Posted: Sat Oct 17, 2009 2:26 pm Post subject: Tracking Pandemic Vaccine Production Estimates
Work in progress; please check back
* In May, the WHO had forecast a weekly output of 94.3 million doses if full scale vaccine production was launched.
* May 3: 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.
* June 13: Novartis said Friday it was making faster than expected progress on the production of a vaccine against swine flu, ....weeks ahead of expectations. Baxter International Inc. said it is in "full scale" production of a vaccine for the H1N1 virus and anticipates the first commercially available dosages to be ready in early July. Glaxo said it would be ready within weeks to begin large-scale vaccine production. Sanofi-Aventis also said it had started working on its own version
Baxter is believed to be a leader in cell-based technology, which allows the company to cut production times roughly in half compared with the older process that involves processing by hand millions of chicken eggs. The cell-based method can generate yields in about 13 weeks, compared with 24 weeks in egg-based manufacturing, Baxter said.
* July 16: Baxter International Inc (BAX.N) said on Thursday it has taken ordders for a total of 80 million doses of H1N1 vaccine and will not take any more. The Illinois-based company said it should be ready to ship H1N1 vaccines by the end of July or early August. Baxter-made vaccine as it has not received Food and Drug Administration approval.
*July 16: Currently, an estimated 565 million doses of seasonal flu vaccine will be supplied this year, up from 350 million in 2006. According to experts working in the field, the yearly production capacity for seasonal influenza vaccine is expected to rise to one billion doses in 2010.
* Jul 19: Baxter and Novartis report poor vax harvest. Lab workers are harvesting one dose or less of the component they need from each egg in which the virus is grown, said Eric Althoff, a spokesman for the Swiss drugmaker. That's between 1/3 and 1/2 of the typical yield for a seasonal flu vaccine.To remedy that, the WHO laboratory network is again trying to generate new vaccine viruses from patients who have been infected.
July 19:Robinson said that about 60 million to 80 million doses could be made available starting in September if the decision were made to go ahead with final production steps Aug 15. He said Aug 15 is a reasonable date when vaccine makers could start those steps, as they are currently still producing their seasonal flu vaccines.
Robinson said HHS has contracted for 193 million doses of vaccine so far, assuming 15 mcg per dose. After 2.5 weeks of production, manufacturers have made 18 million doses worth of bulk vaccine, he said. Robinson said yields are actually right in line with what HHS had expected from experience with H5N1 vaccines: about 1.4 doses per egg. MedImmune, Robinson reported. Instead of low yields, the company is getting surprisingly high yields.
They've already actually made a super virus seed that's actually producing 2 logs titer higher than you'd normally see, he said. That means there's going to be more bulk product available than we can actually fill.
* During a late July meeting of a federal immunization advisory panel, which targeted 159 million people to receive the first doses, authorities projected that 120 million doses would be available in October, with another 80 million per month in the following months.
* Mid Aug: But the latest expectation is 45 million doses by mid October, with manufacturers delivering 20 million doses per week after that, due to lower yields, limited fill and finish capabilities and one of the companies making seasonal flu vaccine is having problems finishing up production.. The delay has impacted vaccine timelines by 4 to 6 weeks, he said.
* A new seed strain developed to replace the slower-growing strain in lab studies looks like it will produce better novel H1N1 antigen yields that are on par with those for the seasonal vaccine, Robinson said, adding that federal officials will be working with manufacturers over the next 2 weeks to see if the improved yields are also seen in commercial production.
* Aug 6: Manufacturers initially said they were finding low yields in making vaccines for the H1N1 pandemic strain of the virus, but that it is now improving. "We are on track in development," Marie-Paule Kieny, WHO director of the Initiative for Vaccine Research, told a news conference in Geneva.
* Aug 14: Federal officials today during a pandemic H1N1 planning update dialed back the number of novel flu vaccine doses they expect in October from 120 million to 45 million, listing several reasons for the smaller projection.
Aug 20: researchers at the New York Medical College in Valhalla have created improved strains by growing one sample of the virus repeatedly in chicken eggs until it adapted and grew faster. They will send two to vaccine manufacturers this week (still needs testing) NIBSC has also created a faster-growing virus, which it sent to manufacturers earlier this month. It poses an extra problem, however: it was made using methods not used before for commercial vaccines.
Late Aug (Gellin): He said it wasn't until late August that an accurate assay for measuring the amount of hemagglutinin became available.
* Sept 16: Since August, federal officials have predicted that 45 million pandemic vaccine doses would be available by mid October, but today the CDC said the total so far is 11.4 million.
* Sept 20: Gregory Hartl said output next year will be substantially less than the 4.9 billion doses annual production forecast. Some 25 pharmaceutical laboratories working on vaccines have indicated that weekly production is lower than 94 million doses
* Oct 16: Meanwhile, some sites are reporting shortages of seasonal flu vaccine, Schuchat noted. So far, 82 million doses have been distributed, which is 5 million more than the previous week. Federal officials have said they expect producers to make 114 million seasonal flu vaccine doses.
Oct 23.: Novartis: most of the company's vaccine supply may not be delivered until the first quarter of 2010, Novartis has a $979 million contract to supply H1N1 vaccine to the US Department of Health and Human Services (HHS). The company is expected to supply about 35% of the total projected US supply of about 251 million doses, the Bloomberg story said.
Oct 23: Frieden said a total of 16.1 million doses have become available for distribution so far. Yesterday Dr. Anne Schuchat of the CDC predicted that the number will reach 28 million doses by the end of this month.
Oct 27: Frieden.. Only 8 million doses of vaccine against the pandemic H1N1 influenza virus have become available since last Wednesday, As of today, a total of 22.4 million doses of swine flu vaccine are now available. The agency had hoped to be getting 20 million doses per week by now and expected a minimum of at least 50 million doses to be on hand by the end of the month.
Oct. 28: vaccine doses available reached 23.2 million today, up about 800,000 from yesterday's 22.4 million (Cidrap)
Oct. 29: The CDC said today that total US H1N1 vaccine received is now at 24.8 million doses (Cidrap)
Oct 29: Novartis said today it is on track to produce 90 million units of bulk pandemic vaccine antigen to the US market, enough for 60 million doses. It expects multidose and prefilled vial deliveries to reach 25 to 30 million by the end of November. The company has shipped 7.5 million doses. Novartis said early vaccine yield was low, but a new seed strain it began using in mid September is getting a 63% yield.
* yields are said to be between 1/3 to 1/2 of seasonal production
* cap and fill production is having problems
* One company is behind on finishing seasonal
* MedImmune problems with dispensers
* manufactures experiencing problems with new line production
* Sanofi, which has said it makes 40 percent of the world's supply of flu vaccine, said it is continuing to make seasonal influenza vaccine for the 2009/2010 northern hemisphere flu season, as recommended by the UN World Health Organization.
Production of seasonal flu vaccine for both northern and southern hemispheres is still a priority, the company said.
Sanofi has said that at full capacity, its two Pennsylvania factories can make 150 million doses of seasonal influenza vaccine a year. Its French plant can make 120 million doses per year, according to Sanofi.
* Feb. 25: In the most likely case, manufacturers could produce 2.5 billion doses of pandemic vaccine in the 12 months following receipt of the production strain, requiring four years to satisfy global demand, the study said.
In the current best-case scenario, 7.7 billion doses could be produced in the first 12 months, requiring 1.5 years to satisfy global demand, it said. Production was expected to increase significantly over the next five years.
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