Health Canada announced authorization for the Novavax vaccine on February 17, 2022. Novavax filed their submission under the “amended Food and Drug Regulations on August 27, 2021, to support a permanent authorization” and is expected to roll their product out to the Canadian public in the coming weeks.
Originally, the interim order came into effect on September 16, 2020 and “is one of the fastest mechanisms available to the federal government for putting in place temporary regulations to help make health products available to address large-scale public health emergencies.” It “allows for the issuance of an expedited authorization for the importation, sale and advertising of drugs used in relation to COVID-19.”
Since it’s now been a year and a half since the order was originally signed by the now-reshuffled minister of health, Patty Hajdu, and it expired after one year, the government got around this by introducing amendments under the Food and Drug Regulations to make these authorizations permanent.
The Novavax vaccine is partly plant based.
According to Dr. Bonnie Henry, it’s “an interesting one, as it uses no human-derived materials in its development and instead uses a moth cell put into this matrix made out of the soap bark tree extract,” and is “similar to a flu shot,” where you get injected with inactivated fragments of the virus combined with an adjuvant that basically aggravates your immune system to respond and start to produce antibodies.
Concerned citizens filed an Access to Information request about this regulatory authorization and forwarded me the findings. Health Canada responded by throwing 8, 313 pages at the requester. Being mostly redacted, the documents are virtually useless.
Page 305 is a largely redacted invoice, but it appears that the vaccines were procured in January of 2021.
What was the hold up?
Well, in the fall of 2021 Novavax stocks plunged after Politico reported that the company faced significant hurdles while seeking regulatory approval apparently due to issues over purity. Low purity levels mean that contaminates or other substances are found in the final product, which can mean decreased efficacy or increased chances for adverse reactions.
It’s hard to know what the regulatory hurdles were and how they were remedied because everything of relevance on the Drug Submission Forms beginning on page 1,915 is blacked out.
Poking around on the Health Canada website, they claim to keep up with the department's commitment to openness and transparency. Cue: largely redacted ATIP.
What I found instead is the Novavax product monograph.
Here are some highlights:
“WARNINGS AND PRECAUTIONS” (pg. 6), under Fertility: researchers say it’s unknown if this injection will have an impact on fertility. Animal models did not indicate direct or indirect harmful effects on female fertility or reproductive toxicity. Did they even bother to test males?
Further down in 7.1 Special Populations, 7.1.1 Pregnant Women: the safety hasn’t been established.
Under Breast-feeding: It is unknown if the injection is excreted in human milk. A risk to newborns/infants cannot be excluded.
In NON-CLINICAL TOXICOLOGY (pg. 19), under Carcinogenicity (meaning, does the injection have the ability to cause cancer): it looks like it has not been evaluated for carcinogenicity in animals, as carcinogenicity studies were not considered relevant to this vaccine. Seriously???
Page 21 outlines everyone who shouldn’t take the vaccine, other instances that you should consult your doctor about, and that this injection has never been studied in conjunction with other vaccines.
Yet the “experts” touted that mixing and matching manufacturers is safe and effective.
I still want to know what the regulatory approval issues were and how Novavax remedied them before rolling this injection out to the general public. To find this out, I filed our own Access to Information request. And if it comes back redacted, we’ll appeal that decision. You can help to support this kind of work at RebelInvestigates.com.