"The vaccine was rushed."

[BumRushDaShow]

58. If you had actually followed what has going on the past couple years

you would have noticed that a number of companies other than the ones we are familiar with who eventually got EUAs, were "developing" COVID-19 vaccines and had to delay or withdraw them, so they are NOT finished "development" nor are approved.

Development for the currently approved (either EUA or BLA) vaccines were not just started "a few months after he said that".

E.g., one of the "Operation Warp Speed" companies that received research money - GSK/Sanofi partnership - attempted to "develop" one and found with early trials that it FAILED for targeted efficacy and/or elicited insufficient immune response . Similarly other U.S. government-funded companies also opted to delay and/or start over -

Sanofi
Merck
Novavax
AstraZeneca-BARDA (due to manufacturing issues with Emergent BioSolutions)

Why the three biggest vaccine makers failed on Covid-19
GlaxoSmithKline, Merck and Sanofi are left playing catch-up to upstarts with new technology

Hannah Kuchler in New York and Leila Abboud in Paris February 16 2021

As pharmaceutical companies raced to develop Covid-19 vaccines, crossing the finishing line in record time, the world’s three biggest vaccine makers were also-rans. GlaxoSmithKline, Merck and Sanofi are now left playing catch-up, after upstarts including Moderna and BioNTech demonstrated their mastery of new technologies that will shape the industry for years to come.

New Jersey-based Merck recently dropped its vaccine development programme completely, while Paris-based Sanofi and the UK’s GSK are having to redo an early-stage trial of the jab they are jointly developing, after a dosing mistake. According to Zain Rizvi, a medicine access researcher at advocacy group Public Citizen, the “immense scarcity” of vaccines around the world is directly connected to these big pharma groups being “missing in action”.

The vaccine market already looks completely different this year — and depending on variants in the virus that causes Covid-19 and the need for boosters, some of the changes could stick. In 2020, GSK, Sanofi, Merck and Pfizer dominated the market with best-selling vaccines for flu, pneumonia, HPV and shingles.

Among the top vaccine makers, only Pfizer has a successful Covid-19 vaccine, developed with German company BioNTech. This year, life sciences data platform Airfinity forecasts Pfizer will triple its vaccine revenue thanks to its Covid-19 vaccine, while vaccine sales at Novavax and Moderna will overtake those at Merck, GSK and Sanofi.

https://www.ft.com/content/657b123a-78ba-4fba-b18e-23c07e313331

So Fauci was correct that typically it takes time to develop these vaccines to spec and desired outcomes (efficacy and safety) and this ALSO must include getting the manufacturing details right.

I.e., "development" from start to finish is not just creating the active biologic itself and making it through the trials, but also requires nailing manufacturing scale-up that complies with required cGMPs and produces consistent QA results, which is what can bog the whole thing down, but is included in that reference for the "time normally required".

The fiasco with manufacturing Janssen (J&J) locally, since currently, pending Merck's partnership to scale up manufacturing, all the doses are imported from Belgium (and this issue includes the similarly platformed AstraZeneca, which was originally part of Operation Warp Speed having received funding here in the U.S. and was to be co-manufactured at that same plant) is exactly the type of example of the lengthy processes that can and do happen with getting vaccines (or any type of drug or medical device) approved. The ones that got done the fastest were the ones who knew the drill and had actually started earlier with related vaccine R&D (including trials) for SARS COV-1 vaccines before actually switching to focusing on the later-related SARS COV-2 vaccine effort.

Since you are a lawyer (and not a scientist as I am) - see 21CFR 600 and 610 specifically for part of what is required from the regulatory perspective.