COVID News: Pfizer, AstraZeneca, Merck & Co. & More

The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Pfizer, AstraZeneca, Merck & Co., Lilly, GSK, Novavax, BioNTech, World Health Organization, US government, South African government, Indian government, COVAX, Cellvera, and Charles River Laboratories.

Manufacturing and supply of COVID-19 vaccines and drugs

Pfizer, Novasep in Supply Pact for COVID-19 Drug
Pfizer and Novasep, a Lyon, France-based CDMO of active pharmaceutical ingredients (APIs) and antibody drug conjugates, have signed an agreement for the supply of Pfizer’s oral COVID-19 antiviral treatment, Paxlovid (nirmatrelvir and ritonavir).

Novasep will manufacture the API at is facility in Mourenx, France. The facility will be incorporated into the supply chain of Pfizer as early as the third quarter of 2022 with further expansion to other Novasep facilities and increased volumes in 2023.

Technical transfer, onsite development, and equipment installation activities will begin immediately (as reported on January 17, 2022). Novasep’s Mourenx facility in France is expected to be incorporated into the protease inhibitor against COVID-19.

Overall, Pfizer is projected to make up to 120 million patient packs of the drug globally by the end of 2022.

Source: Novasep

US Gov’t Buys More Doses of AstraZeneca’s COVID-19 Combo
The US government has agreed to purchase an additional 500,000 doses of Evusheld (tixagevimab co-packaged with cilgavimab), AstraZeneca’s long-acting antibody combination for the prevention of COVID-19.

Delivery of the additional 500,000 doses is anticipated in the first quarter of 2022. This follows the previous US government agreement for the purchase of 700,000 doses of Evusheld.

Source: AstraZeneca

EMA OKs Mfg Increase of AstraZeneca’s COVID-19 Vaccine
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved a scale-up of manufacturing for Vaxzevria, AstraZeneca’s COVID-19 vaccine.

An existing manufacturing site operated by Universal Farma, a Guadalajara, Spain-based pharmaceutical company, will add a second filling line for the finished product.

The EMA says this change is expected to support the continued supply of Vaxzevria, including for donations to third countries through COVAX, a global initiative for equitable access to COVID-19 vaccines.

Source: European Medicines Agency

COVAX Delivers 1-Bn Doses of COVID Vaccines
COVAX, a global initiative for equitable access to COVID-19 vaccines, supplied its one billionth dose of COVID-19 vaccines on January 15, 2022 through the delivery of 1.1 million doses of COVID-19 vaccines to Rwanda.

Source: World Health Organization

Merck in Pacts for Supply of COVID-19 Drug to Low-Income Countries
The Medicines Patent Pool (MPP), a United Nations-backed public health organization, has signed agreements with 27 generic manufacturing companies for the manufacturing of molnupiravir, Merck & Co.’s oral antiviral drug for treating mild-to-moderate COVID-19 in adults, in order to supply the drug in 105 low- and-middle-income countries.

The sublicense agreements are the result of the voluntary licensing agreement signed by MPP and Merck & Co. in October 2021 to facilitate affordable global access for molnupiravir, which Merck developed in partnership with Ridgeback Biotherapeutics, a Miami, Florida-based biopharmaceutical company.

The non-exclusive sublicenses allow generic manufacturers to produce the raw ingredients for molnupiravir and/or the finished drug itself. Five companies will focus on producing the raw ingredients, 13 companies will produce both raw ingredient and the finished drug, and nine companies will produce the finished drug. The companies span 11 countries: Bangladesh, China, Egypt/Jordan, India, Indonesia, Kenya, Pakistan, South Africa, South Korea, and Vietnam.

Neither Merck, Ridgeback Biotherapeutics, nor Emory University, which invented the drug, will receive royalties from sales of molnupiravir from the MPP sublicensees while COVID-19 remains classified as a public health emergency of international concern by the World Health Organization.

In addition, Merck & Co. and Ridgeback Biotherapeutics have signed a long-term supply agreement with the United Nations Children’s Fund (UNICEF) to facilitate broad global access for molnupiravir.

