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Pfizer Seeks FDA Emergency Authorization for Omicron BA.5 COVID Vaccine Booster

The mRNA vaccines target the BA.4 and BA.5 omicron variant and are intended for everyone ages 12 and up.

A vial of COVID-19 vaccine against a light blue background
A new COVID-19 vaccine could be available soon. 
Narin Sapaisarn/500px/Getty Images
For the most up-to-date news and information about the coronavirus pandemic, visit the WHO and CDC websites.

A fresh round of COVID-19 vaccines aimed at the omicron strain of the virus could be right around the corner -- just in time for a potential surge in cases as we come into fall and winter. Vaccine manufacturer Pfizer and its German partner, BioNTech, each submitted an application to the US Food and Drug Administration for emergency authorization of their updated vaccines, according to a Monday blog post.

The companies have also begun work on a conditional marketing authorization application with the European Medicines Agency for use in the European Union. Both companies expect to complete the application in the coming days.

The mRNA vaccines use encoding of the original SARS-CoV-2 spike protein, along with the encoding of the spike protein present in the newer omicron BA.4/BA.5 variant, to create a vaccine that has shown promise in neutralizing antibody responses against a wide variety of omicron strains, according to the blog post. 

A clinical study of the vaccine in people 12 years and older will begin later this month.

"The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed," Albert Bourla, Pfizer's chairman and CEO, said in the blog post. "Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges." 

It is not yet known when the vaccines will be available to the public. 

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.