Momentum builds for cell-culture flu vaccines

first_imgJun 27, 2005 (CIDRAP News) – You’ve got to gather a lot of eggs to supply the world with influenza vaccine, but that might change before long.As governments and scientists wrestle with how best to protect people from the annual onslaught of typical flu and the unpredictable attack of pandemic flu, they’re seeking alternatives to egg-based vaccines.A production method common to other vaccines, cell culture, is increasingly gaining currency. Cell-culture technology involves growing key vaccine components in human, monkey, canine, insect, or other cells in enclosed vats.The process has been used for vaccines such as polio, hepatitis A, chickenpox, and shingles, said Robin Robinson, PhD, senior project officer for the Office of Public Health Emergency Preparedness in the US Department of Health and Human Services (HHS).Growing flu vaccines in cell cultures would mark a huge departure from the traditional method.The decades-old production method used today involves growing vaccines in fertilized chicken eggs. It depends on the availability of hundreds of millions of eggs and requires adapting the virus strain to grow in eggs. The production process takes at least 6 months, according to the National Institute of Allergy and Infectious Diseases. And in the event of an emergency, there is no way to quickly scale up the supply, since eggs must be ordered in advance.With cell-culture methods, the virus does not need to be adapted for growth in eggs, and in an emergency, manufacturers could boost production without waiting for chickens to lay enough eggs. Although estimates vary as to how much time would be saved with cell-culture production, experts familiar with both methods say it could shorten the process by at least a month.Besides being faster, production of cell-culture vaccines is considered safer and cleaner than egg-based systems because it uses a closed system of bioreactors.An improving climateDespite the disadvantages of egg-based vaccines, however, there has been little pressure to pursue cell culture. The functional egg-based infrastructure, the relatively low profits for flu vaccines, and the challenges of adapting the flu virus for cell culture production have slowed research and development, authorities say.Egg-based vaccines “have always been a very cheap product, and there was never a real incentive in the industry to change that process,” explained Manon Cox, DrS, MBA, chief operating officer of Protein Sciences Corp. in Meriden, Conn., in a recent interview. Protein Sciences is developing a cell-culture flu vaccine using caterpillar cells.The climate for cell-culture flu vaccines is improving because of shortages in the US vaccine supply and the growing fear that the next pandemic could be brewing right now in Southeast Asia.While some companies have been researching cell-culture techniques for years, others now have incentives to join the push. The United States has worked in the last year and a half to encourage a number of contracts to “secure, expand, and diversify the influenza vaccine supply in the United States” for both seasonal and pandemic flu, Robinson said.HHS in April awarded vaccine maker Sanofi Pasteur a $97 million, 5-year contract to develop cell-culture technology. The contract is for developing the technology and design for a facility to manufacture at least 300 million doses of vaccine for use in a pandemic.HHS has already issued another request for proposals to boost flu vaccine research and development, Robinson said. The contracts call for producing a pandemic flu–like vaccine that must go through phase 1 and 2 clinical trials “so they have a candidate that will be both safe and immunogenic,” he said.Bruce Gellin, director of the National Vaccine Program at HHS, explained why it’s important to end the era of the egg in testimony before a congressional subcommittee on Apr 12:”Using a cell culture approach to producing influenza vaccine offers a number of benefits. Vaccine manufacturers can bypass the step needed to adapt the virus strains to grow in eggs. In addition, cell culture–based influenza vaccines will help meet surge capacity needs in the event of a pandemic or shortage. US licensure and manufacture of influenza vaccines produced in cell culture will also provide security against risks associated with egg-based production, such as the potential for egg supplies to be contaminated by various poultry-based diseases.”Cell-based techniques would allow manufacturers to double or triple vaccine production, from, say, 10 million doses a week to perhaps 20 million or 30 million, Robinson said.In addition, safety could be greatly improved with cell-culture vaccines, he noted. Egg-based vaccine production involves open systems, whereas cell-culture production involves a bioreactor, which is a closed system. Cell-culture technology far safer from contamination by pathogens, which would be of crucial importance in the event of a pandemic, he said.Caterpillar cells as vaccine factoriesSanofi Pasteur is but one of several companies working to develop cell-culture flu vaccine, according to a list Robinson compiled. They include Solvay Pharmaceuticals of the Netherlands, Baxter in Austria, Chiron in Germany, GlaxoSmithKline in Belgium, ID Biomedical of Canada, and Medimmune in the United States. None of the vaccines is on the market yet.”Today everybody is trying to do this,” said Cox, of Protein Sciences.Protein Sciences is betting on the baculovirus system for its cell culture flu vaccine. The baculovirus has a reputation in nature for easily infecting insect cells, Cox said.Protein Sciences’ process starts with recombinant hemagglutinin (rHA), she said. Hemagglutinin (H) and neuraminidase (N) are the surface proteins of the flu virus. H helps the virus bind to and enter host cells, and N enables new copies of the virus to leave a cell so they can infect others.The rHA is essentially zipped up like DNA, creating a more stable, less shift-prone blueprint, Cox said. The rHA