Industry Blog

Vaccinations.

In England alone 400,000 health and social care workers have been given the vaccine against swine flu.

The Health Department claims that there has been and estimated 387,000 people vaccinated and the number of doses given to the priority groups in 3.7 Million which also includes pregnant woman, 132,000 of them and finally including 214,000 children in good health aged 6 months to 5 years old.

Pharmaceutical companies have been shipping the vaccine out.

National Pandemic Flu Line Closed.

It has been said today that the Pandemic Flu service will be withdrawn as from 11th February but can be restored within 7 days if it is needed.

The phone line & the website will be taken down, and any leaflets ect will be excluded from advertising it. The website holds information about Swine Flu, such as the symptoms and what to do and who to call, as well as the phone line in which you can call to talk to some one with relevant information.

Dr Ridge explains “the antiviral collection points will continue to operate until the end of the flu season (the end of March 2010) but antivirals will only be authorised via health care professionals using either antiviral authorisation vouchers or the right hand side of FP10s”.

Six allergic reactions to H1N1 jab

Doctors in Canada have stopped using a batch of swine-flu vaccines after six recipients became seriously ill, pharmaceutical company GlaxoSmithKline says.

Spokesman Gwenan White said the firm had advised medical staff to refrain from using the particular batch while the cause of the reaction was investigated, adding that no other stocks had been affected.

White said the company always monitored drugs for signs of problems, but that allergic reactions in some people were always a risk.

Tim Vail, a spokesman for Canada’s health minister, confirmed that six people had suffered an adverse reaction to the vaccine, adding that the majority of the batch in question had now been administered.

“We’re not seeing any thing wild or spooky or crazy about our vaccine at all,” Vail said.

GlaxoSmithKline has distributed around 7.5 million doses of the vaccine in Canada.

Copyright © Press Association 2009

Measures to fight H1N1 swine flu in Europe

Here are some details about measures
taken to fight H1N1, swine flu, which has killed more than 7,900
people globally, according to the latest European Centre for
Disease prevention and Control (ECDC) tallies.

The World Health Organisation (WHO) declared an H1N1 pandemic on June 11, indicating the first influenza pandemic since 1968 was under way.

 * LATEST MEASURES BY GOVERNMENTS:

CROATIA - The Health Ministry says the first delivery of 140,000 vaccines arrived on Tuesday. Vaccination against H1N1 will start on Nov. 27, with those seen as most at risk to be targeted first — people with chronic diseases, pregnant women, young children, the obese and healthcare workers.

FRANCE - Almost 240 schools around the country have had to close in an effort to contain particularly virulent outbreaks.

– A recent jump in cases has given a much-needed boost to a national vaccination campaign, with queues forming at centres over the weekend as word spread of a rise in deaths.

– When the centres initially opened earlier this month, the French media, said they were largely deserted, with medical staff having to throw away large numbers of unused vaccinations.

HUNGARY - Many schools around the country have ordered temporary shutdowns, none for more than a few days.

– Schools are mandated to vaccinate students, but parental approval is needed.

– Hungary is establishing vaccination centres, 200 will be in operation by Nov. 27.

– For weeks, most Hungarians refused to get vaccinated, for fear of side effects, especially in children and pregnant women.

NETHERLANDS - The Netherlands started vaccinating children against H1N1 on Monday. Some 830,000 children aged from six months up to and including four-year-olds will be vaccinated.

– Babies up to six months old will not be vaccinated because the vaccine has not been tested on that age group. Some 200,000 members of families with babies younger than six months will be vaccinated instead.

– At 237 different locations across the Netherlands, parents can visit centres of municipal health organisation GGD to have the vaccinations, with most vaccinations taking place this week. A second round of shots will occur in mid-December.

– The vaccination of children comes after the Netherlands started vaccinating risk groups against the virus on Nov. 9.

POLAND - Poland’s Health Ministry decided last week to release its Tamiflu stock to pharmacies.

