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Some cold chain issues with Pfizer’s COVID vaccine but US confident of supplies

US military officials say several trays of Pfizer and BioNTech’s COVID-19 vaccine needed to be replaced after being stored at excessively cold temperatures. Details of the replacement were disclosed yesterday during a press conference about efforts to roll out the vaccine. General Gustave F. Perna, who is running the US’ Operation Warp Speed (OWS), said some vaccine sent to California and Alabama was replaced after it was stored at a temperature lower than the recommended 70°C. “We had two trays…

Sinovac raises $500m to fund Coronavac trials and production

by Gareth Macdonald

Sinovac Biotech has secured financing of $500m to fund further development of its candidate COVID-19 vaccine. The funding – which gives investor Sino Biopharma a 15% stake in the Beijing biotech – will be used to support clinical development of Coronavac, a vaccine that uses inactivated forms of COVID-19 to induce immune responses. Sinovac is conducting large-scale clinical trials of the vaccine in Brazil – the study was suspended in October before resuming last month – and Indonesia. In November…

Politics and COVID driving manufacturing back to the US, says Avid

by Dan Stanton

“Southern California is not a bad place to be right now,” says CDMO Avid Bioservices as it discusses how politics and COVID-19 have made localized manufacturing more appealing. Contract development and manufacturing organization (CDMO) Avid Bioservices’s Myford and Franklin facilities are in California. Meanwhile, a third plant is in the works at the Myford site. But speaking last week to discuss its FY2021 Q2 results, CEO Nick Green did not dismiss the idea of expanding its capabilities further afield. “We…

Bayer launches CGT unit on back of Bluerock and AskBio acquisitions

by Dan Stanton

Having closed its $2 billion acquisition of Asklepios BioPharmaceutical (AskBio), Bayer has established a cell and gene therapy platform. The Cell and Gene Therapy (C&GT) Platform within Bayer’s Pharmaceuticals division aims to bring various acquisitions, capabilities, and assets together. According to the firm, the unit “will provide an innovation ecosystem within which the different participating partners, whether they be independent companies or strategic collaborators, can operate most effectively. They keep and further develop their passion and biotech spirit, scientific leadership…

Moderna working 24/7 on COVID-19 vaccine manufacture and supply

by Gareth Macdonald

Moderna is confident its supply and distribution chains are robust enough to support COVID-19 vaccine scale up and roll out. The vaccine – mRNA-1273 – consists of mRNA coding for the SARS-CoV-2 spike protein inside a lipid nanoparticle. It is seen, along with jabs being developed Pfizer and AstraZeneca, as one of the best hopes for combatting the pandemic. So when clinical trial data released in November showed mRNA-1273 was 94.1% effective at protecting people from SARS-CoV-2, the news was…

European Commission considers regulation for ‘bedside’ manufacturing

by Ben Hargreaves

The European Commission has published its pharmaceutical strategy to increase access to innovative and safe medicine, including steps to adapt regulation to advanced therapies. The ‘Pharmaceutical Strategy for Europe’ was announced last week by the European Commission (EC) in order to strengthen and protect the European Union’s pharmaceutical supply chain, in light of medical innovation and the on-going pandemic. Within the subsection entitled ‘Enabling innovation and digital transformation’, the first example of innovation given is advanced therapies. In particular, the…

mRNA vaccine: Pfizer’s inhouse approach vs Moderna’s use of third parties

by Dan Stanton

Though not heavily reliant on external suppliers, Pfizer is taking a higher distribution risk than Moderna and CureVac due to making its mRNA vaccine inhouse, says research firm Third Bridge. Earlier this month, both Pfizer and Moderna reported Phase III trial data showing their respective messenger RNA (mRNA) vaccines were above 90% effective against COVID-19. Pfizer submitted an Emergency Use Authorization (EUA) application with the US Food and Drug Administration (FDA) earlier this month, and Moderna is doing so today.…

Resilience launches with $800m to ‘break’ biomanufacturing bottlenecks

by Ben Hargreaves

Though details are scarce, Resilience claims it will provide ‘new, better, faster ways’ to manufacture cell and gene therapies. The new entity begins with bases in Boston and San Diego, as well as over 750,000-square-feet of operating space. Officially known as ‘National Resilience’, the company announced its entrance on the market by suggesting that it would be a ‘first-in-kind’ biomanufacturing and technology operation that has been set up specifically to address capacity issues in the advanced therapeutics area. Resilience plans…

SaudiVax works with Cytiva to produce halal vaccines

by Ben Hargreaves

Cytiva provides its FlexFactory solution, as SaudiVax looks to meet vaccines and biologics demand in the Middle East and Africa. The FlexFactory platform is being installed as part of Saudi Arabia’s Saudi Vaccine and Bioprocessing Center (SVBC), which will become the first bioprocessing facility for halal vaccines in the region. It also represents new ground for Cytiva, with the FlexFactory installation being the first for the company in the Middle East and North African (MENA) region. The SVBC is backed…

Pfizer looks to freezer farms and thermal shippers to make COVID vaccine distribution ‘doable’

by Dan Stanton

Pfizer says it is prepped to overcome the logistical challenges of distributing its mRNA vaccine against COVID-19 as it submits an Emergency Use Authorization (EUA) to the US FDA. Today, Pfizer submitted a request to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of BNT162b2, an mRNA vaccine candidate codeveloped with Germany’s BioNTech, against SARS-CoV-2. The news follows Phase III trial data showing the vaccine has an efficacy rate of 95% and marks a major milestone…