I've Never Launched A Call To Action With This Little Time Until The Vote. Voting Is In Just A Few Hours, So Don't Sleep On This.

This has a mere hours before the vote, so if you see this... this is your moment.

ACIP, the CDC vaccine practices committee, is meeting today.

The meeting starts just a few hours after this is going out.

So, time is not really something we have a lot of on this one…

But… I don’t need a lot of people for this action.

I just need a small group of very serious people.

Time limit is around noon eastern… so, a few hours.

Maybe that’s you, maybe it’s not… but I still think you’ll like where I’m going here.

If you caught my article from last week, then you know ACIP is meeting to decide who can access COVID vaccines and how many are allowed.

You will be able to watch the first day of the meeting here.

The voting language in question.

Now, this is currently in the context of the immunocompromised, but that original rule was set up to allow access for anyone because the vaccine administrators were barred from asking for proof of your immunocompromised status.

If someone denied you access, you could actually report them to the state's pharmacists’ board and they would fix the problem so you could access the additional dose.

But that’s just not fair for anyone to have to go through.

Now, why is this necessary?

In January 2023 we switched to the “once a year” plan and let’s just say that didn’t really work out the way they hoped. The meeting that rolled out after the endorsement at VRBPAC happened on June 15, 2023 and was ironically our first presentation that included the need for access to additional shots.

So, we were moving to reverse the ‘once a year’ as fast as possible.

They thought that one COVID vaccine a year would be sufficient, but really, the goal (which was clearly stated), was to align our COVID response with our influenza response, and that included getting just one shot a year.

The problem is that regardless of whether you prefer mRNA or Novavax…

There is a reality that you might need as many as THREE of these shots in a year.

I don’t really like the idea of people needing three shots in a year, but hear me out…

mRNA has been widely used as a COVID vaccine and there are probably more studies on mRNA vaccines than any vaccine in history, but what has been made clear is that mRNA protection only aims for “protection from hospitalization and death” and that protection only lasts for about 112 days.

I want to point out that these are three entirely different studies.

No period after 112 days reached adequate protection levels

Effectiveness reduces after 3 months and can return to normal values after a boost

The XXB.1.5 mRNA waned the same way the previous version did.

We are currently preparing for a summer wave in 2025 and it’s likely that the CDC is going to recommend at least two shots a year; so one every six months.

But how do we get from here to there?

Originally, the goal was to treat COVID as a seasonal virus, and that seasonal plan was why the rapid waning of mRNA was seen as acceptable. COVID is actually agreeing by being a virus we have to be concerned about during every season.

That means people need complete, year-round protection and for mRNA that means potentially needing three shots a year…

Because last I checked a year is 365 days, right?

112 x 3 is 336 days which still falls a bit short but I’m sure that 3 would likely cover it.

For Novavax folks, they need three shots in their first year…

So, that’s two shots eight weeks apart with a third no sooner than six months.

This chart isn’t an exact interpretation but it shows how the shots build on each other.

And with that priming, they only need probably one shot a year and maybe on big mutational jumps like this year they need one every six months.

The same is actually true of mRNA…

This is a relative antigenic chart of most of the pandemic…

Demonstrating the antigenic gap between XBB.1.5 and JN.1… The largest jump yet.

mRNA needs two vaccines to update memory responses on years with BIG jumps or else it relies on viral exposure for “hybrid immunity,” which is simply unethical.

And for Novavax, the additional dose should compensate for the mutational jumps…

The effects of multiple exposures to Matrix-M are well documented at this point.

Multiple exposures to Matrix-M increases the breadth of your existing antibodies.

So, where does that leave us now?

If you are a subscriber then you’ve probably heard all this before.

Well, this time things are a bit different than usual.

Normally we would have to advocate for an idea and fight or argue why that idea is necessary or even true.

But this time, not so much.

See, VRBPAC, the FDA advisory committee, was already talking about loosening the restrictions and that the immunocompromised route was meant as a middle ground for anyone to have access.

So, right now… we really just need the people from VRBPAC and the people from ACIP to talk to discuss what is happening at the meetings…

And to implement the conversation happening at VRBPAC by making recommendations at ACIP.

You might expect this discussion would already be happening, and though it’s possible some of them are talking … generally speaking this all goes through the meetings.

And as you all may know, sometimes the conversation can be limited in context.

This year it’s an even greater issue because we have almost an entirely new ACIP membership meaning that all but 2-3 are entirely new members.

What we need is for ACIP members to alter the voting language so that it is not limited to immunocompromised patients.

