HHS buys 1.2 million flu vaccine doses from abroad

first_imgDec 7, 2004 (CIDRAP News) – The federal government is buying 1.2 million doses of flu vaccine made in Germany to augment the strained US supply, the Department of Health and Human Services (HHS) announced today.HHS Secretary Tommy Thompson announced the purchase of the vaccine, made by GlaxoSmithKline, at a news teleconference. “We’ll have it available this month,” he said. “This will allow us to get more vaccine into the hands of those who need it most.”Because the vaccine is not licensed in the United States and licensing is a lengthy process, it will be used under “investigational new drug” (IND) rules, Thompson said. That means people will have to sign a consent form acknowledging their awareness of possible risks before getting a shot. But Thompson and Lester Crawford, acting commissioner of the Food and Drug Administration (FDA), said the vaccine is safe.The vaccine, called Fluarix, is used in 30 countries. The FDA reviewed GlaxoSmithKline’s manufacturing processes and inspected the plant that makes the vaccine before HHS decided to buy it, Thompson said.The consent form will explain “what the public should expect in terms of risk,” said Crawford. “What the public should know at this point is that the vaccine is not investigational because we have real questions about it, but because the company elected not to enter the US market last year, so they didn’t apply for approval.” He called the probability of safety problems with the vaccine “very low indeed.”Thompson said GlaxoSmithKline has agreed to supply up to 4 million doses to the US under IND rules, but he didn’t predict how many doses HHS might buy beyond the initial 1.2 million.The 1.2 million doses will increase the total US supply for this season to slightly more than 62 million doses, which includes about 58 million doses from Aventis Pasteur and 3 million doses of MedImmune’s FluMist, Thompson said.Thompson said the Centers for Disease Control and Prevention will distribute the GlaxoSmithKline vaccine doses where they are needed and will release a distribution plan in a few days. The company is charging HHS about $7 per dose, but there will be some additional costs for distribution, he said.GlaxoSmithKline said the IND rules provide that the vaccine can be given to people at least 3 years old who qualify for vaccination under the current US guidelines, which reserve the shots for people in high-risk groups.Another foreign firm viewed as a potential supplier of flu vaccine to the United States, Canada’s ID Biomedical, announced today that it must save its remaining doses for Canada, according to a Canadian Press (CP) report. HHS officials had previously said they were considering buying 1.2 million doses from the Vancouver, B.C., company.The company said it was selling the doses on the Canadian market at the request of the government, according to the CP report. The story said reports of the US vaccine shortage spurred an unusual Canadian demand for flu shots earlier this fall, sparking fears of a shortage in Canada.At the news conference, Crawford acknowledged the ID Biomedical announcement but said the FDA was still discussing the possibility of buying some vaccine from the company. The CP report said FDA officials spent a week inspecting the firm’s vaccine plant in Ste.-Foy, Que.Crawford also said that two companies have announced this week that they want to enter the US flu vaccine market, one as early as 2005 and the other by 2007. This year Aventis Pasteur and MedImmune are the only companies providing licensed flu vaccines in the US. California-based Chiron Corp. was to have supplied up to 48 million doses before contamination problems at the company’s plant in Liverpool, England, prompted British authorities to shut down the plant, triggering the American vaccine shortage.Crawford didn’t name the two companies planning to enter the market, but ID Biomedical yesterday announced a long-term agreement to sell flu vaccine to three US wholesalers, starting as early as next year, depending on licensing of the vaccine. The company said the agreement covers at least 8 years. The firm’s production capacity in 2005 will be about 22 million doses, officials said.GlaxoSmithKline, in a news release about the sale of doses to HHS, said it has “a long-term strategy” to seek FDA licensing of Fluarix.In other comments, Crawford said the FDA has been reviewing proposals by Illinois, New Mexico, and New York City to buy a total of 750,000 doses of non-US-licensed flu vaccine made abroad by Aventis. “By the end of the week we expect to have gotten through all of the information,” but he didn’t predict whether the FDA will approve the plans.last_img read more

Hong Kong govt warns removing US special status is “double-edged sword”

first_imgHong Kong’s government warned Washington that withdrawing its special US status, which has underpinned the city as a global financial hub, could be a “double-edged sword” and urged the United States to stop interfering in internal affairs.The statement came as US President Donald Trump is due to announce later on Friday his response to the Chinese parliament’s advancement of national security legislation for Hong Kong, which democracy activists and Western countries fear could erode the city’s freedoms.The former British colony enjoys a high degree of autonomy under a “one country, two systems” formula since it returned to Chinese rule in 1997. The US Department of State said in a report on Thursday it could “no longer certify that Hong Kong continues to warrant [differential] treatment” from Beijing.Trump’s top economic adviser Larry Kudlow warned that Hong Kong, which has enjoyed special privileges under US law based on its high degree of autonomy from Beijing, may now need to be treated like China on trade and other financial matters.In a separate statement on Friday, published in several local newspapers, Hong Kong leader Carrie Lam urged “fellow citizens” to “join hands to pursue our dreams while putting aside our differences”.She said the legislation was needed because of a “terrorist threat” and because organizations advocating “independence and self-determination” have challenged the authority of Beijing and local governments and pleaded for foreign interference.The five demands of last-year’s pro-democracy protest movement included universal suffrage and an independent inquiry into police handling of the protests, but not independence. A minority of protesters waved “Hong Kong independence” flags.Independence is anathema for Beijing.The security legislation, along with a bill to criminalize disrespect for China’s national anthem, are seen by protesters as the latest attempt by Beijing to tighten its control on the city.The security legislation, expected to be enacted before September, was condemned also by Britain, Australia, Canada and others. Britain said it will give greater visa rights to British national overseas passport holders from Hong Kong unless China suspends its plans. Topics :center_img “Any sanctions are a double-edged sword that will not only harm the interests of Hong Kong but also significantly those of the US,” the city’s government said late on Thursday.It added that from 2009 to 2018, the US trade surplus with Hong Kong was the biggest among all its trading partners, totaling $297 billion of merchandise and 1,300 US firms are based in the city.Beijing says the new legislation will tackle secession, subversion, terrorism and foreign interference in the city. It could see Chinese intelligence agencies set up bases there.The plan has ignited the first big protests in Hong Kong for months, as thousands of people took to the streets this week, prompting police to fire pepper pellets in the heart of the city’s financial district to disperse crowds.last_img read more