Path to swine flu vaccine has major hurdles

first_imgMay 1, 2009 (CIDRAP News) – National and international health authorities said today that they have begun the first steps in manufacturing a vaccine against the novel H1N1 swine influenza, though they appeared to disagree over whether full-scale manufacturing will move forward.But flu-vaccine experts in several countries warned that major manufacturing and regulatory hurdles lie in the path toward achieving a pandemic vaccine, hurdles that have been recognized by governments for years but never successfully dealt with.There is agreement on one point: The current seasonal flu vaccine will not protect against the novel virus. If authorities decide that a swine-flu vaccine is necessary, a new one will have to be formulated.”There is very little chance that the seasonal vaccine as used in the vast majority of countries in the world would be effective against this particular virus,” Dr. Marie-Paule Kieny, director of the World Health Organization’s Initiative for Vaccine Research, said in a briefing today in Geneva.This year’s seasonal vaccine formula will be administered soon in the southern hemisphere and currently is being manufactured for the northern hemisphere. Some manufacturers have grown all the vaccine virus needed for their production run, have moved the result to bulk storage for later packaging, and therefore could be ready to start a limited-production test of the new virus if necessary. But others are not done: According to the Centers for Disease Control and Prevention, some manufacturers have had difficulty growing one of the three major seasonal vaccine components, a strain that induces immunity to the family of viruses known as influenza B.That lag raises the possibility that manufacturers could be asked to short-circuit work on the seasonal vaccine in order to begin handling the seed strain of the novel virus, a move that would reduce the amount of vaccine available in the northern hemisphere next winter.”Some of the manufacturers may be 60% through, some of the manufacturers may be a little bit less, and not the same level either for the three components,” Kieny said. “We are in discussion with them to try to see at what moment it might be the best solution to stop the seasonal and to start the pandemic” formula.An immutable timelineWHO and CDC representatives said today that the timeline for producing even test lots of a swine-flu vaccine is immutable.It begins with the CDC’s Atlanta labs—the lead institution of the four international influenza collaborating centers—developing a “seed strain” of vaccine virus out of one of the isolates taken from the swine flu victims. That process, which takes 2 to 3 weeks, aims to develop a hybrid virus that retains the immune profile of the original virus but grows well in embryonated chicken eggs, which are the main growth medium used in flu-virus manufacturing. The result is then given to manufacturers to develop small pilot lots of vaccine for animal and human trials, a process that can take up to 11 weeks of production before any trials begin.Rumors are circulating among some flu scientists that the strain being used at the CDC for the vaccine seed strain is not growing well in eggs. The WHO and CDC appeared to acknowledge this Friday, disclosing that they are preparing two seed strains for manufacturers: one that was naturally reassorted by allowing viruses to mix in eggs, and another tuned via a patented process called reverse genetics that cuts and pastes genes from the swine virus with a non-pathogenic virus in order to achieve the highest possible growth rate. Manufacturers will be allowed to choose, the agencies said.At the moment, the naturally reassorted strains are being grown at the CDC and at New York Medical College, and the reverse-engineered strains are being worked on at the CDC and the other WHO collaborating centers along with the Food and Drug Administration. WHO convened an international meeting of manufacturers 2 days ago, and “several dozen” are prepared to receive strains, Kieny said.Vaccine yield is unpredictableThat production will go smoothly is not guaranteed: Since 2000, seasonal flu-vaccine delivery has been delayed several times because strains did not grow as well as predicted or eggs proved vulnerable to contamination. But if the swine-flu seed strains grow as well as hoped, by early autumn manufacturers and regulatory authorities will have to consider how to begin testing the pilot lots.That is a key issue for safety: In the abortive 1976 swine-flu outbreak, the vaccine caused a paralysis (Guillain-Barre syndrome) that occurred approximately once in every 1 million doses given, a proportion that was not reflected in the trials conducted then. But it will also determine in what size doses the vaccine will be given, if it moves to full manufacture—and that is a critical issue because international capacity for making vaccine is limited.The “standard dose” of antigen for flu vaccine is 15 micrograms (mcg) of flu-virus proteins. (Seasonal vaccines comprise three doses of 15 mcg—two from the influenza A family and one representing influenza B—in a single shot.) The larger the dose needed to produce immunity, the smaller the number of people who can be vaccinated if the formula moves to full production. Testing would also determine whether immunity could be achieved with one dose or would require two, a need that would effectively halve the number of shots available.Current estimates of global capacity vary wildly. Rear Admiral Anne Schuchat, MD, interim deputy director of the CDC’s Science and Public Health Program, told Congress Thursday that US manufacturing capacity would allow for the production of 600 million doses, or two shots for every US resident. Kieny said Friday the current global capacity is approximately 700 million doses. A report released in March by the International federation of Pharmaceutical Manufacturers and Associations puts current global capacity at 917 million doses—but it relies on assumptions that include an average dose of 9 micrograms, not 15.Still dependent on eggsBoth the limitation on manufacturing capacity and the time it takes to produce doses are dictated by the dependence on chicken eggs, a technology that has been essentially unchanged for 50 years. Since concerns over avian flu H5N1 first sparked in 1997, numerous experts have warned that egg-based vaccines would leave the world exposed to vaccine shortfalls at a critical moment. Nevertheless, plants with faster, cleaner next generation-technology, cell culture, are not scheduled to come online in the United States for 2 more years.”That is the real frustration, that we have been talking about this for 12, 13 years and have not yet found the will to do this better and faster,” said Dr. Gregory Poland, director of the Mayo Clinic’s Vaccine Research Group. “And here we are in a global emergency, at phase 5 of 6. What does it take?”The WHO and CDC seemed to disagree Friday over whether manufacture of a vaccine would move ahead, with the CDC’s Dr. Nancy Cox, director of the influenza division, saying that discussions are under way, and Kieny saying, “It seems most likely we will proceed.”If pilot lots pass clinical trials and move to full manufacture—a process that would take several more months—another significant hurdle remains: how to get the vaccine past government regulators.A monovalent vaccine (one containing only one strain) could be presented to the FDA under existing licenses, said Dr. David Fedson, a former vaccine-industry researcher and longtime critic of pandemic preparations—but authorities would then have to rely on citizens to return for one or two shots in addition to the standard seasonal vaccine. Combining the new vaccine with the existing vaccine into a quadrivalent (four-strain) product, while potentially more acceptable to consumers, would face far more regulatory hurdles because it would represent a new formulation—and, if it were contaminated or held up by manufacturing problems, could imperil potentially the entire seasonal vaccine supply.The issue of manufacturing capacity, and possibly also of immunogenicity, could be solved at a stroke if a new vaccine were to include an adjuvant, effectively an immune-system activator that allows doses to be diluted and thus makes many more shots available. Pandemic planners have pushed for adjuvant licensure in the United States for years; they were first called for after the 1957 pandemic. But so far, only one adjuvant has been licensed in the United States, and regulators have said that in order to be approved, any adjuvanted vaccine must be tested using the exact adjuvant-antigen dosage that will be marketed—thus requiring an additional layer of testing that is unlikely to fit the need for speed in achieving a pandemic vaccine.See also: CDC press briefing transcript press briefing audio filelast_img read more

