Pharma COVID Roundup: News from Pfizer, GSK, Sanofi, BI, ModernaBy
The latest on manufacturing, potential treatments, and testing for COVID-19 with news from Pfizer, GSK, BI, Sanofi, Roche, Moderna, Novavax, Hetero, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
EC, Pfizer/BioNTech Agree To Accelerate COVID-19 Vaccine Delivery
The European Commission (EC) and Pfizer/BioNTech have agreed to accelerate the delivery of 10 million doses of Pfizer’s/BioNTech’s COVID-19 vaccine to the European Union for the second quarter of 2021.
The accelerated delivery of 10 million doses of the vaccine will bring delivery in the second quarter 2021 to the EU up to more than 200 million doses.
The doses would be drawn forward from the EU’s option of 100 million doses in a second Pfizer/BioNTech contract, foreseen for the third quarter and the fourth quarter of 2021. The proposal by the EC needs to be approved by EU member states in the joint Steering Board.
Source: European Commission
Hetero Agrees to Produce Russia’s COVID-19 Vaccine
Hetero, a Hyderabad, India-headquartered generics pharmaceutical company and contract manufacturer, through its biologics arm, Hetero Biopharma, has agreed to produce in India more than 100 million doses of Sputnik V, a COVID-19 vaccine developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology.V. Hetero formed the agreement with the Russian Direct Investment Fund (RDIF), a sovereign wealth fund in Russia.
Sputnik V is made up of two different viruses belonging to the adenovirus family, Ad26 and Ad5. These adenoviruses have been modified to contain the gene for making the SARS-CoV-2 spike protein. The two adenoviruses are given separately. Ad26 is used in the first dose, and Ad5 is used in the second to boost the vaccine’s effect.
Currently, Phase III clinical trials are approved and are ongoing in Belarus, the United Arab Emirates, Venezuela and other countries, as well as Phase II/III trials in India. Vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea, and other countries. The companies say requests for more than 1.2 billion doses of Sputnik V vaccine came from more than 50 countries.
The companies intend to start the production of Sputnik V in 2021.
Source: Hetero Labs
Updates on COVID-19 treatments and vaccines
Novavax Reports Efficacy Results of its COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, reports that efficacy rates for its COVID-19 vaccine against the original COVID-19 strain and the South African variant.
Novavax reported efficacy of 96.4% against mild, moderate, and severe disease caused by the original COVID-19 strain in a Phase III trial in the UK. The company also reports efficacy of 55.4% against the South African variant (B1.351) from a Phase IIb trial in South Africa among HIV- negative trial participants. Across both trials, NVX-CoV2373 demonstrated 100% protection against severe disease, including all hospitalization and death.
Moderna in Pediatric COVID-19 Vaccine Trial; Evaluates Refrigerator-Stable Vaccine
Moderna, a biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has dosed the first participants in a Phase II/III pediatric study evaluating its COVID-19 vaccine and has begun a Phase I study evaluating a potential refrigerator-stable COVID vaccine, mRNA-1283.
The Phase II/III pediatric study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health and 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 company intends to enroll approximately 6,750 pediatric participants in the US and Canada ages six months to less than 12 years.
Separately, Moderna is evaluating mRNA-1283 in a Phase I study as a potential refrigerator-stable mRNA vaccine. The Phase I study will evaluate three dose levels, 10 µg, 30 µg, and 100 µg in healthy adults as a two-dose series, 28 days apart, and as a one-dose level, 100 µg, in healthy adults in a single dose. These will be compared with a two-dose series of 100 µg of mRNA-1273, the company’s currently authorized COVID-19 vaccine and dose level. mRNA-1283 is intended to be evaluated in futures studies for use as a booster dose for previously vaccinated or seropositive as well as in a primary series for seronegative individuals.
GSK, Medicago Start Phase III Trial of COVID-19 Vaccine
GlaxoSmithKline (GSK) and Medicago, a Quebec-based biopharmaceutical company, have started a Phase III clinical trial of Medicago’s plant-derived COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant.
Medicago received approval from Canadian and US regulatory authorities to proceed with enrolment of healthy adults in the Phase III portion of the Phase II/III trial based on positive interim Phase II results.
Medicago’s plant-derived COVID-19 vaccine candidate uses coronavirus virus-like particles technology with the vaccine composed of recombinant spike glycoprotein expressed as virus-like-particles co-administered with GSK’s pandemic adjuvant. The companies started the Phase II/III clinical trials in November 2020. The Phase II portion of the trial is approaching completion, and results are expected to be made publicly available in April 2021.
The vaccine candidate, in combination with the pandemic adjuvant, was granted fast-track designation by the US Food and Drug Administration in February (February 2021).
BI Discontinues Phase II Trial for COVID-19 Drug
Boehringer Ingelheim has decided to discontinue a Phase II study assessing the company’s investigational candidate, BI 764198, for reducing the risk or severity of acute respiratory distress syndrome in patients hospitalized for COVID-19 and requiring non-invasive oxygen support.
The decision is based on the recommendation of the trial’s independent data monitoring committee after an interim look at unblinded safety and efficacy data showing a lack of benefit for use of BI 764198 in patients hospitalized for COVID-19 and needing oxygen support.
The company says a final assessment of the efficacy and safety of the compound will be published in the coming months (as reported on March 12, 2021), following review of the full trial data set.
Source: Boehringer Ingelheim
Sanofi, Translate Bio Initiate Phase I/II Trial of COVID-19 Vaccine
Sanofi Pasteur, the vaccines business unit of Sanofi, and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, have started a Phase I/II clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. The companies expect interim results from this trial in the third quarter of 2021.
Preclinical studies are ongoing and will continue over the next several months (as reported on March 12, 2021) to evaluate whether MRT5500, as well as additional mRNA vaccine candidates, will induce neutralizing antibodies against the emerging SARS-CoV-2 variants, with the potential to inform current and future clinical development.
The joint development team is working on improving the temperature stability of the mRNA vaccine candidate and are targeting a -20°C storage temperature for late-stage clinical trials and at launch. Efforts are also underway to enable the product to be stable at routine refrigerator temperature (2-8°C).
MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.
News on COVID-19 testing
Roche Launches SARS-CoV-2 Variant Test
Roche has launched a COVID-19 test, the cobas SARS-CoV-2 Variant Set 1 Test, to detect and differentiate mutations found in variants that originated in the UK, South Africa, and Brazil.
The company says the research-use laboratory test can be used to help scientists track mutation prevalence and to assess any potential impact on diagnostics, vaccines, and therapeutics.
FDA OK First COVID Test Using Traditional Premarket Review Process
The US Food and Drug Administration (FDA) has granted marketing authorization to BioFire Diagnostics’ COVID-19 test, making it the first marketing authorization for a diagnostic test using a traditional premarket review process.
The BioFire Respiratory Panel 2.1 (RP2.1) is a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs obtained from individuals suspected of COVID-19 and other respiratory tract infections.
The test had previously received emergency use authorization by the FDA in May 2020 and is now approved using the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. It is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency. In granting the De Novo approval, the FDA has also revoked the emergency use authorization for the test.
Source: US Food and Drug Administration