Dr Steve Reed, President & Founder of IDRI gives his presentation on ‘TB: Discover & develop improved vaccines’.

The World Vaccine Congress & Expo is now in its 13th year and is the biggest and most comprehensive event for the industry. Covering everything from the latest R&D to manufacturing to the corporate development strategies you’ll be sure to find answers to all your questions.

It’s not been a great year for the HPV vaccine. First we learned that the completion rates in the US remain alarmingly low, and now the Japanese health ministry has withdrawn is recommendation for the vaccine altogether, according to The Asahi Shimbun. While the Ministry of Health, Labor and Welfare is not suspending the use of the HPV vaccine, it has instructed local governments not to promote it for the time being. The decision apparently comes after the reporting of 1,968 cases of possible side effects, including long-term pain and numbness. In a follow-up piece, the newspaper says that the figure includes 357 serious cases, such as convulsions and difficulties in breathing or walking, and the focus of attention is complex regional pain syndrome (CRPS).

“The decision (not to recommend the vaccination) does not mean that the vaccine itself is problematic from the viewpoint of safety,” says Mariko Momoi, vice president of the International University of Health and Welfare. “By implementing investigations, we want to offer information that can make the people feel more at ease.”

Medical institutions must now inform girls wanting to receive the vaccine that the ministry does not recommend it, although they currently can still receive it for free. The ministry’s task force is currently looking to establish whether or not there is a cause-and-effect relationship between the vaccination and the pain and numbness. The investigation is expected to take about six months, but an initial discussion of 43 of the cases concluded that a relationship between the vaccine and the side effects could not be established.

However, the decision to withdraw the recommendation was not unanimous. The study group was made up of five experts, three of which supported withholding the recommendation.

The decision has also courted some controversy in the country.

“Withholding the recommendation is tantamount to advising against the vaccination,” said a municipal government official. “The central government has merely thrown all the decision-making to (those involved). I suspect that medical institutions cannot give a sufficient explanation (to people wondering whether or not to be vaccinated).”

“A few million people have been vaccinated in Japan, and a large majority have not reported any problems,” said Ryo Konno, of the Jichi Medical University’s Saitama Medical Center. “No country has suspended recommending the vaccination.”

GlaxoSmithKline’s Cervarix and Merck’s Gardasil were previously recommended for girls aged 12 to 16 to reduce the risk of developing cervical cancer.

What do you think? Are you concerned? Do you think this will be very damaging publicity for the HPV vaccine? Or are you in favour of the Japanese ministry’s decision? You can leave a comment in the box below, or on LinkedIn group discussion. Want more from Vaccine Nation? Sign up to our newsletter for free here.

Read the Asahi Shimbun article here >

If you want to know more about strategy and innovation in vaccines, you might be interested in attending the World Vaccine Congress Europe 2013, 16-17 October 2013, Lille.

Research by Krishnaa Mahbubani, Alexander Edwards and Professor Nigel Slater in the University of Cambridge Department of Chemical Engineering and Biotechnology has shown that a material called bile-acid adsorbing resins (BARs) can be used to protect bacteria from the destructive effects of bile in the small intestine. BAR is mixed with dried bacteria in a capsule that can be swallowed. The movement of bile into the capsule is held back by the resin long enough for water to rehydrate the bacteria, before the capsule finally breaks open, enabling the bacteria to survive.

For more information, see http://www.cam.ac.uk/research/features/clearing-the-bar-to-oral-vaccines-0”

Download the free eBook here >

15 Industry insights into how vaccine sponsors choose CROs

Pharma’s increased need for partners to assist with their clinical development pipeline is putting more and more pressure on their outsourcing and R&D departments. They are looking for service providers that can help them get as many promising drugs to market in the shortest amount of time, at reasonable costs, while adhering to increased safety concerns.

CROs are not making it easy on Pharma; they are not differentiating themselves. Pharma needs information; an objective evaluation of CRO performance that is independent of their own experiences. For only with this information can Pharma act confidently when entrusting a service provider with their clinical assets.

Understand the key strategies that sponsors employ in structuring their outsourcing strategy, what selection criteria are important to sponsors in today’s challenging climate and what evidence you can provide to differentiate yourself from other CROs. This ebook outlines the 10 most common criteria used when selecting a CRO and what CROs need to display to differentiate themselves from the competition.

