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03/29/2022

Pfizer, BioNTech obtain EU authorization for 2nd COVID-19 booster

The FDA authorized a second booster dose in adults aged 50 years old and older and for those aged 12 years old and older with compromised immune systems.
Sandra Levy
Senior Editor
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Pfizer and BioNTech SE have received the Food and Drug Administration's emergency use of their COVID-19 vaccine to include a second booster dose in adults aged 50 years and older who have previously received a first booster of any authorized COVID-19 vaccine.

The FDA also has authorized a second booster dose for individuals aged 12 years old and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine. The additional booster is to be administered at least four months after the first booster and is the same formulation and strength as prior Pfizer-BioNTech COVID-19 vaccine doses, the company said. 

[Read more: Retailers begin offering Pfizer COVID-19 booster shots]

Expanded Emergency Use Authorization is based on the totality of scientific evidence shared by the companies including immunogenicity data from an ongoing, open-label study in 154 healthcare workers aged 18 years old and older at a single center in Israel who received two booster doses during a period when Omicron was the predominant variant. Among these individuals, approximately 11-fold increases in geometric mean neutralizing antibody titers against wild-type virus, and Delta and Omicron variants, respectively, were reported at two weeks after the second booster as compared to five months after the first booster dose. No new safety concerns were noted among study participants. The companies also shared with the FDA data from the United States and elsewhere showing a decline in vaccine effectiveness against COVID-19 three to six months after the initial booster and evidence from Israel that an additional booster dose can improve protection against severe disease and death. 

Together, the data demonstrate the public health need in the most vulnerable individuals and suggest that an additional booster dose of the Pfizer-BioNTech COVID-19 vaccine administered at least four months after the initial booster may restore antibody levels, improve protection in older people, and provide a similar safety profile to that of previous doses. In addition, emerging data underscores the importance of considering an additional booster dose for all individuals included in this EUA, the companies said. 

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The Pfizer-BioNTech COVID-19 Vaccine was previously authorized under EUA as a single booster administered to individuals aged 12 years old and older who have completed the primary vaccination series with the Pfizer-BioNTech COVID-19 Vaccine, as well as to individuals aged 18 years old and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The second booster authorized today for those age 50 years old and older is meant to extend high levels of protection against COVID-19 for the most vulnerable populations in advance of potential future waves.

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