Plexus Buys into KMS

first_imgPlexus has made an investment of £735,000 to acquire a 49% interest in KMS, a precision engineering business focused on the oil and gas industry. The transaction is said to be in line with management’s strategy to position Plexus as an IP-led company based around its POS-GRIP friction grip method of engineering with a design, development and now a machining capability.KMS was founded in 2001 and manufactures parts used in harsh and demanding subsea environments within the oil and gas industry. KMS supplies a range of blue-chip international clients, including Schlumberger, Halliburton, GE Oil & Gas, NOV and Weatherford.Post the sale of its niche wellhead exploration equipment services business for jack-up applications to TechnipFMC in February 2018, Plexus is focused on commercialising and exploiting its existing IP as well as developing new POS-GRIP-enabled products either organically or with partners such as TechnipFMC, with whom the company has entered into a collaboration agreement.It is anticipated that KMS will provide Plexus with additional means by which to machine bespoke equipment for new applications and technologies as well as for R&D testing, and will potentially enable Plexus to more effectively supply specific markets.Plexus is acquiring its 49% interest in KMS by means of a subscription for new shares in KMS. KMS intends to use the proceeds from the Transaction to expand existing capacity and fund other growth initiatives. For example, KMS has recently acquired a new large bore machine which has already resulted in a significant expansion in capacity. KMS intends to use circa £310,000 of the proceeds arising from Plexus’ investment, in settlement for this piece of machinery. Under the terms of the transaction, Plexus will be entitled to future distributions/dividend payments which would provide an annual return on Plexus’ investment, subject to KMS’ profitability, in addition to any capital appreciation in the value of Plexus’ 49% shareholding in KMS. An additional cash payment of up to £150,000 may be payable by Plexus to the current owners of KMS, subject to the future performance of KMS in the year to 31 December 2018.Plexus’ CEO Ben Van Bilderbeek said, “As a highly experienced engineering company based in Aberdeenshire with a blue-chip customer base, KMS shares many similarities with Plexus. We already have first rate IP in the form of our POS-GRIP technology, and now thanks to today’s transaction, we are further able to support our programme to expand the application of our proprietary technology throughout the oil and gas supply chain and beyond into areas such as geothermal and decommissioning. Having established our jack-up exploration wellhead business as the dominant supplier to the North Sea HP/HT market, we know the challenges companies operating in the sector face. Therefore, we look forward to working with and supporting the KMS team going forward, as we look to grow our business substantially over the coming years.“last_img read more

