J&J files for authorization of COVID-19 booster shot

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Johnson & Johnson filed for emergency use authorization from the FDA Oct. 5 for a booster dose of its COVID-19 vaccine for people ages 18 and older. 

The drugmaker said its submission to the FDA to support authorization of a booster includes data from a phase 3 trial that found a booster dose given 56 days after the first dose was 94 percent effective at preventing symptomatic COVID-19. The trial also showed the booster was 100 percent effective against severe or critical COVID-19 at least 14 days after vaccination. 

Data from a phase 1/2a study also showed that a booster of J&J's COVID-19 vaccine given six months after the first dose increased antibody levels nine-fold one week after the shot and by 12-fold after four weeks. 

On the same day, AstraZeneca filed for emergency use authorization from the FDA for its COVID-19 antibody drug for prophylaxis of symptomatic COVID-19. 

The drugmaker said clinical trials found the drug caused a 77 percent reduction in risk of developing symptomatic COVID-19, and that the drug has the potential to protect people not expected to have an adequate immune response to a vaccine.

"Vulnerable populations such as the immunocompromised often aren't able to mount a protective response following vaccination and continue to be at risk of developing COVID-19. With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines," Menelas Pangalos, PhD, executive vice president of  biopharmaceuticals research and development at AstraZeneca, said in a news release. 

More than 75 percent of the clinical trial participants had comorbidities associated with an increased risk of severe COVID-19 or a reduced immune response to vaccination. 

If authorized, it would be the first antibody drug cleared for COVID-19 prevention. 

 

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