Under the agreement, Merck & Co. will allocate up to three million courses of molnupiravir to UNICEF throughout the first half of 2022 for distribution in more than 100 low- and middle-income countries following regulatory authorizations. Molnupiravir has been authorized for use in more than 10 countries, including in the US, UK, and Japan.

Source: Medicines Patent Pool and Merck & Co.

US Gov’t Ships 400 M COVID-19 Vaccines to 112 Countries
The US government has shipped 400 million COVID-19 vaccine doses to 112 countries as part of a plan to donate 1.2 billion COVID-19 vaccine doses. The announcement was made in a January 26, 2022 press briefing by the White House COVID-⁠19 Response Team and public health officials.

Source: White House

NantWorks Founder To Build Vaccine-Mfg Facility in Africa
Dr. Patrick Soon-Shiong, Chairman and CEO of NantWorks, a multinational conglomerate holding company, is partnering with the South African government to build a vaccine manufacturing campus in South Africa.

Officials are launching the Access to Advanced Healthcare Coalition, which combines the efforts of biotechnology and pharmaceutical companies, government agencies, non-profit organizations and academia, for establishing new pharmaceutical manufacturing capabilities to produce COVID-19 vaccines and other vaccines.

Source: South African government

Updates on COVID-19 treatments and vaccines

Pfizer, BioNTech Initiate Study for Omicron-Based COVID-19 Vaccine
Pfizer and BioNTech have initiated a clinical study to evaluate an Omicron-based COVID-19 vaccine candidate in adults 18 through 55 years of age.

The study will have three cohorts examining different regimens of the current Pfizer/BioNTech COVID-19 vaccine or an Omicron-based COVID-19 vaccine. The study will draw upon some participants from the companies’ Phase III COVID-19 booster study and is part of ongoing efforts to address Omicron and determine the potential need for variant-based vaccines.

Pfizer and BioNTech also reported new results from two laboratory studies demonstrating that three doses of the Pfizer/BioNTech COVID-19 vaccine elicited antibodies that neutralize the Omicron variant (B.1.1.529).

The companies previously announced that they expect to produce four billion doses of the Pfizer/BioNTech COVID-19 vaccine in 2022, and this capacity is not expected to change if an adapted vaccine is required.

Source: Pfizer (Omicron-based COVID-19 vaccine), Pfizer (neutralizing antibodies), BioNTech (Omicron-based COVID-19 vaccine), and BioNTech (neutralizing antibodies).

Pfizer Reports Results of COVID-19 Drug Against Omicron 
Pfizer reports results from in-vitro studies that suggest that Paxlovid (nirmatrelvir and ritonavir), its oral COVID-19 antiviral treatment, is maintained against the SARS-CoV-2 variant Omicron.

These in-vitro studies suggest that Paxlovid has the potential to maintain plasma concentrations many-fold times higher than the amount required to prevent Omicron from replicating in cells, according to the company.

Paxlovid is currently authorized for conditional or emergency use in several countries globally. Pfizer has submitted applications for regulatory approval or authorization to multiple regulatory agencies and anticipates further regulatory decisions to follow.

Health Canada, the regulatory body of Canada, has authorized Paxlovid to treat adults with mild-to-moderate COVID-19 who are at high risk of progressing to serious disease, including hospitalization or death.

Source: Pfizer and the Canadian government

FDA Revises Authorizations for Two COVID-19 Drugs
The US Food and Drug Administration has revised the authorizations for two monoclonal antibodies for treating COVID-19—(1) Eli Lilly and Company’s bamlanivimab and etesevimab (administered together) and (2) Regeneron Pharmaceuticals’ REGEN-COV (casirivimab and imdevimab)—to limit their use to only when the patient is likely to have been infected with or exposed to a COVID-19 variant that is susceptible to these treatments.

Source: US Food and Drug Administration

FDA OKs Gilead’s Remdesivir for COVID-19 Progression
The US Food and Drug Administration (FDA) has granted expedited approval of a supplemental new drug application (sNDA) for Veklury (remdesivir), Gilead Sciences’ antiviral drug for treating COVID-19, to include the treatment of non-hospitalized patients at high risk of progression to severe COVID-19, including hospitalization or death.