Download the free eBook here >

This eBook was produced in conjunction with the World Vaccine Congress Europe. For more information about the event and to attend, please visit the website >

Sanofi Pasteur’s newly-approved quadrivalent influenza vaccine (QIV) [Sanofi nabs quadrivalent flu vaccine FDA approval for under 2s] may earn as much as $384 million in 2022, according to a forecast by GlobalData.

“With the addition of a fourth strain, participating vaccine manufacturers have undertaken a step towards developing a universal vaccine that could potentially protect against both seasonal and pandemic influenza strains,” said Ramya Kartikeyan, PhD PPM, GlobalData’s Head of Infectious Disease. Kartikeyan expects that a new wave of QIVs will cannibalize sales revenues generated by trivalent vaccines before fully supplanting them as the standard for vaccination.

Read the GlobalData commentary here >

What do you think? You can leave a comment in the box below, or on LinkedIn group discussion. Want more from Vaccine Nation? Sign up to our newsletter for free here.  If you want to know more about strategy and innovation in vaccines, you might be interested in attending the World Vaccine Congress Europe 2013, 16-17 October 2013, Lille.

Click here to download the White Paper provided by Virocyt: “Why Virus Quantification matters”.

There is growing evidence that the number of non-infectious viral particles is of significant biological importance and can impact both in vitro and in vivo studies. This mounting data suggests a need for rapid quantification of the total number of viral particles in a virus containing sample, which is now possible using the innovative Virus Counter 2100.

Click here to download the White Paper provided by Virocyt: “Why Virus Quantification matters”.

Sanofi Pasteur has announced that the US Food and Drug Administration (FDA) has approved its four-strain influenza vaccine, Fluzone Quadrivalent. Whilst trivalent vaccines used in previous influenza seasons contained two A strains and one B strains, a quadrivalent vaccine such as Fluzone will also offer protection against a second type B flu strain.

The 2013 season will be the first season in which quadrivalent influenza vaccines will be available in the US. But Sanofi is not alone in the US quadrivalent marketplace. The company’s newest addition to the Fluzone family will align itself against GSK’s Fluarix Quadrivalent and AstraZeneca’s FluMist Quadrivalent (Top 4 influenza vaccine FDA approvals). A key selling point for Sanofi’s vaccine, however, is that it is licensed for use in children as young as 6 months, a good 18 months earlier than FluMist.

In 6 of the past 12 influenza seasons, the dominant circulating B strain was from the B-lineage not selected for the vaccine. David Greenberg, MD, Vice President U.S. Scientific and Medical Affairs, Sanofi Pasteur, said: “Protection against the type B flu strain may be an especially important factor that healthcare providers consider when immunizing children since influenza B causes a substantial number of illnesses, hospitalizations and deaths in the pediatric population.”

Read the press release >

What do you think? You can leave a comment in the box below, or on LinkedIn group discussion. Want more from Vaccine Nation? Sign up to our newsletter for free here. 

If you want to know more about strategy and innovation in vaccines, you might be interested in attending the World Vaccine Congress Europe 2013, 16-17 October 2013, Lille.

Medicago has announced that it is “first in the world” to report positive interim results from a pre-clinical trial for an H7N9 Virus-Like Particle (VLP) vaccine candidate. The company reports that three micrograms of its H7 vaccine administered with and without adjuvant induced high antibody titres after one dose.

According to Andy Sheldon, President and CEO of Medicago, the results are very significant because they come against a background of general concern that H7 vaccines will be of low immunogenicity in humans. “To our knowledge, this is the first report of preclinical results for an H7 vaccine developed for the recent H7N9 virus, further demonstrating that Medicago is well positioned to be a first responder in the face of a pandemic,” he said.

The plant-made H7N9 vaccine was developed for the H7N9 virus that is responsible for the recent influenza outbreak in China that killed 37 of the 133 reported cases as of May 29, 2013. In order to produce the vaccine, Medicago say they only require the genetic sequence of the viral strain, and thus this dramatically reduces the delays that occur using traditional manufacturing systems.

Read the press release here >

What do you think? You can leave a comment in the box below, or on LinkedIn group discussion. Want more from Vaccine Nation? Sign up to our newsletter for free here. 

If you want to know more about strategy and innovation in vaccines, you might be interested in attending the World Vaccine Congress Europe 2013, 16-17 October 2013, Lille.