is inserted into a baculovirus, and the baculovirus is added to caterpillar cells.”The rest happens on its own,” Cox said. “There’s an infection, the baculovirus infects the insect cells, and it sets about producing the product of interest [baculovirus copies containing rHA]. The insect cell is a little factory, which is now starting to produce whatever that baculovirus wants it to produce.””Vaccine manufacturers have recognized that this baculovirus system is an enormously powerful system to make vaccines against viral or parasitic diseases,” she said. “We need to convince venture capitalists and other partners that this is indeed the product to go for,” she added. It will probably be 3 years before the company seeks FDA approval.The company’s efforts may have taken a stride forward with the announcement in mid-June of preliminary results from its initial field efficacy study of the FluBlOk vaccine, made through the process described above.The study included 460 healthy people aged 18 to 49 at three US sites, according to a news release from the company. Subjects were injected with one of two different formulations of FluBlOk, with the same amount of H3 antigen but two different amounts of H1 and influenza B antigens, or with a placebo. The 135-microgram dose was 100% efficacious in preventing culture-positive influenza compared with the placebo, the company said. In addition, the vaccine groups had a 50% lower rate of flu-like illness than the placebo group.The trial showed safety and induced strong antibody responses against influenza in all vaccinated subjects, the company said, adding that final assessments are still under way.Seeking licensing in the Netherlands, USThe Dutch company Solvay Pharmaceuticals has been working on a cell-culture flu vaccine since the early 1990s, according to Bram Palache, MSC, PhD, biochemist and global medical affairs director for influenza vaccines.Solvay’s vaccine is made in canine cells, a line that has been approved for use in the Netherlands, although it wasn’t approved when Solvay selected it, Palache said. The company is in the process of validating its factory, and hopes to make clinical lots there this year. From there it’s a relatively short step to final licensure of the flu vaccine for use in the Netherlands, he added.Solvay is seeking US Food and Drug Administration approval of the flu vaccine and the cell line used to produce it, Palache said. He was not ready to speculate on how long it might be before the vaccine would be available in the US.The importance of alternatives to eggs for vaccine production came home to Solvay in 2003, when the company lost chickens during an outbreak of H7N7 avian flu in the Netherlands. The company had to scramble to get approval to bring in eggs from disease-free areas so it could produce flu vaccine on time.”We had a real-life situation where the vulnerability of eggs for the production of influenza vaccines was really making the difference between having vaccine and having no vaccine,” Palache said. “There’s nothing wrong with egg production per se. But once the cell-culture vaccine is implemented . . . more companies will come in, using that technology. Ultimately it will replace the current production technology.”Cell culture just part of US strategyRobinson cautioned that in the flu vaccine arena, there are more pressing short-term goals than developing cell-culture technology. “We approach it in two phases. One is preparedness to hopefully have stockpiles of a virus that is as close as we think it can be to the [potential pandemic] threat. And then to have the manufacturers ready to go with virus seed strain. And then to have the capacity.”The short-term US goals are aimed at improving the current flu vaccine production processes to improve yield and making the available vaccine supplies stretch further, he said. The goals include developing adjuvants to boost immune response and finding alternative methods for injecting the vaccine.Robinson said he wants the nation to have the surge capacity to produce at least 20 million doses of monovalent vaccine per week by 2009.Ultimately, what the United States would need for a pandemic flu strain is 600 million doses of vaccine—two doses for every American. Compare that with the numbers for the 2004-05 flu season: Authorities hoped to have 100 million doses available, but obtained only 61 million. The leap from the unmet goal of 100 million doses to 600 million is so daunting that even experts such as Robinson break down the numbers.”That’s why we like to talk about it in terms of weeks,” he said.And while cell-culture technology may improve flu vaccine production capacity, it is not a panacea for the challenge of a flu pandemic. A vaccine cannot be specifically tailored to a pandemic virus until the virus emerges, so even with cell-culture technology, an optimal vaccine would not be available for the first several months of a pandemic.Moreover, only nine countries have the capacity to produce flu vaccine on a commercial scale. The advent of cell-culture technology does not automatically solve the problem that current global annual production capacity is fewer than 1 billion doses of flu vaccine in a world of more than 6 billion people—or the challenge of actually administering vaccine to billions of people in a pandemic situation. And even if the United States could eventually secure enough doses for its own population, the nation would not be immune to the global economic disruption that a pandemic would cause.Aside from pandemic-related concerns, Palache said that switching production methods won’t address a key problem with flu vaccine: demand.”[Neither] Solvay nor any other company will produce three times as much vaccine just because they can do it if by the end of the day it isn’t sold. Flu vaccines can’t be put on the shelf for the next year,” he said. “Whether they’re eggs or cells, demand drives supply.”See also: Transcript of Bruce Gellin’s testimonyhttp://www.hhs.gov/asl/testify/t050412.htmllast_img read more

