COVID News: Novavax, Pfizer, Moderna & More
The latest on COVID-19 vaccines/drugs and manufacturing from Novavax, Pfizer, BioNTech, Moderna, and Shiongi. Highlights below.
Manufacturing and supply of COVID-19 vaccines and drugs
* US Gov’t Secures 3.2 M Doses of Novavax’s COVID-19 Vaccine
Updates on COVID-19 therapeutics and vaccines
* Pfizer’s/BioNTech’s COVID-19 Vaccine Gets Full FDA Approval in Adolescents
* Moderna Reports Results for Omicron Booster Candidate
* Shionogi Advances COVID-19 Drug in China, Japan
Manufacturing and supply of COVID-19 vaccines and drugs
US Gov’t Secures 3.2 M Doses of Novavax’s COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based vaccine company, has signed an agreement with the US Department of Health and Human Services, in collaboration with the US Department of Defense, to provide an initial 3.2 million doses of its COVID-19 vaccine, contingent on receiving emergency use authorization from the US Food and Drug Administration (FDA) and a recommendation from the US Centers for Disease Control and Prevention (CDC).
Last month (June 2022), the FDA’s Vaccines and Related Biological Products Advisory Committee voted to recommend that the FDA grant EUA for Novavax’s COVID-19 vaccine for individuals aged 18 and over. Earlier this week (July 13, 2022), the full FDA authorized the vaccine for emergency use in individuals aged 18 and over.
Source: Novavax (emergency use authorization) and Novavax (supply pact)
Updates on COVID-19 therapeutics and vaccines
Pfizer’s/BioNTech’s COVID-19 Vaccine Gets Full FDA Approval in Adolescents
The US Food and Drug Administration (FDA) has approved Pfizer’s and BioNTech’s supplemental biologics license application (sBLA) of their COVID-19 vaccine, Comirnaty, to include individuals 12 through 15 years of age. The vaccine was previously made available to this age group in the US under emergency use authorization (EUA).
Comirnaty was previously approved by the FDA for individuals 16 years and older in August 2021. Pfizer and BioNTech have also submitted a sBLA to the FDA to extend the approval of the vaccine to include booster doses for individuals ages 16 years and older, who are currently authorized under EUA.
Moderna Reports Results for Omicron Booster Candidate
Moderna reported new data for its bivalent Omicron booster candidate, mRNA-1273.214, which showed that a 50-µg booster dose of mRNA-1273.214 elicited higher neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the company’s currently authorized booster (mRNA-1273) regardless of prior infection status or age (adults over 18, greater or less than 65 years old).
Moderna is developing two bivalent candidates for the fall based on different market preferences for Omicron subvariants. The company’s mRNA-1273.214 bivalent booster demonstrated higher titers against the BA.4/5 strain in a clinical trial before the fall booster season, when compared to its currently authorized booster. The second bivalent booster candidate, mRNA 1273.222, is based on the BA.4/5 strain and is being developed with recent advice from the US Food and Drug Administration. Both bivalent candidates contain 25 µg of the currently authorized booster (mRNA-1273) and 25 µg of an Omicron subvariant.
Source: Moderna
Shionogi Advances COVID-19 Drug in China, Japan
Ping An-Shionogi, a joint venture between Shionogi, an Osaka, Japan-based bio/pharmaceutical company, and Ping An Life Insurance Company of China, have initiated preparation materials for a new drug approval application for S-217622, an orally administered antiviral drug for treating COVID-19, to the Center for Drug Evaluation (CDE) of China’s National Products Administration.
Prior to the formal submission of the new drug application, Ping An-Shionogi has submitted a communication meeting application to the CDE to facilitate the new drug application process.
The drug is a protease inhibitor created through joint research between Shionogi and Hokkaido University in Sapporo, Japan. Shionogi has already been submitting non-clinical, manufacturing/chemistry, manufacturing and controls (CMC) data, and clinical trial data to Japan’s Pharmaceuticals and Medical Devices Agency. Trials up to Phase IIb have been completed, and currently the Phase III part of a Phase II/III clinical trial in patients with mild/moderate symptoms and the Phase IIb/III part in patients with asymptomatic/only mild symptoms are in progress.
Source: Shionogi
