HHS cancels VaxGen anthrax vaccine contract

first_img The firm has not decided whether to appeal the decision, Lance Ignon, VaxGen’s vice president for corporate affairs, told CIDRAP News today. “We find it, I think, regrettable that we were unable to have an open and productive dialogue with HHS about how to ensure all the work that’s gone into this could result in an anthrax vaccine,” he said. Project Bioshield was intended to promote the development of medical defenses against biological, chemical, and radiological weapons by guaranteeing that the government would buy promising products, which otherwise would be unlikely to find a market. But major pharmaceutical companies have shown little interest in pursuing BioShield contracts, leaving the field mostly to small companies like VaxGen. The VaxGen vaccine is based on a recombinant form of protective antigen (rPA), a key anthrax protein. It was expected to provide immunity in 3 doses, rather than the 6 doses required for AVA, and to cause fewer side effects. Some military personnel have objected to AVA because of reported serious side effects. The company also makes a smallpox vaccine but has no contract for it. The firm has a “state-of-the-art manufacturing facility,” Ignon said. “And we are reasonably well capitalized. We do have options.” He indicated that the stability problem has not yet been solved. “It’s clear that more work needs to be done on the stability issue, but that’s not an uncommon challenge to face in vaccine development,” he said. The contract was the first and largest award under Project BioShield, designed to stimulate the production of medical countermeasures for biological weapons and related threats. The cancellation came the same day President Bush signed new legislation designed to revive the faltering $5.6 billion program. Because of concerns about the vaccine’s stability, the Food and Drug Administration (FDA) refused to allow VaxGen to start a phase 2 trial on Dec 18, as required by the Department of Health and Human Services (HHS), said Marc Wolfson, a spokesman for the HHS Office of Public Health Emergency Preparedness. Meanwhile, HHS has been stockpiling the older anthrax vaccine, now made by Emergent BioSolutions, Gaithersburg, Md. The agency ordered 5 million doses in May 2005 and exercised an option for another 5 million in May 2006. “Thus far we have just over 8 million doses that have been delivered to the stockpile,” Wolfson said. See also: Then on Nov 3, the company said the FDA had ordered it to postpone the phase 2 trial because of concern that the vaccine would lose potency during the study, clouding the results. That prompted HHS to warn that it might cancel the contract unless VaxGen fixed the problem quickly. On Dec 9, Congress passed legislation designed to strengthen the BioShield program and improve public health preparedness in other ways. The bill, signed by President Bush yesterday, sets up a Biomedical Advanced Research and Development Authority within HHS. The agency will be empowered to pay contractors when they achieve certain development milestones, instead of requiring them to deliver a finished product before getting any money. Because of the missed deadline for starting the trial, “the [HHS] staff and the contracting officer determined the course of action would be to terminate them for default,” Wolfson said. Nov 6 CIDRAP News story “FDA orders delay of anthrax vaccine trial” Ignon said VaxGen is not stopping all work on the vaccine immediately, but “there will clearly be a significant diminution of our efforts.” He noted that the National Institutes of Health has been supporting anthrax vaccine research by Avecia, based in Manchester, England. May 11 CIDRAP News storyhttp://www.cidrap.umn.edu/cidrap/content/bt/anthrax/news/may1106anthrax.html Because of the missed deadline, HHS told VaxGen in a letter, “The government is terminating this contract for default.” Ignon said the termination didn’t come as a complete surprise. “They had certainly given us ample warning that this was a potential outcome.” VaxGen officials met with the FDA Dec 13 and presented data on the vaccine’s stability, Wolfson said. “The FDA looked at that and said, ‘We’re sorry, there’s not enough here to prove sufficient vaccine stability to lift the hold and allow you to begin phase 2 clinical trials,'” he said. Wolfson said HHS is “still committed to a next-generation anthrax vaccine,” but no decisions have been made about next steps. “I’d expect that early next year there’ll be an announcement from the department,” he said. The original contract, awarded in November 2004, called for VaxGen to deliver the first 25 million doses in just 2 years, or November 2006, and provided for no payments to the company until delivery. But the company announced last May that the first doses would be delayed at least until late 2007 and probably until 2008. HHS granted the company an extension at that point, but set a Dec 18 deadline for starting phase 2 trials, according to Wolfson. In a news release yesterday, VaxGen, based in Brisbane, Calif., said it was “actively exploring its strategic and legal alternatives.” Dec 19 VaxGen news release Dec 20, 2006 (CIDRAP News) – The US government yesterday canceled its $877.5 million contract with VaxGen Inc. for a new anthrax vaccine, after problems with the vaccine’s stability caused the company to miss a deadline for starting a clinical trial. The contract, awarded in 2004, called for VaxGen to produce 75 million doses of a new anthrax vaccine for the US civilian stockpile, or enough to immunize 25 million people. The hope was that the vaccine would improve on the anthrax vaccine used by the US military, called anthrax vaccine adsorbed (AVA), which was developed in the 1950s.last_img read more

