Glaxo to Manufacture Novavax Covid Shot, Securing U.K. Supply

Source: Bloomberg

By Suzi Ring; March 29, 2021, 12:00 PM EDT Updated on 

  •  U.K. company to handle fill-finish for up to 60 million doses
  •  Novavax plans to apply for U.K. approval of shot next quarter

GlaxoSmithKline Plc agreed to help manufacture as many as 60 million U.K. doses of a Covid-19 vaccine from Novavax Inc. as the government looks to shore up supplies amid tensions with the European Union.

The British pharmaceutical company will provide the fill-finish capacity — putting the vaccine into vials and packaging — for the Novavax shot at its Barnard Castle site in Durham, England, Glaxo said in a statement Monday. Novavax is expected to apply for U.K. approval of its vaccine in the second quarter, with production at the Glaxo plant starting as early as May.

The drug substance for the shot is also being produced in the northeast of England by Fujifilm Diosynth Biotechnologies U.K. Ltd. The deal was put together by the U.K. government’s Vaccine Taskforce, which agreed to purchase 60 million doses from Novavax last year.

The agreement has the potential to reduce the U.K.’s reliance on overseas vaccine supplies amid a spat with the EU over exports. The bloc has fallen behind peers in vaccination rates, inoculating about 10% of its population, compared with 45% in the U.K. and about 28% in the U.S., according to the Bloomberg vaccine tracker. EU leaders gave their guarded support to plans to restrict vaccine exports last week after it emerged the bloc had sent more shots to the rest of the world than to its own residents.

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4 replies

  1. GSK to support manufacture of up to 60 million doses of Novavax’ COVID-19 vaccine

    – Manufacturing to take place at GSK UK facility at Barnard Castle

    LONDON and GAITHERSBURG, Md., March 29, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, GSK and the UK Government Vaccines Taskforce announced that they have reached an agreement in principle to support manufacturing of up to 60 million doses of Novavax’ COVID-19 vaccine candidate (NVX-CoV2373) for use in the UK. GSK will provide ‘fill and finish’ manufacturing capacity at its Barnard Castle facility in the North East of England beginning as early as May 2021, with a rapid technology transfer between the two companies beginning immediately. GSK and Novavax will negotiate a final agreement to include additional terms and conditions.

    The UK Government has secured 60 million doses of the vaccine under an advance purchase agreement with Novavax. The protein antigen component of NVX-CoV2373 is also produced in the North East of England by Novavax’ manufacturing partner, FUJIFILM Diosynth Biotechnologies, at their site in Billingham, Stockton-on-Tees.

    Fill and finish, to be provided by GSK, is the completion stage of vaccine manufacturing, preparing vials of the final vaccine and packaging them for distribution and use. The GSK site at Barnard Castle, which will deliver the vaccine doses under this collaboration, is a specialised facility in GSK’s global manufacturing network, which supports production of GSK pharmaceutical and vaccine products.

    Roger Connor, President, GSK vaccines, said: “GSK is delighted to support Novavax and the UK Vaccines Taskforce with this manufacturing arrangement for the UK and our Barnard Castle facility is now undertaking the rapid preparation work required to manufacture up to 60m doses of this vaccine. We have ensured that we can deliver these volumes without impacting supply of our other vital medicines and vaccines, and without disruption to the other COVID-19 collaborations GSK is engaged in globally.”

    https://finance.yahoo.com/news/gsk-support-manufacture-novavax-covid-200200112.html

  2. GSK to support manufacture of up to 60 million doses of Novavax’ COVID-19 vaccine

    – Manufacturing to take place at GSK UK facility at Barnard Castle

    LONDON and GAITHERSBURG, Md., March 29, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, GSK and the UK Government Vaccines Taskforce announced that they have reached an agreement in principle to support manufacturing of up to 60 million doses of Novavax’ COVID-19 vaccine candidate (NVX-CoV2373) for use in the UK. GSK will provide ‘fill and finish’ manufacturing capacity at its Barnard Castle facility in the North East of England beginning as early as May 2021, with a rapid technology transfer between the two companies beginning immediately. GSK and Novavax will negotiate a final agreement to include additional terms and conditions.

    The UK Government has secured 60 million doses of the vaccine under an advance purchase agreement with Novavax. The protein antigen component of NVX-CoV2373 is also produced in the North East of England by Novavax’ manufacturing partner, FUJIFILM Diosynth Biotechnologies, at their site in Billingham, Stockton-on-Tees.

    Fill and finish, to be provided by GSK, is the completion stage of vaccine manufacturing, preparing vials of the final vaccine and packaging them for distribution and use. The GSK site at Barnard Castle, which will deliver the vaccine doses under this collaboration, is a specialised facility in GSK’s global manufacturing network, which supports production of GSK pharmaceutical and vaccine products.

    Roger Connor, President, GSK vaccines, said: “GSK is delighted to support Novavax and the UK Vaccines Taskforce with this manufacturing arrangement for the UK and our Barnard Castle facility is now undertaking the rapid preparation work required to manufacture up to 60m doses of this vaccine. We have ensured that we can deliver these volumes without impacting supply of our other vital medicines and vaccines, and without disruption to the other COVID-19 collaborations GSK is engaged in globally.”

  3. The news that the Novavax vaccine is going to go through a process known as fill and finish in the UK is an interesting development.

    Fill and finish is the process by which vaccines are packaged up in vials, ready to be sent out to vaccination clinics.

    The original plan was for this to be done in Europe once the vaccine product was manufactured by plants in the north east.

    But a deal has been struck with drug firm GSK to do that here.

    Officially, the government is saying that it is all part of their investment in the British life science industry.

    But given the threats from Europe about restricting exports of vaccines, it begs all sorts of other questions too.

    The north east plants have already started manufacturing the 60m doses ordered by the government. If it gets approval by the regulator – expected in the coming weeks – supplies could be available in June.

    https://www.bbc.com/news/uk-england-tees-56570168

  4. WARSAW, April 1 (Reuters) – Poland’s Mabion aims to start production of U.S. firm Novavax’s coronavirus vaccine for Europe from the third quarter, representatives of the biotechnology company said.

    Mabion and Novavax last month signed a framework deal on the transfer of COVID-19 vaccine technology to Mabion’s plant in central Poland, which was designed to produce a rare diseases drug yet to be registered.

    “The production of our core product is much more complicated (than vaccine),” Mabion board member Adam Pietruszkiewicz told Reuters.

    Mabion is adding equipment necessary to start Novavax vaccine production, not without problems, as access to such machines has been limited. It is taking advantage of Novavax’s strong negotiation position with equipment suppliers.

    “We still have to buy some equipment intended solely for the production of vaccines. However, our main machine park is ready. After completing this process, we should enter the commercial production phase at the beginning of the second half of the year,” Pietruszkiewicz said.

    Mabion would produce the active substance of the COVID-19 vaccine in the form of a recombinant virus protein. The active ingredient will be sent in 10 litre bags to a company in Germany, where the fill and finish will take place.

    “Typically, companies that specialise in the production of recombinant proteins very rarely have bottling lines with significant capacity. As a rule, these are specialised companies that have the infrastructure to fill vials in large quantities in a short time,” Mabion management board member Slawomir Jaros said.

    https://finance.yahoo.com/news/polands-mabion-aims-produce-novavax-125822127.html

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