First participants enrolled in clinical trial received Omicron-based vaccine candidate as a two-dose primary series and as a booster dose
Product candidates will be based on BioNTech’s proprietary mRNA technology and on Pfizer’s antigen technology. Clinical trials are expected to start in the second half of 2022
First emergency use authorization in the United States for a Covid-19 vaccine booster in adolescents 12 through 15 years of age
According to the companies’ preliminary data, a third dose provides a similar level of neutralizing antibodies to Omicron as is observed after two doses against wild-type and other variants that emerged before Omicron
These results demonstrate the potential benefits of heterologous boosting (mix-and-match). The article describing these results have been posted on medRxiv
Emergency Use Authorisation (EUA) is granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups
In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year
The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of Covid-19 disease
The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.
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