September 25, 2022

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Omicron vaccine: Pfizer/BioNTech Launches trials in Healthy Adults Ages 18-55!

Omicron vaccine: Pfizer/BioNTech Launches trials in Healthy Adults Ages 18-55!



 

Omicron vaccine: Pfizer/BioNTech Launches trials in Healthy Adults Ages 18-55!

Omicron mRNA vaccine! Pfizer/BioNTech Launches Clinical Study: Testing in Healthy Adults Ages 18-55!

on January 25, Pfizer and BioNTech  announced the initiation of a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based mRNA vaccine candidate in healthy adults aged 18-55.

The study will have 3 cohorts, testing different regimens of the current COVID-19 mRNA vaccine (Pfizer-BioNTech COVID-19 vaccine), as well as an Omicron-based vaccine.

The study, which will utilize selected subjects from Pfizer and BioNTech’s Phase 3 COVID-19 booster study, is part of an ongoing effort by both parties to address Omicron to identify the potential need for a variant-based vaccine.

The first subjects have been enrolled in the clinical trial and received the Omicron-based vaccine as a 2-shot primary immunization schedule plus a booster shot.

Specifically, the study will evaluate 3 cohorts of up to 1,420 subjects:

  • Cohort 1 (n=615) : Subjects had received 2 doses of the current COVID-19 mRNA vaccine (Pfizer-BioNTech COVID-19 vaccine) 90-180 days prior to enrollment. In this study, subjects were Will receive one or two doses of the Omicron-based vaccine.
  • Cohort 2 (n=600) : Subjects had received 3 doses of the current COVID-19 mRNA vaccine (Pfizer-BioNTech COVID-19 vaccine) 90-180 days prior to enrollment. In this study, subjects were Will receive a dose of the current current COVID-19 mRNA vaccine (Pfizer-BioNTech COVID-19 vaccine) or an Omicron-based vaccine.
  • Cohort 3 (n=205) : Subjects who have not been previously vaccinated will receive 3 doses of the Omicron-based vaccine.

Omicron vaccine: Pfizer/BioNTech Launches trials in Healthy Adults Ages 18-55!

“While current research and real-world data suggest that booster shots continue to provide high levels of protection against severe illness and hospitalization of people with Omicron infection, we recognize the need for Be prepared for this protection to wane over time and potentially help address Omicron and future new variants.

Staying vigilant against the virus requires us to identify new ways to keep people at high levels of protection , we believe that developing and researching variant-based vaccines, such as this one, will be critical to our efforts to achieve this goal.”

Professor Ugur Sahin, CEO and co-founder of BioNTech, said: “Vaccines continue to provide robust protection against severe disease caused by Omicron. However, new data suggest that vaccine-induced protection against infection and mild to moderate disease is stronger than previous Virus strains declined faster. This study is part of our science-based approach to develop a variant-based vaccine with similar levels of protection to Omicron as earlier variants, but for a longer period of time.”

Pfizer/BioNTech’s COVID-19 vaccine is based on BioNTech’s proprietary mRNA technology , co-developed by BioNTech and Pfizer.

BioNTech is the holder of a Marketing Authorisation in the US, EU and UK, and is also the holder of an Emergency Use Authorisation (EUA) or equivalent in the US (along with Pfizer), Canada and other countries.

The parties plan to submit applications for regulatory approval in the countries where the EUA or equivalent authorization was originally granted.

 

(source:internet, reference only)


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