A purported COVID-19 expert recently shared advice suggesting COVID-19 vaccines can be given concurrently alongside other vaccines in anyone six months of age and older.
The full summary document was published on December 9 by the National Advisory Committee on Immunization (NACI), which was the day after the FDA authorized the bivalent COVID-19 vaccine boosters for children down to six months of age.
The very next day, which was the same day as that summary issuance, Health Canada rubber stamped the bivalent booster for the same demographic of infants, toddlers and preschoolers.
Yet the advice that the boosters can be given concurrently, or co-administered with other vaccines like the flu or standard childhood routine vaccines, seems to directly contradict the manufacturers own inserts.
Both the Pfizer and Moderna “Fact Sheet for Healthcare Providers” clearly lay out that there is “no information on the co-administration” of either vaccine with other vaccines.
This contradicts the quote from NACI chair Shelley Deeks who “hopes that the new recommendation on concurrent administration will improve access and uptake for all recommended childhood vaccines.”
Or that of Canada’s Chief Public Health Officer Theresa Tam, who says the updated guidance “will make it easier for young children to stay up to date with all their recommended vaccines, including the 2022-23 seasonal influenza vaccine.”
In the document itself, there is a number to call to obtain additional information, but it turns out that they aren’t prepared to answer questions related to the summary document.
Eventually, I was directed to Health Canada’s media relations line — where no one answered — and the email address listed in the summary document directed me back to the media email address.
My inquiry to Health Canada wondered if Deeks and Tam (who are quoted in the document) were responsible for reviewing the manufacturer's fact sheets? If not, who is? And how does NACI and/or the PHAC reconcile the advice in the summary statement that appears to directly contradict the manufacturers own “fact sheet”?
Health Canada responded:
The Public Health Agency of Canada acknowledges that the advice and recommendations set out in Advisory Committee Statements are based upon the best current available scientific knowledge at the time of publication. People administering vaccines should also be aware of the contents of the relevant product monographs, which can be found on Health Canada’s Drug Product Database.
NACI recommendations for use and other information set out within the Statements may differ from that set out in the product monographs of the Canadian manufacturers of the vaccines.
When searching the link provided, I was able to locate Moderna’s bivalent Spikevax listings and the listings for Pfizer’s Comirnaty injection — for both injections I sourced the ones recommended for infants aged six months and up.
Pfizer’s package insert clearly states on page 53 that “No interaction studies have been performed. There is no information on the co-administration of COMIRNATY with other vaccines.”
And Moderna’s own package insert states, on page 29, that “no interaction studies have been performed.”
I replied to Health Canada’s media line and once again asked them how they reconcile safety advice from NACI that contradicts manufacturers statements about their own products?
Health Canada responded reiterating that “NACI recommendations for use and other information set out within the statements may differ from that set out in the product monographs of the Canadian manufacturers of the vaccines.”
Then they provide additional context in an email:
The National Advisory Committee on Immunization (NACI) is 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.
When deciding whether to authorize a vaccine, Health Canada reviews data submitted by the manufacturer, which was collected from clinical trials and testing for recommended dosage. That is what ends up being the product monograph.
When developing recommendations, NACI reviews clinical trial data, as well as data from real-world use of vaccines.
NACI’s recommendations complement Health Canada’s regulatory indications by providing additional context and information on public health strategies based on available and emerging evidence.
NACI assesses how best to use an authorized vaccine to achieve the greatest public health benefits in Canada.
NACI can make off-label vaccine recommendations when there is a clear need supported by a public health ethics analysis. This means that NACI may provide recommendations that are broader or narrower than the conditions of use approved by Health Canada.
Provinces and territories are responsible for planning and delivering their immunization programs. They consider NACI advice but determine the best way to run their immunization programs and manage their vaccine supply based on their unique circumstances.
Consult with your local public health authority for information on COVID-19 immunization programs in your area.
Concerned parents and caregivers should speak with their health care provider for questions about their child’s health, including questions about COVID-19 and vaccination.
It appears that NACI has made this alarmingly controversial recommendation without any data, but they will collect it in real time.
The aim, as evident by the quotes from Tam and Deeks, is to get as many vaccines injected into babies as possible — even if safety has never been established as stated by the manufacturers themselves.