Panthers’ Roberto Luongo moves into second place for career appearances by a goaltender

first_imgLuongo made the majority of these appearances during two stints with the Panthers from 2000-2006 and 2013. He also spent eight seasons with the Canucks and reached the Stanley Cup Final in 2011.His first 24 appearances came in 1999-00 season as a member of the Islanders. 20 years into his NHL career and Roberto Luongo is still making history as he now second all-time in appearances by a goaltender.Luongo entered his 1,030th game Sunday night at the end of the second period against the Lightning, passing Patrick Roy for sole possession of second place. He will likely remain No. 2, as he is 236 appearances behind all-time leader Martin Brodeur.  Second All-Time in Games Played.LUONGOAT. 🐐 pic.twitter.com/q1WlW4zX5j— Florida Panthers (@FlaPanthers) February 11, 2019The Montreal native has the opportunity to add to his historic career again this season as he currently sits one win away from tying fellow Canadian Ed Belfour for the third most career wins. Luongo is also third in time on ice, seventh in save percentage and ninth in shutouts.The six-time All-Star inherited a 3-2 Panthers’ deficit from James Reimer and allowed two power-play goals in the third period, extending Tampa Bay’s lead to three before the game’s end.Luongo will have his first chance to make more history this season Feb. 12 at home against the Stars.last_img read more

Stormy Daniels settles for 450K in strip club arrest lawsuit

first_imgPorn star Stormy Daniels is settling her lawsuit against the Ohio city of Columbus for more than 400-grand.The settlement comes more than a year after Daniels, whose real name is Stephanie Clifford, was charged with three misdemeanor counts of illegally touching a patron at the Sirens Gentlemen’s Club.The charges against Daniels were dropped 12 hours later.She then sued the city claiming her arrest was politically motivated.Daniels told WBNS-TV she was pleased with the outcome of the settlement, and that the lawsuit was never about the money.“It was the changes that were made in bringing awareness to how the law isn’t written fairly, and they targeted me and other women,” Daniels said. “I’m really proud of how the city of Columbus stepped up and took responsibility in actively making changes and holding those officers accountable.”Stormy Daniels is the woman at the center of the scandal that landed former Trump attorney Michael Cohen in jail. She is one of the two women who claimed to have received money in exchange for silence about an alleged affair with President Trump.Cohen is currently serving a three-year prison sentence for violating campaign finance laws and lying to Congress.In February, he told Congress that Trump instructed him to move illegally move campaign funds to pay off Daniels and Karen McDougal before the 2016 election.Trump has adamantly denied all of the allegations.last_img read more

