Pharma COVID Roundup: News from Pfizer, Moderna, and Roche

The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Pfizer, Moderna, Roche, Thermo Fisher, Inovio, Regeneron, the US government, and others.

Manufacturing and supply of COVID-19 vaccines and drugs

Pfizer/BioNTech, US in COVID Vaccine Pact to Low- and Middle-Income Countries
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, plan to provide the US government with 500 million doses of their COVID-19 to support multilateral efforts to address the pandemic in low- and lower middle-income countries.

The companies will provide 200 million doses in 2021 and 300 million doses in the first half of 2022 to the US government at a not-for-profit price, and in turn, the US government will donate the vaccine doses to low- and lower middle-income countries and organizations that support them.

As part of the plan, the US will allocate the vaccine doses to 92 low- and lower middle-income countries and economies as defined by Gavi’s COVAX Advance Market Commitment, a financing instrument aimed at supporting the procurement of vaccines, and the 55 member states of the African Union. The US government and the companies will work with COVAX, a mechanism for procurement and equitable distribution of COVID-19 vaccines.

The doses are part of Pfizer’s and BioNTech’s previously announced pledge to provide two billion doses of the COVID-19 vaccine to low- and middle-income countries over the next 18 months (as reported on June 10, 2021).

Deliveries of the 200 million doses will begin in August (August 2021) and continue through the remainder of the year (2021). The 300 million doses for 2022 will be delivered between January (January 2022) and end of June (June 2022). The US government also has the option for additional doses in 2022.

The plan is to produce the doses being purchased by the US government in Pfizer’s US facilities. Those US-based sites involved in the production of the COVID-19 vaccine include Kalamazoo, Michigan, Andover, Massachusetts, Chesterfield, Missouri, Groton, Connecticut, and McPherson, Kansas.

To date (as reported on June 10, 2021), Pfizer and BioNTech have shipped 700 million COVID-19 doses to more than 100 countries or territories globally. The companies have direct supply agreements in place with 122 countries and discussions are ongoing with more countries. Based on current projections, Pfizer and BioNTech expect to manufacture up to three billion doses of the COVID-19 vaccine in 2021.

Source: Pfizer and BioNTech

US Gov’t Introduces Plan To Increase COVID-19 Vaccines to Other Countries
The US government has issued a three-part plan to increase and/or supply COVID-19 vaccines to other countries as the White House says it is “confident” of the supply of authorized vaccines in the US.

The plan calls for sharing a total of 80 million doses by the end of June (June 2021), donating additional COVID-19 doses as supply becomes available, and facilitating increases in global vaccine-manufacturing capacity and supply.

The plan establishes a framework for sharing at least 80 million US COVID-19 vaccine doses globally by the end of June (June 2021). The US will share 75% of these vaccines through COVAX, a mechanism for procurement and equitable distribution of COVID-19 vaccines, and share 25% for immediate needs to help with surges globally.

The allocation plan for the first 25 million doses of COVID-19 vaccines will include nearly 19 million doses to be shared through COVAX with the following allocations: (1) approximately 6 million doses for South and Central America; (2) approximately seven million doses for Asia; and (3) approximately five million doses for Africa to be shared with countries that will be selected in coordination with the African Union.

In addition, as part of the allocation plan for the first 25 million doses, approximately six million will be targeted toward regional priorities and partner recipients, including Mexico, Canada, and the Republic of Korea, West Bank and Gaza, Ukraine, Kosovo, Haiti, Georgia, Egypt, Jordan, India, Iraq, and Yemen, as well as for United Nations frontline workers. In March (March 2021), the US government shared over four million doses of its AstraZeneca vaccine supply with Canada and Mexico.

Furthermore, on June 3, 2021, US Vice President Kamala Harris informed Mexican President López Obrador that the US government would deliver over one million doses of Johnson & Johnson’s (J&J) COVID-19 vaccine. On the instructions of the President, the doses will be used in the municipalities on the Mexico-US border. The Mexican government has held talks with J&J and with the regulatory and health authorities in the US and Mexico to finalize the details of the delivery. To date (as reported on June 8, 2021), Mexico has received or fill-finished almost 44 million doses of COVID-19 vaccines, including doses from Pfizer/BioNTech, Sinovac, Sputnik, and CanSinoBio.

Additionally, as part of its thee-part plan, the Administration will pursue additional measures beyond funding for COVAX, such as donating from the US vaccine supply globally, working with US manufacturers to increase vaccine production globally, and assisting countries in expanding capacity to produce vaccines through support of global supply chains.

To that end, the US government is removing requirements under the Defense Production Act (DPA) that prioritized that US companies supply COVID-19 vaccines to the US. The US government removed DPA priority ratings for the COVID-19 vaccines of AstraZeneca, Novavax, and Sanofi’s to allow US-based companies that supply COVID-19 vaccines to make their own decisions on which orders to fulfill first.

Source: White House (three-part plan), White House (vaccine sharing), and the Mexican government

Moderna, Medison Pharma in Pact for COVID-19 Vaccine
Moderna, a bio/pharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has agreed to commercialize its COVID-19 vaccine with Medison Pharma, a Petah Tikva, Israel-based bio/pharmaceutical company, across Central and Eastern Europe and Israel. Moderna also has formed a supply agreement with the government of Botswana, which has issued an emergency use authorization for the vaccine.

The agreement with Medison Pharma covers the commercialization of Modern’s COVID-19 vaccine in the following countries: Poland, Czech Republic, Romania, Hungary, Bulgaria, Slovenia, Slovakia, Croatia, Estonia, Latvia, Lithuania, Serbia, Ukraine, Moldova, Albania, Bosnia and Herzegovina, Kosovo, North Macedonia, Montenegro, and Israel.

