Pharma COVID Roundup: News from Moderna, AstraZeneca, Lilly, RocheBy
The latest on manufacturing, potential treatments, and testing for COVID-19 with news from Moderna, AstraZeneca, Lilly, Roche, Thermo Fisher, Inovio, Sinovac, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
Moderna Expands COVID Vaccine Supply Pacts with Israel, Swiss, Canadian Gov’ts
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has expanded separate supply agreements with the governments of Israel, Canada, and Switzerland for additional doses of its vaccine candidate against COVID-19, mRNA-1273.
Moderna expanded its supply agreement with the Ministry of Health of Israel for an additional 4 million doses of mRNA-1273. The Israeli government has now secured 6 million doses of mRNA-1273. The company has already initiated the rolling regulatory review process with the Ministry of Health in Israel.
The Canadian government has increased its confirmed order commitment by 20 million doses of mRNA-1273 to bring its confirmed order commitment to 40 million doses. Moderna says it could ship the vaccine as soon as this month (December 2020) if regulatory approval is granted in Canada this month (December 2020). The company has already initiated the rolling review process with Health Canada, Canada’s national pharmaceutical regulatory agency. The Canadian vaccine supply will be sourced from Moderna’s European production capacity with its strategic manufacturing partners, Lonza and Laboratorios Farmacéuticos Rovi of Spain, a pan-European pharmaceutical company and CDMO, for fill–finish services.
Additionally, the Swiss federal government has increased its confirmed order commitment of the vaccine from 4.5 million to 7.5 million doses of mRNA-1273. Swiss vaccine supply will be sourced from Moderna’s European production capacity with its manufacturing partners, Lonza and Rovi.
Overall, Moderna says it continues to scale up its global manufacturing of its vaccine to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021.
Moderna has also submitted a request for emergency use authorization to the US Food and Drug Administration for the vaccine with the FDA scheduled to review the request next week (December 17, 2020). It has also filed for conditional approval with the European Medicines Agency, with the agency scheduled to provide an evaluation no later than January 12, 2020. In addition, the company says it intends to seek prequalification and/or emergency use listing with the World Health Organization.
Moderna has reported efficacy of 94.1% for the vaccine based on an interim and confirmatory analysis from a Phase III study of mRNA-1273.
Source: Moderna (Israel), Moderna (Canada), and Moderna (Switzerland)
Updates on COVID-19 treatments and vaccines
AstraZeneca Provides Positive Interim Results for COVID-19 Vaccine
AstraZeneca has reported positive results of an interim analysis from a Phase III study of AZD1222, its COVID-19 vaccine licensed from and being developed with Oxford University.
The results demonstrated that AZD1222 is safe and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalization. The interim analysis showed that the vaccine is effective at preventing COVID-19, with no severe cases and no hospitalizations more than 21 days after first injection.
The interim analysis for efficacy was based on 11,636 participants accruing 131 symptomatic infections from the Phase III UK and Brazil trials conducted by Oxford University. The safety data published in The Lancet was from over 20,000 participants enrolled across four clinical trials in the UK, Brazil, and South Africa.
These results follow earlier results that showed the vaccine was is 70.4% effective at preventing symptomatic COVID-19 with a two-dose regimen given 14 days apart based on the pooling of two dosing regimens. A further analysis of efficacy showed that when the vaccine was given as two full doses, vaccine efficacy was 62.1% and 90.0% in participants who received a half dose followed by a full dose.
In addition to the Oxford University-led study, AstraZeneca is conducting a large study in the US and globally. In total, Oxford University and AstraZeneca expect to enroll more than 60,000 participants globally
The company says submission of data to global regulatory authorities has already begun as part of ongoing rolling reviews. The company is also seeking emergency use listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries.
With regard to manufacturing, AstraZeneca says it is making progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval.
Lilly, UnitedHealth Partner for Study of Lilly’s COVID-19 Drug
Eli Lilly and Company and UnitedHealth Group, a health insurer, have entered into a partnership to conduct a study of bamlanivimab, Lilly’s neutralizing antibody against COVID-19, in high-risk, COVID-19 infected individuals. The study will identify and treat a large, diverse population of high-risk individuals for COVID-19 with bamlanivimab under real-world conditions with a goal of reducing the severity of illness and hospitalizations.
Bamlanivimab recently received emergency use authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of mild-to-moderate COVID-19 patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.
The study will be used to detect and treat high-risk symptomatic patients who test positive for COVID-19, including through daily symptom tracking, in-home SARS-CoV-2 testing, and in-home infusion services. The study will enroll up to 500,000 people, with at least 5,000 people expected to receive bamlanivimab therapy.
Source: Eli Lilly and Company and UnitedHealth Group
Moderna Initiates Phase II/III Study of COVID-19 Vaccine in Adolescents
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has announced that the first adolescent participants have been dosed in a Phase II/III study of mRNA-1273, its vaccine candidate against COVID-19. The company says it intends to enroll 3,000 adolescent participants in the U.S. ages 12 to less than 18 years. The study is being conducted in collaboration with 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.
Inovio Initiates Phase II Trial of COVID-19 Vaccine
Inovio, a Plymouth Meeting, Pennsylvania-based biopharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, has dosed its first subject in a Phase II clinical trial evaluating INO-4800, its COVID-19 vaccine candidate, as part of a Phase II/III clinical trial in the US.
