Argentum Infection Prevention & Control Announcements

Pfizer Inc. and BioNTech SE today announced the companies have submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of an additional booster dose for adults 65 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. The submission is based on two real-world data sets from Israel analyzed at a time when the Omicron variant was widely circulating. These data showed evidence that an additional mRNA booster increases immunogenicity and lowers rates of confirmed infections and severe illness.

The U.S. Food and Drug Administration has approved the Moderna vaccine, making it the second COVID-19 vaccine to go from emergency use authorization (EUA) to full approval. With this approval, the company will begin to market the vaccine under the name Spikevax. The approval means the vaccine has met FDA standards for “safety, effectiveness, and manufacturing quality,” according to the FDA.

The CDC yesterday announced that it is preferable to get an mRNA vaccine—such as Pfizer or Moderna in a two-shot series—over the Johnson & Johnson one-shot vaccine.  

CDC director Dr. Rochelle Walensky today announced that the CDC recommends and encourages booster shots for ages 16 and 17, as well as reinforcing the previous announcement that those older than 18 get the booster.  

With the increase in cases of the Omicron COVID variant, the FDA and CDC have announced some updates that can help guide testing decisions and action. 

The CDC made a change to its recommendations, saying “Everyone ages 18 and older should get a booster shot.” Previously, the CDC had said everyone “may” get a booster. This stronger recommendation comes in the wake of the emergence of the Omicron variant and the prospect of winter holidays, travel, and close quarters.  

The Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has recommended emergency use authorization (EUA) of molnupiravir. The oral capsule medication made by Merck is designed to treat “mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization,” says the FDA.  

While the World Health Organization has classified a new variant of the coronavirus, Omicron, as a “variant of concern,” as of Nov. 26, no cases have been reported in the United States.

The U.S. Food and Drug Administration has authorized a single booster dose for all individuals 18 and older who have had their primary vaccinations. The booster would be given six months after the primary series with Moderna or Pfizer, and two months after Johnson & Johnson.

CDC director Dr. Rochelle Walensky gave the go-ahead for vaccination of 5- to 11-year-olds against COVID-19, following the recommendations of the FDA and the CDC Advisory Committee on Immunization Practices (APIC).