The first edition of the renowned world gastronomic guide for Croatia – Gault & Millau Croatia

first_imgOn over 300 pages, in Croatian and English, the Gault & Millau Croatia guide will present the 100 best restaurants and 100 best wines from all over Croatia, as well as 50 POP places, popular informal bars for pleasant outings.With the arrival of the Gault & Millau guide, Croatia has thus entered the circle of countries that every year are very excited to receive awards for the best achievements in the world of cuisine. In addition to the chef of the year, there are also awards for the chef of traditional cuisine, for the chef of tomorrow, for young talents and for the best POP place. One of the most important gastronomic events of the year will bring together 200 chefs and chefs, professionals, and special guests will be some of the world’s most distinguished chefs such as Ana Roche and San Degeimbre and Gault & Millau President Come de Cherisey. “The release of the Gault & Millau guide for Croatia is a turning point on the domestic gastronomic scene. This is the first time that one of the world’s most prestigious guides has dedicated himself to restaurants, bistros, taverns and other catering facilities throughout Croatia. This is the first time that the selection has been completely anonymous and that the quality assessments have been made on the basis of an assessment methodology developed by Gault & Millau for almost 60 years and which is the same in all countries where there is a guide.”, Said Ingrid Badurina Danielsson, CEO of Gault & Millau Croatia.Mastercard and Gault & Millau Croatia introduce a new award Payment Excellence AwardThe partner of the first Croatian edition of the guide is Mastercard, which initiated the award in an additional category – given the payment options that restaurants offer and the communication of these options to visitors. The restaurant and POP location with the most points in this category will be awarded a prize Payment Excellence Award, with the aim of encouraging the introduction of electronic payments in catering facilities in Croatia. Namely, we increasingly encounter media articles such as those that tourists in Croatia are bothered by the fact that cards are not accepted in restaurants and other catering facilities, so an initiative like this is aimed precisely at encouraging financial inclusion.A mobile application is already available to mobile phone users, showing ratings and detailed descriptions of restaurants in countries that are part of the Gault & Millau family. The app finds restaurants, bistros, patisseries, wine bars that are nearby.last_img read more

NP Krka presented a new lookout in the Čikola canyon

first_imgOn the occasion of the International River Day, March 14, the Krka National Park Public Institution presents a newly renovated slaughterhouse and lookout in the Čikola canyon with a view of this exceptional karst river, which, cramped with limestone rocks, is fighting drought. The lookout is located on the right bank of Čikola, right next to the road that leads from the direction of Šibenik to Pakovo selo, and the invested funds are HRK 292.891,65.By the way, the river Čikola is the largest tributary of the river Krka. It springs near the village of Čavoglave in the Dalmatian hinterland, and in Krk it flows above Skradinski buk, so that the lower part of its course is within the boundaries of the Krka National Park. With the raising of the travertine barrier of Skradinski Buk, thirteen kilometers of the Krka River and three kilometers of the Čikola River were submerged, creating the most unusual landscape in Croatia, which makes the island of Kalički Busen even more special. Krk from the mouth of Čikola.Photo: NP KrkaČikola flows through Petrovo polje and the town of Drniš, and through the canyon that leads it to Krka, into which it flows above Skradinski buk. At the mouth of the Čikola there is a natural phenomenon: a spring in the shape of Lake Torak. Although it is a spring, due to its round shape, the Torak looks more like a lake, so we call it a lake spring. Its diameter is 150 m, depth 30 m, and the source is located at the bottom of the lake. This karst spring amazes with its beauty precisely because of its unusual position at the confluence of two rivers and the characteristic flora of the grasslands and shrubs that surround it.NP Krka is developing step by step from year to year and raises the quality of the entire National Park, and they are one of the few positive examples of how NP and PP should be developed sustainably and strategically.Related news: NEW HIKING TRAIL GORIŠ – TUESDAY IN KRKA NATIONAL PARK OPENEDlast_img read more

CNTB announces list of fairs for 2019

first_imgThe Croatian National Tourist Board has published a list of fairs at which it will perform in 2019.At these fairs, there is a possibility of co-exhibiting in a smaller or larger co-exhibiting place, depending on the size of the stand and the position within the stand (details can be found in the Co-exhibition Agreement 2019 and General Terms of Lease and Co-Exhibition). These fairs are tourist fairs for a wide and / or business audience and specialized fairs – camping, congress and nautical fairs.Source: CNTBYou can search for the general terms and conditions as well as the Co-exhibition Agreement signed with the CNTB HERE (on the left). By the way, as of this year, a new concept and creative solution for the appearance of the CNTB at tourism fairs was presented, find out more about this topic in the attachment.RELATED NEWS:NEW CONCEPT AND CREATIVE SOLUTION OF CNTB’S APPEARANCE AT TOURIST FAIRS PRESENTEDNEW CONCEPT AND CREATIVE SOLUTION FOR CNTB’S APPEARANCE AT FAIRS SELECTEDlast_img read more

