The Food and Drug Administration (FDA) is currently considering the approval of this year’s strain-matched COVID-19 vaccines in response to the high and peaking summer wave of the virus. According to a report by CNN, the FDA may sign off on the vaccines as early as this week, in light of the surge in cases across the country.
Last year, the FDA approved the 2023–2024 COVID shots on September 11, which coincided with the peak of SARS-CoV-2 transmission during that year’s summer wave. This year, the summer wave started earlier and is showing much higher levels of transmission compared to previous years. Wastewater detection of SARS-CoV-2 in 32 states and the District of Colombia indicates “very high” virus levels, while an additional 11 states have been listed as having “high” levels.
The southern and western regions of the country are currently reporting SARS-CoV-2 levels in wastewater that rival the peaks seen during the winter waves of 2022–2023 and 2023–2024. Test positivity rates have also been high, with a weekly rate of 18.1 percent for mid-August, the highest since the towering omicron wave in January 2022.
Despite the high transmission levels, emergency department visits and deaths have not shown similar increases. The percentage of emergency department visits with a COVID-19 diagnosis remains low, similar to last year’s summer wave. Deaths, while low, are still provisional counts for the most recent weeks.
The FDA has traditionally focused on offering annual COVID-19 vaccines ahead of winter waves to prevent overwhelming healthcare systems. However, the seasonality of COVID-19 has proved unpredictable, with summer waves now as common as winter ones. Some experts have recommended getting vaccinated during the summer surge to protect against the virus.
Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, advised getting vaccinated during the surge. However, the current vaccines target last year’s strains and may not offer strong protection against the current variants. Even if the FDA approves the 2024–2025 vaccines this week, it may take two weeks for full protection to develop, by which time the summer wave may be declining.
Timing for maximum protection against the likely winter wave is also crucial. The CDC recommended one shot for healthy individuals five years and older last year, with peak protection lasting around four months. Older individuals and those who are immunocompromised may need additional doses of the updated vaccine.
Subheadings:
Summer Wave and FDA Approval
The FDA is considering approving strain-matched COVID-19 vaccines in response to the high and peaking summer wave of the virus.
Transmission Levels and Test Positivity
Wastewater detection of SARS-CoV-2 and test positivity rates have been high, indicating widespread transmission of the virus.
Vaccination Strategy and Timing
Experts recommend getting vaccinated during the summer surge to protect against the virus, but timing for maximum protection against the likely winter wave is also crucial.
