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COVID News: Pfizer, Moderna, Daiichi Sankyo & More

The latest on COVID-19 vaccines/drugs and manufacturing from Pfizer, Moderna, Novavax, Daiichi Sankyo, Bharat Biotech, Veru, CanSino, and Sinovac.  Highlights below.

Manufacturing and supply of COVID-19 vaccines and drugs
* New Consortium Launches To Supply COVID-19 Oral Antivirals
Updates on COVID-19 Vaccines and Therapeutics
* Canada Authorizes Moderna’s COVID-19 Omicron Booster Vaccine
* Daiichi Sankyo Advances mRNA COVID-19 Vaccine
* EMA Advisory Committee Recommends Novavax’s COVID-19 Vaccine Booster
* Bharat Biotech Gets OK In India for COVID-19 Nasal Vaccine
* FDA Advisory Committee to Meet to Discuss Veru’s COVID-19 Drug
* CanSino Gets OK in China for COVID-19 Inhaled Vaccine
* Chile OKs Clinical Trial for Sinovac’s COVID-19 Omicron Vaccine

Manufacturing and supply of COVID-19 vaccines and drugs

New Consortium Launches To Supply COVID-19 Oral Antivirals
The COVID Treatment Quick Start Consortium has been launched to provide oral antiviral treatments to high-risk patients in 10 low- and middle-income countries and to scale up wider access through 2023. The consortium consists of the following as implementing partners: Duke University; the Clinton Health Access Initiative, a global health initiative; the COVID Collaborative, an assembly of government and business leaders, health experts, and philanthropic organizations; and Americares, a health-focused relief and development organization. It is supported by Pfizer, the Conrad N. Hilton Foundation, and the Open Society Foundations, a global organization supporting justice, democratic governance, and human rights. The consortium will support governments to introduce and scale up access to COVID-19 oral antiviral therapies in high-risk populations and expects patients to start receiving treatment in select countries in September (September 2022). Partner countries include Ghana, Kenya, Laos, Malawi, Nigeria, Rwanda, South Africa, Uganda, Zambia, and Zimbabwe.

The project will kick-start programs through a donation by Pfizer of 100,000 courses of its antiviral COVID-19 drug, Paxlovid (nirmatrelvir/ritonavir), for which the World Health Organization (WHO) issued a strong recommendation for use in high-risk individuals with mild to moderate COVID-19, administered within five days of symptom onset. In addition to donating Paxlovid, Pfizer will provide financial support to help further the activities and objectives of the consortium but will not participate in project design or have access to country-level data generated through operational research.

Source: Clinton Health Access Initiative

Updates on COVID-19 Vaccines and Therapeutics

Canada Authorizes Moderna’s COVID-19 Omicron Booster Vaccine
Health Canada, the pharmaceutical regulatory authority of Canada, has authorized Moderna’s Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.214, in individuals 18 years of age and older. The booster, Spikevax Bivalent Original/Omicron, is a bivalent vaccine that targets both the original strain of SARS-CoV-2 and the Omicron variant of concern (BA.1).

Late last month (August 2022), Moderna announced an agreement with the government of Canada to supply 12 million doses of Omicron-containing bivalent COVID-19 boosters. As part of that agreement, the government of Canada exercised its option to purchase an additional 4.5 million doses of a bivalent vaccine from Moderna, in addition to moving forward the scheduled delivery of 1.5 million bivalent doses from 2023 to 2022. There was also an agreement to convert an additional six million doses of the company’s original COVID-19 vaccine, Spikevax, to mRNA-1273.214, Moderna’s Omicron-targeting bivalent COVID-19 booster vaccine, Supply is expected to commence in early September.

In addition to Canada, Moderna has received approval for mRNA-1273.214 in the UK, Australia, and Switzerland and has completed regulatory submissions for the next-generation vaccine worldwide.

Source: Moderna

EMA Advisory Committee Recommends Novavax’s COVID-19 Vaccine Booster
Novavax, a Gaithersburg, Maryland vaccines company, reports that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended expanded conditional marketing authorization (CMA) in the European Union (EU) of its COVID-19 vaccine, Nuvaxovid, as a homologous and heterologous booster against COVID-19. caused by the severe acute respiratory syndrome coronavirus in adults aged 18 and older.

