FDA Approves Updated COVID-19 Vaccines from Moderna and Pfizer/BioNTech

With a summer surge of COVID-19 impacting the United States, the FDA has approved updated vaccines from Moderna and Pfizer/BioNTech as of Thursday.

Moderna and Pfizer announced that their updated mRNA vaccines will soon be available at pharmacies and clinics.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized the importance of vaccination in preventing COVID-19. “These updated vaccines meet the FDA’s high standards for safety, effectiveness, and manufacturing quality,” he stated. “With immunity levels declining from past infections and vaccinations, we strongly recommend that eligible individuals receive the updated COVID-19 vaccine for enhanced protection against currently circulating variants.”

A CVS representative stated that doses of the updated COVID-19 vaccine are expected to begin arriving at its locations within a few days. Amy Thibault from CVS noted, “Once the vaccine supply arrives at our pharmacies, we will accept walk-ins.” Additionally, CVS’s digital scheduler will be updated to reflect available vaccination appointments, allowing customers to check local availability online.

Walgreens customers will be able to schedule appointments for the updated vaccine starting September 6, with availability expected within 24 hours. A Walgreens spokesperson added that walk-ins will also be accommodated as vaccine supplies become available in the coming days.

According to CDC data, SARS-CoV-2 virus levels in wastewater are at “very high” levels nationwide, marking the highest summer peak in the U.S. since July 2022. Wastewater monitoring provides insight into the virus’s spread, especially as testing and other forms of surveillance have decreased.

The CDC reports rising rates of severe disease, including hospitalizations and deaths, though they remain below the peaks seen in previous years.

The current predominant strain in the U.S. is KP.3.1.1, which now accounts for 37% of cases over the past two weeks, a significant increase from a month ago. KP.3.1.1 and KP.2, which is included in the updated mRNA vaccines, are both variants of JN.1. JN.1 will also be targeted by an updated protein-based vaccine from Novavax, with all these strains being versions of the Omicron variant.

In June, the U.S. Centers for Disease Control and Prevention (CDC) recommended that everyone over 6 months old receive both an updated COVID-19 vaccine and a flu shot this year.

As of Thursday, the FDA has announced that individuals aged 5 and older are eligible for an updated Pfizer or Moderna COVID-19 vaccine, provided it has been at least two months since their last dose.

For unvaccinated children aged 6 months to 4 years, the updated Pfizer vaccine is available in a three-dose series, while the updated Moderna vaccine is offered in a two-dose series. Children in this age group who have been previously vaccinated can receive one or two doses of the updated vaccines, based on their prior vaccination history. Additionally, some children aged 6 months to 11 years with weakened immune systems may qualify for extra doses.