– Health Minister Ewa Kopacz has said not enough tests have been conducted to ensure flu vaccinations are safe and is wants more guarantees from pharmaceutical firms before any purchase.

– Several schools have been temporarily closed across the country, but there has been no central recommendation to do so.

PORTUGAL - Portugal started vaccination in the top priority group including pregnant women on Oct. 26, spreading it to the next group including babies below 2 years of age on Nov. 16.

– The government has ordered 6 million doses of GlaxoSmithKline’s Pandemrix vaccine aiming to cover a third of the population of about 10 million.

 

* SOME NUMBERS:

TOTAL REPORTED DEATHS: 7,909*

REGIONAL BREAKDOWN:

AREA TOTAL DEATHS:

EU AND EFTA COUNTRIES                                 714

OTHER EUROPEAN COUNTRIES & CENTRAL ASIA 91

MEDITERRANEAN AND MIDDLE-EAST                                       539

AFRICA                                                       108

NORTH AMERICA                                                                                 2,088

CENTRAL AMERICA & CARIBBEAN                   174

SOUTH AMERICA                                                                                 2,780

NORTH-EAST & SOUTH ASIA                                                          833

SOUTH-EAST ASIA                                                                              367

AUSTRALIA & PACIFIC                                   215

Source: Reuters.com

Police raid drug importers for illegally marketing antiviral meds

Police raided the offices of five pharmaceutical importers on Wednesday for illegally advertising the anti-influenza drug Tamiflu online.

Osaka Prefectural Police searched the five drug importers after they advertised the anti-flu drug without government authorization — a violation of the Pharmaceutical Affairs Law.

It was the first time police have carried out raids in the investigation of the illegal trade of anti-influenza virus medication, which is becoming increasingly common as swine flu spreads rapidly throughout Japan.

Currently, the Ministry of Health, Labor and Welfare restricts sales of Tamiflu to its official Japanese distributor Chugai Pharmaceutical Co., and the advertisement or sale of the drug by other dealers is prohibited by the pharmaceutical law.

Investigators have searched a total of 12 locations in six prefectures, including the branch offices of one Osaka-based company, three Tokyo firms and one individual importer in Okayama.

Police allege the five distributors advertised the product by uploading photographs of Tamiflu 75mg packages to their Web site, in an apparent attempt to sell them for between 8,200 and 16,000 yen per 10 capsules, while claiming to be personal trade facilitators providing import management services.

Police will investigate whether the importers have already sold unapproved anti-flu drugs to customers.

Source: www.mdn.mainichi.jp

Swine flu causes surge of garlic sales in Serbia

Belgrade’s open-air markets were a welter of busy customers on Friday, pushing and shoving to buy one item — garlic.

In Serbia, garlic has long been regarded as a good-luck charm and a guard against many ailments. As far as the public is concerned, that includes the swine flu pandemic, which recently has spread in Serbia and triggered near panic among the local population.

That is now evident in Belgrade’s produce markets, where the price of garlic has shot up, thanks to a sudden increase in demand. The smell of the little white cloves also has become prevalent in public places as people munch on them as if eating apples.

Health officials have publicly urged the population not to take garlic’s healing properties so seriously. Instead, they recommend opting for more conventional precautions, such as washing hands, wearing face masks, or eventually getting vaccinated.

But those calls seem to have been in vain.

“Garlic is the best, forget the vaccines,” said Marko Jankovic, an elderly Belgrader, with the pungent smell of garlic obvious as he spoke at the crowded Kaleniceva Pijaca market. “From the vaccine, you can get sick. From garlic, you can only get bad breath.”

Facing a surge of swine flu cases, Serbia’s Health Ministry on Friday ordered 3 million vaccines from Swiss pharmaceutical company Novartis AG.

The authorities said Serbia has about 270 proven swine flu cases and eight deaths — up from about 130 cases and two deaths at the beginning of November.

