Manufacturing and supply of COVID-19 vaccines and drugs
BioNTech, Fosun Pharma To Supply China with COVID-19 Vaccine
BioNTech, a Mainz, Germany-based immunotherapy company, and Fosun Pharma, a Shanghai-based pharmaceutical company, have announced an agreement to supply Mainland China with an initial 100 million doses of their BNT162 mRNA-based vaccine candidate against COVID-19 in 2021. BioNTech is partnered with Pfizer for the BNT162 COVID-19 vaccine globally, excluding China, where BioNTech has a collaboration with Fosun Pharma for both clinical development and commercialization.
The supply pact with Fosun is subject to regulatory approval. Initial supply will be delivered from BioNTech’s production facilities in Germany. Last month (November 2020), the companies initiated a Phase II clinical trial of the COVID-19 vaccine, BNT162b2, in Jiangsu Province, China. The trial commenced with the recruitment of 960 healthy participants, between 18 to 85 years old, to assess the safety and immunogenicity of the vaccine candidate and to support future biologic license application in China.
Last week (December 11, 2020), Pfizer and BioNTech received emergency use authorization for the vaccine in the US. The vaccine is now (as of December 14, 2020) authorized for emergency use in six countries: the US, the UK, Canada, Bahrain, Saudi Arabia, and Mexico, and global filings and reviews are ongoing.
Source: BioNTech and Fosun Pharma
Novavax in Supply Pact with New Zealand Gov’t for COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has entered into an advance purchase agreement with the New Zealand government to supply 10.7 million doses of its COVID-19 vaccine candidate, NVX-CoV2373.
Currently in Phase III clinical testing in the UK, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’s proprietary adjuvant, Matrix-M, to enhance the immune response to the vaccine. Under the agreement, Novavax will manufacture NVX-CoV2373 with a target of delivering initial doses by mid-2021. The company will work with Medsafe, New Zealand’s pharmaceutical regulatory agency, to obtain product approvals. Given the urgency of timely approval and delivery of vaccine during the pandemic, the company says the regulatory review process may use review by prioritized regulatory bodies such as the US Food and Drug Administration, the European Medicines Agency and/or Medicines and Healthcare products Regulatory Authority in the UK.
Updates on COVID-19 treatments and vaccines
Sanofi, GSK Report Delay in COVID-19 Vaccine Program
Sanofi and GlaxoSmithKline (GSK) have reported a delay in advancing their adjuvanted recombinant protein-based COVID-19 vaccine in older adults. Phase I/II study interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen.
As a result, the companies plan to start a Phase IIb study with an improved antigen formulation in February 2021 with support from US government: the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services. The study will include a proposed comparison with an authorized COVID-19 vaccine. If data are positive, the companies say a global Phase III study could start in the second quarter of 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, thereby delaying the vaccine’s potential availability from mid-2021 to the fourth quarter of 2021.
Sanofi’s and GSK’s adjuvanted recombinant protein-based vaccine candidate was selected in July 2020 by US government’s Operation Warp Speed, a US government initiative to speed the development of treatments and vaccines for COVID-19. The companies have also updated governments and the European Commission, where a contractual commitment to purchase the vaccine has been made.
Lilly, Incyte Report Positive Data for Baricitinib for Treating COVID-19
Eli Lilly and Company and Incyte, a Wilmington, Delaware-based biopharmaceutical company, report positive results from their Phase III study of Olumiant (baricitinib), a drug already approved for treating rheumatoid arthritis, in combination with Gilead Sciences’ remdesivir in treating COVID-19, and the publishing of the data in The New England Journal of Medicine. In the study, the combination of baricitinib and remdesivir reduced median time to recovery in hospitalized COVID-19 patients from eight days to seven days.
Last month (November 2020), Lilly received emergency use authorization from the US Food and Drug Administration for baricitinib, in combinatioin with remdesivir, as a treatment for COVID-19 in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Source: Eli Lilly and Company, Incyte, and the National Institute of Allergy and Infectious Diseases
Novartis Reports Disappointing Results of Anticancer Drug for COVID-19
Novartis and Incyte, a Wilmington, Delaware-based biopharmaceutical company, report disappointing results from a Phase III study of their drug Jakafi (ruxolitinib), an anticancer drug, that evaluated hospitalized patients with severe COVID-19 associated cytokine storm.
Ruxolitinib is approrved for treating myelofibrosis (a form of bone-marrow cancer), polycythemia vera (a form of bone-marrow cancer), and acute graft-versus-host disease.
The drug failed to meet its primary endpoint and showed that treatment with ruxolitinib plus, standard of care did not reduce the number of hospitalized COVID-19 patients who experienced severe complications (death, mechanical ventilation, or intensive care unit care). The companies also report that the trial also did not show clinically relevant benefit among secondary and exploratory endpoints, including mortality rate, and time to recovery (no longer infected, or ambulatory with no or minimal limitations).
The study is complete, and the data will be further analyzed to determine any potential impact on other studies of ruxolitinib in patients with COVID-19 and will be submitted for publication.
