Argentum COVID-19 Announcements

Instead of keeping with COVID-19 vaccine boosters that target the original strain of SARS-CoV-2, an FDA advisory panel said this week that it favors reformulating the doses to also work against newer Omicron subtypes, reports the New York Times.

To the relief of many parents and caregivers, panels for the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have determined that the known and potential benefits of vaccinating children 6 months of age and older outweigh the known and potential risks in the pediatric populations authorized for use for use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine. Vaccinations began this week.

Drugmaker Moderna asked the Food and Drug Administration on Thursday to authorize a fourth shot of its Covid-19 vaccine as a booster dose for all adults.

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.  

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.  

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.