The latest on COVID-19 vaccines/drugs and manufacturing from Moderna, Takeda, Novavax, and Daiichi Sankyo. Highlights below.

* Moderna, EU Amend COVID-19 Vaccine Supply Pact
* Novavax Files To Expand Use of COVID-19 Vaccine Booster
* Daiichi Sankyo Provides update on mRNA COVID-19 Vaccine

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Manufacturing and supply of COVID-19 vaccines and drugs

Moderna, EU Amend COVID-19 Vaccine Supply Pact
Moderna and the European Commission (EC) have amended the contractual delivery schedules for Moderna’s booster of its COVID-19 vaccine

The amendment allows participating European Union member states to have Moderna’s COVID-19 vaccine booster doses scheduled for delivery in the second quarter of 2022 to be delivered later in calendar year 2022 or early calendar year 2023. Participating EU member states will have the possibility to receive the expected updated bivalent booster following approval by the European Medicines Agency.

Moderna’s bivalent prototype and Omicron booster vaccine candidate (mRNA-1273.214) is currently being evaluated in a Phase II/III study. The company expects initial data on mRNA-1273.214 in June (June 2022) to inform selection of its candidate for the Northern Hemisphere fall 2022 booster.

Moderna continues to expect advanced purchase agreements of approximately $21 billion for 2022 and continues to believe that COVID market dynamics will result in sales slightly higher in the second half of 2022 than in the first half.

Separately, Moderna and Takeda have announced the transfer of the marketing authorization in Japan for Moderna’s COVID-19 vaccine, Spikevax, from Takeda to Moderna, effective August 1, 2022.Moderna will assume responsibility for all Spikevax activities, including import, local regulatory, development, quality assurance, and commercialization. Takeda will continue to provide distribution for a transitional period.

Source: Moderna (EU), Moderna (Takeda), and Takeda

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Updates on COVID-19 treatments and vaccines

Novavax Files To Expand Use of COVID-19 Vaccine Booster
Novavax, a Gaithersburg, Maryland-based vaccine company, has submitted a request to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to expand the conditional marketing authorization (CMA) of its COVID-19 vaccine, Nuvaxovid, as a homologous and heterologous booster dose for individuals aged 18 and over.

The MHRA granted CMA for Nuvaxovid in February 2022 in individuals aged 18 and over and Novavax filed for expanded CMA for use in adolescents aged 12 through 17 in April 2022.

Separately, Novavax has initiated a Phase III strain change trial to determine if its COVID-19 Omicron-specific vaccine, NVX-CoV2515, induces superior antibody responses against the Omicron variant compared to its original COVID-19 vaccine, NVX-CoV2373, in participants who have received either a primary (two doses) or booster (three doses) series of an mRNA vaccine.

The trial will also seek to determine the antibody responses to a bivalent vaccine, containing both NVX-CoV2373 and NVX-CoV2515, administered in participants who have received a booster series of an mRNA vaccine.

Additionally, NVX-CoV2373 is one of two COVID-19 vaccines that will be studied as a third dose booster in adolescents aged 12 through 15 years to evaluate the potential use of vaccines from different manufacturers to achieve immune protection against COVID-19. All participants will have completed a two-dose schedule of Pfizer’s/BioNTech’s COVID-19 vaccine at least three months before joining the trial. A third dose of either NVX-CoV2373 or Pfizer’s/BioNTech’s COVID-19 vaccine will be administered as part of the trial.

Source: Novavax, (UK), Novavax (Phase III booster trial), and Novavax (booster study in adolescents)

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Daiichi Sankyo Provides Update on mRNA COVID-19 Vaccine
Daiichi Sankyo has provided updates on a booster vaccination trial and updates on a Phase II trial in unvaccinated subjects, both evaluating its COVID-19 vaccine, DS-5670.

The booster vaccination trial is being conducted as a Phase I/II/III in healthy adult and elderly subjects who received two doses of an mRNA vaccine approved in Japan at least six months before receiving the additional dose of DS5670 (third vaccination) in order to evaluate the booster effect of DS-5670. In response to the trial results, Daiichi Sankyo initiated an active-controlled non-inferiority trial to compare DS-5670 to an approved mRNA vaccine in order to further evaluate the booster effect and evaluate the safety of DS-5670.

In response to the Phase II trial in unvaccinated subjects presenting no significant safety concerns, Daiichi Sankyo says it will proceed with preparation to initiate a Phase III trial of DS-5670 in the first half of 2022.

The company is aiming for the commercialization of DS-5670 during 2022.

Source: Daiichi Sankyo