The European Commission (EC) previously granted CMA for Nuvaxovid in adults aged 18 and older in December 2021. Additionally, the EC granted CMA for Nuvaxovid to prevent COVID-19 in adolescents aged 12 through 17 in July 2022.

In addition, earlier this month (September 2022), Swissmedic, the pharmaceutical regulatory agency of Switzerland, expanded its temporary authorization of Nuvaxovid in Switzerland in adolescents aged 12 through 17 and as a heterologous and homologous booster dose for adults aged 18 and older. Swissmedic granted temporary authorization in April 2022 for use of Nuvaxovid in adults aged 18 and older.

In the 12 through 17 year-old population, the vaccine has been authorized in the US, the EU, the UK, Australia, New Zealand, Japan, Thailand, India, and South Korea. The vaccine has also been authorized in Japan, Australia, and New Zealand as a booster. Nuvaxovid is actively under review for both indications in other markets.

Separately, the World Health Organization (WHO) has approved a variation to allow SK bioscience to manufacture and supply the active substance in the Nuvaxovid COVID-19 vaccine. for countries who recognize WHO exceptional use license from two major vaccine suppliers – SK bioscience and the Serum Institute of India. SK bioscience currently manufactures drug substance and drug product of Nuvaxovid for the South Korean market, drug substance for the EU, and now, drug substance for the WHO as well.

Source: Novavax (EMA Advisory Committee), Novavax (Swissmedic), and Novavax (WHO)

Daiichi Sankyo Advances mRNA COVID-19 Vaccine
Daiichi Sankyo has initiated a Phase III trial of DS-5670, a mRNA vaccine against COVID-19, in healthy unvaccinated adults. DS-5670 uses a cationic lipid discovered by Daiichi Sankyo designed to produce antibodies against the receptor binding domain of the spike protein of the novel coronavirus (COVID-19). The clinical development of DS-5670 is being conducted through projects by the Japan Agency for Medical Research and Development and the Japanese Ministry of Health, Labour and Welfare.

Source: Daiichi Sankyo

Bharat Biotech Gets OK In India for COVID-19 Nasal Vaccine
Bharat Biotech, a Hyderabad, India-based bio/pharmaceutical company, announced that its COVID-19 nasal vaccine, iNCOVACC ,has received approval in India under restricted use in emergency situation for individuals aged 18 and older.  

iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a prefusion stabilized spike protein. It was developed in partnership with Washington University St. Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy. Product development related to preclinical safety evaluation, large-scale manufacturing scale-up, formulation, and delivery device development, including human clinical trials were conducted by Bharat Biotech. The vaccine has been specifically formulated to allow intranasal delivery through nasal drops.

Bharat Biotech has established large-scale manufacturing capabilities for the vaccine at multiple sites across India, including Gujarat, Karnataka, Maharashtra, and Telangana with operations pan India.

Source: Bharat Biotech

FDA Advisory Committee to Meet to Discuss Veru’s COVID-19 Drug
Veru, a Miami, Florida-based bio/pharmaceutical company developing medicines for COVID-19 and other viral and respiratory reports that the US Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee will meet on October 6, 2022, to discuss the company’s request for emergency use authorization of sabizabulin for hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome.

Source: Veru

CanSino Gets OK in China for COVID-19 Inhaled Vaccine
The National Medical Products Administration of China has granted CanSino Biologics, a Tianjin, China-based bio/pharmaceutical company, approval for its inhaled COVID-19 vaccine, Convidecia Air, to be used as a booster dose. 

Using the same adenovirus vector technological platform as the intramuscular version of the vaccine, Convidecia Air provides an option that uses a nebulizer to change liquid into an aerosol for inhalation through the mouth.

Source: CanSino Biologics

Chile OKs Clinical Trial for Sinovac’s COVID-19 Omicron Vaccine
Sinovac Biotech, a Beijing,China-based bio/pharmaceutical company, reports that the Chilean Public Health Institute has approved a Phase II clinical trial for its inactivated Omicron strain COVID-19 vaccine and trivalent COVID-19 vaccine (ancestral, Delta and Omicron variants). The clinical trial will evaluate the immunogenicity and safety of one booster dose of the two candidate vaccines in adults who had received two booster doses of CoronaVac (its COVID-19 vaccine), mRNA, or adenovirus vector COVID-19 vaccines.

Source: Sinovac