Pharma COVID Roundup: News from Pfizer, Moderna, Roche, and J&JBy
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Pfizer, Moderna, J&J, Roche, AstraZeneca, Sanofi, GSK, Regeneron, Emergent BioSolutions, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
Pfizer/BioNTech, Moderna Update COVID-19 Mfg Activity
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have signed a letter of intent with Eurofarma Laboratórios, a Sao Paulo, Brazil-based bio/pharmaceutical company, to manufacture Comirnaty, their COVID-19 vaccine, for distribution within Latin America. Separately, the European Medicines Agency (EMA) has approved additional manufacturing sites for the production of COVID-19 vaccines from Pfizer/BioNTech and Moderna.
Pfizer/BioNTech Partner with Eurofarma in Latin America
Under the companies’ agreement, Eurofarma will perform manufacturing activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which includes more than 20 manufacturing facilities. Activities will begin immediately (as reported on August 26, 2021) to facilitate Eurofarma’s involvement in the process, technical transfer, on-site development, and equipment installation. Per the agreement, Eurofarma will obtain drug product from facilities in the US, and manufacturing of finished doses will commence in 2022. At full operational capacity, the annual production is expected to exceed 100 million finished doses annually. All doses will exclusively be distributed within Latin America.
COVID-19 Vaccine Mfg in the EU
Separately, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted recommendations that will increase manufacturing capacity and supply of Pfizer’s/BioNTech’s and Moderna’s COVID-19 vaccines in the European Union (EU).
The CHMP approved an additional manufacturing site in Saint Rémy sur Avre, France, operated by Delpharm, a Boulogne-Billancourt, France-based CDMO, for the production of Comirnaty, Pfizer’s/BioNTech’s COVID vaccine. Delpharm will manufacture finished product and provide up to 51 million additional doses in 2021.
The EMA also approved a new manufacturing line at BioNTech’s manufacturing site in Marburg, Germany, which increases the active substance manufacturing capacity by approximately 410 million doses in 2021.
The CHMP has also approved an additional manufacturing site in Bloomington, Indiana and operated by Catalent for finished product manufacturing of Spikevax, Moderna’s COVID-19 vaccine. The CHMP also approved several alternative sites responsible for batch control/testing and packaging of the finished product of Moderna’s vaccine manufactured by Catalent. In addition, in July (July 2021), the CHMP approved a scale-up of the active substance manufacturing process for Moderna’s COVID-19 vaccine at two sites in the US: Moderna’s site in Norwood, Massachusetts and Lonza Biologics’ site in Portsmouth, New Hampshire. All together, these changes are estimated to allow for the production of 40 million additional doses of Spikevax to supply the EU market in the third quarter of 2021.
Spanish Gov’t OKs Purchase of Sanofi’s/GSK’s COVID-19 Vaccine
Spain’s Council of Ministers has authorized the purchase of 500,000 doses of Sanofi’s/GlaxoSmithKline’s (GSK) COVID-19 vaccine with delivery scheduled for the first quarter of 2022.
Within the framework of the European Vaccination Strategy, the European Commission formalized an advance acquisition agreement (APA) with Sanofi and GSK for the development, production, and priority options for purchasing and supplying a vaccine against COVID-19.
Thus far, APAs have been formalized in the European Union with eight bio/pharmaceuticals companies: AstraZeneca, Sanofi/GSK, CureVac, Johnson & Johnson’s Janssen, Pfizer/BioNTech, and Moderna. The APAs were made prior to the authorization of the vaccine to allow clinical trials to continue, begin industrial manufacturing, and proceed to scale-up production after the relevant authorization. Thus far, four COVID-19 vaccines (from AstraZeneca, J&J, Pfizer/BioNTech, and Moderna) have obtained marketing authorization from the European Commission.
Updates on COVID-19 treatments and vaccines
UK Authorizes Moderna’s COVID-19 Vaccine for Adolescents; Other Updates
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has extended the current UK authorization of Spikevax, Moderna’s COVID-19 vaccine, to allow its use in adolescents aged 12 to 17 years old. Additionally, Moderna has completed the rolling submission process for its biologics license application (BLA) to the US Food and Drug Administration (FDA) for the full licensure of its COVID-19 vaccine in individuals 18 years of age and older.
In the UK, the conditional marketing authorization (CMA) extension granted by the MHRA to adolescents aged 12 to 17 years old is valid in Great Britain only. It was approved via the European Commission Decision Reliance Route, under which the marketing authorization application made by the company references the decision made by the EMA’s Committee for Medicinal Products for Human Use. Spikevax is already authorized in adolescents aged 12-17 years in Northern Ireland under the CMA extension granted by the European Medicines Agency in July 2021. The Spikevax vaccine is also authorized in the UK in adults aged 18 years and over.