The expanded indication allows for Veklury to be administered in qualified outpatient settings that can administer daily intravenous infusions over three consecutive days. The FDA has also expanded the pediatric emergency use authorization of Veklury to include non-hospitalized pediatric patients younger than 12 years of age who are at high risk of disease progression.

Source: Gilead Sciences and the US Food and Drug Administration

WHO Recommends Lilly’s, GSK’s COVID-19 Drugs
The World Health Organization (WHO) has recommended two new drugs for COVID-19: (1) Eli Lilly and Company’s baricitinib, an oral drug for treating rheumatoid arthritis and (2) GlaxoSmithKline’s/Vir Biotechnology’s sotrovimab.

Source: World Health Organization

Australia Provisionally OKs Novavax’s COVID-19 Vaccine
Australia’s Therapeutic Goods Administration (TGA) has granted approval for provisional registration of NVX-CoV2373, Novavax’s COVID-19 vaccine (adjuvanted). The vaccine will be supplied to Australia under the brand name Nuvaxovid.

A booster trial for Nuvaxovid and a Phase I/II trial for a combination seasonal influenza and COVID-19 vaccine are currently underway in Australia (as reported on January 19, 2022).

Source: Novavax

Indian Gov’t OKs Two COVID-19 Vaccines
The National Regulator, Drugs Controller General of India (DCGI), has given market authorization for two COVID19 vaccines, Covaxin, by Bharat Biotech, a Hyderabad, India-based bio/pharmaceutical company, and Covishield, by AstraZeneca, subject to certain conditions.

The Subject Expert Committee of the Central Drugs Standard Control Organization recommended upgrading the status of the vaccines from restricted use in emergency situations to granting new drug permission with conditions in adults population.

Source: India Ministry of Health and Family Welfare

Everest Medicines in Pact for Oral COVID-19 Drug
Everest Medicines, a New York-based bio/pharmaceutical company, and Singapore’s Experimental Drug Development Center (EDDC), a platform for drug discovery and development, have entered a global licensing agreement under which Everest will obtain exclusive global rights to develop, manufacture, and commercialize EDDC’s series of viral 3C-like (3CL) protease inhibitors as COVID-19 oral antiviral treatments.

Under the agreement, Everest will obtain exclusive global rights to EDDC’s series of 3CL protease inhibitors. Everest has full rights to sub-license the drug further and will receive full technology transfer. The lead compound is EDDC-2214, a SARS-CoV-2 3CL protease inhibitor, which Everest will develop as an oral antiviral COVID-19 therapy. Clinical trials evaluating EDDC-2214 are expected to begin later this year (2022).

Under the transaction, EDDC will receive an initial upfront payment and downstream clinical and commercial milestone payments, as well as typical royalties on net sales of products.

Source: Everest Medicines

Cellvera Gets $20-M Order for COVID-19 Oral Antiviral
Cellvera, a Dubai, United Arab Emirates-based bio/pharmaceutical company developing and commercializing antiviral therapies, and the Global Response Aid, a joint venture established by Agility, a Sulaibiya, Kuwait-based logistics company, and AiPharma, a commercial-stage bio/pharmaceutical company, has received a $20-million purchase order to supply millions of its COVID-19 oral antiviral Avigan (favipiravir) to Malaysia in the coming weeks (as reported on January 24, 2022).

Cellvera holds directly, or through its affiliates global (excluding Japan), exclusive rights to Avigan and all strengths and formulations of favipiravir.

Source: Cellvera

News on COVID-19 testing

Charles River, La Jolla Institute in COVID-19 Research Pact 
Charles River Laboratories, a Wilmington, Massachusetts-headquartered contract research organization, and the La Jolla Institute for Immunology (LJI) have entered a research pact to launch a new project to uncover exactly how different cells in the human immune system respond to SARS-CoV-2, the virus that causes COVID-19.

Source: La Jolla Institute for Immunology