Pharma COVID Roundup: News from Lilly, Pfizer, Novavax, CSL

The latest on COVID-19 vaccines/drugs and manufacturing from Lilly, Pfizer, Novavax, CSL, Sinovac, and Sinopharm.

Manufacturing and supply of COVID-19 vaccines and drugs

Lilly To Accelerate Availability of COVID-19 Drugs in India
Eli Lilly and Company is accelerating availability in India of Olumiant (baricitinib), its arthritis drug also authorized for treating COVID-19, after gaining permission for restricted emergency use in India with supply increasing via donations and licensing agreements.

Lilly is offering donations of baricitinib to the Indian government through Direct Relief, a nonprofit aid organization, while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic.

An initial donation of 400,000 baricitinib tablets is being made immediately available (as reported on May 4, 2021) to the Indian government for eligible hospitalized COVID-19 patients. Lilly says it will work to increase the quantity of donated product over the coming weeks (as reported on May 4, 2021).

Lilly received permission for restricted emergency use from India’s Central Drugs Standard Control Organization, a division of India’s Ministry of Health, for baricitinib (2 mg and 4 mg) in combination with remdesivir, Gilead Sciences’ antiviral COVID-19 drug, for treating suspected or laboratory confirmed COVID-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.

Additionally, Lilly is donating both baricitinib (4-mg tablet) as well as its COVID-19 combination therapy of bamlanivimab (700 mg) and etesevimab (1,400 mg) to Direct Relief to enable the organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries.

Separately, the European Medicines Agency (EMA) has started evaluating an application to extend the use of Olumiant to include treatment of COVID-19 in hospitalized patients from 10 years of age who require supplemental oxygen. The EMA will communicate on the outcome of its evaluation, which is expected by July (July 2021) unless supplementary information is needed.

Source: Eli Lilly and Company (India), Eli Lilly and Company (donations), and the European Medicines Agency

Novavax, Gavi in Supply Pact for COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has finalized an advance purchase agreement (APA) with Gavi, a global vaccine alliance, for the supply of 1.1 billion doses of its COVID-19 vaccine candidate, NVX-CoV2373, to the COVAX Facility, a mechanism for pooled procurement and equitable distribution of COVID-19 vaccines.

Under the APA, Novavax is expected to manufacture and distribute 350 million doses of NVX-CoV2373 to countries participating in the COVAX Facility. Under a separate purchase agreement with Gavi, the Serum Institute of India, a Pune, India-based vaccine manufacturer, is expected to manufacture and deliver the balance of the 1.1 billion doses of Novavax’s vaccine.

Under the APA, Novavax expects to deliver doses with antigen and adjuvant manufactured at facilities directly funded by the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private partnership focused on vaccine development against emerging infectious diseases. CEPI invested nearly $400 million in Novavax in the spring of 2020 to advance preclinical and early clinical development, manufacturing scale-up, technology transfer, and manufacturing capacity reservation for the vaccine.

Together, Novavax and the Serum Institute of India expect to initiate delivery of a cumulative 1.1 billion doses in the third quarter of 2021, pending receipt of appropriate regulatory authorizations. Novavax will receive an upfront payment from Gavi later this month (May 2021) and an additional payment after it secures emergency use listing for the vaccine by the World Health Organization. In addition, Novavax has agreed to provide additional doses in the event that the Serum Institute cannot materially deliver expected vaccine doses to the COVAX Facility.

Separately, Novavax has initiated an expansion of its Phase III clinical trial in the US for the vaccine to evaluate the efficacy, safety, and immunogenicity in up to 3,000 adolescents aged 12-17.

Source: Novavax (Gavi) and Novavax (pediatric expansion)

CSL Provides Update on Mfg of AstraZeneca’s COVID-19 Vaccine
CSL reports that its production of AstraZeneca’s COVID-19 vaccine for Australia has reached more than a million doses a week. These volumes are due to be released from mid-late May (May 2021) following required quality checks.

To date (as reported on May 1, 2021), more than 3.7 million COVID-19 vaccines have been released from the Australian manufacturing facilities of CSL and Seqirus, a subsidiary of CSL.

