Pharma COVID Roundup: News from Pfizer, Sanofi, GSK, RocheBy
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Pfizer, Sanofi GlaxoSmithKline, Roche, and Lilly.
Manufacturing and supply of COVID-19 vaccines and drugs
Pfizer, BioNTech Formally Announce New EU Pact for COVID Vaccine
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have formally announced the supply of an additional 1.8 billion does of their COVID-19 vaccine to be delivered to the European Union following the European Commission’s announcement of the 1.8 billion-supply pact earlier this month. Pfizer and BioNTech have now committed a total of up to 2.4 billion doses of their COVID-19 vaccine to the European Commission since the beginning of the pandemic.
Separately, the companies have entered into an agreement with Turkey’s Ministry of Health to supply 60 million additional doses of the companies’ COVID-19 vaccine, with an option for an additional 30 million doses. In December 2020, the companies announced an initial agreement to provide 30 million doses of the vaccine to Turkey. This second supply agreement brings the total number of doses to be supplied to Turkey to up to 120 million, all of which will be delivered in 2021.
US, EU approve new storage conditions
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved a change to the existing storage conditions of the companies’ COVID-19 vaccine. The agencies are both authorizing undiluted, thawed vaccine vials to be stored in the refrigerator at 2 °C to 8 °C (35 °F to 46 °F) for up to one month. Previously, thawed, undiluted vaccine vials could be stored in the refrigerator for up to five days.
Source: BioNTech (EU), BioNTech (Turkey), BioNTech (storage conditions), Pfizer (EU), US Food and Drug Administration (storage conditions) and European Medicines Agency (storage conditions)
Pfizer To Invest $40 M To Expand Irish Site for COVID-19 Mfg
Pfizer plans to invest $40 million to expand its Grange Castle site in Dublin, Ireland to manufacture the drug substance of the Pfizer–BioNTech COVID-19 vaccine, according to IDA Ireland, an economic development agency in Ireland.
The expansion of the Grange Castle site will allow for extra production that will be part of the Pfizer–BioNTech COVID-19 vaccine supply-chain network. Seventy-five new roles are to be created as a result of the expansion.
Source: IDA Ireland
Lilly, Natco Pharma in Pact for COVID-19 Drug in India
Natco Pharma, an Hyderabad, India-based pharmaceutical company, has signed a royalty-free, non-exclusive, voluntary licensing agreement with Eli Lilly and Company for the manufacture and commercialization in India of baricitinib, Lilly’s arthritis drug also authorized for treating COVID-19.
In line with the licensing agreement, Natco has withdrawn its application filed with the Indian Patent Office seeking a compulsory license against Lilly in India for baricitinib for treating COVID-19.
Earlier this month (May 2021), Lilly signed royalty-free, non-exclusive voluntary license agreements with three other Indian pharmaceutical companies (Cipla, Sun Pharma, and Lupin) for the manufacture and commercialization of baricitinib as a COVID-19 treatment in India.
Natco had earlier received an emergency use authorization \from India’s Central Drugs Standard Control Organization for baricitinib in combination with remdesivir, Gilead Sciences’ antiviral COVID-19 drug, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.
Source: Natco Pharma
Updates on COVID-19 treatments and vaccines
Sanofi, GSK Report Interim Phase II Results for COVID-19 Vaccine
Sanofi and GlaxoSmithKline (GSK) have reported positive Phase II interim results for their adjuvanted recombinant protein COVID-19 vaccine candidate.
The companies reported that the vaccine achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all adult age groups in a Phase II study with 722 volunteers. The Phase II interim results showed 95% to 100% seroconversion following a second injection in all age groups and across all doses, with acceptable tolerability and with no safety concerns.
Based on these positive Phase II interim results, the companies plan to initiate a global Phase III study with a 10-µg dose, in combination with GSK’s pandemic adjuvant, in the coming weeks (as reported on May 17, 2021). This Phase III trial is expected to enroll more than 35,000 adult participants from a broad range of countries and will assess the efficacy of two vaccine formulations, including the D614 (Wuhan) and B.1.351 (South African) variants.
In parallel, the companies intend to conduct booster studies with various variant formulations in order to assess the ability of a lower dose of the vaccine to generate a strong booster response regardless of the initial vaccine platform received. Pending positive Phase III outcomes and regulatory reviews, the companies anticipate that the vaccine will be authorized in the fourth quarter of 2021.
Source: Sanofi and GlaxoSmithKline
GSK, Medicago Report Interim Phase II Results for COVID-19 Vaccine
GlaxoSmithKline (GSK) and Medicago, a Quebec-based biopharmaceutical company, have reported positive interim Phase II data for Medicago’s plant-derived COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant.
The companies report that results showed similar antibody response in adults and in the elderly after two doses. Additionally, neutralizing antibody responses were ten times higher than in people recovering from COVID-19. These results are part of an ongoing Phase II/III study
The Phase III trial launched in March 2021. Trial sites are currently enrolling subjects in Canada, the US, the UK, and Brazil, with additional sites expected to be added in the coming weeks (as reported on May 18, 2021). The vaccine candidate has received fast-track designation by the US Food and Drug Administration in the US, and Health Canada has initiated a rolling review of the vaccine.
Source: GlaxoSmithKline and Medicago
FDA Issues Guidance on Master Protocols for COVID-19 Treatments
The US Food and Drug Administration (FDA) has issued final guidance on master protocols for evaluating prevention and treatment options for COVID-19.
The guidance, COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention Guidance for Industry, describes the FDA’s current recommendations to sponsors of master protocols evaluating drugs for the treatment or prevention of COVID-19. A master protocol is a protocol designed with multiple sub-studies, which involve coordinated efforts to evaluate one or more investigational drugs, in one or more disease subtypes, with one or more objectives, all within the same overall trial structure.
This guidance focuses on the design, conduct, and statistical considerations of master protocols intended to generate or contribute to substantial evidence of effectiveness and adequate characterization of safety of drugs for the treatment or prevention of COVID-19. Additionally, this guidance provides administrative and procedural recommendations to sponsors of master protocols for COVID-19 drugs.
Source: US Food and Drug Administration
News on COVID-19 testing
Roche Gets FDA OK for COVID-19 Test for Asymptomatic People
The US Food and Drug Administration (FDA) has authorized Roche’s cobas SARS-CoV-2 Test for testing individuals without symptoms or reasons to suspect COVID-19.
This authorization supports the guidance update from the US Centers for Disease Control and Prevention (CDC) to expand SARS-CoV-2 testing to include people without symptoms in an effort to reduce the spread of disease and applies to pooled samples containing up to and including six individual samples.
Asymptomatic testing with the cobas SARS-CoV-2 Test is also available in countries accepting the CE mark. A CE Mark indicates that a product has been assessed by the manufacturer and deemed to meet European Union safety, health and environmental protection requirements.