Pharma COVID Roundup: News from Pfizer, Moderna, J&J, GSK, Novavax
The latest on manufacturing and potential treatments for COVID-19 with news from Pfizer, Moderna, J&J, GSK, Novavax, Alexion, CureVac, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
EU In Talks to Purchase More Doses of Pfizer’s/BioNTech’s COVID-19 Vaccine
The European Commission (EC) has proposed to European Union (EU) member states to purchase an additional 200 million doses of Comirnaty, Pfizer’s and BioNTech’s COVID-19 vaccine, with the option to acquire another 100 million doses. BioNTech is in talks with the EC to purchase the additional doses
This proposal would enable the EU to purchase an additional 200 million doses of Comirnaty to be supplied to the 27 EU member states, with an option for the EC to request an additional 100 million doses. This would add to the 300 million doses that have already been committed to the EU through 2021 under the original supply agreement signed between the parties last year (2020).
The additional doses would be delivered starting in the second quarter of 2021. This would bring the total number of doses to be delivered to EU member states by the end of 2021 to 500 million doses, with the potential for an additional 100 million if the option is exercised.
In addition to the Pfizer/BioNTech vaccine, a second vaccine, produced by Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, was authorized in the EU on January 6 2021, with other vaccines under development.
Novavax, Australian Gov’t in Supply Pact for COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has executed an advance purchase agreement with the Australian government to supply 51 million doses of its COVID-19 vaccine candidate, NVX-CoV2373.
This follows an agreement in principle that was announced in November 2020. NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’s proprietary adjuvant, Matrix-M to enhance the immune response.
Novavax is currently conducting late-stage clinical studies to demonstrate the efficacy, safety and immunogenicity of NVX-CoV2373 for the prevention of COVID-19. This includes two large Phase III clinical trials in the US, Mexico and the UK, as well as a Phase IIb trial in South Africa.
Novavax says it will work with Australia’s regulatory agency, the Therapeutics Goods Administration, to obtain product approvals upon demonstrating efficacy in clinical studies. The company says it aims to deliver initial doses by mid-2021. As part of the agreement, Australia will have the option to purchase up to an additional 10 million doses. Additional terms of the agreement were not disclosed.
Updates on COVID-19 treatments and vaccines
Moderna’s COVID-19 Vaccine Authorized in UK, Switzerland
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and Swissmedic, the Swiss pharmaceutical regulatory agency, have approved its COVID-19 vaccine.
The UK government has also exercised its option to purchase an additional 10 million doses of the vaccine to bring its confirmed order commitment to 17 million doses. The first deliveries of the COVID-19 vaccine to the UK from Moderna’s dedicated non-US supply chain are expected to commence early in 2021.
The Swiss government has secured 7.5 million doses of Moderna’s COVID-19 vaccine. Following this authorization, the first deliveries are expected to begin in Switzerland in the next week (as reported on January 12, 2021).
Moderna has also received authorization for its COVID-19 vaccine from regulatory authorities in the US, Canada, Israel, and the European Union. Additional authorizations are currently under review in other countries, including Singapore, and by the World Health Organization.
Pfizer Reports Early Results Evaluating COVID-19 Vaccine Against New Strains
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, report results from an in vitro study evaluating their COVID vaccine against two highly transmissible strains of SARS-CoV-2, the virus that causes COVID-19. The study showed that the antibodies from people who received the vaccine effectively neutralized SARS-CoV-2 with a key mutation that is also found in two highly transmissible strains. The study was conducted by Pfizer and the University of Texas Medical Branch (UTMB). The results are available here.
Pfizer, BioNTech, and UTMB say they are encouraged by these early, in vitro study findings. Further data are needed to monitor the vaccine’s effectiveness in preventing COVID-19 caused by new virus variants. If the virus mutates such that an update to the vaccine is required to continue to confer protection against COVID-19, the companies believe that the flexibility of BioNTech’s proprietary mRNA vaccine platform is well suited to enable an adjustment to the vaccine.
