More about the complexity of "traditional" vaccine approaches below.
These timelines assume the process has been "scaled up" and everything is in place & ready to go: facility, equipment, raw materials, etc. Unexpected issues can add weeks or months. 2/
As variants spread and #vaccines are deployed, we’re not sequencing enough to keep up w/the virus.
As a stopgap, we should sequence viruses from every vaccinated person who develops #COVID to identify vaccine escape mutations. 1/ washingtonpost.com/health/2021/01…
We call these “vaccine breakthroughs,” and we’ll see more of them as the B.1.351 and P.1 variants spread. Sequencing all breakthrough viruses will help us to track those variants and identify new mutations that might contribute to vaccine escape. 2/
Back in October, I said the Warp Speed timelines were extraordinarily optimistic given the inherent risks of vaccine development, manufacturing and distribution. All of those risks and others have materialized. 1/
Much of the risk is in "scaling up" production to produce large volumes of vaccine in a facility, and “scaling out” to manufacturing partners to expand capacity. This thread is about vaccine manufacturing and the challenges we’ll continue to face. 2/
The good news is we're likely to see higher levels of vaccine efficacy against variant-associated severe disease and death. J&J has provided the first evidence of this in their press release (insufficient severe dz in the Novavax interim analysis). 3/
@BhadeliaMD@kavitapmd@ashishkjha@ASlavitt@RanuDhillon@RebeccaKatz5 Manufacturing partnerships are necessary for any company to ramp up manufacturing of #COVID vaccines, since no company has enough capacity to meet the world’s needs. Nearly all vaccines in late-stage trials have partnerships in place for this purpose. 1/ 🧵
TIMELINES: Depending on maturity and complexity of the process and partner capabilities, it takes a *minimum* of several months to transfer manufacturing to a new partner & facility. 3/
This table and thread focuses on the AZ vaccine, where more data on a delayed second dose is available than with the Pfizer vaccine. It is not intended to address questions about single-dose regimens or mix & match approaches. 3/
THREAD
There’s much debate around the UK's recommended use of the AZ vaccine with a two-dose schedule and flexible timing of second dose. Some thoughts on the AZ recommendation (not Pfizer) based on available data with refs to some excellent threads. 1/
UK’s MHRA and JCVI are highly-experienced in vaccine assessments and recommendations, and they've surely weighed the benefits & risks of this recommendation carefully. That said, it would be good to see all the data underpinning their recommendation. 2/
In general, vaccines should be taken on a schedule tested in an efficacy trial. But it wasn’t possible to conduct the typical dose and schedule optimization prior to these Ph3 trials, and those trials provided valuable data to inform these recommendations. 3/