BLA to the FDA
In the US, as part of the completed BLA submission, Moderna has requested priority review of its COVID-19 vaccine by the FDA. The FDA’s fast-track designation received in May 2020 permitted Moderna to submit sections of the BLA on a rolling basis, and Moderna announced the initiation of the BLA submission on June 1, 2021.
Moderna’s COVID-19 vaccine is currently available in the US for individuals 18 years of age and older under an emergency use authorization (EUA) granted by the FDA in December 2020. Since then, Moderna has released more than 300 million doses of the vaccine to the US government. Moderna also filed for an EUA for adolescents ages 12 and above with the FDA.
UK Authorizes Regeneron’s COVID-19 Antibody Cocktail
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorization (CMA) for the antibody cocktail of casirivimab and imdevimab for treating COVID-19 from Regeneron Pharmaceuticals, a Tarrytown, New York-based bio/pharmaceutical company.
In addition to the CMA, which affects people in England, Scotland and Wales, the MHRA has also authorized emergency supply of the antibody cocktail to prevent and treat acute COVID-19 infection for people in Northern Ireland.
The antibody cocktail is authorized to treat people across the UK who have an existing infection or to prevent COVID-19 infection. The MHRA authorizations are based on results from two Phase III trials evaluating the antibody cocktail to treat high-risk non-hospitalized patients and prevent symptomatic infection in asymptomatic household contacts (both uninfected and infected) of SARS-CoV-2 infected individuals.
Regeneron invented REGEN-COV and is collaborating with Roche to increase global supply of the antibody cocktail, with Roche primarily responsible for development and distribution outside the US.
Source: Regeneron and the UK Medicines and Healthcare products Regulatory Agency
J&J Reports Data Supporting Booster Dose for COVID-19 Vaccine
Johnson & Johnson (J&J) reported data supporting a booster shot of its COVID-19 vaccine for people previously vaccinated with its single-shot COVID-19 vaccine.
In anticipation of the potential need for boosters, J&J conducted two Phase I/IIa studies in individuals previously vaccinated with its single-shot vaccine. New interim data from these studies, as reported by the company, demonstrate that a booster dose of its COVID-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination. Significant increases in binding antibody responses were observed in participants between ages 18 and 55, and in those 65 years and older who received a lower booster dose.
The company is engaging with the US Food and Drug Administration, US Centers for Disease Control and Prevention, European Medicines Agency, and other health authorities regarding boosting with its COVID-19 vaccine.
Source: Johnson & Johnson
India Authorizes Zydus Cadila’s COVID-19 Vaccine
Zydus Cadila, an Ahmedabad, India-based bio/pharmaceutical company, has received an emergency use authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D, its plasmid DNA COVID-19 vaccine.
ZyCoV-D is a three-dose vaccine. ZyCoV-D is a needle-free vaccine administered using PharmaJet, a needle-free applicator. The authorization is for adults and adolescents aged 12 to 18 years old. The company also plans to seek approval for the two-dose regimen of the vaccine.
Source: Zydus Cadila
EMA Begins Evaluation of Roche’s Arthritis Drug as COVID-19 Treatment
The European Medicines Agency (EMA) has started evaluating Roche’s anti-inflammatory medicine, RoActemra (tocilizumab), to extend its use to include treatment of hospitalized adult patients with severe COVID-19.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) will carry out an accelerated assessment of the data submitted in the application, including results from four large randomized studies in patients hospitalized with severe COVID-19, to decide whether the extension of the indication should be authorized. The CHMP’s opinion, together with any requirements for further studies and additional safety monitoring, will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU member states.
The EMA says it will communicate on the outcome of its evaluation, which is expected by mid-October (October 2021) unless supplementary information is needed.
Source: European Medicines Agency
AstraZeneca Reports Results for COVID Antibody Combo
AstraZeneca reports positive results from a Phase III pre-exposure prophylaxis trial of AZD7442, a long-acting antibody (LAAB) combination of tixagevimab and cilgavima.
The company reported that AZD7442 achieved a statistically significant reduction in the incidence of symptomatic COVID-19, the trial’s primary endpoint. The company reported that AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo. The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.
AstraZeneca says it will prepare regulatory submission of the prophylaxis data to health authorities for potential emergency use authorization or conditional approval of AZD7442. Full results from the Phase III trial will be submitted for publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting (as reported on August 20, 2021).