CureVac Initiates Phase IIb/III Trial for COVID-19 Vaccine
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics, has enrolled the first participant in its Phase IIb/III study of its mRNA vaccine candidate against COVID-19, CVnCoV.
The Phase IIb/III trial will assess the safety and efficacy of CVnCoV in adults at a dose of 12 µg. The study is expected to include more than 35,000 participants at sites in Europe and Latin America.
Following completion of the trial, subjects will continue to be monitored in a one-year extension study. The extension study will collect additional data to evaluate long-term safety, persistence of antibodies to SARS-CoV-2, the virus that causes COVID-19, and the occurrence of COVID-19 cases to assess the duration of vaccine efficacy.
CSL Decides Not To Advance COVID-19 Vaccine
The University of Queensland (UQ) in Australia and CSL report that they will not progress their COVID-19 vaccine candidate to Phase II/III clinical trials following consultation with the Australian government after Phase I results.
UQ commenced a Phase I trial of the COVID-19 vaccine candidate in July 2020 to assess safety and immunogenicity in healthy volunteers. CSL was working toward taking responsibility for a Phase II/III clinical trial and large-scale manufacture of the vaccine, upon completion of successful trials. There were no serious adverse events or safety concerns reported in the 216 trial participants of the Phase I trial.
The Phase I data also showed the generation of antibodies directed toward fragments of a protein (gp41), which is a component used to stabilize the vaccine. Trial participants were fully informed of the possibility of a partial immune response to this component, but it was unexpected that the levels induced would interfere with certain HIV tests. The companies say there is no possibility the vaccine causes infection, and routine follow-up tests confirmed there is no HIV virus present.
With advice from experts, CSL and UQ have worked through the implications that this issue presents to rolling out the vaccine into broad populations. It is generally agreed that significant changes would need to be made to well-established HIV testing procedures in the healthcare setting to accommodate the rollout of this vaccine. Therefore, CSL and the Australian government have agreed vaccine development will not proceed to Phase II/III trials.
The Phase I trial will continue, where further analysis of the data will show how long the antibodies persist, with studies so far showing that levels are already falling. UQ plans to submit the full data for peer-reviewed publication.
Inovio Receives $36.7-M US Gov’t Grant for COVID Treatment
Inovio, a Plymouth Meeting, Pennsylvania-based biopharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, has received a $37.6-million grant from the US government to develop DNA-encoded monoclonal antibodies (dmAbs) as both a therapeutic and preventive treatment for COVID-19.
Inovio and a team of scientists from The Wistar Institute, a biomedical research institution at the University of Pennsylvania, AstraZeneca, the University of Pennsylvania, and Indiana University received the $37.6-million grant from the US Defense Advanced Research Projects Agency (DARPA), a research and development agency of the US Department of Defense and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.
As part of DARPA’s two-year grant, Inovio and Wistar teams will construct COVID-19 dmAb candidates mirroring AstraZeneca’s traditional recombinant monoclonal antibody candidates currently being tested in clinical trials to treat COVID-19. The dMAb candidates will then be advanced into preclinical studies and then into first-in-human clinical trials within one year of funding.
News on COVID-19 testing
FDA OKs First OTC At-Home Diagnostic Test for COVID-19
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19.
The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample from any individual 2 years of age or older.
The announcement follows the authorization of the first prescription COVID-19 test for home use and the announcement of the first non-prescription test system, in which a lab processes the self-collected sample. The FDA has authorized more than 225 diagnostic tests for COVID-19 since the start of the pandemic, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing. The Ellume COVID-19 Home Test is the first COVID-19 test that can be used completely at home without a prescription.
Full details of how the Ellume COVID-19 Home Test can be found here.
Source: US Food and Drug Administration
FDA OKs COVID-19 Rx Home Test
The US Food and Drug Administration (FDA) has issued a new emergency use authorization (EUA) for a COVID-19 test for use by patients at home with a prescription.
The BinaxNOW COVID-19 Ag Card Home Test is authorized for prescription use at home with self-collected nasal swab samples. The test will be offered in partnership with a telehealth service that will take users step-by-step through the sample collection process and provide assistance in reading and understanding the results. The telehealth provider will also report all test results to the relevant public health authorities in accordance with local, state, and federal requirements.
A different product than this home use test, the BinaxNOW COVID-19 Ag Card, from Abbott Diagnostics Scarborough’s, a Scarborough, Maine company that manufactures surgical and medical instruments, is authorized for use at the point-of-care under an EUA that was issued in August 2020.
Source: US Food and Drug Administration
Roche Launches COVID-19 Antigen Test
Roche has launched its Elecsys anti-SARS-CoV-2 S antibody test in markets accepting the CE Mark and has also filed for emergency use authorization (EUA) from the US Food and Drug Administration (FDA). 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.
The Elecsys SARS-CoV-2 Antigen test is for the in vitro qualitative detection of the nucleocapsid antigen of SARS‑CoV‑2, the virus that causes COVID-19.
Roche says it will be able to ramp up production to a double-digit million number of tests per month, in early 2021, depending on the demand of healthcare systems, globally.