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Let me make this clear - there is NO ban on the export of vaccine raw materials in effect in the US. I challenge any reporter or person claiming this to prove me wrong.
When Biden was sworn in on Jan 21st he invoked the Defense Production Act in an Executive Order. The text of the entire EO is below, show we where there is a ban: https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/21/executive-order-a-sustainable-public-health-supply-chain/
What it does is say that US suppliers manufacturing products and components for COVID pandemic effots must make sure they prioritize US pandemic needs. There is no ban. This EO has been in place for 3 months, why are we hearing it about now?
Because the Serum Institute of India CEO wants to engage in a CYA action because he knows he needs to reduce/stop vaccine supply outside of India and focus on India. SII is a key supplier to the UN COVAX program for low income nations and he wants to make sure he has an excuse...
It doesn't hurt the GoI to also have its citizens get angry at Uncle Sam instead of the GoI in this time of peak crisis. To repeat - there is no ban on exports.
Poonawalla is talking about a theoretical shortage in the future if he were to try to source a much greater quantity of materials from US suppliers and if they were to say sorry we can't supply such a large volume.
Well US is not the only or even the dominant supplier of these components. There are alternate sources and since these components are not Active Pharmaceutical Ingredients, there is much less risk to switching or adding an alternate supplier source.
Yes the State Department spokesman gave a bad answer. The Biden admin should engage in a big clean up action and charm offensive next week to address Indian concerns, even though a lot of them are optics and not real issues.
Biden just participated in a Quad Head of States meeting on March 12th where Modi was present. The fact sheet put out by the White House spends most of it talking about vaccine cooperation within the Quad. https://www.whitehouse.gov/briefing-room/statements-releases/2021/03/12/fact-sheet-quad-summit/
It also states that the US Govt will provide funding to an Indian manufacturer (Biological E) to make the J&J vaccine in India.
J&J applied to the Indian regulators on April 12th (had to resubmit to another agency on April 19th) to conduct a bridging trial .... https://timesofindia.indiatimes.com/business/india-business/jj-seeks-permission-for-phase-3-trial-of-its-single-shot-covid-vaccine-in-india-import-licence/articleshow/82150152.cms
A bridging trial relies on approval by another regulatory authority (in this case US FDA) and does a smaller local trial to prove safety and immunogenicity (production of antibodies at an adequate level) ...
... and does not need to a large Phase 3 trial to prove efficacy (since already proven to the US FDA). Such a trial will likely take a couple of months to enroll patients and have data so maybe end of June to complete it and seek approval in India.
It also appears that India is concurrently allowing importing of vaccines made elsewhere in US and Europe that are approved without a bridging trial https://www.livemint.com/news/india/jjs-covid-vaccine-expected-to-be-imported-to-india-by-july-says-dbt-secy-11619108328638.html
I don't know if this means that J&J no longer needs to do that bridging study or if the bridging study will still be required for any vaccine drug substance manufactured in India by Biological E as opposed to the scenario where J&J exports bulk drug substance for its vaccine ...
... to Biological E and then Biological E handles the final fill and finish part to put it in vials. But the bottomline is that as late as last week a US company J&J was working with Indian regulators to bring its vaccine to the Indian market by July.
None of this is consistent with the Biden admin somehow "punishing" Modi or engaging in vaccine nationalism by banning exports. If this was true, why would he just one month ago talk about funding this vaccine through US Govt funds at the Quad meeting?
Why would all appearances indicate that the plan to tech transfer J&J vaccine tech to Biological E was proceeding as expected?
In my opinion anti-American hysteria is being whipped up in India by Indian Govt & vaccine manufactures as a CYA action and to deflect blame. They received an assist in this from a dumb ass State Department PR person but I am sure it will be cleaned up next week by Biden admin.
