Tag Archives: ACIP

Lets co administer these two VXs for ease and convenience….but we actually have no studies, trial data or evidence of the safety of doing so in children or adults

From the Health Forum NZ @ fb

NEW CDC RULING…

FLU AND COVID VAX CAN BE ADMINISTERED AT THE SAME TIME

Influenza vaccines can be co-administered with COVID-19 vaccines for both CHILDREN AND ADULTS, according to updated recommendations from the CDC’s Advisory Committee on Immunization Practices (ACIP) – Advisory Committee on Immunisation Practices in USA)
In a unanimous 14-0 vote on Thursday, the committee approved language for co-administration of influenza and COVID-19 vaccines, in line with current CDC guidance that says COVID-19 vaccines can be administered with other vaccines, THOUGHT PROVIDERS SHOULD BE AWARE OF INCREASED REACTOGENICITY (e.g. more adverse reaction risk)
Some ACIP members took issue with the LACK OF DATA ON CO ADMINISTRATION in children, though CDC staff noted there had been one pre-print examining co-administration of influenza vaccine and the Novavax COVID-19 vaccine that showed no changes in antibody titers for influenza vaccine and no safety issues.
ACIP member Matthew Daley, MD, of Kaiser Permanente Colorado, encouraged additional study about co-administration of COVID-19 and influenza vaccines, especially in children and adolescents.

Take home message…
Lets co administer these two vaccines for ease and convenience….but we actually have no studies, trial data or evidence of the safety of doing so in children or adults.

https://www.medpagetoday.com/meetingcoverage/acip/93283?xid=nl_mpt_DHE_2021-06-26&eun=g1775334d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202021-06-26&utm_term=NL_Daily_DHE_dual-gmail-definition&fbclid=IwAR2Hg-9w4S6T_axYvSguoFWBD8tQrRZe_WVtElkOak2hcvNFIw19N90DiBEh

Important info on the CV VX fast track approval for your children

From The Health Forum NZ fb page

With the vaccination of our NZ children looming, you might be interested to see how “exceptional circumstances” allow for the fast tracking of the Covid 19 vaccine for children. I recommend you read this after you have had a few alcoholic beverages, or doused yourself in lavender oil.

FDA vs. CDC and the adolescent vaccine

The Pfizer vaccine is now authorized, by the FDA, for emergency use among people aged 12+. In other words, you could go right now and get a vaccine in your 12 year old’s arm (dependent on your state and physician, I’ll get to that in a little). However, the CDC advisory board (called ACIP) has yet to meet (they are meeting Wednesday; here is the agenda). So, what’s going on?
In normal times…
A vaccine sponsor (like Pfizer) would collect at least 6 months of follow-up data from Phase III clinical trials and submit an extensive application to the FDA. Then, the FDA would have 10 months to review, approve, and license. During this time it’s federally mandated that an external review board for the FDA (called VRBPAC) has a meeting. This is where we (the public) get to see the clinical trial data for the first time (hundreds and hundreds of pages). VRBPAC provides a formal recommendation to the FDA.

Then an external committee for the CDC (called ACIP) offers a second recommendation. The CDC Director has to ratify the ACIP decision.
The CDC typically needs to approve for three reasons:
1. Insurance to cover the vaccine
2. Government funds to be adjudicated to pay for the vaccine for uninsured kids (called the Vaccines for Children program)
3. CDC handles the logistics for delivery of vaccine, so they have to formally approve what they are distributing.

In abnormal times…If there’s a pandemic or global emergency, a sponsor can apply for an Emergency Use Authorization (EUA). The sponsor only needs 2 months of follow-up clinical trial data to apply. Then, the rest of the process is basically the same. When a sponsor applies for a EUA, it’s under the assumption that the sponsor will apply for a full license once they have the follow-up data (showing vaccine longevity, continued safety) and necessary documents (like manufacturing processes). Then the FDA has 6-10 months to review. This is where the adult Pfizer vaccine is right now.

But this is abnormal times…
The adolescent vaccine is NOT a new EUA; it’s an extension or an amendment of the adult EUA. So, the FDA doesn’t require a VRBPAC meeting. The FDA internally reviewed data and deemed it safe and effective for emergency use (which led to today’s announcement).
The ACIP meets Wednesday, which is basically a formality. Importantly, though, we (the public) will get to see some data. In some states, only pediatricians can give vaccines to kiddos (not pharmacies). Also, a LOT of physicians will still wait for the ACIP recommendation. So, this CDC meeting is still an important step.
Bottom line: The Pfizer vaccine is officially authorized for patients. We will still get a lot of new and important information on Wednesday.
I hope I didn’t make this already confusing process even more confusing.
Love, YLEData sources on my newsletter here: https://yourlocalepidemiologist.substack.com/…/fda-vs…Post reproduced from
https://www.facebook.com/profile.php?id=100053149454347