AstraZeneca seeks EUA for COVID-19 prophylaxis 

AstraZeneca (LON:AZN) has filed paperwork with the FDA for an emergency use authorization (EUA) for AZD7442, a long-acting antibody (LAAB) cocktail, as a COVID-19 prophylaxis.

The paperwork filed for the EUA request includes data from the PROVENT and STORM CHASER Phase 3 trials.

A Phase 3 trial of AZD7442 showed statistically significant protection against COVID-19 infection. Compared to the placebo, the investigational drug offered 77% protection in the PROVENT trial against symptomatic disease compared to placebo.

The PROVENT study included 5,197 participants, with two-thirds receiving AZD7442 and the remainder getting placebo.

A single injection of AZD7442 could offer up to 12 months of protection from symptomatic SARS-CoV-2 infection.

The study also found that the drug was well-tolerated.

AstraZeneca foresees that the drug would be used alongside vaccines to protect vulnerable populations.

AZD7442 comprises two agents, tix…

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Why emergency authorization of COVID-19 therapies could pose thorny regulatory questions

Image by Arek Socha from Pixabay

Few of the COVID-19 therapies in use in the U.S. have won full FDA approval. The widespread use of emergency use authorization may accelerate the distribution of disease-modifying agents and vaccines to patients, but it also could cause regulatory complications.

“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard,” said Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland.

The FDA’s decision to grant emergency use authorization to investigational vaccines could lead to the development of a “marketplace” where vaccines are deemed “good enough to be authorized, but never approved,” Doshi opined in the public comment period of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Johnson & Johnson’s vaccine.

Further compl…

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