Pharma COVID Roundup: News from J&J, AstraZeneca, and PfizerBy
The latest on COVID-19 vaccines/drugs and manufacturing from J&J, AstraZeneca, Pfizer, Novavax, Regeneron, CureVac, Daiichi Sankyo, and the US government.
Manufacturing and supply of COVID-19 vaccines and drugs
Update on Mfg Review of J&J’s COVID-19 Vaccine in US, EU
The US Food and Drug Administration (FDA) has approved three batches of Johnson & Johnson’s (J&J) COVID-19 vaccine substance manufactured at Emergent BioSolutions’ facility in Baltimore, Maryland.
The FDA’s decision to include these three batches of vaccine substance manufactured at the Emergent facility means that this vaccine substance can be used in the US or exported to other countries and is suitable for use. The FDA says it is not yet ready to include the Emergent BioSolutions plant in J&J’s emergency use authorization as an authorized manufacturing facility, but says that it continues to work through issues with management from both companies.
Separately, Aspen Pharmacare, a Durban, South Africa-based pharmaceutical company, reported that batches of J&J’s COVID-19 vaccine manufactured at Aspen’s production site in Gqeberha, South Africa and designated for the South African market have to be destroyed due to risk of isolated material in the vaccine substance supplied to Aspen by J&J from Emergent BioSolutions. The batches manufactured had been retained in storage awaiting the outcome of the FDA’s assessment.
Separately, the European Medicines Agency reported that authorities in the European Union (EU) are aware that a batch of the active substance for J&J’s COVID-19 vaccine had been contaminated with materials for another vaccine manufactured at the same site and occurred at the Maryland-based manufacturing site owned by Emergent BioSolutions. Based on available information, batches of the J&J’s COVID-19 vaccine released in the EU are not affected by the cross contamination. However, while the batch was not intended for the EU market, as a precaution, the supervisory authorities have recommended not releasing vaccine batches containing the active substance made at around the same time that the contamination occurred.
Source: Emergent BioSolutions, US Food and Drug Administration (initial batch authorization), US Food and Drug Administration (additional batch authorization), European Medicines Agency and Aspen Pharmacare
Daiichi Sankyo Ships AstraZeneca’s COVID-19 Vaccine
Daiichi Sankyo Biotech, a subsidiary of Daiichi Sankyo, will provide AstraZeneca’s COVID-19 vaccine to Southeast Asian countries and other regions as part of an agreement with the Japanese government.
Under a contract manufacturing agreement, Daiichi Sankyo Biotech has been involved in manufacturing the vaccine, including vial filling and packaging since March 2021.
The Japanese government announced that it will supply 30 million doses of AstraZeneca’s COVID-19 vaccine to various countries and regions through the COVAX Facility, a global initiative for equitable access to COVID-19 vaccines, and through other means. In response to this announcement, a portion of the COVID-19 vaccine to be shipped from Daiichi Sankyo is expected to be provided to countries and regions, including Southeast Asian countries through the Japanese government.
Source: Daiichi Sankyo
Updates on COVID-19 treatments and vaccines
Biden Administration Announces $3.2 Bn for COVID-19 Antivirals
The Biden Administration announced that it is providing $3.2 billion in funding to accelerate the discovery, development, and manufacturing of antiviral COVID-19 medicines.
The plan, called the Antiviral Program for Pandemics, will be implemented through the US Department of Health and Human Services (HHS), including the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR).
Under the plan, the NIH will evaluate, prioritize and advance antiviral candidates to Phase II clinical trials using current and expanded contract resources and the NIH’s National Center for Advancing Translational Sciences laboratories to de-risk early-stage development with sponsors and guide candidates along development paths. The plan provides more than $300 million for research and lab support, nearly $1 billion for preclinical and clinical evaluation, and nearly $700 million for development and manufacturing through NIAID and BARDA.
Additionally, the plan allocates up to $1.2 billion to support the creation of collaborative drug-discovery groups called Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern for antiviral drug discovery and development. These centers will create platforms that will initially target coronaviruses and then could be expanded to other viruses with pandemic potential.
The plan accelerates and expands the Administration’s ongoing efforts to support clinical trials to test prioritized drug candidates for COVID-19 and to support the advanced development of promising therapies. Working through a public-private partnership called ACTIV (Accelerating COVID-19 Therapeutics and Vaccines), 19 therapeutic agents have thus far been prioritized for clinical testing.
Source: National Institutes of Health
Novavax Reports Positive Efficacy Results for COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, reports that NVX-CoV2373, its COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its Phase III trial. The vaccine is a recombinant nanoparticle protein-based vaccine.
The company intends to file for regulatory authorizations in the third quarter of 2021, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls requirements. Upon regulatory approvals, Novavax remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter of 2021 and 150 million doses per month by the end of the fourth quarter of 2021.