Emergent BioSolutions Initiates Phase III Trial of COVID-19 Treatment
Emergent BioSolutions, a Gaithersburg, Maryland-based specialty bio/pharmaceutical company and contract manufacturer, has initiated a Phase III clinical trial to evaluate its investigational SARS-CoV-2 immune globulin intravenous (COVID-HIG) plasma-derived therapy as a potential outpatient treatment for patients with COVID-19 that are at high risk of progression to severe disease.
The clinical study is sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The study will evaluate the safety and efficacy of hyperimmune globulin products derived from plasma of individuals who have recovered from COVID-19 and have developed neutralizing antibodies to SARS-CoV-2, the virus that causes COVID-19.
Source: Emergent BioSolutions
Novavax To Evaluate COVID-19 Vaccine in Immunocompromised Individuals
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, is evaluating NVX-CoV2373, its recombinant nanoparticle protein COVID-19 vaccine candidate, in the UK to evaluate the safety and immunogenicity of a third COVID-19 vaccine dose in participants with impaired immune systems.
Funded by the UK government’s Vaccines Taskforce and the UK Research and Innovation (UKRI), the study is being led by the University of Glasgow and University of Birmingham. It is a follow-on to a study to evaluate the immune response to COVID-19 vaccines in participants with impaired immune systems due to cancer, inflammatory arthritis, kidney or liver diseases, or a stem-cell transplant.
In this follow-on study, participants with lymphoid malignancies from the first study and similar studies who demonstrated low or no response to two doses of a primary COVID-19 vaccine regimen will be randomly assigned to receive a third vaccine dose from one of three manufacturers at least 14 days after completing the initial two-dose regime. The individuals may receive the same vaccine as the first two doses or one from another manufacturer. Of these participants, one third will be administered NVX-CoV2373.
Participants will be evaluated for changes in vaccine-specific immune responses and any adverse events, with findings expected later in 2021. The UK’s Medicines and Healthcare products Regulatory Agency and Joint Committee on Vaccination and Immunization will review the results to further inform the use of vaccination in immunocompromised populations.
Inovio Gets OK To Conduct Phase III Trial of COVID-19 Vaccine
Inovio, a Plymouth Meeting, Pennsylvania-based biopharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, has received regulatory authorization from the Agência Nacional de Vigilância Sanitária (ANVISA), the Brazilian national health surveillance agency, to initiate the global Phase III segment of its Phase II/III trial for INO-4800, its COVID-19 DNA vaccine.
Inovio plans to conduct the global Phase III segment in multiple countries, including Brazil, with its partner Advaccine Biopharmaceuticals Suzhou, a Suzhou, China-based bio/pharmaceutical company.
The Phase III segment of the Phase II/III clinical trial will evaluate the efficacy of INO-4800 in a two-dose regimen (2.0 mg per dose), administered one month apart, in a two-to-one randomization in men and non-pregnant women 18 years of age and older in several countries across Latin America, Asia, and Africa. The primary endpoint of the Phase III trial is virologically confirmed COVID-19.
Earlier this month (August 2021), Inovio received regulatory allowance in China for two clinical trials evaluating mixed boosted regimens of INO-4800 and CoronaVac, a COVID-19 vaccine developed by Sinovac Biotech, a Beijing-based bio/pharmaceutical company.
News on COVID-19 testing
NIH Develops New Sample Preparation Method for COVID-19 Test
Scientists at the National Institutes of Health (NIH) have developed a new sample preparation method to detect SARS-Cov-2, the virus that causes COVID-19.
The method bypasses extraction of the virus’ genetic RNA material, simplifying sample purification and potentially reducing test time and cost. The method is the result of a collaboration among researchers at the National Eye Institute, the NIH Clinical Center, and the National Institute of Dental and Craniofacial Research.
Source: National Institutes of Health
Qiagen To Increase Mfg of COVID-19 Reagents
The US Department of Defense, on behalf of and in coordination with the US Department of Health and Human Services (HHS), has awarded a $600,000 contract to Qiagen, a provider of molecular diagnostics and sample preparation technologies, to expand the company’s manufacturing capacity of enzymatic reagents and reagent kits used in COVID-19 molecular diagnostic tests.
The expansion will allow Qiagen to increase its monthly production of reagent kits by 7,000 and enzymes by 5,100 milligrams in its Beverly, Massachusetts facility by the end of February 2022 to support domestic laboratory testing for COVID-19.
Source: US Department of Defense