The US Food and Drug Administration (FDA) has taken a step in the ongoing battle against the Covid-19 pandemic. The FDA has granted emergency use authorization for updated mRNA Covid-19 vaccines. These vaccines have been specifically engineered to offer enhanced protection against the currently circulating variants of the virus, particularly the Omicron variant KP.2strain.
The decision by the FDA comes at a critical juncture. Observations have shown that immunity derived from previous exposure to the virus and prior vaccination has been waning over time. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated Covid-19 vaccine to provide better protection against currently circulating variants, said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
The updated mRNA Covid-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals 12 years of age and older. Additionally, the Moderna Covid-19 Vaccine and Pfizer-BioNTech Covid-19 Vaccine have been authorized for emergency use for individuals aged 6 months through 11 years.
The approval of these updated vaccines comes amid a surge in Covid-19 cases this summer, with the US leading the world in Covid deaths for two months. The updated vaccines from Pfizer-BioNTech and Moderna target the current KP.2 strain of SARS-CoV-2, a descendant of the highly contagious Omicron subvariant JN.1.
The vaccines are expected to be available to consumers within a week. Unvaccinated individuals aged 6 months to 4 years can receive three doses of the updated Pfizer-BioNTech vaccine or two doses of the Moderna vaccine. Previously vaccinated individuals in the same age group may receive one or two doses of the updated vaccine based on their vaccination history.
For children aged 5 to 11, the FDA recommends getting a single dose of the updated Moderna or Pfizer-BioNTech vaccine regardless of their vaccination status. However, if previously vaccinated against Covid-19, the updated vaccine must be administered at least 2 months after the last shot. Those aged 12 and older can receive a single dose of the updated Comirnaty or Spikevax vaccine. If they are previously vaccinated, the shot may be given at least 2 months after the last shot.
The surge in cases is largely fueled by the emergence of new highly transmissible variants, particularly FLiRT strains like KP.3 and its relative, KP.3.1.1. The most recent estimates show that variant KP.3.1.1 is now leading, causing about 37% of cases in the U.S. Meanwhile, KP.3 is responsible for about 17% and KP.2.3 is causing a little more than 14% of cases. However, JN.1 itself has dropped off considerably and is now responsible for just 0.2% of cases, according to estimates from the CDC.
The timing of the updated dose is crucial for maximum protection. High-risk situations such as travel or large events should be kept in mind while planning the dose. For instance, if you have a major trip planned or are attending a high-risk event like a large indoor wedding, it would be advisable to get vaccinated beforehand.
The decision to target the KP.2 variant is a departure from the recommendations of the World Health Organization and some other countries, which had called for shots aimed at the JN.1 variant. However, the CDC's Natalie Thornburg clarified that all the currently circulating viruses are very similar to each other, and the different sounding names are merely a matter of nomenclature.
The approval of these updated vaccines is a significant step forward in the fight against Covid-19. It is a testament to the relentless efforts of scientists and healthcare professionals worldwide who have been working tirelessly to protect the global population from this deadly virus. As we continue to navigate these challenging times, it is crucial to stay informed, follow the advice of health experts, and get vaccinated to protect ourselves and our communities.