FDA removes monovalent COVID-19 vaccines from the market

The FDA has moved forward with authorizing the bivalent vaccines (original and omicron BA.4/BA.5 strains) instead, citing a need to 'simplify the vaccination schedule.'

FDA removes monovalent COVID-19 vaccines from the market
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Citing a need to “simplify the vaccination schedule,” the FDA has amended emergency use authorization for the original monovalent vaccines in favour of the novel bivalents.

“The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States,” a press release issued by the United States Food and Drug Administration (FDA) on April 18 reads.

It means that individuals who have received just one dose of the two-dose primary series are no longer eligible for another dose.

The FDA has moved forward with authorizing the bivalent vaccines (original and omicron BA.4/BA.5 strains) instead, citing a need to “simplify the vaccination schedule.”

Corporate lawyer Daniel Freiheit from Pace Law in Toronto states that this change effectively nullifies every human resources policy requiring proof of double vaccination.

For anyone still unvaccinated, “they can receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent mRNA vaccines,” the release further states.

This amendment has many wondering if Health Canada will follow suit.

This is not the first time that a health regulator prioritizes convenience when it comes to vaccine recommendations.

Health officials recommended COVID-19 vaccines be administered at the same time as routine childhood vaccines, in a recommendation issued in December 2022. This was done in direct conflict with both Pfizer and Moderna’s own product monographs that stated that the safety of such had not been established.

“No interaction studies have been performed. There is no information on the co-administration of COMIRNATY with other vaccines,” Pfizer’s package insert states on page 53.

Similarly, Moderna’s own package insert states, on page 29, that “no interaction studies have been performed.”

When Rebel News contacted Canada’s National Advisory Committee on Immunization (NACI) to confirm the scientific basis of this recommendation, they replied that they “can make off-label vaccine recommendations when there is a clear need supported by a public health ethics analysis.”

Apparently, it is more ethical to make off-label recommendations and collect safety data in real time than to establish safety with clearly defined scientific rationale and data before mass-injecting novel pharmaceutical products into the arms of children.

NACI describes itself as “an external body of experts that provides recommendations to the Public Health Agency of Canada (PHAC) on the use of authorized vaccines to support the federal government and the provinces and territories in planning vaccine programs in Canada.”

Canada United States COVID Vaccines Public Health Agency of Canada
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