Pharma COVID Roundup: News from Moderna, Pfizer, Lilly, Takeda, CSL
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The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Moderna, Pfizer, Lilly, Takeda, CSL, Novavax, Sinovac, Emergent BioSolutions, and others.

Manufacturing and supply of COVID-19 vaccines and drugs

FDA Revises Doses Per Vial for Moderna’s COVID-19 Vaccine To Address Supply
The US Food and Drug Administration (FDA) has announced two revisions regarding the number of doses per vial available for Moderna’s COVID-19 vaccine.

The first revision clarifies the number of doses per vial for the vials that are currently available, in that the maximum number of extractable doses is 11, with a range of 10-11 doses. The second revision authorizes the availability of an additional multi-dose vial in which each vial contains a maximum of 15 doses, with a range of 13-15 doses that can potentially be extracted.

Depending on the type of syringes and needles used to extract each dose, the FDA says there may not be sufficient volume to extract more than 10 doses from the vial containing a maximum of 11 doses or more than 13 doses from the vial containing a maximum of 15 doses.

The dosing regimen remains unchanged; the vaccine is administered as a two-dose series, 0.5- mL each dose, one month apart.

Moderna is working with its partners and the US government to identify ways to facilitate accelerated vaccine administration, address bottlenecks, and accelerate production. One identified constraint on the production process has been the capacity of the fill–finish process. Moderna studied the possibility of adding more doses to each vial of vaccine to address bottlenecks, accelerate production and reduce the need for consumable materials that are in high demand. Moderna says it will continue to collaborate with its manufacturing partners and the federal government to increase the efficiency of its production process.

Additionally, the FDA authorized Moderna’s COVID-19 vaccine to be kept at room-temperature conditions once removed from the refrigerator for administration for 24 hours, an increase from the previous 12 hours. Also, a punctured vial is now useable for up to 12 hours, an increase from the previous six hours.

Source: US Food and Drug Administration and Moderna


Sinovac Builds Up Annual Capacity of 2 Bn for COVID-19 Vaccine
Sinovac Biotech, a Beijing, China-based biopharmaceutical company, has announced that the annual capacity of CoronaVac, its COVID-19 vaccine, has reached 2 billion doses and a third production line for the vaccine was completed and put into commercial production.

To date (as reported on April 2, 2021), over 200 million doses of the vaccine have been delivered to over 20 countries, including China. The company estimates that over 100 million doses of the vaccine have been administered during the vaccination rollout in different countries.

Sinovac’s COVID-19 vaccine has received emergency use authorization or conditional marketing authorization in more than 30 countries. The facility and quality management system of CoronaVac has been inspected by China, Brazil, Indonesia, Chile, Singapore, Saudi Arabia, and the World Health Organization.

CoronaVac was evaluated in four clinical trials conducted, including randomized, double-blind, placebo-controlled Phase I/II clinical trials in people aged 18-59 years and in elderly aged 60 years and above, a Phase III clinical efficacy trial in Brazilian health professionals aged 18 years and above, and a Phase IIIb bridging trial in different production scales and different populations.

Source: Sinovac (doses) and Sinovac (trials)


Updates on COVID-19 treatments and vaccines

NIH To Evaluate Allergic Reactions in Pfizer’s, Moderna’s COVID Vaccines
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has a Phase II trial underway to determine whether people who are highly allergic or have a mast-cell disorder are at increased risk for an allergic reaction to the COVID vaccines by Moderna and Pfizer/BioNTech.

A mast cell disorder is a disease caused by a type of white blood cell called a mast cell that is abnormal, overly active, or both, predisposing a person to life-threatening reactions that look like allergic reactions.

In addition, investigators will examine the biological mechanism behind the reactions and whether a genetic pattern or other factors can predict who is at most risk.

Source: National Institutes of Health


Lilly, Incyte Report Phase III Results for Arthritis Drug as COVID-19 Treatment
Eli Lilly and Company and Incyte, a Wilmington, Delaware-based biopharmaceutical company, report results from a Phase III study evaluating Olumiant (baricitinib), a drug already approved for treating rheumatoid arthritis, for treating COVID-19.

The results showed that baricitinib (4 mg once daily) plus standard of care (SoC) versus placebo plus SoC did not meet statistical significance on the primary endpoint of progression to non-invasive ventilation or invasive mechanical ventilation or death.

Lilly intends to publish detailed results of this study in a peer-reviewed journal in the coming months (as reported on April 8, 2021). Lilly says it will share the data from the study with regulatory authorities in the US, European Union, and other geographies to evaluate the next steps for baricitinib for treating hospitalized COVID-19 patients.

Additional research is ongoing to further evaluate baricitinib in COVID-19, including the National Institute of Allergy and Infectious Diseases’ trial evaluating the efficacy and safety of baricitinib or dexamethasone in combination with remdesivir in hospitalized adults with COVID-19 on supplemental oxygen, a separate trial in the UK, and several investigator-initiated trials.

An emergency use authorization (EUA) was issued by the US Food and Drug Administration in November 2020 for baricitinib in combination with remdesivir in hospitalized patients with COVID-19 requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.

Lilly and Incyte formed an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases in 2009.

Source: Eli Lilly and Company and Incyte


FDA Issues Q&A Guidance on Generic Drugs During COVID-19
The US Food and Drug Administration (FDA) has issued a new question-and-answer guidance document to provide general recommendations to prospective generic-drug applicants on generic-drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by the FDA during the COVID-19 public health emergency.

