultants at the centre.

Approved by the World Health Organization (WHO) this H1N1 vaccine will now be available at the centre between 9 am and 8.30 pm everyday.
http://timesofindia.indiatimes.com/city/bangalore/H1N1-vaccine-out-in-city/articleshow/6216357.cms

H1N1: Pregnant women out of nasal vaccine safety net
Teena Thacker


Posted: Mon Jul 26 2010, 03:29 hrs
New Delhi:

While pregnant women account for 30 per cent of deaths from H1N1 virus, they continue to be out of the protective umbrella of a vaccine. Nasovac, the single-dose nasal vaccine launched recently, has not been approved for use either.



?Tests have been conducted on pregnant rats and the vaccine has been found to be safe. However, since trials cannot be conducted on pregnant women, the institute advises caution and consultation with a doctor before administration of the vaccine,? say officials of Serum Institute, the manufacturers of the vaccine.



Recent figures compiled by the Union Health Ministry suggest that women account for 30 per cent of all deaths (an increase from 10-11 percent last year) caused by the H1N1 virus this year.



The Pune-based Serum Institute of India (SII) announced the launch of Nasovac in Delhi on Tuesday ? an injection free, nasal vaccine for the H1N1 swine flu virus. The cheapest vaccine developed till date, the vaccine costs Rs 158 and ensures immunity for at least one year.


The vaccine has been approved by the Drug Controller General of India for usage by any individual above three years of age. For now the company is selling the vaccine in packs of five. However, it plans to launch a single dosage package shortly. ?Though we have an installed capacity to produce 45 million dosages annually, we are targeting sales of 20 million dosages this fiscal,? SII Executive Director (Operations) Adar C Poonawalla said.



SSI is the country?s largest vaccine maker. It exports its vaccines to nearly 140 countries and is also looking for an international market for Nasovac. ?We are awaiting WHO pre-qualification, we plan to export the vaccine to around 40 countries,? Poonawalla said.
The SII, in consultation with the World Health Organisation and the Ministry of Health, had started work on the vaccine after the H1N1 outbreak in 2009.
http://www.indianexpress.com/news/h1n1-pregnant-women-out-of-nasal-vaccine-safety-net/651658/2

Kalmadi in a vaccine spot


Posted: Mon Jul 26 2010, 02:49 hrs Suresh Kalmadi found himself in an uncomfortable situation at a function last week to felicitate Dr Cyrus Poonawalla and his son Adar Poonawalla, the founders of the Serum Institute of India which recently launched the intra-nasal vaccine for H1N1. Since the duo hail from Pune, Kalmadi, who is an MP from the city, was also present at the function. The senior Poonawala inhaled the vaccine to prove its efficacy and safety. The media then asked Kalmadi to do the same. At first Kalmadi tried to wriggle out of the situation, but finally gave in, taking a whiff of the vaccine before hurrying out of the venue.
http://www.indianexpress.com/news/kalmadi-in-a-vaccine-spot/651643/0

 

[Ronan Kelly]

Re: India: Indigenous vaccine information

Panacea Biotec to launch Pandyflu this monthSohini Das | 2010-10-09 04:20:00
H1N1 Influenza ResearchAds by GoogleHA NA NP Proteins, Antibody, ELISA >140 Influenza Research Reagents SinoBiological.com/Influenza_H1N1
After having missed the deadline of launching its swine flu vaccine in April this year, Delhi-based Panacea Biotec is now all set to launch it anytime this month.

"Things are almost through. The launch can be anytime now. We are ready," said Rajesh Jain, joint managing director, Panacea Biotec.

Panacea has invested close to Rs 100 crore to set up a 45 million dose per annum facility at Lalru in Punjab for the Pandyflu vaccine, which is an inactivated split version vaccine using egg-based technology.The company has also entered into an advance marketing agreement with Ministry of Health and Family Welfare (MHWF) for supplying its H1N1 swine flu vaccine Pandyflu. The Union ministry of health and family welfare has been in discussions with indigenous vaccine manufacturers to assess their capacity to develop, manufacture and supply H1N1 swineflu vaccine for national programme.

continues at; http://sify.com/finance/panacea-biotec-to-launch-pandyflu-this-month-news-equity-kkjeuphjggf.html

 

[Ronan Kelly]

Re: India: Indigenous vaccine information

Bharat Biotech launches India?s first H1N1 vaccine
Posted: Tue Oct 19 2010, 01:09 hrs
Hyderabad:
Hyderabad-Based Bharat Biotech on Monday announced the launch of country?s first indigenously developed cell culture H1N1 swine flu vaccine under the brand name HNVAC, a press release put up by the company on its website said.



HNVAC is the only developing world flu vaccine to be manufactured in cell culture, a highly sterile and controlled manufacturing process, instead of eggs, the firm stated. HNVAC was tested in one of the largest Phase I, II and III clinical trials for flu vaccines in India and is safe.



Bharat Biotech?s chairman and managing director Dr Krishna Ella said, ?We are pleased to announce the launch of HNVAC to help prevent the spread of H1N1 pandemic influenza, which can spread rapidly with a high rate of disease and death. Bharat Biotech is proud to develop and offer this vaccine with the best USFDA recommended cell culture technology for Indian consumers. Our goal right now is get the flu vaccine easily accessible and at affordable cost to high risk groups.?

?The key benefit of our cell culture vaccine is its potential to scale up and produce large quantities quickly. It also has a much more sterile and faster production cycle, without the external dependence on eggs and thus enabling quicker response times. We will also explore ways in which Bharat Biotech can assist consumers and government agencies throughout this and subsequent flu season to get HNVAC flu shot,? Dr Ella added.
http://www.indianexpress.com/news/Bharat-Biotech-launches-India-s-first-H1N1-vaccine/699266