A port town like a wine mecca?

first_imgTherefore that this city and its surroundings, due to the sparing of the tourist machinery, have preserved their authenticity, which today in some places is trying to preserve or return with difficulty at least in the contours. So there are a lot of wine reasons to come. And those who are attached to natural beauties. But let’s not forget the most important ones – human – which will make this event special. Because it always starts and ends with people and for people.  Employees of the Ploče Tourist Board thought about this in this way when, in cooperation with a Pločanin with an Osijek address, the famous wine writer Željko Garmaz, they decided to show everyone that they have something to be proud of on the Croatian wine list and to include their city in the directory of unavoidable wine events. they cannot and must not be bypassed. And so it arises Plates Summer Wine Festival. The idea itself caused astonishment and questioning – why a wine festival? why June? why Ploče? Our answers are: simple and full Therefore: In Ploče you can wait for the ferry to Pelješac, the train to Herzegovina, the bus to Vrgorac, and you can’t get to nearby Komarna without meeting Ploče. So, maybe in Ploče there are no grand cru vineyards worth daily mention in the media, but Ploče – the people of Ploče themselves know this best, not only the Port and the dormant buildings have sprung up in the last 70 years. Therefore that Ploče no longer wants to be perceived only as a Port City or a Ferry Port – is determined to tell its authentic and sustainable tourist stories.  Here, the goldsmith has reached the status of the best Dalmatian white variety, as a fascinating thorn bush blows around her neck, an autochthonous wine child that thrives only in the triangle that borders Imotski, Vrgorac and Ljubuški. Chardonnay from the mouth of the Neretva into the sea, from a vineyard built on the ground of the dried-up lake Modrič, has been one of the best shoots of this variety in Croatia among wine connoisseurs for years. And Komarna, until recently a karst, overnight became one of the most prestigious vineyards in which Plavac mali, tribidrag and – pošip have fantastically settled. And cheese! There is no need to waste words on the range of Plavac mali in the top Pelješac positions. The Ploče Summer Wine Festival is one of them. There are more. Such as, for example, Ploče fishing, which should be experienced both as a visitor and as a chef and as an organizer of events. ummer Wine Festival is also special in that it combines oenology & film music. The musical backdrop of the Ploce wine festival will be created by great artists from the Zagreb band FilmMusicOrkestar. PZ “Kuna 1898” Therefore which is Ploče in itself an ideal traffic-geographical-natural intersection of different directions of the Neretva region, southern Dalmatian islands, Dalmatian hinterland and Herzegovina.  The plates are from Umčani and Vina and Kobiljača and Imotski and Komarna and Pelješac. Or, as some would say, stick a compass in Ploče and pull a circle 20 kilometers away, you have a place that boasts really respectable wines. In this context, it is safe to say that Ploče is trembling from the tectonic disturbances caused by local winemakers, making the area currently, perhaps, the most vibrant wine region in Croatia. If you’re not familiar with this fact, it’s time to change that. Therefore what this beautiful area has to say when it comes to winemaking. The best proof of this are the 40 winemakers who will present themselves at this festival.  Photo: Tourist Board of the City of Ploče Find out more about the Summer Wine Festival HERE Unlike large folk festivals, which are regularly held in Ploče on the waterfront next to the Church of the Queen of Heaven and Earth, the wine festival will have its household on the terrace of the House of Culture and will, on a symbolic level, show that wine from that area is sublime and , perhaps, the best invitation to come to Ploče and go down to the nearby wine cellars. Authors: Željko Garmaz, Marinela Dropulić Ružićlast_img read more

In the first six months, 15 cruises of foreign ships were realized

first_imgIn the first six months of 2020, 15 cruises of foreign ships were realized In the period from January to June 2020, six foreign cruise ships sailed into Croatian seaports, making 15 cruises. There were 3 passengers on these ships, who stayed in Croatia for 737 days. In the period from January to June 2020, the number of foreign cruise ships in Croatian seaports decreased by 88,9% compared to the same period in 2019. In the first six months of 2020, foreign cruise ships decreased by 94,5% and the number of days spent on the Croatian Adriatic by 91,5% compared to the same period in 2019. The number of passengers on these ships compared to the same period In 2019, it is lower by 99,1%. Twelve voyages were made by ships flying the flag of Malta, while the largest number of passengers arrived by ships flying the flag of Italy (2 passengers). Due to the COVID-19 pandemic, measures were introduced to ban the entry of ships on international cruises, which directly affected the reduction of the number of foreign cruise ships in Croatian seaports in March 2020 and their absence in April, May and June 2020. Out of a total of 15 cruises, 73,3% of trips were realized in Dubrovnik-Neretva County, while the remaining 26,7% of trips were realized in Istria County. Photo: Pixabay.com Large drop in the number of cruise ships on the Croatian Adriatic due to the COVID-19 pandemiclast_img read more