Pharma COVID Roundup: News from Moderna, AstraZeneca, and RocheBy
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Moderna, AstraZeneca, Roche, J&J, Pfizer, Novavax, CureVac, Sinovac, and Thermo Fisher.
Manufacturing and supply of COVID-19 vaccines and drugs
EMA OKs Additional Mfg Sites for J&J’s, Pfizer’s/BioNTech’s COVID-19 Vaccines
The European Medicines Agency’s Committee for Medicinal Products for Human Use has approved additional manufacturing sites for the production of Johnson & Johnson’s (J&J) and Pfizer’s/BioNTech’s respective COVID-19 vaccines.
The J&J site, located in Anagni, Italy, is operated by Catalent. The site will perform finished product manufacturing. The site is expected to support the continued supply of J&J’s COVID-19 vaccine in the European Union (EU).
The EMA approved two sites for the PfizerBioNTech vaccine. One Pfizer/BioNTech site, located in Reinbek, Germany, is operated by Allergopharma. The other site in Stein, Switzerland is operated by Novartis. The sites will perform finished-product manufacturing steps at different stages of the process. The two new sites are expected to support the continued supply of the companies’ COVID-19 vaccine in the EU.
Source: European Medicines Agency (J&J) and European Medicines Agency (Pfizer/BioNTech)
WHO, IMF, WTO, World Bank Bank Meet To Set COVID-19 Vaccine Targets
The heads of the World Bank Group, International Monetary Fund, World Health Organization, and World Trade Organization convened late last month (June 2021) the first meeting of the Task Force on COVID-19 Vaccines, Therapeutics and Diagnostics for Developing Countries to discuss the urgency of increasing supplies of vaccines, therapeutics, and diagnostics for developing countries. The task force also looked at practical and effective ways to track, coordinate, and advance delivery of COVID-19 vaccines to developing countries.
As a first step, the task force is calling on G20 countries to: (1) support COVID-19 vaccination targets of at least 40% in every country by the end of 2021 and at least 60% by the first half of 2022; (2) share more vaccine doses now, including by ensuring at least 1 billion doses are shared with developing countries in 2021 starting immediately; (3) provide financing, including grants and concessional financing, to close funding gaps; and (4) remove all barriers to export of inputs and finished vaccines and other barriers to supply-chain operations.
In addition, to enhance transparency, the task force agreed to compile data on dose requests (by type and quantity), contracts, deliveries (including through donations), and deployments of COVID-19 vaccines to low and middle-income countries and make it available as part of a shared country-level dashboard.
Source: World Health Organization
Updates on COVID-19 treatments and vaccines
FDA Authorizes Roche’s Arthritis Drug for Treating COVID-19
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Roche’s Actemra/RoActemra (tocilizumab), a drug for treating rheumatoid arthritis, for the treatment of COVID-19. The drug was authorized for treating hospitalized adults and pediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The EUA is based on results from four randomized, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. The results of these studies suggest that Actemra/RoActemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.
Source: Roche and the US Food and Drug Administration
Moderna’s COVID Vaccine Gets Emergency Use Authorization in India
Moderna’s COVID-19 vaccine has been granted emergency use authorization by the Indian government. Separately, Moderna has provided clinical updates regarding its COVID-19 vaccine against emerging variants.
The government of India issued a registration certificate and a permission to import Moderna’s COVID-19 vaccine for restricted use in an emergency situation. With the authorization in India, Moderna has received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine from health agencies in more than 50 countries and an emergency use listing from the World Health Organization.
Separately, the company announced new results from in vitro neutralization studies of sera from individuals vaccinated with its COVID-19 vaccine showing activity against variants of SARS-CoV-2, the virus that causes COVID-19. The company reported that vaccination with Moderna’s COVID-19 vaccine produced neutralizing titers against all variants tested, including additional versions of the Beta variant (B.1.351, first identified in South Africa), three lineage variants of B.1.617 (first identified in India), including the Kappa (B.1.617.1) and the Delta variants (B.1.617.2); the Eta variant (B.1.525, first identified in Nigeria); and the A.23.1 and A.VOI.V2 variants first identified in Uganda and Angola, respectively.
Moderna is pursuing a clinical development strategy against emerging variants as the virus continues to evolve. The company is also studying mRNA-1273.211, a multivalent booster candidate, which combines a 50-50 mix of mRNA-1273, Moderna’s authorized vaccine against ancestral strains, and mRNA-1273.351, the company’s strain-matched booster, in a single vaccine at several dose levels in an ongoing study.
