Health Canada authorizes new COVID-19 vaccine after ordering the destruction of previous versions

The federal health agency cited a “thorough scientific review” for the justification to authorize yet another COVID-19 injection earlier today.

Vaccination is your best defense against COVID-19. Health Canada has approved the Moderna (KP.2 Variant) vaccine after a thorough scientific review.

Learn more: https://t.co/9Ujp6vYh6I#Covid19 pic.twitter.com/7YjIEcueBE

— Health Canada and PHAC (@GovCanHealth) September 17, 2024

Moderna’s Spikevax modified RNA injection targeting the KP.2 strain was authorized on a rolling basis with terms and conditions so that Health Canada can “continue to gather information on the safety, effectiveness and/or quality of the product.”

🚨 PHAC Orders Destruction of COVID Vaccines 🚨

The Public Health Agency of Canada (PHAC) has directed the immediate withdrawal and destruction of all COVID-19 XBB vaccines, sparking concerns and confusion with many stating this is an attempt to destroy evidence of harm. The… pic.twitter.com/HMNdPOwrnj

— Tamara Ugolini 🇨🇦 (@TamaraUgo) September 12, 2024

The latest injection is “indicated for active immunization against coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in individuals 6 months of age and older,” according to the package insert.

Under warnings and precautions, it is stated that “As with any vaccine, vaccination with SPIKEVAX may not protect all recipients.”

Adverse events including allergic reactions and notes on myocarditis/pericarditis follow. “There is an increased risk for myocarditis and pericarditis following vaccination with SPIKEVAX, primarily within 14 days of vaccination and more often in young male adults. These events have been observed more often after the second dose compared to the first dose and less often after subsequent doses,” it reads.

The safety and efficacy of this injection in pregnant women have not been established, and it is “unknown if SPIKEVAX is excreted in human milk.” The insert warns that “A risk to the newborns/infants cannot be excluded.”

The safety and efficacy of the latest injection is “inferred from several studies of a primary series and booster dose of SPIKEVAX Bivalent.” It found that:

"Overall, after both the SPIKEVAX Bivalent 50 mcg booster dose and the SPIKEVAX original 50 mcg booster dose there was a higher reported rate of solicited adverse reactions in younger age groups. The incidence of pain, erythema, swelling/induration, lymphadenopathy (axillary swelling/tenderness), fatigue, headache, myalgia, arthralgia, and nausea/vomiting was higher in adults 18 to 64 years of age than in those 65 years of age and above."

Safety data in adolescents aged 12 to 17 were collected in an ongoing study, NCT04649151, that was completed in June 2024. According to the clinical trial data website, study results have not been submitted.

Safety data in children aged six to 11 were based on study NCT04796896. It was completed in March this year, yet final results have not been submitted.

For babies aged six months of age and up, safety was inferred from study NCT05436834. The study concluded in June 2024 but, in similar fashion to the above, the results have not been posted.

This move comes after the Public Health Agency of Canada directed provincial health authorities to destroy previous COVID-19 vaccine formulations, leaving gaps in purported “life-saving” coverage.

As Health Canada grapples with contamination concerns, including the unknown risk associated with DNA fragments and the SV40 promoter, the uptake of the novel injections remains low.