Moderna Announces Health Canada Approves its COVID-19 Vaccine
“Health Canada’s approval of our COVID-19 vaccine is an important milestone as it is our first full approval for Spikevax. I would like to thank
The Moderna COVID-19 vaccine was originally authorized in
The Moderna COVID-19 vaccine, brand name SPIKEVAX, is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein. On
In 10 years since its inception,
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases.
AUTHORIZED USE IN
SPIKEVAX (elasomeran mRNA vaccine) has been granted approval by
IMPORTANT SAFETY INFORMATION
• Do not administer SPIKEVAX to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of SPIKEVAX
• Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of SPIKEVAX. Monitor SPIKEVAX recipients for the occurrence of immediate adverse reactions according to the
• Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose.
• Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
• Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to SPIKEVAX.
• SPIKEVAX may not protect all vaccine recipients.
• Adverse reactions reported in clinical trials following administration of SPIKEVAX include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site.
• The following adverse reactions have been reported following administration SPIKEVAX during mass vaccination outside of clinical trials:
o Severe allergic reactions, including anaphylaxis
o Myocarditis and pericarditis
• Available data on SPIKEVAX administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Data are not available to assess the effects of SPIKEVAX on the breastfed infant or on milk production/excretion.
• There are no data available on the interchangeability of SPIKEVAX with other COVID-19 vaccines to complete the vaccination series. Individuals
• Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of SPIKEVAX.
• If a patient experiences a side effect following immunization, healthcare professionals should complete the Adverse Events Following Immunization (AEFI) Form appropriate for the province/territory (https://www.canada.ca/en/public-health/services/immunization/reporting-adverse-events-following-immunization/form.html) and send it to the local Health Unit.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the effectiveness and safety of the Company’s vaccine against COVID-19 (mRNA-1273), brand name SPIKEVAX. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the
1 BARDA, part of ASPR within the
Director, Corporate Communications
Senior Vice President & Head of Investor Relations