Source: CSL

Updates on COVID-19 treatments and vaccines

Pfizer/BioNTech Get OK for COVID-19 Vaccine in Adolescents; Seek OK in EU, US
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have received authorization from Health Canada, Canada’s pharmaceutical regulatory body, to expand the use of their COVID-19 vaccine to include individuals 12 to 15 years of age. The companies have submitted a request to the European Medicines Agency (EMA) to expand the use of their vaccine to include this age group. A similar request had earlier been made to the US Food and Drug Administration (FDA).

Health Canada has expanded the interim order authorization for Pfizer’s and BioNTech’s COVID-19 vaccine to include individuals 12 to 15 years of age, making it the first COVID-19 vaccine authorized in Canada for use in this age group. A pediatric study evaluating the safety and efficacy of the COVID-19 vaccine in children six months to 11 years of age is ongoing.

In the European Union, the companies have submitted a variation to the conditional marketing authorization to the EMA for their COVID-19 vaccine, Comirnaty, to request use in adolescents 12 to 15 years of age. The EMA expects to make a decision in June (June 2021) unless supplementary information is needed.

Last month (April 2021), Pfizer and BioNTech submitted a similar request to the FDA for emergency use authorization for adolescents 12 to 15 years of age The companies plan to request additional amendments with other regulatory authorities globally.

Separately, the companies announced the signing of a memorandum of understanding with the International Olympic Committee to donate their COVID-19 vaccine to help vaccinate athletes and their delegations participating in the Olympic and Paralympic Games Tokyo 2020, which are scheduled to begin on July 23, 2021.

Source: BioNTech (EU), BioNTech (Canada), BioNTech (Olympics), Pfizer, the Canadian government, and the European Medicines Agency

Second Lilly/AbCellera COVID-19 mAb Enters Clinical Trials
AbCellera, a Vancouver, British Columbia, Canada-based biopharmaceutical company, has announced that a second monoclonal antibody (mAb)from its collaboration with Eli Lilly and Company, LY-CoV1404, has entered clinical trials for treating mild-to-moderate COVID-19.

Lilly has expanded its ongoing trials to evaluate LY-CoV1404 alone and together with other monoclonal antibodies.

In support of this clinical study, AbCellera released preclinical data showing LY-CoV1404 binds to a rarely mutated region of the SARS-CoV-2 spike protein and neutralizes all currently known variants of concern, including those first identified in the UK, South Africa, Brazil, California, and New York.

AbCellera and Lilly formed a pact in March 2020 to develop COVID-19 treatments. The first mAb from this pact was bamlanivimab, which received emergency use authorization from the US Food and Drug Administration. Lilly subsequently developed bamlanivimab and etesevimab for administration together in order to meet the potential challenge of SARS-CoV-2 variants likely to resist treatment with either monoclonal antibody used alone. The emergency use authorization of bamlanivimab alone was subsequently revoked at Lilly’s request.

Source: AbCellera

EMA Starts Rolling Review of Sinovac’s COVID-19 Vaccine
The European Medicine Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has started a rolling review of a COVID-19 vaccine developed by Sinovac Life Sciences, a wholly owned subsidiary of Sinovac Biotech, a Beijing, China-based biopharmaceutical company.

The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and clinical studies. These studies suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease.

Source: European Medicines Agency

WHO Committee Evaluates Sinopharm’s COVID-19 Vaccine
The World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) has reviewed the COVID-19 vaccine (BBIBP-CorV) from Sinopharm, a Beijing, China-based company. SAGE reviews evidence and gives recommendations on policy and dosages associated with a vaccine.

According to a report from SAGE in reviewing the data, the group had a high level of confidence for the efficacy for the vaccine against PCR-confirmed COVID-19 in adults but low levels of confidence for the efficacy for the vaccine against PCR-confirmed COVID-19 in older adults and individuals with co-morbidities or health states that increase risk for severe COVID-19. Additionally, SAGE reported very low levels of confidence for the vaccine in safety-serious adverse events in older adults and individuals with co-morbidities or health states that increase risk for severe COVID-19.

BBIBP-CorV is a two-dose β-propiolactone-inactivated, aluminium hydroxide-adjuvanted COVID-19 vaccine. The vaccine has been authorized by 45 countries and jurisdictions for use in adults 18 years or older with 65 million doses of the vaccine administered through emergency use programs. An emergency use listing with WHO is pending.

Source: World Health Organization

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