Pharma COVID Roundup: News from Moderna, Pfizer, Sanofi, RegeneronBy
The latest on COVID-19 vaccines/drugs and manufacturing from Moderna, Pfizer, BioNTech, Sanofi, Regeneron, Roche, Novavax, the CDC, and PAHO.
Manufacturing and supply of COVID-19 vaccines and drugs
Moderna To Supply Peru with 20 M Doses of COVID-19 Vaccine
Moderna has entered into a supply agreement with the government of Peru for 20 million doses of its COVID-19 vaccine to begin delivery in the first quarter of 2022. Moderna’s COVID-19 vaccine is not currently approved for use in Peru, and the company says it will work with regulators to pursue necessary approvals prior to distribution.
PAHO Selects Argentina, Brazil as Mfg Centers for mRNA COVID Vaccines
The Pan American Health Organization (PAHO), a public health agency for the Americas, has selected two centers in Argentina and Brazil as regional hubs for the development and production of mRNA-based vaccines in Latin America.
The Bio-Manguinhos Institute of Technology on Immunobiologicals at the Oswaldo Cruz Foundation (FIOCRUZ) in Rio de Janeiro was selected as the center in Brazil. The institute has experience in vaccine manufacturing and has made advances in the development of an mRNA vaccine against COVID-19.
Sinergium Biotech, a private sector bio/pharmaceutical company, was selected as the center in Argentina. Sinergium will partner with mAbxience, a bio/pharmaceutical company specializing in research, development and manufacturing of biosimilars, to develop and manufacture active vaccine ingredients. The two companies have experience in the production and development of vaccines and biologic-based medicines.
PAHO recently launched a new entity, the Regional Platform to Advance the Manufacturing of COVID-19 Vaccines and Other Health technologies in the Americas, to support collaboration across countries and agencies to apply existing regional biomanufacturing capacity to the production of COVID-19 vaccines and other medical technologies.
Source: Pan American Health Organization
Updates on COVID-19 treatments and vaccines
CDC Statement on Pfizer’s/BioNTech’s COVID-19 Vaccine Booster
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices issued its recommendations for a booster shot of Pfizer’s/BioNTech’s COVID-19 vaccine in certain populations and also recommended a booster dose for those in high risk occupational and institutional settings. The recommendation follows the US Food and Drug Administration’s authorization for emergency use of a booster dose of Pfizer’s/BioNTech’s COVID-19 vaccine for certain populations last week (September 22, 2021).
The single booster dose, to be administered at least six months after completion of the primary series, has been recommended by the CDC for:
- people 65 years and older and residents in long-term care settings;
- people aged 50–64 years with underlying medical conditions;
- people aged 18–49 years with underlying medical conditions, based on their individual benefits and risks; and
- people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting, based on their individual benefits and risks.
The CDC says it will continue to monitor the safety and effectiveness of COVID-19 vaccines to ensure appropriate recommendations and will also evaluate available data in the coming weeks (as reported on September 24, 2021) to make additional recommendations for other populations or people who received. the Moderna or Johnson & Johnson COVID-19 vaccines.
Pfizer, BioNTech Submit Data for COVID-19 Vaccine in Children
Pfizer and BioNTech have submitted to the US Food and Drug Administration (FDA) data from a Phase II/III trial of their COVID-19 vaccine in children 5 to less than 12 years of age.
A formal submission to request emergency use authorization of the companies’ COVID-19 vaccine in children 5 to less than 12 years of age is expected to follow in the coming weeks (as reported on September 28, 2021). Submissions to the European Medicines Agency (EMA) and other regulatory authorities are also planned.
Topline immunogenicity and safety readouts for the other two age cohorts from the trial, children 2 to less than 5 years of age and children 6 months to less than 2 years of age, are expected as soon as the fourth quarter of this year (2021).
Novavax Files for Emergency Use of COVID-19 Vaccine with WHO
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, and the Serum Institute of India (SII), a Pune, India-based vaccine manufacturer, have for an emergency use listing (EUL) for Novavax’s COVID-19 vaccine with the World Health Organization (WHO).
The submission to WHO is based on the companies’ previous regulatory submission to the Drugs Controller General of India. The grant of EUL by WHO is a prerequisite for exports to countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries.
In addition to this submission to WHO, SII and Novavax completed the submission of modules required by regulatory agencies in India, Indonesia, and the Philippines for the initiation of review of the COVID-19 vaccine, including preclinical, clinical, and chemistry, manufacturing and controls data.
Separately, Novavax has reported positive Phase III results from a Phase III clinical trial of NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate with Matrix-M adjuvant. Full details of the results can be found here.
Pfizer Starts Phase II/III Study of COVID-19 Oral Antiviral Candidate
Pfizer has started a Phase II/III study to evaluate its oral antiviral candidate, PF-07321332, co-administered with a low dose of ritonavir, for the prevention of COVID-19 infection.
PF-07321332 is an oral antiviral SARS-CoV-2-3CL protease inhibitor. The Phase II/III trial is part of a global clinical research program. In addition to this study, the global program consists of multiple ongoing clinical trials, including one in SARS-CoV-2 infected patients who are at high risk of severe illness (including hospitalization or death), which began in July 2021, and another in infected patients who are at standard risk (i.e., do not have risk factors for severe illness), which began in August 2021.
Regeneron, Roche Report Phase II/III Results for COVID-19 Antibody Cocktail
Regeneron Pharmaceuticals, a Tarrytown, New York-based bio/pharmaceutical company, report positive Phase II/III results for its antibody cocktail for treating COVID-19, casirivimab and imdevimab, known as REGEN-COV in the US and Ronapreve in other countries. Regeneron invented REGEN-COV and is collaborating with Roche to increase global supply, with Roche primarily responsible for development and distribution outside the US.
The companies report that the trial met its primary endpoint and showed reduced viral load within seven days of treatment. The trial was conducted in patients hospitalized with COVID-19 who did not require high-flow oxygen or mechanical ventilation at baseline.
Multiple analyses have shown that the antibody cocktail retains potency against the main variants of concern circulating within the US, including Delta (first identified in India), Gamma (first identified in Brazil), Beta (first identified in South Africa) and Mu (first identified in Colombia). Regeneron says it will continue monitoring the potency of the antibody cocktail against emerging variants.
Sanofi To Focus COVID-19 Vaccine Efforts on COVID-19 Vaccine with GSK
Sanofi has decided not to pursue the development of its mRNA-based COVID-19 vaccine candidate into a Phase III clinical study despite positive interim results from a Phase I/II study.
Taking into account public health needs and given sufficient mRNA COVID-19 vaccines supply, Sanofi says it will focus on completing the final development steps of its COVID-19 recombinant vaccine being developed in partnership with GlaxoSmithKline.