COVID News: Moderna and Lilly
The latest on COVID-19 vaccines/drugs and manufacturing from Moderna and Eli Lilly and Company. Highlights below.
Manufacturing and supply of COVID-19 vaccines and drugs
* EU To Buy More Doses of Moderna’s COVID-19- Omicron Vaccine Boosters
* Lilly Plans Commercial Launch of COVID-19 Drug Bebtelovimab
Manufacturing and supply of COVID-19 vaccines and drugs
EU To Buy More Doses of Moderna’s COVID-19- Omicron Vaccine Boosters
The European Commission has amended its supply agreement with Moderna to convert doses of Moderna’s primary COVID-19 vaccine, Spikevax, to the company’s Omicron-containing bivalent vaccines, pending regulatory approval, and has agreed to purchase an additional 15 million doses of Omicron-containing vaccine booster candidates from Moderna.
Under the amendment, contractually scheduled doses in July and August of Moderna’s COVID-19 vaccine, Spikevax, will be deferred to later in 2022, with all remaining contractually agreed doses of Spikevax converted to Omicron-containing bivalent vaccines, pending approval of the booster vaccines by the European Medicines Agency.
Moderna is advancing two bivalent vaccine booster candidates for the fall: mRNA-1273.222, which consists of Moderna’s primary COVID-19 vaccine, Spikevax, plus the Omicron BA.4/5 strain mRNA, and (2) mRNA-1273.214, which contains the BA.1 Omicron strain.
Earlier this month (August 2022), Moderna and the US government entered into a supply pact, worth up to $1.74 billion, under which the US secured 66 million doses of a Moderna COVID-19 bivalent vaccine booster candidate, mRNA-1273.222, with options to purchase up to an additional 234 million doses of COVID-19 vaccine booster candidates from Moderna.
Source: Moderna
Lilly Plans Commercial Launch of COVID-19 Drug Bebtelovimab
Eli Lilly and Company plans to make its COVID-19 antibody drug, bebtelovimab, commercially available to US states, hospitals and other healthcare providers from August 15, 2022. The drug is authorized for emergency use by the US Food and Drug Administration (FDA), which removed the requirement that distribution be controlled by the US government.
Upon commercial launch starting the week of August 15, 2022, bebtelovimab will be available to purchase from a sole distributor, AmerisourceBergen Specialty Distribution.
In late June (June 2022), Lilly modified its purchase agreement with the US government to supply an additional 150,000 doses of bebtelovimab for approximately $275 million with the US government having an option for an additional 350,000 doses to be exercised no later than September 14, 2022.
The drug is specifically authorized for adults with mild-to-moderate COVID-19, and children aged 12 or older, who are at high-risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
Source: US Food and Drug Administration and Eli Lilly and Company