The FDA authorizes the first e-cigarette; an FDA meeting will discuss mix-and-match booster vaccines; OSHA submitted the initial text of an emergency vaccine rule to the OMB for review.
On Tuesday, the FDA issued its first marketing authorization for an e-cigarette, saying the vaping device can help smokers cut back on conventional cigarettes. However, the agency also stressed that e-cigarettes are neither safe nor approved by it, and nonsmokers should not start using them. This authorization only applies to the Vuse Solo closed ENDS e-cigarette and its tobacco-flavored nicotine cartridges, with the agency saying its decision was based on data from manufacturer RJR Vapor Company that showed this e-cigarette helped smokers significantly reduce their cigarette consumption or quit smoking cigarettes. The FDA is currently reviewing the company’s request to sell a menthol-flavored nicotine formula, after rejecting 10 other flavors. Just last month, the FDA failed to meet the deadline set by a federal judge to decide which e-cigarettes can remain on the market.
FDA scientists did not take a clear position on whether the agency should authorize booster shots of the Moderna COVID-19 vaccine, STAT News reported. In documents posted October 12, ahead of 2-day meeting on Moderna and Johnson & Johnson boosters (J&J), the FDA made a case both for and against the authorization and need for a third dose of the Moderna vaccine. The meeting will also discuss a study by the National Institutes of Health, which analyzed the effects of mix-and-match boosters. Meanwhile, The New York Times reports that J&J data are insufficient to support the pharma giant’s application for a booster for its 1-shot COVID-19 vaccine, citing the psVNA assay it used to gauge the immune booster response lacked sensitivity and the FDA’s questioning if the data paint a reliable picture of immune response.
The Occupational Safety and Health Administration (OSHA) submitted the initial text of an emergency vaccine rule to the Office of Management and Budget (OMB) for review, bringing President Joe Biden’s vaccine mandate for large businesses a step closer to reality, FOX News reported. This comes a month after Biden announced businesses with more than 100 employees will be required to mandate COVID-19 vaccines or administer weekly tests and to pay employees for time off to get vaccinated and recover from the adverse effects. The rule will go into effect after the OMB finishes its review and it is published in the federal register.