J&J Publishes Positive Interim Data for COVID-19 Vaccine
Johnson & Johnson (J&J) has published positive interim Phase I/IIa data for its single-dose regimen of its investigational COVID-19 vaccine candidate (JNJ-78436735) being developed by the Janssen Pharmaceutical Companies of J&J.
The interim data demonstrated that JNJ-78436735 provided an immune response that lasted for at least 71 days, the duration of time measured in this study in participants aged 18-55 years. A preview of part of these interim data was posted on medRxiv in September 2020.
The company anticipates announcing topline Phase III data for its single-dose Janssen COVID-19 vaccine candidate in late January 2021. If the single-dose vaccine is shown to be safe and effective, the company expects to submit an application for emergency use authorization with the US Food and Drug Administration shortly afterwards, with other regulatory applications around the world to be made subsequently.
Janssen is investigating multiple doses and dosing regimens of its COVID-19 vaccine candidate to evaluate long-term efficacy. The company is studying a single-dose of its vaccine candidate in a Phase III trial, which completed enrollment on December 17, 2020, and a two-dose regimen in a Phase III study which is ongoing.
Source: Johnson & Johnson
GSK, Vir in Pact with UK Gov’t for COVID-19 Treatment
GlaxoSmithKline and Vir Biotechnology, a San Francisco-based clinical-stage biopharmaceutical company, have announced an agreement with the UK government to evaluate VIR-7832, the companies’ investigational drug for treating mild-to-moderate COVID-19, in a Phase Ib/IIa clinical trial. The trial is due to begin in the first quarter of 2021.
The companies say that preclinical data suggests VIR-7832 has two distinguishing properties: an enhanced ability to clear infected cells and the potential to enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.
VIR-7832 is set to become the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment. The first antibody, VIR-7831, is currently being investigated in two global Phase III studies: for the early treatment of COVID-19 in patients who are at high risk of hospitalization and for the treatment of hospitalized patients with COVID-19.
Alexion Pauses Enrollment of Phase III Study of Rare-Disease Drug for COVID-19
Alexion Pharmaceuticals, a Boston-based biopharmaceutical company, has announced plans to pause further enrollment in a global Phase III study of (ravulizumab-cwvz) for treating patients with severe COVID-19 requiring mechanical ventilation. Ultomiris is approved indicated to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disease that causes red blood cells to break apart.
This decision is based on the recommendation of an independent data monitoring committee (IDMC) following its review of data from a pre-specified interim analysis. The IDMC recommended that additional enrollment be paused, pending further analysis of the data, due to lack of efficacy when Ultomiris was added to best supportive care, compared to best supportive care alone. There were no new safety findings observed. The company says the study will continue for patients already enrolled, including completion of all study visits and planned Ultomiris dosing according to the study protocol.
In the UK, a study led by Cambridge University Hospitals NHS Foundation Trust, which includes an Ultomiris cohort, is evaluating the potential of earlier immune modulatory treatment (hospitalized patients not requiring mechanical ventilation) in preventing progression of the virus, including reducing the need for ICU admission and ventilation. This independent study remains ongoing.
Source: Alexion Pharmaceuticals
CureVac Reports Positive Early Results for COVID-19 Vaccine
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics, has reported preclinical data of its COVID-19 vaccine candidate, CVnCoV, in non-human primates.
The company reported the publication of preclinical data demonstrating the induction of antibody and T cell responses of CVnCoV in non-human primates. Furthermore, rhesus macaques were shown to be protected from challenge infection with SARS-CoV-2, the virus that causes COVID-19, following vaccination with 8 µg of CVnCoV. The company says that the data provided evidence on the immunogenicity and protective efficacy of CVnCoV at low doses, supporting the ongoing international clinical Phase IIb/III efficacy study applying a 12-µg dose.