In many parts of the world, the distinct taste and smell of garlic are considered essential in many meals. But in Serbia — as elsewhere in the Balkans — many people consider it more important than that.

Garlic is kept on doorsteps or in pockets to keep vampires away, and under babies’ pillows to ensure a healthy and prosperous life. Serbs often consume garlic as a snack together with slivovitz, a strong plum brandy.

These days, Serbian media often compare what happened at two popular music festivals as proof of the alleged medicinal virtues of garlic.

That’s because Serbia’s first swine flu cases were confirmed after the annual Exit rock music festival in July in the town of Novi Sad, where authorities say the mostly young audience indulged in beer and marijuana.

By contrast, the media say, no swine flu cases resulted from the equally popular folk music festival in Guca, central Serbia, where the generally older, more tradition audience gorged on meat dishes heavily spiced with garlic, and drank slivovitz.

For centuries, garlic has been regarded by many people around the world as a successful medical treatment for everything from indigestion to respiratory problems. Recent medical studies also have shown that garlic can reduce a person’s blood pressure.

But in Serbia, doctors are telling the public to stop considering it as a swine flu defense.

“People must take this pandemic more seriously and focus on real prevention and medicine,” not garlic, said Zoran Djordjevic, a virology doctor at a Belgrade hospital.

Source: rep-am.com

Society Welcomes Swine Flu Vaccinations For Pharmacists

At the special swine flu update session at the Royal Pharmaceutical Society’s annual conference, John Lawlor, Chief Operating Officer for NHS Flu Resilience, announced that pharmacists would now be on the priority staff list for vaccination against swine flu.

Commenting on the announcement, David Pruce, the Society’s Director of Policy and Communications said:

“We welcome the announcement that pharmacists and their clinical staff who have regular clinical contact with patients, or are directly involved in patient care as part of their practice, will now be eligible for the vaccine.

“This anomaly was a bone of contention amongst the profession and the cause of a great deal of concern. Frontline pharmacists in community and hospital settings are highly likely to be treating patients with swine flu and we are pleased the Department has now remedied this issue.”

www.medicalnewstoday.com

Pandemic (H1N1) 2009 influenza update

Source: WebWire
Date: 14-08-2009

London UK - GSK today issued an update on its progress to develop a vaccine against the Pandemic (H1N1) 2009 influenza virus, and announced that it has commenced the clinical development programme for its adjuvanted pandemic vaccine. Enrolment into this first study has been completed.

Dr.Thomas Breuer, Head of Global Clinical R&D and Chief Medical Officer of GSK Biologicals, said “GSK is making good progress with the development of its pandemic vaccine. Enrolment into the first study has been completed and in total, GSK will conduct 16 clinical trials of its pandemic vaccine in over 9000 individuals across Europe, Canada and the US. We continue to work closely with regulators and governments to assess and develop this vaccine.”

The first clinical trial, being conducted in Germany, will assess the use of the vaccine in healthy adults. Initial data is expected to be available for sharing with regulatory authorities in September.

Further trials of the Pandemic (H1N1) 2009 adjuvanted vaccine covering infants, children, adults and the elderly will commence over the coming weeks across Europe, Canada and the US. The clinical development programme, which has been designed in close partnership with regulatory authorities, will evaluate the immune response as well as tolerability and other safety aspects of the vaccine.

All the final data on the clinical development programme will be submitted to the regulators as soon as they are available and will be posted on GSK’s Clinical Study Register.

About the pandemic (H1N1) 2009 vaccine

The vaccine will comprise antigen of the recently isolated Pandemic (H1N1) 2009 influenza strain and also contain GSK’s proprietary adjuvant system AS03. In clinical studies using the bird flu influenza strain (H5N1), the adjuvanted formulation has been shown to stimulate a higher immune response while using a smaller amount of antigen as compared to a formulation without adjuvant. The vaccine containing the adjuvant system therefore helps to substantially increase the number of vaccine doses that can be provided for mass vaccination.1 In addition, in clinical studies with the bird flu programme, the adjuvanted vaccine demonstrated the potential to provide protection even if the influenza strain drifts (changes slightly).2,3 Both the antigen sparing approach as well as the potential for additional protection against drifting strains are features for an impactful vaccine for use in a pandemic setting.

