FDA Amends EUA For Pfizer-BioNTech’s COVID-19 Vaccine Booster

May 23, 2022 - FDA recently amended the emergency use authorization for Pfizer and BioNTech’s COVID-19 vaccine booster to include individuals 5– 11 years of age at least five months after completing the primary series.  

The agency based its decision on an analysis of immune-response data in a subset of children from the randomized, placebo-controlled clinical trial that supported the October 2021 authorization of the Pfizer and BioNTech vaccine primary series in this age group. 

FDA evaluated antibody responses in 67 study participants who received a booster dose seven to nine months after completing a two-dose primary vaccine series. The antibody level against the virus one month after the booster dose increased significantly compared to before. 

“The Pfizer-BioNTech COVID-19 vaccine is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the announcement.  

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups.” Marks continued.  

In January, FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for individuals 12 through 15 years of age after completing the primary vaccination series.  

And most recently, experts assessed the safety of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine in nearly 400 children 5–11 years of age who received a booster dose at least five months after completing a two-dose primary series. 

Notably, there were no severe adverse events.  

AstraZeneca Enters Agreement to Develop COVID-19 Antibodies 

AstraZeneca recently entered into a license agreement with RQ Biotechnology Ltd for a portfolio of early-stage monoclonal antibodies (mAbs) against SARS-CoV-2.  

UK-based RQ Bio focuses on developing treatments and preventative therapies based on potent broad-spectrum mAbs to address areas of unmet need in vulnerable patient populations. 

Under the agreement terms, AstraZeneca acquired an exclusive global license to develop, manufacture, and commercialize mAbs against COVID-19.   

“The COVID-19 pandemic has changed the landscape for immune therapies, including the use of monoclonal antibodies to protect vulnerable patients who can’t respond adequately to vaccination alone,” Iskra Reic, executive vice president of vaccines and immune therapies at AstraZeneca, said in the announcement. 

Scientific innovation is rapidly accelerating, and this agreement reflects our continued commitment to the discovery and development of new medicines to help prevent and treat infectious diseases, including COVID-19,” Reic concluded.  

Novavax Files for Emergency Use Authorization of COVID-19 Vaccine in Taiwan  

Novavax recently submitted a request for emergency use authorization to Taiwan’s Food and Drug Administration for its COVID-19 vaccine, NVX-CoV2373, to prevent the virus in individuals 18 years of age and older.  

The company’s submission includes data from two pivotal Phase 3 clinical trials, PREVENT-19 and a UK-based trial with nearly 15,000 adult participants.  

PREVENT-19 enrolled about 30,000 individuals aged 18 years and older in the US and Mexico, while the UK-based trial enrolled 15,000 adults. NVX-CoV2373 demonstrated efficacy with a reassuring safety profile in both trials. 

The serious and severe adverse events were low in number and balanced between the vaccine and placebo groups.