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Swine flu vaccine production hits a snag: yield so far is 'less than optimal'

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  • Swine flu vaccine production hits a snag: yield so far is 'less than optimal'

    By Helen Branswell – 35 minutes ago
    TORONTO — Swine flu vaccine production has hit a snag, with manufacturers reporting a disappointingly low yield when vaccines viruses are grown in eggs.
    The World Health Organization says so far the yield for egg-based production is half or less what manufacturers get when they make vaccine to protect against seasonal H1N1 viruses. The lion's share of influenza vaccine is made by companies that grow the viruses in eggs.

    New seed strains are being made in the hopes of increasing the vaccine yield, a report by the WHO's vaccine chief, Dr. Marie-Paule Kieny says.
    But if the yield cannot be increased, it will slow the rate at which pandemic vaccine comes out of the production pipeline, adding to the time it takes to protect populations in countries like Canada that have purchased vaccine. And countries that haven't pre-ordered pandemic vaccine would face substantial delays before manufacturers have product to sell to them.

    "There's nothing to suggest it will take longer to make vaccine, if in fact everything goes as planned. The question is: How much?" says Dr. Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota.
    "There is nothing magical about making this virus. The questions will be: How much? When? and Where will it be available?"
    The yield problem is revealed in presentations WHO staff made to last week's special meeting of the expert panel that advises the Geneva-based global health agency on vaccine issues.

    The body - called the strategic advisory group of experts on immunization or the SAGE - was convened to give WHO counsel on a variety of questions about pandemic vaccine use. Those include which groups should be given priority when vaccine becomes available and whether the WHO should recommend companies use adjuvants, which are boosting compounds that could help stretch limited supplies.
    Kieny, head of the WHO's initiative for vaccine research, was not available for interview Sunday. The WHO is expected to reveal details of the SAGE's deliberations and recommendations on Monday.

    But a report to the meeting by Dr. Wenqing Zhang of the WHO's global influenza program says that vaccine manufacturers who use so-called wild-type viruses (unmodified viruses like those now circulating around the globe) are reporting yield rates similar to what they get when they grow seasonal H1N1 viruses in Vero cells, a cell culture medium. However, few manufacturers produce flu vaccine this way.
    Most make vaccine in eggs, using a reassortant or hybrid seed strain designed to improve the chances of a good yield. These seed strains can be made by a couple of methods, but the end result is a hybrid with the external genes of the virus that vaccine is to protect against and the internal genes of a virus with a proven track record for growing well.

    Zhang's presentation says that of the various reassortant vaccine viruses that have been made, the one with the highest output still only generates about half of the yield seen with seasonal H1N1 vaccine production.
    Kieny's presentation calls the yield "less than optimal" and says laboratories in the WHO's lab network are generating new sets of vaccine viruses as quickly as possible.

    Her presentation illustrates the impact low yield would have on availability of vaccine.
    Somewhere between 850-900 million and 1.8 billion doses of pandemic vaccine are already spoken for, she reports. The low end of the scale represents what would be needed by countries with contracts if it is shown that one shot will be enough to protect a person; the high end represents what those countries would need if two shots per person are required.

    If all manufacturers used the lowest possible effective dose, if yields are on a par with seasonal H1N1 production and if countries only used one dose per person, manufacturers could fill all their advantage purchase orders by mid-November, Kieny's presentation suggests.
    That best-case scenario also requires that all manufacturing capacity remains devoted to pandemic vaccine and no portion shifts back to the production of seasonal vaccine for next year's Southern Hemisphere flu season.

    If companies don't use low doses and countries that have pre-purchased vaccine demand two shots for all their citizens, it could be mid-April before the vaccine manufacturers in high-income countries have free capacity to devote to making vaccine for middle-and-low income countries, Kieny's presentation estimates.
    Ninety per cent of the world's flu vaccine production capacity is in the high-income countries that use seasonal flu vaccine.
    A lower yielding vaccine "would considerably push back the timelines," the presentation warns.
    Assuming the yield is half that of seasonal flu vaccine production, it would be mid-January before producers could fill all contracts if they use a single-shot, low-dose regime, Kieny estimates.

    She suggests even with low-dose shots, a low-yield scenario would mean manufacturers would not be able to fill all their existing contracts until next June if the countries opt for two shots per person for all their citizens.

    http://www.google.com/hostednews/can..._1ZIxwdlZOqJuQ
    Last edited by AlaskaDenise; July 12, 2009, 08:11 PM. Reason: format
    CSI:WORLD http://swineflumagazine.blogspot.com/

    treyfish2004@yahoo.com

  • #2
    Re: Swine flu vaccine production hits a snag: yield so far is 'less than optimal'

    Now swine H1N1 vaccine reality is finally setting in...how long till they report there isn't enough Tamiflu or Relenza to go around either?

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    • #3
      Re: Swine flu vaccine production hits a snag: yield so far is 'less than optimal'

      relenza production is only 60mill doses/yr - they may be able to go to 160m /yr with new deliver system registration
      best outcome is good ph 3 result from biotas lani - due out 31 july - important because this new generation antiviral is only taken 1/week prophilactically and once for cure - so not so bulky and easier to produce in bulk - good resist profile like relenza - these are the co who did research that led to relenza and tamiflu so lets hope for a good result with lani - it could save millions of lives.

      Comment


      • #4
        Re: Swine flu vaccine production hits a snag: yield so far is 'less than optimal'

        is there any information on the manufacturing capacity?