The FDA issued the guidance, the Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers, so that the development of generic drugs and submission of applications can continue during the COVID-19 public health emergency.

Source: US Food and Drug Administration


EU Launches $126 M in Funding To Study COVID Variants
The European Commission (EC) announced funding of EUR 123 million ($126 million) to study COVID-19 variants from Horizon Europe, the European Union’s (EU) research and innovation program.

The research into COVID-19 variants is part of the European biodefense preparedness plan under the European Union’s Health Emergency Preparedness and Response Authority (HERA) incubator, which was announced in February (February 2021), aimed at preparing Europe for an increased threat of coronavirus variants.

HERA is part of the European Health Union and was formed in September 2020 to provide a dedicated structure to support the development, manufacturing, and deployment of medical countermeasures during a health crisis of natural or deliberate origin. The EC announced the start of an online public consultation, to run for six weeks, until May 12, 2021, to gain feedback on the role of HERA, which will be put forth in a legislative proposal later this year (2021). The EC will consider the feedback received before finalizing the legislative proposal. In parallel to the public consultation, the EC will also hold talks with member states and stakeholders.

Source: European Commission (HERA) and European Commission (funding)


Alliance with Takeda, CSL End Development of COVID-19 Treatment
The CoVIg-19 Plasma Alliance, a collaboration, founded by Takeda and CSL Behring and supported by other global organizations, reports that a Phase III clinical trial to evaluate an investigational anti-coronavirus hyperimmune intravenous immunoglobulin medicine for COVID-19 did not meet its endpoints.

The study aimed to determine whether the candidate medicine could reduce the risk of disease progression when added to standard of care treatment, including remdesivir in hospitalized adult patients at risk for serious complications.

The trial was sponsored and funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. No serious safety signals were raised in the trial. Following the outcome of the trial, the CoVIg-19 Plasma Alliance’s work concludes.

Source: Takeda


Emergent Reports Data from Phase III COVID-19 Immunoglobulin Trial
Emergent BioSolutions, a Gaithersburg, Maryland-based specialty biopharmaceutical company and contract manufacturer, reports disappointing results from a Phase III trial evaluating its investigational COVID-19 treatment, SARS-CoV-2 Immune Globulin Intravenous (Human) (COVID-HIG), in hospitalized COVID-19 patients.

Topline data from the trial demonstrated that the addition COVID-HIG to standard of care, inclusive of remdesivir, for hospitalized adult COVID-19 patients did not provide clinical benefit when compared to standard of care plus placebo. There were no serious safety concerns identified.

The Phase III trial was sponsored and supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

Emergent says it will continue to explore COVID-HIG as a treatment in ongoing clinical trials.

Source: Emergent BioSolutions


Rokote Laboratories Finland To Develop COVID-19 Nasal Spray Vaccine
Rokote Laboratories Finland, a spinout company from the University of Helsinki and the University of Eastern Finland, is working to develop a nasal spray vaccine against COVID-19.

The vaccine is based on gene-transfer technology studied in a gene therapy to treat cardiovascular diseases and cancer. The vaccine uses an adenovirus carrier that contains a cloned DNA strand, which causes nasopharyngeal cells to produce the virus protein which, in turn, produces a response to the vaccine. There is no actual SARS-CoV-2 virus in the vaccine. Preliminary results show that the vaccine has performed well in animal studies, and clinical testing in humans will start within a few months (as reported on March 8, 2021).

The development of the vaccine started in the spring of 2020, and the universities’ research groups have been funded by the Academy of Finland, a government-funded body for scientific research. The company is negotiating on funding for further development and advancing to clinical trials.

Source: University of Helsinki and University of Eastern Finland


Novavax Initiates Clinical Trial Crossover of COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has initiated crossover arms in two ongoing clinical trials of NVX-CoV2373, the company’s COVID-19 vaccine candidate.

Crossover allows participants to continue in trials and ensures the administration of active vaccine to all participants in the trials. Crossover has begun for Novavax’s Phase IIb trial in South Africa and its Phase III trial in the UK and has been planned for the trial being conducted in the US and Mexico.

Under Novavax’s updated clinical trial protocols, all participants in the UK and US Phase III trials will be offered the opportunity to receive an additional round of injections.

Source: Novavax


Sound Pharmaceuticals Awarded $3.1-M Grant for COVID-19 Treatment
Sound Pharmaceuticals, a Seattle, Washington-based company developing therapeutics for hearing loss, has been awarded a Cooperative Grant from the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) for $3.1 million to support the testing of a COVID-18 treatment, SPI-1005, in two Phase II clinical trials.

SPI-1005 is an oral capsule containing ebselen, a small molecule with anti-inflammatory properties being developed for several neurotologic, neuropsychiatric, and respiratory indications. The company reports that Ebselen was recently shown to inhibit SARS-CoV-2, the virus that causes COVID-19, in three separate in vitro studies involving two different cell lines and in vivo in a rodent model.

Source: Sound Pharmaceuticals


News on COVID-19 testing

FDA Authorizes First At-Home COVID-19 Antibody Test
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first COVID- antibody test with home-collected dried-blood spot samples.

The Symbiotica COVID-19 Self-Collected Antibody Test System collects samples at home. Those samples are then sent to a Symbiotica laboratory for analysis.

Source: US Food and Drug Administration

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