Four Drug Companies Reach Last-Minute Settlement in Opioid Crisis, Avoiding Trial

first_imgNearly a half million overdose deaths between 1997 and 2017 are attributed to opioids.AmerisourceBergen, Cardinal Health, McKesson and Teva are involved in the settlement, the details of which are expected later today.It’s not clear if a fifth defendant, pharmacy chain operator Walgreens Boots Alliance, was also part of the settlement. Four large drug companies reached a last-minute $260 million legal settlement over their role in the U.S. opioid addiction epidemic, averting the first federal trial that was scheduled to start Monday morning in Cleveland, Ohio.The trial, set to begin today, came as Ohio’s Cuyahoga and Summit counties were seeking $8 billion dollars for treatment programs and health care expenses.The Ohio counties, 4 drug firms reach $260 million settlement on eve of landmark federal trial over responsibility for opioid epidemic— The Washington Post (@washingtonpost) October 21, 2019last_img read more

Another noose was found on a NASCAR track property over the weekend

first_img“The sport is changing … Whoever it was, you’re not gonna take away my smile.”- @BubbaWallaceWhat a moment. #IStandWithBubba— FOX: NASCAR (@NASCARONFOX) June 23, 2020Added NASCAR president Steve Phelps before Monday’s race: “This is a difficult time for our sport, but we are going to react swiftly and again we’re going to use all the means, resources at our disposal and of those of the FBI to make sure this person or persons are caught and dealt with swiftly and severely. There’s no room for this at all, and we won’t tolerate it.”The garage area at Talladega was not open to fans Sunday because of the coronavirus. Only race teams, NASCAR/track officials and safety crews were allowed access.NASCAR’s race weekend at Talladega also prompted protests from Confederate flag defenders, including a parade of trucks and motorcycles displaying the stars and bars outside the track on Saturday and a “Defund NASCAR” banner featuring the flag being flown by a plane over the track Sunday. Added Steve Page, the track’s president who also serves as its general manager (via NBC Sports): “Our staff, on-site business tenants and local law enforcement have been contacted and asked to share any information they may have. The incident is under investigation by the Sonoma County Sheriff’s Department. Sonoma Raceway takes this incident very seriously and is dedicated to operating a facility that is welcoming to everyone.”MORE: Wallace sees how NASCAR “is changing”Sonoma Raceway’s annual NASCAR Cup Series race, which originally was scheduled for June 14, was moved to Charlotte because of the COVID-19 pandemic and held on May 27. Sonoma is expected to be added back to the schedule in 2021. Speedway Motorsports owns Sonoma Raceway.The noose in Wallace’s garage was discovered a day later at Talladega Superspeedway, which is owned by NASCAR and located in Talladega, Ala. It was found almost two weeks after Wallace’s push to have the Confederate flag banned from NASCAR races became successful. NASCAR on June 10 announced it had prohibited the display of the flag at all of its events and properties.Both the FBI and NASCAR are investigating the Talladega noose, which is believed to have been placed at some point during Sunday’s rain delay of the Geico 500. Wallace never saw the noose. The race eventually was postponed to Monday because of inclement weather.”The deal that happened yesterday, sorry I’m not wearing my mask, but I wanted to show whoever it was that you’re not going to take away my smile and I’m going to keep on going,” Wallace said on the Fox broadcast after finishing the race 14th, standing in front of a crowd of supporters in the stands. The noose found in Bubba Wallace’s garage stall at Talladega Superspeedway was not the only one that appeared at a NASCAR racing facility over the weekend.The president of Sonoma Raceway, a road course located in Sonoma, Calif., that has hosted NASCAR Cup Series races since 1989, claims that on Saturday a “staff member discovered a piece of twine tied in what appeared to be a noose hanging from a tree on raceway property.”last_img read more

