Pharma COVID Roundup: News from Pfizer, AstraZeneca, LillyBy
The latest on manufacturing, potential treatments, and testing for COVID-19 with news from Pfizer, AstraZeneca, Lilly, Sinovac, Grifols, and Abbott.
Manufacturing and supply of COVID-19 vaccines and drugs
Pfizer, BioNTech Provide Mfg, Delivery Updates of COVID-19 Vaccine
Pfizer and BioNTech report that they have developed a plan that will allow the scale-up of manufacturing capacities of their COVID-19 vaccine in Europe to be able to deliver more doses in the second quarter (second quarter 2021).
To accomplish this, certain modifications of production processes are required now. In a January 15, 2021 statement, BioNTech says its facility in Puurs, Belgium will experience a temporary reduction in the number of COVID-19 vaccine doses delivered in the upcoming week. The company says it will be back to the original schedule of deliveries to the European Union (EU) beginning the week of January 25, 2021, with increased delivery beginning the week of February 15, 2021, resulting in the ability to deliver the fully committed quantity of vaccine doses in the first quarter and more in the second quarter.
The companies say they will inform the European Commission, EU member states, and other countries impacted by the changes about the updated delivery schedules. The companies say that they are working to support the further rollout of vaccination campaigns worldwide by not only expanding their own manufacturing capacities but also by adding further suppliers as well as contract manufacturers to increase total manufacturing capacity.
Updates on COVID-19 treatments and vaccines
Lilly Reports Positive Results of COVID-19 Drug in Long-Term Facilities
Eli Lilly and Company reports data from a Phase III trial that bamlanivimab, its neutralizing antibody against COVID-19, reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities.
The Phase III trial, conducted in partnership with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network, enrolled residents and staff at nursing and assisted living facilities, commonly referred to as nursing homes, across the US. An independent data and safety monitoring board oversaw the trial. The company says that the full results from the trial will be presented at a future medical congress and submitted for publication in a peer-reviewed clinical journal.
In the trial, the safety profile of bamlanivimab was consistent with observations from Phase I and Phase II trials. Serious adverse events were reported at a similar frequency in the bamlanivimab and placebo groups. Across multiple clinical trials, Lilly has collected safety and efficacy data in more than 4,000 patients treated with bamlanivimab, either alone or administered together with another antibody.
Bamlanivimab is authorized for emergency use by the US Food and Drug Administration for the treatment of mild-to-moderate COVID-19 in high-risk patients.
Source: Eli Lilly and Company
Brazil Authorizes Sinovac’s, AstraZeneca’s COVID-19 Vaccines
The Brazilian National Health Surveillance Agency (Anvisa) has given temporary authorization for emergency use of the COVID-19 vaccine candidates respectively from Sinovac, a Beijing, China-based biopharmaceutical company, and AstraZeneca.
CoronaVac, the COVID-19 vaccine candidate of Sinovac, is being developed in partnership with Instituto Butantan, a Brazilian biologic research center. Covishield, the COVID-19 vaccine candidate of AstraZeneca, is being produced by the Serum Institute of India, a vaccine manufacturer, in partnership with Oxford University, and Fiocruz, a scientific institution for research and development in biological sciences.
For Sinovac’s CoronaVac, completion of immunogenicity studies is slated by February 28, 2021 as part of a Phase III trial and will be presented to Anvisa. The agency says both Fiocruz and Instituto Butantan must continue their studies and generate data to allow health registration at Anvisa. Both need to maintain vaccine safety monitoring. Anvisa, as a federal regulatory body, can review and adjust the conditions for emergency use in the face of results that are considered relevant, including data and information from international regulatory authorities.
Source: Brazilian National Health Surveillance Agency
African Union Secures 270 M Doses of COVID-19 Vaccines
The African Union has secured a provisional 270 million COVID-19 vaccine doses and has initiated a COVID-19 vaccines pre-order program for all African Union member states.
The African Vaccine Acquisition Task Team secured the provisional COVID-19 vaccines doses from Pfizer, Johnson & Johnson, and AstraZeneca. The Africa Medical Supplies Platform (AMSP) has opened pre-orders to offer equitable access of COVID-19 vaccines doses for 55 African Union member states.
To support vaccination operations, the AMSP has also launched a new category on vaccine accessories that will help member states to procure products such as ultra-low temperature freezers, personal protection equipment, cotton wool rolls, syringes, and needles.
African Export-Import Bank, a Pan-African multilateral financial institution, will facilitate payments by providing advance procurement commitment guarantees of up to $2 billion to the manufacturers on behalf of the member states.