Transgender woman shot and killed in Pompano Beach

first_imgA transgender woman was shot and killed Friday night in Pompano Beach just after 10 PM. Police are searching for the shooter.Cameron Breon was found shot at 244 N.W. 12th Street in Pompano Beach. She was pronounced dead at the scene.Deputies have not released a description of the shooter.Anyone with information regarding this case is asked to contact Det. Louis Bonhomme at 954-321-4377. If you wish to remain anonymous, contact Broward Crime Stoppers at 954-493-TIPS (8477) or online at browardcrimestoppers.org.last_img read more

Haryana cabinet expansion on November 14

first_imgThe first cabinet expansion of the Manohar Lal Khattar led Bharatiya Janta Party-Jannayak Janta Party coalition government would take place on November 14.An official statement said that Haryana Governor Satyadeo Narain Arya will administer the oath of office and secrecy to Ministers in Chandigarh on November 14.Mr. Khattar , was sworn in as the Chief Minister of Haryana for the second time on October 27 while JJP’s Dushyant Chautala took oath as Deputy Chief Minister of the State. However, no other ministers were sworn in even though it was expected that a few MLAs would be inducted in the council of ministers along with the Chief Minister and his deputy.The BJP emerged as the single largest party by winning 40 seats the in the Assembly polls but it fell short of six seats to form the government on its own. The BJP and the JJP, which secured 10 seats in the polls decided to come together to form an alliance government in the State.last_img read more

10 months agoMan Utd teenager Angel Gomes: Old Trafford deafened me!

first_imgAbout the authorFreddie TaylorShare the loveHave your say Man Utd teenager Angel Gomes: Old Trafford deafened me!by Freddie Taylor10 months agoSend to a friendShare the loveManchester United teenager Angel Gomes says he was deafened by the Old Trafford crowd during Wednesday’s 3-1 win over Huddersfield Town.Gomes, 18, made his third appearance for the club when he replaced Juan Mata in the 80th minute.There could be more game time under caretaker manager Ole Gunnar Solskjaer, who has brought a sense of optimism to the club, which Gomes says was audible.”Yes, it’s always nice to come on, especially when you are a young lad, following in the footsteps of the other players who are progressing and doing well,” Gomes told MUTV. “To come on and hear the crowd cheering you on was a great feeling for me.”My ears actually blocked! I couldn’t really hear, but, as soon as I got on, I felt at ease. The players helped me, they spoke to me and gave me instructions and I was fine from then on.” last_img read more

Photo: USC Interim Coach Clay Helton Wrote A Letter To “Trojan Family”

first_imgInterim USC Coach Clay Helton's letter to the Trojan family.Helton LetterClay Helton has taken over as interim coach at USC for the second time in his tenure, and he should provide the program with some much-needed stability. After assuming the head coaching duties, Helton produced a letter for the entire USC family, which USC shared on its official athletics Twitter account last night. Upon taking over as interim head coach, Clay Helton wrote a letter to YOU, the #TrojanFamily. #FightOn pic.twitter.com/dA6M7xCev8— USC Trojans (@USC_Athletics) October 14, 2015Classy move. Helton and his players will get their first chance to “Fight On” this Saturday when they take on their nationally ranked arch-rival Notre Dame at 7:30 PM EST in South Bend. The game will be televised on NBC.last_img read more

