Summary of Cancellation for Nuvaxovid

The Supplement to a New Drug Submission (SNDS) (control #273313) was filed by PPD Development, LP (PPD) on behalf of Novavax Inc for Nuvaxovid COVID-19 Vaccine (Recombinant protein, Adjuvanted) under the framework for flexibilities for designated COVID-19 drugs (SNDS-COVID [SNDS-CV]).

The Sponsor submitted this SNDS for Nuvaxovid COVID-19 Vaccine (Recombinant protein, Adjuvanted) in support of:

1. Expansion of the indication to include a booster dose dosing regimen to include adolescent patients 12-17 years of age at least 5 months after completion of second dose of primary series.

2. Additional data on adult booster as an addendum.

3. The addition of Tinnitus to the label.

4. Response to the following Clinical Terms and Conditions (T&C) Commitments:

   • T&C #4 Issued February 17, 2022: Novavax Inc. is required to provide the results from the blinded crossover period including safety and efficacy data for 12 months from participants after the second dose from Study 2019nCoV-302, when the data become available.

   • T&C #25 (partial) Issued November 17, 2022: Final reports of Studies 2019nCoV-301 and 2019nCoV-501 should be provided once available.

The sponsor submitted an “Adolescent Booster Report (version 1.0; dated 05 January 2023)” to support the extension of indication for the booster. The pivotal clinical safety and efficacy information consisted of data from their Study 2019nCoV-301 adolescent booster extension.

Additionally, as supportive information, the Sponsor supplied a 2019nCoV-301: Adult Booster Report (version 1.0; dated 05 August 2022) and a 2019nCoV-301: Adult Booster Report Addendum (version 1.0; dated 16 December 2022). These data are of a booster dose in an adult population from Study 2019nCoV-301 and considered supportive of the booster in an adolescent population.

The Sponsor supplied a “Safety Signal Evaluation Report – Tinnitus” to support a label update to the Product Monograph in section 7.

The Sponsor supplied an European Union (EU) Risk Management Plan (RMP) version 3.1 dated December 22, 2022, as well as a Canadian Addendum to the RMP version 2.1, dated December 22, 2022.

All the aforementioned reports including updated versions of the RMP have been resubmitted under dossier ID #278519 to support the new Nuvaxovid XBB.1.5 formulation and were under review in that dossier at the time of cancellation of this submission.

At the time of cancellation, the review of the submission was nearing completion. A meeting was held between the Sponsor and Health Canada on October 31, 2023 regarding this dossier (#e255730, control #273313) and the Nuvaxovid XBB.1.5 submission (Dossier ID #e278519). During the meeting, in light of the Sponsor’s clarification that the company’s intent would be to withdraw the original Wuhan vaccine from the market upon approval of Nuvaxovid XBB.1.5, HC indicated that the Sponsor could consider cancelling the Drug Identification Number (DIN) for the original vaccine, as well as the submission for addition of the adolescent booster indication, to streamline future submissions and managing one DIN for one product under one set of T&Cs.

There is no expected impact for patients accessing the drug using Special Access Programme (SAP). In Canada, there are several marketed vaccine products that target COVID-19 disease. All marketed alternatives must be ruled out to be clinically essential under SAP.