FDA warns Sanofi about problems at flu vaccine plant

first_imgJul 5, 2006 (CIDRAP News) – The Food and Drug Administration (FDA) on Jun 30 sent a warning letter to Sanofi Pasteur, Inc., about contamination in a component of Fluzone, the influenza vaccine the company is preparing for the 2006-07 season.Both the FDA and the company said they did not expect the problems to significantly limit production of the vaccine for this season. The company has said it plans to make about 50 million doses, which could be roughly half the US supply.The warning letter discusses contamination of one of the monovalent concentrates, a preparation of one of the three strains of killed flu virus used in the vaccine. The monovalent concentrates are mixed to make the trivalent vaccine, which protects against the three viral strains, the FDA said.According to the FDA, Sanofi Pasteur notified the FDA on Mar 31 about sterility failures in monovalent concentrates. The FDA inspected the company’s Swiftwater, Pa., facility from April 18 to 28 and issued a report to the company. After determining that the company’s response to the report was inadequate, the FDA issued the Jun 30 warning letter.The five-page letter describes a number of “significant deviations from current good manufacturing practices.” The letter says the company must take prompt corrective actions or risk facing enforcement steps, such as license suspension.According to a July 4 USA Today report, the FDA’s Karen Midthun said no more lots of monovalent vaccine have failed sterility testing, but “since we don’t know exactly what it was that caused the failure, we can’t know for sure if it has been corrected.” Midthun is deputy director of the FDA Center for Biologics Evaluation and Research.The failed lots of monovalent concentrate represented a small proportion of the total produced and were not used for further processing, said the FDA. The agency noted that influenza vaccine manufacturers generally produce monovalents of each strain throughout winter and spring and then assemble the final vaccine in early summer.David Johnson, director of scientific and medical affairs for Sanofi Pasteur, said the company believed that the contaminants came from organisms in the chicken eggs used to make the vaccine and that the company was quickly addressing the problem, according to USA Today.In February, Sanofi said it planned to produce about 50 million doses of Fluzone for US distribution, which would represent roughly half of the US flu vaccine supply. According to a Jul 3 Reuters report, the company said it was confident that it would supply 50 million doses in time for fall vaccinations.The Centers for Disease Control and Prevention said last week that vaccine manufacturers expect to make about 100 million doses of vaccine for US distribution in the upcoming fu season.After production problems with Chiron’s influenza vaccine in 2004, which led to serious vaccine shortages, the FDA instituted annual inspections of vaccine manufacturers in 2005. Following its inspection of the Sanofi Pasteur facility last year, the FDA recommended a list of corrective actions. During its recent inspection the FDA determined that some of the problems remained, along with additional concerns.last_img read more

Millennials fail to benefit from slower rise in house prices

first_img “We may still be able to come up with the down payment, but I am afraid we might have difficulty paying the mortgage instalments in the long run, because we are exposed to the risk of losing our jobs and income,” Dara told The Jakarta Post via text message on May 18.Millennial homebuyers, who account for two-thirds of the target market population, mostly look for houses with a price tag of around Rp 500 million (US$33,800), according to Real Estate Indonesia (REI). The millennial segment mostly settles for modest houses of 50 square meters (sqm) or 100 sqm with two bedrooms.However, the pandemic, which has impacted consumer purchasing power and forced companies to lay off workers, has seen residential property sales drop by 43.19 percent year-on-year (yoy) in the first quarter, according to a quarterly survey by Bank Indonesia.This is despite a slowing increase in house prices, as evident in the Residential Property Price Index (IHPR) that grew 1.68 percent year-on-year (yoy) in the January–March period this year, lower than 1.77 percent in the previous quarter. Millennials still find it difficult to buy houses despite the COVID-19 pandemic, which has impacted the property industry, as the threat of layoff looms amid a battered economy.Dara Cantika, a 26-year-old private-sector employee in Surabaya, East Java, delayed her plan to buy a house, fearing a pay cut or sudden layoff, given rampant job cuts due to the pandemic. Wendy Haryanto, the executive director of Jakarta Property Institute (JPI), a non-profit organization advising developers, said Thursday that the threat of job loss due to the pandemic added to a decline in demand among millennials that had begun last year.“For those wanting to buy a house, this is actually a good chance to get a more affordable house,” Wendy said in a text message on May 21. “But millennial consumers are somewhat vulnerable to layoffs in the job market right now.”Furthermore, she said, millennials could afford no more than Rp 3 million in monthly mortgage payments on average.It is not that millennials lack the desire to own a property. According to online property marketplace rumah123.com, the number of searches on its website by potential homebuyers aged between 25 and 35 years rose by 27 percent in 2019.Demand for houses costing less than Rp 500 million made up around a quarter of the total demand, but supply was behind by around 3 percentage points, according to a survey released in February by rumah123.com.However, in 2019, sales of houses to millennials only reached 20,000 or 10 percent of the total sales, according to REI.REI chairman Totok Lusida said on May 21 that developers remained eager to focus on millennial homebuyers.“Despite the declining purchasing power, the opportunity in the market is still very big,” Totok told the Post in a phone interview. “Millennials are our target because they still have the power to buy a house right now.”Developer Ciputra Group, for example, provides housing aimed at millennial buyers starting from Rp 180 million at its Citra Maja Raya complex in Lebak Regency in Banten.Meanwhile, for the upper-middle class segment, the developer is selling houses starting from Rp 660 million at its 1,000-ha Citra Sentul Raya complex in Bogor, West Java.Read also: Residential property sales, prices rise cool as pandemic hits economyMeanwhile, several national banks offer mortgages tailored to millennials.State-owned lender Bank Mandiri, the country’s largest bank in terms of assets, loans and deposits, offers a conditional zero down payment and around 8 percent five-year fixed interest rate for a minimum tenure of 15 years, and 9.15 percent for 10 years.Despite the current difficulties, such offers have enticed 26-year-old Christoffer Rafael, a copywriter based in Jakarta, to settle a down payment for a house by the end of the year.Christoffer is looking to find a house in the Serpong area of South Tangerang, Banten, and he has been making calls to salespersons.“Apparently, there will be a stimulus from the bank [for mortgages],” Christoffer said via text message on May 18. “Moreover, many developers seem to be getting ready to give discounts.”— Riza Roidila Mufti contributed to this story.Read also: ‘We are dying’: No new shopping center openings, leasing grinds to haltTopics :last_img read more