Thread by @jbkrell

Proud of the activism @PrEP4AllNow and others did to get CDC to send more #monkeypox doses to NYC & US. Due to that work, vaccinations will restart soon. But Biden's vaccine strategy is too small & slow to protect 🏳️‍🌈🏳️‍⚧️ communities. We must demand better. What needs to happen: 🧵

https://twitter.com/jbkrell/status/1539994158131200002

The USG OWNS more than a MILLION doses of monkeypox vaccine *ready to go* stuck in freezers in Denmark. These doses COULD have been brought to the US weeks ago had the Biden admin. ordered @US_FDA to inspect the facility, but they didn't, so now they may not come till AUGUST.

The Biden admin. inaction has consequences. NYC, for example, will get less than *6,000* doses over the next few weeks, meaning we will rapidly run out of doses AGAIN as the virus spreads unchecked in Queer persons.

The admin. only plans to have 1.6M doses (only enough for 800K people) available by the *end of this year* for the *entire country*. This is not enough to protect EVEN JUST the MOST AT RISK people (>1.8M ppl). To cover this population would require a *minimum* of 3.6M doses.

We could provide enough doses for all of the most vulnerable people rapidly if steps are taken now. The U.S. owns an additional >15.2M doses of vaccine that just need to be put into vials. But the admin. has no plan to get this done, despite repeated warnings from experts.

What steps should we demand the admin take now? On Tuesday, @prep4allnow & @PIH urged the administration to pursue a three step strategy to ensure robust vaccine supply over the coming weeks. Admin’s response? Crickets. documentcloud.org/documents/2207…

Hey @rajpanjabi, @FDACommisioner, @ASPRgov, when you get a chance, can you know, respond to our letter? I know y’all are busy, but our communities kind of can’t access vaccines, and are unnecessarily getting infected?

Step 1: Since 2007, US taxpayers have spent over $2 billion developing, manufacturing & stockpiling the JYNNEOS monkeypox vaccine to prep for a potential outbreak. Over *1 MILLION* doses are currently ready to go in freezers in Denmark. So why can't we access them?

Vaccines, like all drugs, need to be produced in facilities that comply with a set of regulations called “current good manufacturing practices” or cGMP. For a vaccine to be used in the US, @US_FDA needs to certify that the facility that made the doses is compliant with cGMP.

The JYNNEOS vaccine is made in a factory outside of Copenhagen by @bavariannordic. For reasons that have not been made public, @US_FDA failed to reinspect the facility recently, allowing the factory's US cGMP compliance certificate to expire.

This means that the doses that were produced since the certificate expired can’t be used in the US, until we reinspect the facility. Major fuck up. The entire point of us spending billions of dollars stockpiling JYNNEOS doses was so we would be prepared for a potential outbreak.

But because the admin didn’t ensure that @US_FDA did its job, we can’t use them now, even as queer people are getting infected. And we *already* know that the @bavariannordic facility is complying with cGMP regulations and the doses are safe.

How? @EMA_News DID ITS JOB and reinspected the @bavariannordic facility a year ago and issued a cGMP certificate (valid till 2024). And @US_FDA could choose to recognize EMA’s certificate under a 2017 “mutual recognition” agreement.

But it doesn’t seem willing to do this. @US_FDA could also reinspect the facility — something that should’ve been done weeks ago. Either way, queer people face an uncontrolled outbreak & can’t access doses WE NEED NOW & ALREADY OWN because this admin fucked up.

Remember, once @US_FDA allows those doses to be used in the US, a MILLION more doses of monkeypox vaccine will be available almost instantly. (A direct flight from Copenhagen to NYC takes 7 hours, 23 minutes.)

STEP 2: We own an additional 15.2 million+ doses of monkeypox vaccine that are not yet put into vials. (The doses are instead stored frozen in large, multi-liter plastic bags called “bioprocess bags” in Denmark).

*Last month* the administration spent $100 million+ to begin “lyophilizing” (freeze drying) these doses, to make them last longer and not require refrigeration. The problem is that freeze drying takes a long time — it won’t be complete till *2025*.

But we need those doses ASAP. So the admin needs to 1) ask @bavariannordic to pause its freeze drying campaign, and 2) figure out how to put those *liquid doses* into vials, a process known as “liquid fill and finish”, as quickly as possible.

This should be achievable. In 2013, US taxpayers starting spending *tens of millions* of dollars to build a “fill and finish manufacturing network” (FFMN), designed to “liquid fill and finish” 9.75 million doses of vaccine *a week* on average in the event of an outbreak.

We need @US_FDA and @ASPRgov to figure out if the FFMN can be used to fill and finish these monkeypox doses ASAP. If it can, we could manufacture 15 million more MPX doses ASAP.

If it can’t, we need to find another manufacturer who could fill and finish these doses. Luckily, the world built *BILLIONS of DOSES PER YEAR* of fill and finish capacity for COVID vaccines. As demand has waned, much of that capacity is now idle.

We need to use that capacity to fill and finish these doses. @US_FDA and @ASPRgov need to start searching the world for compatible fill and finish capacity for monkeypox.This needs to be done ASAP.

But even 15 million more doses are not going to be enough. Monkeypox is a global outbreak, and @bavariannordic can only manufacture ~30 million doses of JYNNEOS per year. Which brings us to step 3.

Step 3: We need @US_FDA and @ASPRgov to look for facilities around the world that can begin manufacturing more JYNNEOS drug substance. We need to ensure that everyone in the world who needs it, can access it.

Tl;dr we have the ability to end the monkeypox outbreak. Our government has the resources and the tools to do this, but apparently won’t, unless we force them.