Potential approval of revised Covid-19 vaccines by the FDA could occur within the week, according to unnamed sources.
The authority is predicted to endorse revised mRNA jabs from Moderna and Pfizer/BioNTech, focusing on the virus strain KP.2, as per sources, who chose anonymity due to the undisclosed timeline. Whether the body will simultaneously authorize Novavax's revised shot, centering on the JN.1 strain, remains unclear.
This action would take place several weeks before last year's vaccine approval, which received FDA approval on September 11.
"Now's the time for a jab during this surge," Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told CNN.
Osterholm discussed on his podcast last week that he received a dose of the previous season's vaccine to boost his immunity, given the virus's current high circulation levels and uncertainty over when new shots would become available. He added that he would wait for the updated vaccine in four months, as suggested by health officials.
Back in June, the US Centers for Disease Control and Prevention recommended that individuals aged 6 months and above receive both a revised Covid-19 vaccine and a flu shot this year.
Representatives from Pfizer and Moderna informed CNN that their supply of updated Covid vaccines is sufficient, and they are prepared to distribute doses upon approval. Moderna's spokesperson predicted that the vaccine would be available in stores shortly after FDA approval.
Novavax's vaccine employs protein technology, taking longer to manufacture than mRNA vaccines. Novavax executives informed investors last week that they anticipate their updated vaccine to arrive in warehouses this month and be ready for distribution upon authorization. No immediate comment was received from Novavax upon request for comment on Friday.
A spokesperson for the FDA stated that the agency cannot comment on application timelines but noted that they "anticipate taking prompt action to authorize or approve updated Covid-19 vaccines to make them available this fall."
Subscribe to CNN Health's weekly newsletter
- Subscribe here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team.
National wastewater measurements of the SARS-CoV-2 virus, causing Covid-19, are currently at "very high" levels, according to CDC data, marking the highest summer peak in the US since July 2022. Monitoring of viral levels in wastewater provides insights into the virus's spread, given that testing and other monitoring methods have decreased.
Levels of severe disease, including hospitalization and mortality rates, have increased, according to the CDC, though they are not yet near the levels seen in earlier years.
Virus waves are driven by both diminishing immunity and emerging variations, experts state. The predominant strain in the US currently is KP.3.1.1, according to CDC data, estimated to account for 37% of cases over the past two weeks. This is a significant increase from its level a month ago.
KP.3.1.1 and KP.2 – the strain included in the updated mRNA vaccines – are offshoots of JN.1, the target of Novavax's shot, and all are variations of the Omicron variant.
CNN’s Brenda Goodman contributed to this report.
The revised mRNA vaccines from Moderna and Pfizer/BioNTech, focusing on the KP.2 strain, are anticipated to improve public health during this surge. Due to the high circulation levels of the virus and uncertainty over when new shots will be available, boosters are being recommended by health officials.
