The term is called running the clock…stalling….buying time.
Splitting the measles, mumps, rubella (MMR) vaccine into separate [monovalent] shots could now take 10 years according to mainstream reporting.
A decade to make a presumably safer vaccine for children that a sitting president just signed an executive order to get done.
Trump’s order states:
(b) The Gold Standard Childhood Vaccine Recommendations also recognize that the combined measles, mumps, rubella (MMR) vaccine should be administered in three separate single-disease shots once such products are domestically available and that, to the maximum extent feasible, all childhood immunizations should be administered at separate medical visits.
Two manufacturers - Merck & Co and GSK - are licensed to make combined measles, mumps and rubella shots for patients in the United States.
“Even under current expedited review pathways, it could take years – potentially as many as 10 - to meet the safety and efficacy requirements to obtain FDA approval and then begin manufacturing and commercialization” of single disease shots, Merck said.
Merck and GSK, nothing more than manufacturing companies, have been speaking out of turn in the media:
Merck and GSK said in statements there is no published scientific evidence supporting the separation of the vaccines and decades of evidence supporting the safety of their combined shots.
The President is acting on the best available scientific advice of his task force and agency research regarding the actions in his order. Big Pharma, who profits handsomely and enjoys liability protection, has no place in speaking on the science here.
Currently, the Serum Institute of India is one of the largest global suppliers of both the measles and rubella monovalent (single) vaccines. While the mumps monovalent vaccine is mainly done by Japanese manufacturers for the domestic voluntary market.
Merck and GSK previously marketed monovalent versions themselves (Merck’s Attenuvax, Mumpsvax, and Meruvax II) until discontinuing them around 2008–2009 for commercial reasons. They therefore already possess the strains, cell substrates, production know-how, and regulatory history needed to produce monovalents.
The few hurdles for Merck and GSK are low and the self-imposed decade timeline is insulting in the aftermath of a rushed, emergency mRNA gene therapy injection created for the pandemic response.
The FDA would treat a standalone monovalent as a new biologic product, requiring new clinical trials (hopefully with a true saline placebo}, manufacturing validation, stability data, etc.—even if the antigen is essentially the same one already used in MMR.
These hurdles could be minimized by a fast-track designation from the administration. However, after the FDA’s recent mRNA flu shot approval, HHS would need to guard against the insertion of mRNA MMR monovalents Merck and GSK would look to capitalize on.
I realize I’m war-gaming fast-tracking childhood vaccines to market for Big Pharma. My point here is that the stalling tactics seen since Kennedy was installed at HHS are continuing in full view and almost reflexively by industry. As expected.
One silver lining would be the demand for proper placebo-controlled trials with longer safety monitoring windows.
Internal FDA documents obtained by the Informed Consent Action Network (ICAN) show the combination MMR vaccine should have never been licensed:
“MMR-II was licensed by the FDA based on clinical trials which had a total of 834 children, had no placebo control, and only reviewed safety for 42 days after injection.”
In short, patents are not a primary obstacle here. Merck and GSK could, in principle, restart monovalent production based on their existing intellectual property and know-how if they chose (required) to do so, subject to full regulatory approval.
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