Regulatory Decision Summary for Spikevax

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.


Product type:

Drug

Medicinal ingredient(s):

Elasomeran

Therapeutic area:

Vaccines, for human use

Type of submission:

Supplement to a New Drug Submission

Control number:

262408
What was the purpose of this submission?

 

The main purpose of this submission is to extend the use of a 50 µg dose booster of Spikevax currently approved for adults 18 years and older to adolescents (12 to < 18 years) to prevent COVID-19 caused by SARS-CoV-2.

 

Why was the decision issued?

 

Study P203 (Part 1C-1, data cutoff of May 16, 2022) provides the primary evidence to support the use of the booster dose of Spikevax in adolescents. Study P203 (Part 1C-1) involved 1,364 participants 12 years through 17 years of age who received a 50 µg booster dose of Spikevax at least 5 months after the second dose of the primary series (two doses 28 days apart).

Effectiveness of a booster dose of Spikevax in participants 12 years through 17 years of age was inferred by comparing the post-booster antibody titers from Study P203 to those following the primary series in adults 18 through 25 years in the pivotal adult Study P301 for which vaccine efficacy in preventing COVID-19 has been demonstrated. The study shows that the immune response to the booster dose of Spikevax in the 12 through 17 years age group (n=257) was comparable to the immune response to the two-dose primary series in the young adult participants (n=295).

No emergent safety concerns were identified in the study. The safety of a single booster dose of Spikevax was evaluated in 1,364 participants 12 through 17 years of age, with a median follow-up duration of 116 days after the booster dose. The reported solicited local adverse reactions (ARs) were pain (91%), axillary swelling or tenderness (28%), swelling (hardness) (14%) and erythema (redness) (9%). The reported solicited systemic ARs were fatigue (59%), headache (57%), myalgia (40%), chills (31%), arthralgia (24%), nausea/vomiting (18%) and fever (6%). The median duration of solicited local and systemic adverse reactions was 3 days. There were no cases of myocarditis or pericarditis and no SAEs reported among booster recipients. In addition, no new risks have been identified from the available post-market safety data for Spikevax.

There are some uncertainties or limitations with the available data, including unavailable longer term safety, immunogenicity/efficacy data; the uncertainty around the risk of very rare events such as myocarditis and pericarditis post-vaccination; unavailable safety and immunogenicity data in subjects with severe comorbidities or who are immunocompromised. The limitations are mitigated by Terms and Conditions and by presenting the information in the product monograph. In addition, active and passive safety surveillance will continue during the post authorization period to monitor the vaccine safety.

In conclusion, based on the totality of the data reviewed, the benefit-risk profile for a 50 µg booster dose of Spikevax in adolescents is considered favorable for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), under the NDS-CV framework together with the Sponsor’s legal obligations to comply with the Terms & Conditions; therefore, a booster dose of Spikevax may be administered intramuscularly at least 4 months after completion of the primary series in individuals 12-17 years of age.

For further details about Spikevax (elasomeran), please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.

 

Decision issued

Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.