Source: Moderna (emergency use authorization) and Moderna (clinical update)
FDA Adds Warning to COVID-19 Vaccines for Heart Risks
The US Food and Drug Administration (FDA) has made revisions to the patient and provider fact sheets for Moderna’s and Pfizer’s/BioNTech’s COVID-19 vaccines regarding possible increased risks after vaccination of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart).
For each vaccine, the fact sheet for vaccination providers and the fact sheet for recipients and caregivers has been revised to include a warning about myocarditis and pericarditis. This update follows a review of information and discussion by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting last month (June 2021).
Source: US Food and Drug Administration
AstraZeneca Provides Updates for COVID-19 Vaccine
AstraZeneca has provided updates regarding the immunity response of its COVID-19 vaccine, Vaxzevria, and has provided clinical trial updates for its new COVID-19 variant vaccine candidate, AZD2816.
The company reported that a sub-analysis from the trials led by Oxford University with Vaxzevria induced strong immune responses following either a prolonged second dose interval of up to 45 weeks or following a third boosting dose. In addition, a third dose of Vaxzevria given at least six months after a second dose, boosted antibody levels six-fold and maintained T cell response. A third dose also resulted in higher neutralizing activity against the Alpha (B.1.1.7, “Kent”), Beta (B.1.351, “South African”) and Delta (B.1.617.2, “Indian”) variants. Both the late second dose and the third dose of Vaxzevria were less reactogenic than the first dose.
Additionally, the company announced the first participants were dosed in a Phase II/III trial for AZD2816. The trial will recruit approximately 2,250 participants across the UK, South Africa, Brazil, and Poland.
AZD2816 will be administered to individuals who have previously been fully vaccinated with two doses of Vaxzevria, or a mRNA vaccine, at least three months after their last injection. In non-vaccinated individuals, AZD2816 will be given as two doses, four or twelve weeks apart, or given as a second dose following a first dose of Vaxzevria four weeks apart.
Source: AstraZeneca (immunity) and AstraZeneca (variant)
Novavax Reports Positive Phase III Results of COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, reports positive results from the final analysis of a Phase III clinical trial in the UK of its COVID-19 vaccine candidate.
The final analysis confirmed an overall efficacy of 89.7% with over 60% (half) of the cases caused by the B.1.1.7 (Alpha) variant, and a 96.4% efficacy against non-B.1.1.7 (non-Alpha) variants, which represents strains most similar to the original virus.
CureVac Reports Results from Phase IIb/III Trial of COVID-19 Vaccine
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, has reported results from the final analysis of its Phase IIb/III study of its COVID-19 vaccine candidate, CVnCoV.
In the context of 15 strains circulating within the study population at the time of final analysis, CVnCoV demonstrated an overall vaccine efficacy of 48% against COVID-19 disease of any severity, including single non-respiratory mild symptoms. Protection was demonstrated among participants in the age group of 18 to 60, with an efficacy of 53% against disease of any severity. Across all 15 identified strains, protection against moderate-to-severe disease was calculated to be 77%. In the same age group, CVnCoV provided 100% protection against hospitalization or death.
The study will continue to complete follow-up analyses for trial participants. Available data have been communicated to the European Medicines Agency.
Beyond CVnCoV, the company is developing COVID-19 vaccine candidates in partnership with GlaxoSmithKline (GSK). These candidates are based on new mRNA backbones and include potential variants in multivalent vaccine formats as well as combination vaccines for potential protection against multiple infectious diseases in a single injection. CureVac and GSK expect to progress the vaccine candidate into clinical testing in the third quarter of 2021, with the goal of introducing the vaccine in 2022, subject to regulatory approval.
Sinovac Reports Phase I/II Results of COVID-19 Vaccine in Adolescents
Sinovac Biotech, a Beijing, China-based bio/pharmaceutical company, has reported positive results from Phase I/II clinical trials in China of CoronaVac, its COVID-19 vaccine, in healthy children and adolescents aged three to 17.
The company reported that findings indicate that, after receiving two doses of the vaccine in a 28-day interval, CoronaVac was safe, well tolerated, and induced a strong antibody response in children and adolescents aged three to 17. Prior to this, China had approved the emergency use of CoronaVac in this age group last month (June 2021).
News on COVID-19 testing
Thermo Fisher Launches SARS-CoV-2 Saliva Test
Thermo Fisher Scientific has launched a self-collection saliva kit for SARS-CoV-2 research and surveillance.
The SpeciMAX Saliva Collection Kit is designed for raw saliva collection. The self-collection kits facilitate clean saliva transfers and fit into viral RNA extraction and direct-to-PCR downstream automation workflows for high throughput surveillance testing.
Source: Thermo Fisher Scientific