Separately, Novavax reported positive results from the first co-administration study of NVX-CoV2373 and an approved influenza vaccine, suggesting simultaneous vaccination may be a viable immunization strategy.
Source: Novavax (Phase III results) and Novavax (COVID-19/influenza combo vaccine)
CureVac Reports 47% Efficacy for COVID-19 Vaccine
CureVac, a Tubingen, Germany-based clinical-stage bio/pharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, reports that CVnCoV, its COVID-19 vaccine candidate, demonstrated an interim vaccine efficacy of 47% against COVID-19 in its global Phase IIb/III and did not meet pre-specified statistical success criteria.
Available data were communicated with the European Medicines Agency. The Data Safety Monitoring Board confirmed a favorable safety profile for CVnCoV. The company says it will continue the study to the final analysis, and the totality of the data will be assessed for the most appropriate regulatory pathway.
AstraZeneca Reports Efficacy Data Against Delta Variant
AstraZeneca reports data from Public Health England (PHE) that showed the company’s COVID-19 vaccine offers protection against the Delta variant (B.1.617.2; formerly the Indian variant).
Real-world data from PHE demonstrated two doses of AstraZeneca’s COVID-19 vaccine are 92% effective against hospitalization due to the Delta variant and showed no deaths among those vaccinated. The vaccine also showed a high level of effectiveness against the Alpha variant (B.1.1.7; formerly the Kent variant) with an 86% reduction of hospitalizations and no deaths reported.
AstraZeneca Reports Results for COVID-19 Antibody Combo
AstraZeneca reports that the Phase III trial assessing AZD7442, a long-acting antibody (LAAB) combination, for preventing symptomatic COVID-19 did not meet the primary endpoint of post-exposure prevention of symptomatic COVID-19 with AZD7442 compared to placebo.
In the overall trial population, AZD7442 reduced the risk of developing symptomatic COVID-19 by 33% compared to placebo, which the company says was not statistically significant. Full results from the trial will be submitted for publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting.
In March 2021, AstraZeneca announced an extended agreement with the US government to supply up to 500,000 additional doses of AZD7442 for $205 million, contingent on AZD7442 receiving US Food and Drug Administration emergency use authorization in post-exposure prophylaxis. Discussions regarding next steps with the US government are ongoing (as reported on June 15, 2021).
Regeneron Reports Results for COVID-19 Antibody Cocktail
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, reports a Phase III trial evaluating REGEN-COV, its antibody cocktail consisting of casirivimab and imdevimab for treating COVID-19, met its primary outcome.
The Phase III trial found that adding REGEN-COV to usual care reduced the risk of death by 20% in patients who had not mounted a natural antibody response on their own against SARS-CoV-2, the virus that causes COVID-19, compared to usual care on its own.
Regeneron is in discussions with the US Food and Drug Administration to expand the current emergency use authorization to other populations, including the prevention and hospitalized patient settings. Later this summer (summer 2021), Regeneron expects to submit a full biologics license application for REGEN-COV.
Regeneron is collaborating with Roche to increase global supply of REGEN-COV. Regeneron is responsible for development and distribution in the US, and Roche is primarily responsible for development and distribution outside the US.
Pfizer’s Xeljanz Evaluated for COVID-19 Pneumonia
Pfizer and the Academic Research Organization (ARO) from the Hospital Israelita Albert Einstein in São Paulo, Brazil, report that Pfizer’s Xeljanz (tofacitinib), a drug to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, met its primary endpoint in a trial in patients with COVID-19 pneumonia who were not on ventilation.
The trial demonstrated a lower cumulative incidence of death or respiratory failure through Day 28–the primary outcome of the study–with tofacitinib (18.1%) compared to placebo (29.0%). Death from any cause through Day 28 occurred in 2.8% of patients in the tofacitinib group and in 5.5% in the placebo group.
The trial was a research collaboration between Pfizer and the ARO from the Hospital Israelita Albert Einstein, which was the trial coordinating center.
Daiichi Discontinues Development of COVID-19 Drug
Daiichi Sankyo has decided to discontinue development of DS-2319, a drug product in inhalation dosage form that contains nafamostat mesilate for the treatment of COVID-19.
Daiichi Sankyo proceeded with its development, expecting that nafamostat might exert a therapeutic effect by blocking membrane fusion between the envelope of the virus that causes COVID-19 and the host plasma cell membrane and initiated a Phase I trial in March 2021.
In view of situations of ongoing non-clinical studies and the Phase I trial, Daiichi Sankyo has decided to discontinue the development of DS-2319.
Source: Daiichi Sankyo
Editor’s Note: This article was updated to include the information on the Biden Administration’s $3.2-billion in funding for antiviral COVID-19 treatments.