Global Markets

Vaxart taking COVID-19 tablet vaccine into clinic

Vaxart may not be the first to commercialize a COVID-19 vaccine, but the firm says the ease of administration and stability of its oral tablet could provide a comprehensive and long-term solution to this global pandemic. South San Francisco-based firm Vaxart is developing an oral vaccine – administered by tablet rather than by injection – against COVID-19, caused by the novel coronavirus (SARS-CoV-2). The firm recently announced the US Food and Drug Administration (FDA) has completed its review of an…

Biopharma set for COVID-related single-use shortages, says survey

Biopharma faces delays obtaining single-use systems according to a survey that suggests disruption caused by the COVID-19 pandemic and increasing demand will result in shortages. Single-use bioprocessing technologies now dominate the pre-commercial manufacturing space according to research by Bioplan Associates. The organization quizzed 130 executives at biopharma firms and contract development and manufacturing organizations (CDMOs) and 150 tech suppliers and found that demand for single-use systems (SUS) has continued to increase in recent years. According to Bioplan managing partner Eric…

Gardasil scale-up unaffected by COVID capacity chase, says Merck

Merck says bringing two plants online to feed demand for its blockbuster Gardasil remains a priority, despite industry’s unparalleled need for vaccine capacity driven by COVID-19 projects. In January 2020, Merck & Co. (known as MSD outside North America) told delegates at the JP Morgan Conference in San Francisco that to keep up with the “incredible demand” for its human papillomavirus (HPV) vaccines Gardasil and Gardasil 9, two new production plants representing an investment of over $1.6 billion would come…

Samsung Bioepis: Govs and biopharma must work on post-COVID supply chain security

With biopharma operations still affected by coronavirus, governments and industry must look ahead to ensure the security of manufacturing resources and supply chain structures, says Samsung Bioepis. Like other companies, 2020 has been a challenge for Samsung Bioepis with the global coronavirus pandemic laying waste to ‘normal’ business procedures and supply chain management. “We’ve supplied more than 18 million units of product worldwide since 2016 without experiencing any supply shortages in providing our products to customers and patients,” Kevin Jack,…

How BARDA locked up COVID-19 vaccine manufacturing capacity for Operation Warp Speed

The government agency that develops medical countermeasures for the US stockpile says it had to move quickly to secure contract manufacturing plant capacity for COVID-19 vaccines before the private sector could “capture” it. There was no time to give other contract manufacturers a chance to bid for the work, which the Health and Human Services Department’s Biomedical Advanced Research and Development Authority, or BARDA, recently awarded in a pair of task orders totaling nearly $900 million. BARDA awarded a $628…

Calculated risk is key to rapid COVID-19 vaccine development says CEPI

Taking calculated risks will accelerate SARS-CoV-2 vaccine development according to CEPI, which says traditional techniques are too slow. Developing a vaccine usually takes between six to 11.5 years according to the Gates Foundation backed Coalition for Epidemic Preparedness Innovations (CEPI). In traditional development models target identification can take six months to two years, followed by preclinical testing and up to a decade of clinical development. Manufacturing scale up also takes years. But the COVID-19 pandemic calls for a different approach…

GSK confident traditional vaccine tech has major role in COVID-19 efforts

The headline-makers in the race to develop a COVID-19 vaccine are not the traditional firms, but GSK says its proven adjuvant approach will set its offering apart. During GlaxoSmithKline’s (GSK’s) second quarter financial call, an analyst from Wolfe Research pointed out the vanguard of COVID-19 vaccines were not being developed and made by the big three traditional vaccine firms: GSK, Merck & Co., and Sanofi. Chinese efforts aside, the frontrunners dominating the media coverage are AstraZeneca/University of Oxford’s effort based…

Pfizer blasts Trump’s pricing plans, threatens to pull US investments

CEO Albert Bourla says Pfizer will rethink plans to invest in US R&D and manufacturing after lambasting four executive orders aimed at reducing drug prices unveiled last week. Like most areas of society, Big Pharma’s relationship with US President Donald Trump has been tumultuous. Initial fears of a clampdown on drug pricing through promises to ‘drain the swamp’ were abated through Trump cozying up with the sector once in office. And reforms passed by Congress in 2017 through the ‘Tax Cuts…

Valneva to supply vero-cell based COVID vaccine to UK

Valneva will supply up to 100 million doses of a SARS-CoV-2 vaccine candidate and is looking to expand capacity at facilities in Scotland and Sweden. Under the terms of the deal, French vaccine firm Valneva SE will manufacture up to 100 million doses of its candidate VLA2001 as part of a UK government strategy to secure COVID-19 vaccines. Doses will be supplied from Valneva’s production site for other commercially available travel vaccines and candidates in Livingston, Scotland. “Today’s agreement from the UK…

With capacity assured and platform proven, hopes grow for J&J COVID vaccine

J&J is confident of the success and supply of its COVID-19 vaccine candidate after securing manufacturing capacity and receiving approval of Ebola vaccines based on the same adenovector technology. Johnson & Johnson’s candidate – SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant – is set to enter Phase I/IIa studies later this month (see textbox). It is one of a number of coronavirus vaccines in development but according to the firm, the candidate’s potential for success has been bolstered by the verification of the…