The US Food and Drug Administration (FDA) is expected to approve updated Covid-19 vaccines as early as this week. These vaccines are designed to target newer strains of the virus that are currently circulating, as informed by two sources who chose to remain anonymous. This comes at a time when the US is facing the most significant summer surge of the virus in the last two years.
The anticipated approvals include mRNA vaccines from Moderna and Pfizer/BioNTech that are focused on the KP.2 strain of the virus. The approval status of Novavax’s vaccine, which targets the JN.1 strain, was still uncertain at the time of reporting.
This approval timeline is notably ahead of last year’s schedule, where the vaccines received FDA approval on September 11.
Dr. Michael Osterholm, a prominent expert in infectious diseases at the University of Minnesota, emphasized the urgency of getting vaccinated during this surge. He shared on his podcast that he had recently received a dose of last season’s vaccine to boost his immunity given the high virus circulation and the pending availability of new vaccines. Osterholm plans to get the updated vaccine in four months, following the recommended interval by health officials.
In preparation for the vaccine rollout, representatives from Pfizer and Moderna told CNN that there is sufficient supply of the updated vaccines ready to be distributed immediately upon receiving FDA approval. According to a Moderna spokesperson, the vaccine could be available in stores within days of approval.
Novavax, utilizing a protein-based technology that takes longer to produce than mRNA vaccines, is also gearing up for distribution. Company executives indicated on a recent investor call that their updated vaccine is expected to reach warehouses this month and be ready for distribution upon authorization.
An FDA spokesperson mentioned that the agency could not comment on specific timelines but is poised to act promptly to authorize or approve the updated vaccines to ensure availability this fall.
Amid these developments, CDC data shows that levels of the SARS-CoV-2 virus in wastewater are at very high levels nationally, indicating a widespread virus presence—this being the highest summer peak since July 2022. While hospitalization and death rates are increasing, they remain significantly lower than in past years.
The drive for these updated vaccines comes as the virus continues to evolve, with the prevalent strain in the US now being KP.3.1.1, which, along with KP.2, are derivatives of the JN.1 strain targeted by Novavax’s vaccine. All these strains are versions of the Omicron variant, underscoring the need for ongoing vaccine adaptation and distribution.
