COVID News: Pfizer, Novavax, Moderna & Vaxxinity
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The latest on COVID-19 vaccines/drugs and manufacturing from Novavax, Moderna, Vaxxinity, Pfizer and BioNTech. Highlights below.

Updates on COVID-19 Vaccines and Therapeutics
* EMA Committee Recommends Pfizer’s, BioNTech’s Booster Dose of Omicron-Adapted Vaccine
* EU Authorizes Novavax’s COVID-19 Vaccine as a Booster
* Japan OKs Partial Change to Authorization for Moderna’s COVID-19 Vaccine Booster
* Vaxxinity Initiates Rolling Submission to UK for COVID Booster


Updates on COVID-19 Vaccines and Therapeutics

EMA Committee Recommends Pfizer’s, BioNTech’s Booster Dose of Omicron-Adapted Vaccine
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorization for a 30-µg booster dose of Pfizer’s and BioNTech’s Omicron BA.4/BA.5 bivalent-adapted COVID-19 Vaccine for individuals ages 12 years and older. The European Commission will review the CHMP’s recommendation and is expected to make a final decision soon (as reported on September 12, 2022).

The Omicron BA.4/BA.5 bivalent COVID-19 booster vaccine combines 15-ug of mRNA encoding the wild-type spike protein of SARS-CoV-2 in the original Pfizer–BioNTech COVID-19 vaccines and 15-ug of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants.

The companies report that Omicron BA.4/BA.5 COVID-19 vaccine is available to ship immediately (as reported on September 12, 2022), pending European Commission approval, to support EU vaccination campaigns this fall (fall 2022).

Source: Pfizer and BioNTech


EU Authorizes Novavax’s COVID-19 Vaccine as a Booster
The European Commission (EC) has approved the expanded conditional marketing authorization of Novavax’s COVID-19 vaccine, Nuvaxovid, in the European Union as a homologous and heterologous booster for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults aged 18 and older.

The European Commission previously granted conditional marketing authorization for Nuvaxovid to prevent COVID-19 in adults aged 18 and older in December 2021. Additionally, the it granted an expanded conditional marketing authorization for Nuvaxovid to prevent COVID-19 in adolescents aged 12 through 17 in July 2022.

Nuvaxovid has also been authorized in Japan, Australia, and New Zealand as a booster in adults aged 18 and older and is under review in other markets.

Source: Novavax


Japan OKs Partial Change to Authorization for Moderna’s COVID-19 Vaccine Booster
The Ministry of Health, Labor and Welfare in Japan has granted Moderna approval for a partial change to a new drug application for its Omicron-targeting bivalent COVID-19 booster, mRNA-1273.214 (Spikevax Bivalent Original/Omicron BA.1).

Spikevax Bivalent Original/Omicron contains the company’s original COVID-18 vaccine, Spikevax and a vaccine candidate targeting the Omicron variant BA.1.

Moderna has received authorization decisions for Omicron-targeting bivalent boosters in the US, Australia, Canada, Europe, Switzerland, South Korea, Taiwan, and the UK to date and has completed regulatory submissions worldwide. In Japan, Takeda continues to provide distribution support for Spikevax Bivalent Original/Omicron under Japan’s current national vaccination campaign for Moderna’s COVID-19 vaccines for a transitional period. Supply is expected to commence during September (September 2022, as reported on September 12, 2022).

Source: Moderna


Vaxxinity Initiates Rolling Submission to UK for COVID Booster
Vaxxinity, a Dallas, Texas-based vaccine company, has initiated a rolling submission to the UK’s Medicines and Healthcare products Regulatory Agency in the UK for conditional marketing authorization of its COVID-19 vaccine as a heterologous booster to authorized primary series vaccines.

UB-612, the company’s COVID vaccine, is being assessed in a Phase III trial as a booster vaccine for subjects who have received primary immunization with mRNA, adenovirus vector, or inactivated virus vaccines. Vaxxinity says it plans to have a topline readout of the Phase III trial in the fourth quarter of 2022.

Source: Vaxxinity