Swiss CDMO Lonza and US vaccine maker Moderna have extended and deepened their collaboration on the US biotech’s mRNA- based Covid-19 shot. The new agreement, which calls for the installation of three new production lines and a doubling of existing drug substance production at Lonza’s Visp, Switzerland, site, builds on a 10-year pact signed last year.
The European Commission has confirmed rumors that it has initiated legal action against AstraZeneca for failing to meet contractual obligations for deliveries of Its Covid-19 vaccine. Health commissioner Stella Kyriakides said the action is being taken jointly with all 27 member states.
The rollout of Johnson & Johnson’s Covid-19 vaccine could be resumed starting Apr. 23, Anthony Fauci, the top US infectious-disease expert and chief advisor to US president Joe Biden on pandemic-related issues, has told US media.
The more things change, the more they stay the same, at least in pandemic times, in Europe. After its second look at an unusual string of rare blood clotting incidents, mostly in younger women receiving AstraZeneca's Covid-19 vaccine, the European Medicines Agency (EMA), the EU’s drugs regulator, said on Apr. 7 it believes there is probably a “strong association” but stressed once again that the benefits of vaccination outweigh any risks.
Under an expanded agreement, US contract manufacturer Catalent is dedicating a new high-speed vial filling line at its Bloomington, Indiana, biologics facility to the manufacture of Moderna’s Covid-19 vaccine and potentially to other investigational programs.
Under a contract just announced, Baxter BioPharma Solutions will perform fill & finish services for some 60 to 90 million doses of Moderna’s Covid-19 vaccine in the US this year. The work will take place at the CMO’s facility at Bloomington, Indiana. Part of Baxter International, the company specializes in parenteral pharmaceuticals.
For mRNA vaccine maker Moderna, March is gearing up to roar in like a lion, with the tailwind setting the pace for the year ahead. Reporting 2020 financial results on Feb. 25, the US biotech that before last year had not sold a single product said it expects to take in more than $18 billion in revenue from sales of Covid-19 vaccines during 2021.
The UK’s Medicines and Healthcare Products Regulatory Agency (MRHA) cleared US biotech Moderna’s mRNA-based Covid-19 vaccine for emergency use on Jan. 7, bringing the number of vaccines available in the country to three. At the same time, the British government ordered an additional 10 million doses, with a targeted supply of 17 million.
Moderna’s mRNA-based Covid-19 vaccine will become the second to be administered in Europe. The European Commission granted a conditional marketing authorization to the US biotech on Jan. 6, shortly after the candidate was approved by the European Medicines Agency (EMA).
The US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for US biotech Moderna’s mRNA-based Covid-19 vaccine on Dec.18, a day after the agency’s advisory panel voted 20-0 to recommend it.
US pharma giant Merck has divested its direct holding in Moderna just as the US biotech is on the cusp of receiving an emergency use authorization (EUA) for its mRNA-based Covid-19. It said it expects to “record a small fourth-quarter gain.”
On Nov. 30, US biotech Moderna became the second Covid-19 vaccine maker to apply to the Food and Drug Administration to grant an Emergency Use Authorization (EUA) for its coronavirus vaccine. The filing follows that of the Pfizer-BioNTech team on Nov. 20.
Results from the Phase 3 trial of US biotech Moderna’s mRNA-1273 Covid-19 vaccine candidate unveiled on Nov. 15 showed it to be 94.5% effective against the novel coronavirus, with few side effects.
US vaccine manufacturer Moderna has tapped Takeda as marketing partner for its Covid-19 vaccine candidate mRNA-1273f in Japan. Financial terms of the deal were not disclosed. The Japanese drugmaker will import and distribute the vaccine starting in the first half of next year as well as handle local regulatory approvals. The original contract is for 50 million doses.
Both the Sanofi/GlaxoSmithKline partnership and US vaccine producer Moderna this week announced new advance purchase agreements with Canada for their Covid-19 vaccine candidates.
With some potential Covid-19 vaccine makers suggesting they could have a candidate ready for approval and maybe even deployment this autumn, concerns are arising that a doubting public could shun inoculation.
US-based CDMO Catalent has agreed a collaboration with US biotech Moderna for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate (mRNA-1273) at Catalent’s biologics facility in Bloomington, Indiana, USA.
Swiss fine chemicals producer and CDMO Lonza has signed a 10-year worldwide strategic collaboration agreement with Cambridge, Massachusetts-based US biotech Moderna to enable larger scale manufacture of Moderna’s RNA-1273 based Covid-19 vaccine candidate as well as other of products in future.