The Phase II segment of the trial will enroll approximately 400 participants who are 18 years or older at up to 17 US sites to evaluate safety and immunogenicity in order to confirm the dose(s) for the subsequent efficacy evaluation as part of the Phase III segment of the trial. The company says it plans to fully enroll the Phase II segment of the trial by the end of this month (December 2020).
The US Department of Defense has agreed to provide funding for both the Phase II and Phase III segments of the clinical trial in addition to the $71 million of funding previously announced in June (June 2020) for the large-scale manufacture of the company’s proprietary smart device, Cellectra 3PSP, and the procurement of Cellectra 2000 devices.
In a separate development, Inovio has provided updates of its vaccine in China. The company reports that it and Advaccine Biopharmaceuticals Suzhou Co., a Suzhou, China-based biopharmaceutical company, have dosed the first subject in their Phase II clinical trial evaluating INO-4800 in China.
The Phase II clinical trial being conducted in China is independent of the Phase II/III clinical trial of INO-4800 being advanced in the US and will enroll approximately 640 participants who are 18 years or older. Advaccine is conducting and funding the Phase II trial in China, which is expected to fully enroll by the end of this month (December 2020).
Source: Inovio (US) and Inovio (China)
Sinovac Secures $500-M Funding for COVID-19 Vaccine Development
Sinovac Life Sciences, a wholly owned subsidiary of Sinovac Biotech, a Beijing, China-based biopharmaceutical company, has secured approximately $500 million in funding for further development, capacity expansion, and manufacturing of CoronaVac, its COVID-19 vaccine candidate and for other development and operational activities.
The investor, Sino Biopharmaceutical Limited, a Hong Kong-based pharmaceutical conglomerate in China, through affiliates, has invested approximately $500 million in exchange for an approximately 15% equity stake in Sinovac Life Sciences.
Phase III clinical trials for CoronaVac have been approved in Brazil, Indonesia, Turkey, and Chile. In China, the company reported that results from Phase I/II trials showed that the vaccine induced neutralizing antibodies in more than 90% of volunteers who received two doses of the vaccine. The results were published in the medical journal, The Lancet Infectious Diseases.
Sinovac says it expects to be able to manufacture 300 million doses of the vaccine annually and aims to complete the construction of a second production facility by the end of 2020 to increase the annual production capacity of CoronaVac to 600 million doses. Depending on market conditions and the availability of financing, the company says it may seek to further expand its production capacity.
News on COVID-19 testing
FDA Authorizes First Direct-to-Consumer COVID-19 Test System
The US Food and Drug Administration has authorized the first direct-to-consumer COVID-19 test system, LabCorp’s Pixel COVID-19 Test Home Collection Kit. The test was approved for use by individuals 18 years and older without a prescription.
This product allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by a phone call from a healthcare provider. Negative test results are delivered via email or online portal.
Source: US Food and Drug Administration and LabCorp
FDA OKs COVID-19/Flu Combo Test
The US Food and Drug Administration (FDA) has authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu).
The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider.
Under a healthcare provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collection kit.
Source: US Food and Drug Administration
Roche, Moderna in Pact for COVID-19 Antibody Tests in Vaccine Trials
Roche and Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, have entered into a partnership to use Roche’s SARS-CoV-2 antibody test in research trials for Moderna’s COVID-19 vaccine, mRNA-1273
The Elecsys Anti-SARS-CoV-2 S antibody test will be used to facilitate the quantitative measurement of SARS-CoV-2 antibodies and help to establish a correlation between vaccine-induced protection and levels of anti-receptor binding domain (RBD) antibodies. Moderna’s vaccine triggers antibody response specifically to the RBD of the SARS-CoV-2 spike protein.
This partnership with Moderna, started by using the Elecsys Anti-SARS-CoV-2 test for qualitative determination of anti-N SARS-CoV-2 antibodies. This has been part of Moderna’s vaccine trials for baselining and assessing natural infection in trial participants.
Earlier this month (December 2020), Roche announced that it had received emergency use authorization (EUA) from the US Food and Drug Administration for the Elecsys Anti-SARS-CoV-2 S antibody test.
EU OKs Thermo Fisher’s COVID-19/Flu Combo Kit
Thermo Fisher Scientific has announced CE-marking of its TaqPath COVID-19, Flu A/B, RSV Combo Kit for the in vitro diagnosis of SARS-CoV-2, the virus that causes COVID-19, influenza (flu) A/B, and respiratory syncytial virus (RSV) A/B infections.
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.
Using the new kit, laboratories can now can run a single test for SARS-CoV-2, influenza (flu) A/B, and RSV to detect and differentiate between diseases that share similar clinical symptom and get the information needed to help diagnose and monitor the spread of these respiratory illnesses in approximately three hours.
In a separate development, Thermo Fisher announced the availability of a new direct-from- saliva PCR test for COVID-19 to enable COVID-19 surveillance testing. The Applied Biosystems TaqCheck SARS-CoV-2 Fast PCR Assay uses raw saliva samples and simplifies lab workflows using instruments that are available globally to deliver data quickly.
The company also introduced the Safe Campus Reopening Program to subsidize the cost of the test for US colleges, universities, and post-secondary institutions. Availability of this program coincides with recent guidance issued by the Centers for Disease Control and Prevention that calls for expanded COVID-19 surveillance using PCR-based tests with turnaround times within 24-48 hours.
Source: Thermo Fisher Scientific (CE Mark) and Thermo Fisher Scientific (PCR test)