Whether the preference is mRNA or protein-based, there are perfectly legitimate reasons someone might need three COVID vaccines a year and limiting access to year-round protection from a year-round virus with deadly complications is simply not right.

People shouldn’t have to jump through complex hoops, or lie about their immune status, and the most important factor is that ACIP approval requires insurance to cover the vaccines.

We need to remove these restrictions and let people have access as needed.

For some people that means access to an additional mRNA in the winter months…

And for some it means finishing a priming series with Novavax in a few weeks.

Both situations require the same access which is currently limited.

And the restrictions created by the "‘once a year"‘ policy are responsible.

So, the ask here is for ACIP members to alter the voting language of the upcoming vote from keeping the same immunocompromised access to removing the immunocompromised language and expanding it to all groups equally.

If there are concerns about folks getting too many, then limit it to 3.

There is no situation where folks who are experiencing anything short of an IgG4 disorder that would make them need more than three COVID vaccines in a year and those folks can work with their doctor.

But generally speaking, we need to open up access.

So, what do I want from you, the reader?

We just want to connect the VRBPAC folks with the new ACIP folks.

We have in the past contacted both ACIP and VRBPAC members…

Sometimes they don’t love it, but it works.

Here’s a direct quote, ignore the laughter.

And I suspect a few members even subscribe to this newsletter…

But the important factor is to be kind, direct, and to the point.

We are not looking to harass these folks but we do want to get their attention.

As this is a last minute project, I don’t anticipate a lot of folks to join in and as this is a situation where we need folks to cold email, which we haven’t done in a while, even fewer people will do it.

That’s actually exactly what I want.

We want to contact them and simply verify via VRBPAC members that the discussion of expanding access was on the table… and if you are a VRBPAC member reading this, please contact the ACIP list and see if you can get someone talking.

I know that both VRBPAC and ACIP members don’t have some secret access to vaccines…

As we are headed into what will likely be known as a “brutal” winter, they likely want to make sure both themselves and their loved ones have sufficient access without needing to fight tooth and nail to access the “tools.”

We need the new ACIP members to enact the discussion happening at VRBPAC by removing the word “immunocompromised” so that the rules will allow for anyone to access additional vaccines.

If there are concerns about folks going overboard, limit it to three.

If they want to keep even greater immunocompromised access, then fantastic.

The goal, again, is to get the VRBPAC members talking to the new ACIP members.

And if the ACIP members follow through with what VRBPAC members have been saying they want to do then this is a done deal.

These vaccines are exceptionally safe and if folks want them, they should be able to access them… and the reality is no one is getting more than three a year.

So, not only should there not be a limit on access but insurance should cover them.

We were promised the private market would be an open market…

And instead we have more limitations than ever.

Here are the contacts.

Just send them each other’s contacts with an ask for ACIP members to follow through with the conversation had at VRBPAC about removing the immunocompromised limitations which will open up access to everyone by simply voting yes after altering the language already on the table.

Leaving behind the ‘once a year’ strategy with all of its restrictions…

And all we have to do is remove a single word.

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CDC - ACIP voting Members for contact

Chair: Helen Keipp Talbot: keipp.talbot@vumc.org

Edwin Jose Asturias: edwin.asturias@ucdenver.edu

Noel T. Brewer: ntb@unc.edu

Oliver Brooks: olibro@aol.com

Lin H. Chen: lchen@hms.harvard.edu

Helen Y. Chu: helenchu@uw.edu

Sybil Cineas: Sybil Cineas@brown.edu

Denise J Jamieson: denise-jamieson@uiowa.edu

Mini Kamboj: kambojm@mskcc.org

George Kuchel: kuchel@uchc.edu

Jamie Loehr: Dr.Jamie.Loehr@Gmail.com

Yvonne Maldonado: bonniem@stanford.edu

Charlotte A. Moser: Couldn’t find it

Robert Schechter: R.Schechter@cdph.ca.gov

Albert C Shaw: albert.shaw@yale.edu

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FDA - VRBPAC voting members for contact

Hana M. El Sahly: hanae@bcm.edu

Henry H Bernstein: hbernstein@northwell.edu

Archana Chatterjee: archana.chatterjee@rosalindfranklin.edu

Hayley Gans: hagans@stanford.edu

Holly Janes: hjanes@fhcrc.org

Arnold S Monto: asmonto@umich.edu

Paul A Offit: Not him

Steven Pergam: spergam@fredhutch.org

Stanley M Perlman: stanley-perlman@uiowa.edu

Jay M Portnoy: jportnoy@cmh.edu

Eric J Rubin: erubin@hsph.harvard.edu

Andrea Shane: ashane@emory.edu

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