        CS-8958 is a long acting neuraminidase inhibitor (LANI), and is co-owned with Daiichi-Sankyo.

        The Phase II clinical trial was designed to test the safety and efficacy of CS-8958 in several hundred adult patients who had confirmed, naturally acquired influenza A or B using fever and symptom resolution endpoints after a single inhaled dose. The study was conducted in accordance with guidance from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). In the double-blinded trial, inhaled CS-8958 administered once only was statistically indistinguishable from 75mg of oseltamivir administered twice daily for 5 consecutive days. In earlier pre-clinical tests, CS-8958 has also shown efficacy against H5N1 avian influenza virus as well as influenza A and B.
        above snipped from: http://www.medicalnewstoday.com/articles/116822.php

        details on Phase III trials here: http://new2.ecplaza.net/news/11/1954...s_limited.html

        I cannot find a source about completed phase III.

        .
        Last edited by AlaskaDenise; July 12, 2009, 08:43 PM. Reason: added 1st sentence
        "The next major advancement in the health of American people will be determined by what the individual is willing to do for himself"-- John Knowles, Former President of the Rockefeller Foundation

        Comment


        • #5
          Re: Swine flu vaccine production hits a snag: yield so far is 'less than optimal'

          Originally posted by AlaskaDenise View Post
          is there any information on the manufacturing capacity?




          above snipped from: http://www.medicalnewstoday.com/articles/116822.php

          details on Phase III trials here: http://new2.ecplaza.net/news/11/1954...s_limited.html

          I cannot find a source about completed phase III.

          .
          Phase 111 results due out july 31st - registration process has already begun in japan so they must be anticipating a good result. HHS has paid biota 14mill to fastrack lani - it's easier to sockpile than tami and relenza (as bulk powder)

          Comment


          • #6
            Re: Swine flu vaccine production hits a snag: yield so far is 'less than optimal'

            I'm finding agreements with companies producing Micropump Nebulizers for LANI. If that is an individual device, then I presume there would be a process to produce that bulky product. That would be time consuming.

            .
            "The next major advancement in the health of American people will be determined by what the individual is willing to do for himself"-- John Knowles, Former President of the Rockefeller Foundation

            Comment


            • #7
              Re: Swine flu vaccine production hits a snag: yield so far is 'less than optimal'

              Japanese vaccine makers hit the same snag.

              http://www.flutrackers.com/forum/sho...d.php?t=114755


              SN1987A

              Comment


              • #8
                Re: Swine flu vaccine production hits a snag: yield so far is 'less than optimal'

                Novartis Says Swine Flu Virus Gives Poor Harvest for Vaccine

                By Eva von Schaper

                July 17 (Bloomberg) -- Novartis AG said the virus it?s growing to make a vaccine against pandemic flu doesn?t yield much of the antigen needed to protect people.

                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 a third and half of the typical yield for a seasonal flu vaccine, he said.

                The low yield may slow production of a pandemic vaccine because it means drugmakers like Novartis, Baxter International Inc., Sanofi-Aventis SA and GlaxoSmithKline Plc can extract less of the protective ingredient from each egg. Baxter?s Chief Executive Officer Robert Parkinson and a spokesman for Sanofi also said yesterday the amount of swine flu virus growing in each egg is lower than for seasonal flu.

                The World Health Organization, whose labs supplied the virus to drugmakers, is trying to produce samples that yield more antigen.

                ?There is work ongoing to improve them,? Novartis Chief Operating Officer Joerg Reinhardt said yesterday on a conference call. ?But it?s very difficult to predict what it will be at the end.?

                The H1N1 virus, also known as swine flu, is sweeping the southern hemisphere as tens of thousands of patients test positive for the virus in Australia, Argentina, Chile and other countries. It?s also spreading in the north outside of the usual flu season. The U.K.?s most senior doctor yesterday said the health service is planning for 65,000 deaths from the disease, which has claimed 429 lives worldwide.

                ?Bad Yielder?

                ?The industry at large is challenged,? Baxter?s Parkinson said yesterday.

                Most manufacturers make flu vaccines by injecting chicken eggs with an approved version of the virus to provide it with nutrients to grow and multiply. The amount of virus that grows in the egg and can be turned into shots is called its yield.

                All government vaccine orders include a set yield assumption, Andrin Oswald, who heads Novartis?s vaccine unit, told reporters yesterday. One egg will usually produce enough antigen to make two doses of seasonal flu vaccine, according to Oswald.

                ?It is well known that some strains are good yielders, and some strains are bad yielders,? Marie-Paule Kieny, director of the WHO?s Initiative for Vaccine Research, said in a teleconference on July 13.

                ?Unfortunately we didn?t come up with a good yielder in the first series of strains,? she said. ?To remedy that, the WHO laboratory network is again trying to generate new vaccine viruses? from patients who have been infected. ?We hope that one of them will be giving higher yields, comparable to the ones obtained with seasonal vaccines.?

                Kieny said the existing strain still allows drugmakers to make a vaccine, test it and submit it to regulators while the WHO hunts for a more promising seed virus.

                Vaccine Revenue

                The yield also determines the shot?s potential revenue. Novartis swine flu vaccine sales could be worth between $1 billion and $1.5 billion if a single dose is sold for $10, Karl Heinz Koch, an analyst at Helvea SA in Zurich said in a note to clients today. Novartis has not added this revenue to the current sales outlook, Chief Financial Officer Raymund Breu said on a conference call yesterday.

                To contact the reporters on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net.

                Last Updated: July 17, 2009 08:46 EDT

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