Plans Will Be Put in Place to Address High Bank Charges

first_img Finance and Public Service Minister, Hon. Audley Shaw, says the Government is committed to implementing a time-bound action plan to stop the predatory charges and fees by financial institutions. Story Highlights Finance and Public Service Minister, Hon. Audley Shaw, says the Government is committed to implementing a time-bound action plan to stop the predatory charges and fees by financial institutions.He said the plan will include a review of the Banking Services Act and entrenchment of the Bank of Jamaica Code of Conduct for deposit-taking institutions, which was introduced in September 2017.The measures will also entail the formal establishment of a financial consumer protection entity, either as a separate agency or as a division of the Consumer Affairs Commission (CAC).Minister Shaw was opening the 2018/2019 Budget Debate in the House of Representatives on March 8 under the theme: ‘Stability, Growth and Prosperity – Our Goal, Our Responsibility.’Meanwhile, he informed that during 2017/2018, Jamaica made significant progress in countering the threat of international correspondent banks cutting ties with local financial institutions.Steps were taken to reduce the risk of being associated with transactions that are inconsistent with anti-money laundering/ combating the financing of terrorism.The success of the measures, Minister Shaw said, were “reflected in the low incidence of reduced access to correspondent banking services.  These advances are important, but we should not lose sight of the need to remain vigilant in this regard.” The success of the measures, Minister Shaw said, were “reflected in the low incidence of reduced access to correspondent banking services.  These advances are important, but we should not lose sight of the need to remain vigilant in this regard.” Steps were taken to reduce the risk of being associated with transactions that are inconsistent with anti-money laundering/ combating the financing of terrorism.last_img read more

Tumbler Ridge offers Museum Foundation 50k to open for the summer

first_imgAccording to the mayor’s motion, it would be at the Foundation’s discretion to choose which of the five days each week the museum would be open. The motion passed after a brief discussion.McPherson’s motion also included that the issue of what to do about the Museum FOundation’s funding woes be brought forth to a committee meeting with the intention of drafting a referendum question. “This will take us through the summer, until we get this hopefully taken to a referendum — find out what the people of Tumbler Ridge want,” said McPherson. TUMBLER RIDGE, B.C. — The District of Tumbler Ridge is offering a $50,000 grant to the Tumbler Ridge Museum Foundation so that it can reopen its doors for the summer tourist season, after the museum closed its doors at the end of March. The Museum Foundation was unsuccessful in its application for a $200,000 grant from the District earlier this year, and announced shortly thereafter that it was closing its doors and laying off staff.Tumbler Ridge mayor Don McPherson made the funding motion at the District council meeting on Monday evening so that the Dinosaur Discovery Gallery could open five days a week from June 1st to October 1st. McPherson said that he came up with the $50,000 amount from looking at the Foundation’s budget for the year and tallying up staffing and operating costs. last_img read more

Oil and gas companies receive 139 million in royalty credits from BC

first_imgThe Ministry said that the 20 IRCP projects represent $743 million in private sector capital spending and are expected to create more than 1,742 jobs in B.C. Of those projects, five use BC Hydro electricity, resulting in fewer GHG emissions.The seven CIRCP projects saw $78 million in industry spending that will result in an estimated reduction of 0.6 million tonnes of greenhouse gas emissions.The Province said that companies are required to fully fund and complete an approved project before they can apply to recover up to 50 percent of the project’s cost in royalty deductions. VICTORIA, B.C. – The provincial government says that 27 oil and gas projects in B.C. have been awarded a cumulative total of $139.3 million in royalty credits.In a press release issued back on September 4th, the Ministry of Energy, Mines and Petroleum Resources said that $120 million of the royalty deductions were awarded for 20 new projects under the Infrastructure Royalty Credit Program, while a further $19.3 million in deductions were given out for seven new projects under the Clean Infrastructure Royalty Credit Program.The IRC Program facilitates new pipelines and all-season road projects, creating jobs for service-sector employees and supporting upstream-development prospects, while the CIRC Program supports investments in clean technology that reduce greenhouse gas emissions from specific sources linked to the exploration and production of B.C.’s oil and gas resources.last_img read more