Pharma COVID Roundup: News from Moderna, J&J, Regeneron, AstraZeneca

The latest on COVID-19 vaccines/drugs and manufacturing from Moderna, J&J, Regeneron, AstraZeneca, Biogen, CureVac, Inovio, and Novavax.

Manufacturing and supply of COVID-19 vaccines and drugs

COVAX To Buy 176.5-M Additional Doses of Moderna’s COVID-19
Gavi, a global vaccine alliance, has exercised its option to purchase an additional 176.5 million doses of Moderna’s COVID-19 vaccine for the COVAX Facility, a mechanism for pooled procurement and equitable distribution of COVID-19 vaccines.

Of these additional doses, 116.5 million doses are expected to be delivered in the first quarter of 2022, and 60 million doses are expected to be delivered in the second quarter of 2022.

COVAX also retains the option to purchase 116.5 million doses for delivery in the third quarter of 2022 and an additional 116.5 million doses for delivery in the fourth quarter of 2022. These doses are in addition to the 34 million doses purchased for delivery in the fourth quarter of 2021.

The 210 million doses purchased to date (as reported on October 12, 2021) by COVAX are 100 µg per dose. Recently, Moderna requested authorization of a 50-µg dose as a booster from the same vial, which would increase the number of usable doses procured by COVAX at no additional cost. The average purchase price across all doses purchased to date is just under $10 per 100-µg dose, equating to less than $5 per 50-µg dose.

Through this long-term agreement, UNICEF and its procurement partners have been provided access to up to 500 million doses of Moderna’s COVID-19 vaccine through 2022. This agreement covers 92 low- and lower-middle-income countries as defined by Gavi’s COVAX Advance Market Commitment, a financing instrument supporting procurement of vaccines. Moderna is in discussions to allocate and supply to self-financing participants in the future. COVAX is a global initiative co-led by Gavi, the Coalition for Epidemic Preparedness Innovations, public–private partnership focused on vaccine development against emerging infectious diseases, and the World Health Organization.

Moderna also recently announced an investment of up to $500 million to build a mRNA facility in Africa with the goal of producing up to 500 million doses of vaccines each year at the 50-µg dose level.

Source: Moderna

Updates on COVID-19 treatments and vaccines

FDA Meets to Discuss Boosters of Moderna’s, J&J’s COVID-19 Vaccine
Members of the US Food and Drug Administration’s vaccine expert panel, the Vaccines and Related Biological Products Advisory Committee are meeting on Thursday October 14, 2021 to discuss Moderna’s application for a booster shot for its COVID-19 vaccine and on Friday October 15, 2021 to discuss the J&J’s application for a booster of its COVID-19 vaccine.

Source: US Food and Drug Administration

Roche’s, Regeneron’s COVID-19 Antibody Cocktail Under Review in US, EU
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have respectively accepted for review applications for full marketing authorization for Regeneron Pharmaceuticals’ antibody cocktail (casirivimab and imdevimab) for treating COVID-19.

The FDA has accepted for priority review a biologics license application for the antibody cocktail, known as REGEN-COV in the US, to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The FDA has assigned a target action date of April 13, 2022 and will hold an advisory committee meeting in advance of that date. REGEN-COV has been authorized for emergency use in the US but not for full marketing authorization.

Additionally, the EMA accepted for review the marketing authorization application for the same antibody cocktail, known as Ronapreve outside the US, for use in certain people either as a treatment in infected non-hospitalized patients, or as prophylaxis. The EMA says it evaluate the drug under a reduced timeline and could issue an opinion within two months (as reported on October 11, 2021), depending on the robustness of the data submitted and whether further information is required to support the evaluation.

In parallel, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) completed the preliminary assessment of a risk-management plan proposed by the company, which outlines measures to identify, characterize, and minimize the medicine’s risks.

Regeneron invented the antibody cocktail and is collaborating with Roche to increase global supply, with Roche primarily responsible for development and distribution outside the US.

Source: Regeneron and the European Medicines Agency

CureVac To Shift Focus of COVID-19 Vaccine; Withdraws Application in EU
CureVac, a Tubingen, Germany-based bio/pharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, has withdrawn its application to the European Medicines Agency for its COVID-19 vaccine candidate, CVnCoV, and will instead focus on COVID-19 vaccine candidates being developed with GlaxoSmithKline.

CureVac estimates that the earliest potential approval of CVnCoV would have come in the second quarter of 2022. By this time, it expects the vaccine candidates with GSK to have progressed to late-stage clinical development.

CureVac is therefore ending its existing advanced purchase agreement with the European Commission (EC) for CVnCoV and is assessing the possibility of using CVnCoV commitments for the vaccine candidates with GSK.

CureVac and GSK anticipate entering their COVID-19 vaccine candidate(s) into clinical development in the next months (as reported on October 12, 2021) with the potential for authorization in 2022.

Source: CureVac and the European Medicines Agency

AstraZeneca Reports Phase III Results for COVID-19 Antibody Combo
AstraZeneca reports data from a Phase III trial showed that AZD7442, its long-acting antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalized patients with mild-to-moderate symptomatic COVID-19.

The company says it will be discussing the data with health authorities. On October 5, 2021, the company announced that it had submitted a request to the US Food and Drug Administration for emergency use authorization for AZD7442 for prophylaxis of COVID-19.

Source: AstraZeneca

Inovio Expands Phase III Study of COVID Vaccine; Reports Phase I Booster Results
Inovio, a Plymouth Meeting, Pennsylvania-based bio/pharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, has expanded its Phase III study for INO-4800, its COVID-19 vaccine candidate, to include Columbia following regulatory authorization.

Inovio has received authorization from Colombia’s INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, or the National Food and Drug Surveillance Institute) to conduct a clinical trial in that country as part of the Phase III segment of its global Phase II/III trial, for INO-4800.

In addition to Columbia, Inovio, with its partner Advaccine Biopharmaceuticals Suzhou, a Suzhou, China-based bio/pharmaceutical company, have recently received, in addition to Columbia, regulatory authorization from Mexico, Brazil, and the Philippines to proceed with the global Phase III segment of the clinical trial.

In August (August 2021), Inovio received regulatory allowance in China for two clinical trials evaluating mixed boosted regimens of INO-4800 and CoronaVac, a COVID-19 vaccine developed by Sinovac Biotech, a Beijing-based bio/pharmaceutical company.

Source: Inovio (Phase III study) and Inovio (booster dose)

Novavax Reports Phase III Results for COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, reports full results from a Phase III trial, in which NVX-CoV2373, Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall.

The trial achieved its primary endpoint of efficacy in preventing polymerase chain reaction (PCR)-confirmed, symptomatic mild, moderate-or-severe COVID-19 with onset at least seven days after the second dose.

Source: Novavax

Biogen Reports Results for COVID-19 Vaccines Among People with MS
Biogen reports results of immune response to COVID-19 vaccines among people with multiple sclerosis (MS), which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination. Full details of the analysis can be found here.

Source: Biogen