COVID News: Lilly, AstraZeneca, J&J & More

The latest on COVID-19 vaccines/drugs and manufacturing from Lilly, AstraZeneca, J&J, Pfizer, Roche, Gilead Sciences, Novavax, and Celltrion.

Manufacturing and supply of COVID-19 vaccines and drugs

US, Lilly in $720-M Supply Pact for COVID-19 Drug
Eli Lilly and Company has signed an agreement with the US government to supply up to 600,000 doses of its COVID-19 drug, bebtelovimab, for at least $720 million. The supply agreement calls for the delivery of up to 600,000 doses no later than March 31, 2022 with an option for an additional 500,000 doses no later than July 31, 2022.

Earlier this month (February 2022), the US Food and Drug Administration (FDA) granted emergency use authorization for bebtelovimab for treating mild-to-moderate COVID-19 in adults and pediatric patients, 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. The FDA noted that the new monoclonal antibody retains activity against the Omicron variant.

Lilly licensed and developed bebtelovimab after it was discovered by AbCellera, a Vancouver, British Columbia, Canada-based bio/pharmaceutical company and scientists at the National Institute of Allergy and Infectious Diseases Vaccine Research Center.

Source: Eli Lilly and Company (authorization), Eli Lilly and Company (supply pact), and US Food and Drug Administration

US To Buy More Doses of AstraZeneca’s COVID-19 Drug
The US Department of Health and Human Services has finalized its agreement to purchase an additional one million doses of Evusheld (150 mg of tixagevimab co-packaged with 150 mg of cilgavimab), AstraZeneca’s long-acting antibody combination for the prevention of COVID-19.

This agreement includes the 500,000 additional dose purchase announced by the US government last month (January 2022) and follows the government’s initial agreement for the purchase of 700,000 doses of Evusheld, which are already being administered at sites around the US, for a total of 1.7 million doses. The US government has indicated that it plans to distribute these additional doses to states and territories at no cost.

Source: AstraZeneca

US Donating 5 M Doses of J&J’s COVID-19 Vaccine to Africa
The US is making a direct donation of 5 million doses of Johnson & Johnson’s COVID-19 vaccine to the African Vaccine Acquisition Trust, the African Union’s vaccine procurement and distribution effort.

In a February 14, 2022 press statement, US Secretary of State Antony J. Blinken confirmed that the first five million doses are already shipping to countries across Africa. Together with doses provided in partnership with COVAX, a global initiative for equitable access to COVID-19 vaccines, this brings the total doses the US has donated to Africa to more than 155 million, as part of 435 million doses donated globally.

Source: Statement by US Secretary of State Antony J. Blinken

Updates on COVID-19 vaccines and drugs

Pfizer, BioNTech Extending Filing for COVID-19 Vaccine in Young Children 
Pfizer and BioNTech report that they plan to extend their rolling submission to the US Food and Drug Administration (FDA) for emergency use authorization of their COVID-19 vaccine to include children six months through four years of age. The FDA had requested the extension.  

The trial in children six months through four years of age is ongoing, and data on the first two 3- µg doses in this age group are being shared with the FDA on an ongoing basis.

In conjunction, the FDA is postponed the meeting of the Vaccines and Related Biological Products Advisory Committee, which was originally scheduled for February 15, 2022, to give the agency time to consider the additional data. The FDA says it will provide an update on timing for the advisory committee meeting once it receives additional data on a third dose in this age group from Pfizer’s and BioNTech’s ongoing clinical trial and have an opportunity to complete an updated evaluation. 

Source: Pfizer, BioNTech, and the US Food and Drug Administration

Roche’s Arthritis Drug Gets WHO OK for COVID-19
Roche’s Actemra/RoActemra (tocilizumab), a drug for treating rheumatoid arthritis and approved to treat COVID-19, has been granted World Health Organization (WHO) prequalification for treating COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. WHO prequalification is often a prerequisite for national registrations of new vaccines and medicines in developing countries.

Source: Roche and the World Health Organization

Gilead Reports Data for Remdesivir Against COVID-19 Variants
Gilead Sciences has released data demonstrating the in-vitro activity of Veklury (remdesivir), its antiviral drug for treating COVID-19, against ten SARS-CoV-2 variants, including Omicron.

Gilead reports that the results of the studies are consistent with other in-vitro studies independently conducted by researchers from institutions in other countries, including Belgium, Czech Republic, Germany, Poland, and the US, which confirmed Veklury’s antiviral activity against multiple previously identified variants of SARS-CoV-2, including Alpha, Beta, Gamma, Delta and Omicron.

Source: Gilead Sciences

Singapore Issues Interim OK for Novavax’s COVID-19 Vaccine
The Singapore Health Sciences Authority (HSA) has issued interim authorization for Nuvaxovid, Novavax’s COVID-19 vaccine also known as NVX-CoV2373, to prevent COVID-19 in individuals 18 years of age and older.

Novavax also announced its submission to Swissmedic, the Swiss Agency for Therapeutic Products, for conditional marketing authorization of NVX-CoV2373 for use in adults.

Separately, Novavax reported positive results in a in the pediatric expansion in its Phase III trial, which demonstrated 82% clinical efficacy against the COVID-19 Delta variant. Novavax plans to supplement global regulatory filings with pediatric data in the first quarter of 2022.

Source: Novavax (Singapore), Novavax (Switzerland), and Novavax (pediatric results)

Celltrion Submits for Inhaled COVID-19 Therapy
Celltrion, an Incheon, South Korea-based bio/pharmaceutical company developing innovator drugs and biosimilars, has submitted an investigational new drug (IND) application to conduct a global Phase III clinical trial evaluating an inhaled COVID-19 antibody cocktail therapy.

The inhaled COVID-19 antibody cocktail has been developed to target newly emerging mutations of SARS-CoV-2, including the Omicron variant (B.1.1.529). The global Phase III clinical trial proposed in the IND is designed to evaluate the safety and efficacy profile of the inhaled COVID-19 antibody cocktail. The trial is expected to enroll 2,200 patients globally.

Source: Celltrion