Elche intends to transfer Gorka Guruzeta, from Athletic

first_img12 The Elche CF has decidedly launched into the winter market to get the main reinforcements it expects Potato To finish compensating your workforce. The objectives are a central defense, preferably to act in the left-handed profile, and a forward. For the attack, in addition to aiming to the discards of Cádiz, has also set its sights on the Athletic. Like, and much, Gorka Guruzeta. Gorka Guruzeta, son of the historical center of the Real Sociedad Javier Guruzeta, is a promising footballer of Athletic Club, 23 years old, to which only a serious injury in the crusader of his knee separated him from the dynamics of the first team. Last season he played nine official meetings with the first team, between League and Cup, and premiered as a scorer in the Sánchez Pizjuán stadium in Seville. In April he was injured in a duel of subsidiaries before the Sporting B and eight months later he returned to the competition in the Bilbao Athletic, where he has participated in the last five days.Athletic values ​​the option of leaving him in the second team to take another shoot, although he could also accept an assignment if he sees that the player has options to have some continuity in the lineups. Elche is not the only one who has knocked on the door of agent Luis Alonso, who represents Potato, a junior technician who already trains the loan from Lezama, Andoni López. Rayo Vallecano is one of those who have asked for. Gorka Guruzeta, 1.88 meters high that can act as a second point or fall to either of the two bands. It has a powerful shot that has allowed it to become known as a scorer in the Bilbao Athletic.last_img read more

Moyes appointed new West Ham manager

first_imgThe Hammers sacked manager Slaven Bilic on Monday after a poor run of results that have left the east London side languishing in the relegation zone.Saturday’s chastening 4-1 loss at home to Liverpool convinced Sullivan and co-owner David Gold that Bilic’s time was up, with the pair banking on the 54-year-old Moyes’s understanding of the English game to keep the club in the top flight.“We need somebody with experience, knowledge of the Premier League and the players in it, and we believe David is the right man to turn things around and get the best out of the players at the club,” said Sullivan.“He is highly regarded and respected within the game, and will bring fresh ideas, organisation and enthusiasm.”Moyes has been out of management since he resigned from his post Sunderland at the end of last season, having failed to prevent the northeast club being relegated from the Premier League.Despite that, and an underwhelming stint in Spain with Real Sociedad, the Hammers are backing the Scot to help shore up a leaky defence as well as getting the best out of big-money summer signings Marko Arnautovic and Javier Hernandez.West Ham sacked manager Slaven Bilic after a poor run of results that have left the club in the Premier League relegation zone © AFP/File / Ian KINGTONAfter Moyes emerged as the leading contender to replace Bilic, many West Ham fans regarded his proposed arrival at the London Stadium with scepticism.But Moyes, whose first game in charge will be at Watford a week on Sunday following the international break, urged them to get behind him and his squad.“I’m really looking forward to meeting the supporters and being in the stadium with them,” Moyes said in comments published on West Ham’s Twitter feed.“I’m looking forward to seeing them get right behind the team, and my team also. We need the support, we need everybody with us.”He added: “It’s a big job we have in hand now but I’m sure with everybody together we can get the right results between now and the end of the season.”Former West Ham defender Bilic is the fourth Premier League managerial casualty of the season, the Croatian’s exit following those of Frank de Boer (Crystal Palace), Craig Shakespeare (Leicester) and Ronald Koeman (Everton).0Shares0000(Visited 1 times, 1 visits today) 0Shares0000David Moyes has been unveiled as the manager of West Ham United. Photo/DAILY MAILLONDON, United Kingdom, Nov 7 – West Ham have appointed former Everton and Manchester United boss David Moyes as their new manager, the struggling Premier League club announced on Tuesday.“We believe David is the right man to turn things around and get the best out of the players at the club,” joint chairman David Sullivan said.last_img read more