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Moderna signs contract to supply Covid-19 booster vaccines to the US

Pharmaceutical Technology

Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. Spikevax is the company’s Covid-19 vaccine intended for active immunisation for disease prevention in people aged 18 years and above. 4/5 strain messenger RNA (mRNA).

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Monovalent COVID Vaccine De-Authorized, Second Bivalent Booster OK’d for 65+

Pharma Leaders

The FDA has updated emergency use authorizations for the Pfizer-BioNTech and Moderna COVID-19 bivalent mRNA vaccines to allow individuals 65 years and older to receive a second booster dose at least four months after the first bivalent dose. Related Topics

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Moderna files lawsuits against Pfizer and BioNTech over mRNA technology

Pharmaceutical Technology

Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, is said to have infringed patents filed by Moderna between 2010 and 2016 for its mRNA technology. This technology was vital for developing Spikevax, an mRNA Covid-19 vaccine of Moderna. 5 Omicron-targeting bivalent booster vaccine for Covid-19, mRNA-1273.222.

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Health Canada grants approval for Moderna’s Covid-19 vaccine in children

Pharmaceutical Technology

Health Canada has granted approval for the usage of Moderna’s messenger RNA (mRNA) Covid-19 vaccine, Spikevax, in a 25µg two-dose regimen for active immunisation to prevent Covid-19 in children aged six months to five years. Topic sponsors are not involved in the creation of editorial content.

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UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. Topic sponsors are not involved in the creation of editorial content.

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Moderna and Gavi announce update on Covid-19 vaccine supply deal

Pharmaceutical Technology

Moderna has entered an agreement with Gavi, the Vaccine Alliance, with regard to the delivery of Covid-19 vaccines to lower-income countries supported by the Gavi COVAX Advance Market Commitment (AMC). According to the deal, the parties will cancel pending orders under the existing Covid-19 vaccine supply agreement for this year.

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Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance. It is to be hoped that this will be addressed by an update of the ICH M7(R2) guidance during 2024 ICH M7(R2) 10 currently provides some guidance to establish AIs for mutagenic impurities.