The Department of Health and Human Services wants to know if the FDA followed its rules and procedures in investigating the contamination of baby formula and recalling it.
The Novavax vaccine appears to be about 90% effective at preventing mild, moderate and severe COVID-19, Food and Drug Administration scientists say in an analysis of the company's data.
But Abbott has said that, after production resumes, it could take about two months before new formula begins arriving in stores. The company's factory has been closed due to contamination problems.
The agency says the proposal has the potential to significantly decrease disease and death from tobacco by "reducing youth experimentation and addiction."
The vaccines now in use are based on the form of the virus that circulated at the beginning of the pandemic and are less effective against the omicron variant. New options are in the works.
People who are 50 and older and certain immunocompromised individuals may get a second Pfizer-BioNTech or Moderna COVID-19 vaccine booster four months after they received the first.
The FDA now cautions against using a specific lot of Abbott Nutrition's Similac PM 60/40 after a second infant dies. Abbott voluntarily recalled the specialty product on Monday.
Abbott Nutrition voluntarily recalled some powdered formulas sold under the Similac, Alimentum and EleCare brands. The FDA is investigating links to four bacterial infections, one of which was fatal.
"We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization," FDA officials said in a statement.
The Food and Drug Administration this week approved an injectable drug that helps prevent the spread of HIV. It only has to be taken once every eight weeks, compared to a daily oral pill.