Source: African Export-Import Bank
Grifols Initiates Clinical Trial of COVID-19 Plasma Treatment
Grifols, a Barcelona-based developer of therapies with plasma-derived proteins, will begin a clinical trial in Spain to evaluate the safety and efficacy of a new COVID-19 drug.
The treatment is based on its immunoglobulin, Gamunex-C, containing anti-SARS-CoV-2 polyclonal antibodies from plasma donors who have recovered from the disease.
Grifols expects this clinical trial to begin in February 2021, with the possibility of results in the spring (spring of 2021). About 800 patients, all asymptomatic but having tested positive for the virus in a diagnostic test, will participate in the clinical study, receiving subcutaneously Grifols’ immunoglobulin with anti-SARS-CoV-2 antibodies.
In October 2020, Grifols, with other companies and various US health agencies, began the clinical trial to evaluate the efficacy and safety of the anti-SARS-CoV-2 hyperimmune globulin in hospitalized and serious cases. Results are expected during the first half of 2021.
Gritstone, Genevant Sciences in $192-M Pact for COVID-19 Vaccine
Gritstone Oncology, an Emeryville, California-based personalized cancer immunotherapy company, and Genevant Sciences, a Vancouver, British Columbia, Canada-based nucleic acid delivery company, have formed a pact, worth up to $192-million, which provides Gritstone nonexclusive access to Genevant’s lipid nanoparticle (LNP) technology for use in Gristone’s self-amplifying RNA COVID-19 vaccine program.
Gritstone is advancing a COVID-19 program to develop a vaccine with support from departments within the National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation and a license agreement with the La Jolla Institute for Immunology. Phase I of the NIH-sponsored trial is expected to initiate in the first quarter of 2021.
Genevant’s LNP platform is clinically validated and part of Gritstone’s self-amplifying RNA neoantigen-based cancer immunotherapy now in Phase II testing.
Under the agreement, Genevant is eligible to receive from Gritstone up to $192 million in upfront and contingent milestone payments per product, plus royalties ranging from the mid-single to the mid-double digits on future product sales. In the event that Gritstone outlicenses the COVID-19 program, Genevant may in certain circumstances be entitled to a percentage of amounts that Gritstone receives.
This is the second agreement between Gritstone and Genevant since October 2020. Genevant is a subsidiary of Roivant Sciences, a New York-based healthcare company.
Source: Gritstone Oncology and Genevant Sciences
FDA Updates Guidance on COVID-19 Convalescent Plasma
The US Food and Drug Administration has updated its guidance on convalescent plasma as an investigational treatment for COVID-19.
The use of convalescent plasma is an investigational treatment for COVID-19 where convalescent plasma is collected from individuals who have recovered from COVID-19 and contains antibodies to SARS-CoV-2, the virus that causes COVID-19.
The revisions to the guidance provide recommendations for when individuals qualify as convalescent plasma donors for when they have received an investigational COVID-19 vaccine as a participant in a clinical trial or have received an authorized or licensed COVID-19 vaccine,. In addition, the agency has extended the period of enforcement discretion described in the guidance. The corresponding webpage was also updated.
Source: US Food and Drug Administration (announcement of update) and US Food and Drug Administration (guidance)
News on COVID-19 testing
Abbott Fulfills US Gov’t Purchase of COVID-19 Rapid Antigen Tests
Abbott reports the fulfillment of a US government’s order of 150 million rapid tests to detect COVID-19 and that it will supply 30 million additional tests through March 2021 via a new government order.
The BinaxNOW COVID-19 Ag tests were distributed through the US Department of Health and Human Services (HHS to states, territories and targeted entities, such as nursing homes, assisted living facilities, home health and hospice agencies, historically black colleges and universities, and the Indian Health Service.
Abbott is also in the final stages of completing its self-funded investment in US manufacturing capacity and says it is ready to make tens of millions of BinaxNOW tests available per month for direct purchase to organizations, including schools, workplaces and pharmacies.
Abbott says it will continue supplying the HHS with a total of 30 million tests between now (as reported on January 12, 2021) and March 2021. A breakdown of the initial 150 million tests shipped to states, territories and targeted entities via HHS orders can be found here.
The BinaxNOW COVID-19 Ag Card is an assay for the qualitative detection of specific antigens to COVID-19 in the human nasal cavity. A nasal swab is used to collect specimens from people suspected of having an active infection. The company says the rapid test provides results in 15 minutes and detects the virus when people are most infectious. An at-home, virtually and digitally guided version of the test, is also available at $25 per test.
Under an emergency use authorized issued by the US Food and Drug Administration in August 2020, the rapid test is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists and more with minimal training and a patient prescription.