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

The latest on COVID-19 vaccines/drugs and manufacturing from Merck & Co., Moderna, Pfizer/BioNTech, AGC Biologics, Humanigen, Cenexi, Novavax, and Pardes Biosciences.

Manufacturing and supply of COVID-19 vaccines and drugs

Merck & Co. Supplies 3.1 M Courses of COVID Drug to US
Merck & Co. has supplied a total of approximately 3.1 million courses of molnupiravir, its oral COVID-19 antiviral medicine, to the US government for allocation across the country.

In 2021, Merck entered a procurement agreement with the US government under which the company agreed to supply approximately 3.1 million courses of molnupiravir to the US government upon emergency use authorization or approval from the US Food and Drug Administration.

In addition to the US agreement, Merck & Co. has entered into advance purchase and supply agreements for molnupiravir in more than 30 markets globally, including Australia, Canada, Korea, Japan, Thailand, Ukraine and the UK, pending regulatory authorizations, and is currently in discussions with additional governments. To date (as reported on February 8, 2022), Merck & Co. has shipped molnupiravir to more than 25 countries; in countries where it is approved or authorized, patients have begun to receive the medicine.

Source: Merck & Co.

AGC To Supply pDNA for Pfizer’s/BioNTech’s COVID-19 Vaccine
AGC Biologics, a contract biologics manufacturer, has expanded its partnership to supply more plasmid DNA (pDNA) starting material for Pfizer’s/BioNTech’s COVID-19 vaccine at AGC Biologics’ facility in Heidelberg, Germany.

Source: AGC Biologics

Moderna in Supply Pact with Colombia
Moderna has entered into a new supply agreement with the Colombian government for 10.8 million doses of its COVID-19 vaccine. These doses are in addition to 10 million doses supplied to Colombia in 2021.

Under the agreement, Moderna expects to deliver one million doses in the first quarter of 2022, six million doses in the second quarter of 2022, and 3.8 million doses in the third quarter of 2022.

In Latin America, Moderna recently announced a new supply agreement with the government of Chile for two million doses of its COVID-19 booster vaccine or an updated booster vaccine candidate, if authorized. Under the agreement, Moderna expects to start delivering doses in February 2022, pending obtaining local emergency use authorization.

Source: Moderna

Cenexi To Manufacture Humanigen’s COVID-19 Drug
Cenexi, a Fontenay-Sous-Bois, France-based CDMO specializing in formulation development, analytical development, and manufacturing of complex molecule drugs, has agreed to manufacture lenzilumab, a drug for treating COVID-19 by Humanigen, a Burlingame, California-based bio/pharmaceutical company.

Under the agreement, Humanigen will transfer the technology to Cenexi to allow drug-product processes using its high-speed filling line at its facility in Normandy, France. Cenexi says it will also offer to undertake other steps, such as drug development or regulatory services.

In September 2021, the US Food and Drug Administration declined Humanigen’s request for emergency use authorization for lenzilumab.

Source: Humanigen and Cenexi

Updates on COVID-19 treatments and vaccines

New Zealand Grants Provisional OK for Novavax’s COVID-19 Vaccine
New Zealand’s Medsafe, the medical regulatory body run by the New Zealand Ministry of Health, has granted provisional approval of NVX-CoV2373, Novavax’s COVID-19. The vaccine will be supplied to New Zealand under the brand name Nuvaxovid.

Novavax had previously received conditional marketing authorization for NVX-CoV2373 in the European Union and emergency use listing from the World Health Organization and was granted provisional registration by Australia’s Therapeutic Goods Administration. The vaccine is currently under review by multiple regulatory agencies globally, including the US Food and Drug Administration.

Source: Novavax

FDA OKs IND for Pardes Biosciences’ Oral COVID-19 Drug
The US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for PBI-0451, an oral antiviral COVID-19 drug candidate, from Pardes Biosciences, a Carlsbad, California-based clinical-stage bio/pharmaceutical company.

PB-0451 is currently under evaluation in a Phase I study in New Zealand evaluating it after single and multiple ascending doses. Pardes anticipates reporting data from this ongoing study at a scientific conference later this quarter (as reported on February 3, 2022).

Source: Pardes Biosciences