No Clinical Data in Health Canada’s ‘Thorough’ Review of Latest Pfizer COVID Shot

A sign is displayed in front of Health Canada headquarters in Ottawa in a file photo. Sean Kilpatrick/The Canadian Press

Health Canada says it conducted a “thorough” review before authorizing Pfizer-BioNTech’s latest COVID-19 shot targeting an Omicron variant, but information it tabled this week indicates it’s still waiting on the pharma giant to provide clinical data.

Health Canada provided the information on Dec. 11 in response to multiple vaccine-related questions filed in an order paper by NDP MP Don Davies.

Mr. Davies asked about Health Canada’s authorization of Pfizer-BioNTech’s Comirnaty Omicron XBB.1.5 and Moderna’s Spikevax XBB.1.5 monovalent injections, and whether any clinical data demonstrates their efficacy and safety.

Health Canada answered that effectiveness data were provided for Moderna’s, but not for Pfizer’s.

“Pfizer-BioNTech is conducting a similar clinical trial with COMIRNATY Omicron XBB.1.5 vaccine, the results of this study will be submitted to Health Canada in response to Terms and Conditions issued as part of the approval of this vaccine,” says the health regulator.

“Immunogenicity and safety data will be provided as part of the terms and conditions of the authorization,” it added.

Health Canada said the benefit-risk profile of mRNA shots are “well understood” because they were given to hundreds of millions of people, and that safety and immunogenicity for primary series and booster doses have been “characterized” in several clinical trials.

“Considering the large body of evidence on the safety and efficacy of the mRNA COVID-19 vaccines, as well as the Real World Evidence that has accumulated over time, it is expected that the Omicron XBB.1.5 mRNA COVID-19 vaccines will elicit an immune response that will confer protection against COVID-19.”

Health Canada also said the safety and effectiveness of Pfizer’s XBB.1.5 shot is inferred from studies conducted on its previous mRNA products.

The regulator announced Sept. 28 the approval of Pfizer-BioNTech’s XBB.1.5 product for individuals six months and older. The company had filed its submission for approval in June.

“After a thorough and independent review of the evidence, Health Canada has determined that the vaccine meets the Department’s stringent safety, efficacy and quality requirements,” Health Canada said in a statement that doesn’t mention the lack of clinical data.

The Epoch Times reached out to Health Canada for comment on the matter and was referred to the department’s regulatory decision summary for the approval.

Under the tab “Why was the decision issued?” it reads: “Only non-clinical data was supplied to Health Canada to support the market authorization of the herein product.”

The latest COVID-19 vaccination products target a variant that is all but extinct in Canada. As of Nov. 26, XBB.1.5 accounted for roughly seven percent of variants circulating in Canada, with the dominant one being EG.5.

The Health Canada document says the Public Health Agency of Canada (PHAC) is monitoring evidence from around the world to determine how well the new shots work against current and emerging variants.

PHAC said that as of Dec. 3, More than 5.6 million Canadians have received an XBB.1.5 vaccine. More than 28.8 million Canadians have received at least one dose of COVID vaccination.