Monday, October 11, 2021

Mylan, Novo Nordisk’s, and Moderna’s drugs approved as vaccines

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Jeffrey Ding

Two experts on immunism and vaccine-preventable diseases who participated in an internal C.D.C. committee did not take a position on whether the company Moderna Therapeutics’ Myozyme/Lumizyme and Johnson & Johnson’s Xarelto should be treated as approved vaccines during last week’s panel review, scheduling letters obtained by Engaging in Vaccination states.

“The committee confirmed that MVA85A/Lumizyme has been licensed under Section 53(g) of the [National Vaccine Program] and determined that the Committee will evaluate licensure of MVA85A under Section 53(h) of the VSP Program only in the event of a clinical study evaluating MVA85A for …clinical benefits,” reading one of the letters.

The other letter was for Xarelto, which was also the subject of an internal C.D.C. committee review, and was decided not to be evaluated under Section 53(g) and Section 53(h) of the National Vaccine Program because the agency decided to require a clinical trial and presented the government’s support for Xarelto as a “proven innovation.”

“The committee confirmed that there are no viable alternative strategies to Xarelto for treating coronary artery disease and determined that the Committee will evaluate licensure of Xarelto under Section 53(h) of the VSP Program only in the event of a clinical study evaluating Xarelto for ‘clinical benefits,'” according to the first of the letter.

Xarelto is approved for preventing strokes and other blood clotting and “stops heart attack or death in the main event of the event.” Moderna’s Myozyme and Lumizyme were also approved by the Food and Drug Administration as drugs to treat patients with infantile Pompe disease.

At a Nov. 27 Committee for Medicinal Products for Human Use hearing, it was anticipated that the panel would review whether Moderna’s Myozyme/Lumizyme and Johnson & Johnson’s Xarelto, two new drug therapies created from genetically engineered genes, would be licensed and used in the National Vaccine Program to prevent measles, mumps and rubella in certain children. But, in the committee’s letter to drug makers Moderna and Johnson & Johnson, experts stated that while the company received an Advisory Committee for Biologics Evaluation and Research recommendation to support licensure, the committee did not suggest that “the committee formally take a position on a particular licensure strategy,” meaning that the committee did not make a recommendation about the use of the two products in the National Vaccine Program.

“We, therefore, inform the companies of the Committee’s determination that we will not be reviewing the Clinical Data Monograph [application] that you submitted to the Committee in connection with the conduct of the clinical trial,” the letters stated.

While the committee reviewed the company’s applications, the agency noted in the letters that “we will provide this Consistent Protections to keep … vaccine manufacturers separate from the Advisory Committee process.”

This means the National Vaccine Program can continue to fund the companies, or the companies could file yet another application under the VSP program before licensing is authorized.

While the two companies got the committee’s approval to be included in the VSP, drug makers Zoetis and Actelion and other companies who were not given the committee’s permission to get a hearing, received only a “formal decision.”

That means the committee did not even consider their application and the public was unable to attend the meetings, ultimately sending the companies to merely answer questions from the panelists. This came after the companies’ members of Congress complained the nonprofit’s handling of hearing requests is unfair.

While the latest vaccination advisory committee letters show that non-Vaccine Committee members got the C.D.C.’s endorsement on Xarelto and Moderna’s and Johnson & Johnson’s drugs, the FDA’s letter advises the drug makers that the “primary responsibility” of identifying, tracking and managing access to vaccines must remain with the Vaccine Programs.

The vaccines they will be able to develop and market for use in the program include Genvoya, the HIV drug that Gilead Sciences acquired from Johnson & Johnson in 2014, and Tresiba and Ryzodeg, both diabetes products that German drug company Novo Nordisk has developed and has been selling in Europe since 2006.

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