Moderna’s supply agreement with the government of Botswana is separate from its supply agreement with Gavi, a global vaccine alliance, announced last month (May 2021). The agreement with Gavi, on behalf of the COVAX Facility, a global mechanism for pooled procurement and distribution of COVID-19 vaccines in participating countries, is for the supply of up to 500 million doses of Moderna’s COVID-19 vaccine, including an initial 34 million doses to be delivered in the fourth quarter of 2021.

Source: Moderna (Medison Pharma) and Moderna (Botswana)

Updates on COVID-19 treatments and vaccines

Moderna Files for Authorization for COVID-19 Vaccine Approval for Adolescents
Moderna, a biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has filed for authorization for its COVID-19 vaccine in adolescents aged 12 to 18 with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Health Canada, the regulatory body of Canada.

Moderna’s submissions for emergency use authorization with the FDA, conditional marketing approval with the EMA, and authorization with Health Canada is based on a Phase II/III study of the vaccine in adolescents ages 12 to less than 18 in the US. In May (May 2021), the company announced that the Phase II/III study of its COVID-19 vaccine in adolescents met its primary immunogenicity endpoint.

Moderna has received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine in adults from health agencies in the US, Canada, Israel, the European Union, the UK, Switzerland, Singapore, Qatar, Taiwan, the Philippines, Thailand, Brunei, Paraguay, Japan, South Korea, Botswana and an emergency use listing from the World Health Organization.

Source: Moderna (US), Moderna (EU), and Moderna (Canada)

Inovio, Advaccine Expand Pact for COVID-19 Vaccine
Inovio, a Plymouth Meeting, Pennsylvania-based biopharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, and Advaccine Biopharmaceuticals Suzhou, a Suzhou, China-based biopharmaceutical company, have expanded their partnership to jointly conduct a global Phase III segment of an ongoing Phase II/III trial to evaluate Inovio’s COVID-19 DNA vaccine, INO-4800, in a two-dose regimen (2.0 mg).

Under their expanded collaboration, Inovio and Advaccine intend to share equally, subject to specified limitations and conditions, the total cost of the planned global Phase III trial, which is estimated to be approximately $100 million.

The expanded partnership is an extension of an existing relationship between the two companies, including an exclusive agreement announced in January (January 2021) under which Advaccine has the exclusive rights to develop, manufacture and commercialize INO-4800 within Greater China, inclusive of mainland China, Hong Kong, Macao and Taiwan. Under the expanded agreement, Advaccine obtains rights to additional Asian countries outside of Greater China.

Inovio is also in discussions with several countries for clinical trial sites andadvanced market contracts to potentially supply INO-4800 upon respective regulatory approvals in those countries.

Source: Inovio

FDA OKs Lower Dose of Regeneron’s COVID-19 Antibody Cocktail
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, reports that the US Food and Drug Administration (FDA) has updated the emergency use authorization (EUA) for REGEN-COV, its antibody cocktail consisting of casirivimab and imdevimab for treating COVID-19 by lowering the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab), which is half the dose originally authorized.

The updated FDA authorization is based on data from several trials, including a recently presented Phase III trial which showed REGEN-COV reduced the risk of hospitalization or death by 70% in high-risk non-hospitalized patients, and that the treatment effect was consistent between the 1,200-mg and 2,4000mg doses.

Source: Regeneron Pharmaceuticals

NIH Identifies Potential Oral Antiviral Drug for COVID-19
Researchers at the National Institutes of Health (NIH) have identified Tempol (4-hydroxy-2,2,6,6-tetramethylpiperidin-1-oxyl) as a potential oral antiviral treatment for COVID-19.

NIH reports that Tempol may limit SARS-CoV-2 infection by impairing the activity of a viral enzyme called RNA replicase. Based on previous animal studies of Tempol in other diseases, the study authors noted that the Tempol doses used in their antiviral experiments could likely be achieved in tissues that are primary targets for the virus, such as the salivary glands and the lungs. The study team plans on conducting additional animal studies and will seek opportunities to evaluate Tempol in a clinical study of COVID-19.

Source: National Institutes of Health

News on COVID-19 testing

Roche Gets OK for SARS-CoV-2 Antigen Nasal Self-Test
Roche has received approval in the European Union for its SARS-CoV-2 Antigen Self Test Nasal for at-home testing of SARS-CoV-2, the virus that causes COVID-19.

The test will be available in countries accepting the CE mark through pharmacies and other locations, in packs of five tests. A CE Mark indicates that a product has been assessed by the manufacturer and deemed to meet European Union safety, health and environmental protection requirements.

The SARS-CoV-2 Antigen Self Test Nasal enables individuals to quickly and conveniently test themselves for COVID-19 at home using a simple nasal swab. An early version of the test has already been available as a home-test in a number of European markets under local special approval pathways since February (February 2021).

Source: Roche

Thermo Fisher Scientific Launches SARS-CoV-2 Research Assay 
Thermo Fisher Scientific has launched a research assay to improve SARS-CoV-2 surveillance.

The Ion AmpliSeq SARS-CoV-2 Insight Research Assay is designed to enable early identification of new and known variants from samples that have lower viral loads. By sequencing more than 99% of the SARS-CoV-2 genome, the assay covers all potential serotypes.

The company says the new assay improves local, regional, and national surveillance efforts to discover emerging SARS-CoV-2 variants through highly sensitive next-generation sequencing.

Source: Thermo Fisher Scientific

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