GSK has received regulatory approvals in the European Union and some Asian countries for its pre-pandemic and pandemic H5N1 vaccines, both of which contain the AS03 adjuvant. Currently, clinical trials in over 39,000 people have demonstrated that the AS03 adjuvant system used with an influenza vaccine has an acceptable safety and reactogenicity profile.

About the clinical trials

The first clinical trial, being conducted in Germany, has started this week and enrolment has been completed. The trial will assess the use of the vaccine given as 2 doses, 21 days apart in 128 healthy adults, aged between 18 and 60. Initial data is expected to be available for submission to regulatory authorities in September. Additional trials planned in the clinical development programme are expected to commence shortly and include 8 trials in healthy adults, 5 trials in children (including infants) and 2 trials in the elderly. Details of the clinical development programme will be posted to www.clinicaltrials.gov.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

Cautionary statement regarding forward-looking statements 
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’ s operations are described under ’Risk Factors’ in the ’Business Review’ in the company’ s Annual Report on Form 20-F for 2008

1. Leroux-Roels et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007; 370 (9587): 580–89.

2. Leroux-Roels I et al, Broad Clade 2 Cross-Reactive Immunity Induced by an Adjuvant systemed Clade 1 rH5N1 Pandemic Influenza Vaccine PLoS ONE 3(2): e 1665. doi:10.1371/jounal.pone.0001665

3. Baras et al. Cross-protection against lethal H5N1 challenge in ferrets with an adjuvanted pandemic influenza vaccine. PLoS ONE 2008; 3 (1): e1401.

Cadila to apply for swine flu vaccine clinical trials.

With an aim to launch vaccine for Influenza H1N1 A Virus (swine flu) in India, Cadila Pharmaceutical will seek the government’s nod in two days for initiating clinical trials in this regard.

Cadila Pharmaceutical Ltd (CPL) had set up a joint venture ‘CPL Biologicals Pvt Ltd’ with the US-based vaccine maker Novavax for manufacturing and developing a host of vaccines, including for swine flu, in India.

“The joint venture is going to file the application with the Drug Controller General of India (DCGI) in the next two days for phase-I clinical trials for swine flu vaccine,” CPL Chairman and Managing Director, Mr I A Modi told PTI.

Modi expressed confidence that Cadila would be the first Indian pharma company to launch the swine flu vaccine in India by December. “If we get the permission of DCGI soon, then with the advanced technology available from our partner, (we) would be able to launch it in India by December this year,” Mr Modi said.

With its existing facility, Cipla can produce up to one million doses of the vaccine per month, which can be scaled up to two million doses, Mr Modi said. “Novavax has already received permission for clinical trials from the US Federal Drug Administratio n and if we get it soon, we can simultaneously start the trials,” he added. - PTI.

www.thehindubusinessline.com

The National Pandemic Flu Service

The National Pandemic Flu Service has been launched in England.

If you are in England and feel like you may have swine flu, visit the new website by following the link below, or call 0800 1 513 100 (Textphone - 0800 1 513 200).

www.direct.gov.uk

People who have swine flu symptoms will be given a unique access number and told where their nearest antiviral collection point is. They should then ask a flu friend - a friend or relative who doesn’t have swine flu - to go and pick up their antivirals. The flu friend must show their own ID as well as that of the patient.

Contact your doctor directly rather than using the National Pandemic Flu Service if:

  • you have a serious underlying illness
  • you are pregnant
  • you have a sick child under one year old
  • your condition suddenly gets much worse
  • your condition is still getting worse after 7 days (5 for a child).

http://www.direct.gov.uk/en/Swineflu/DG_177831

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