Health

HEALTH said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The FDA’s new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific

COVID-19 UPDATE data and information that would support an emergency use authorization decision.” Under the requirements for the FDA Issues Guidance on long-awaited EUA, drug makers are to provide data that shows they folEmergency Use Authorization lowed clinical trial participants at least two months after their final vaccine for COVID-19 Vaccines injection. The FDA also wants companies Drug Makers Say Medication Will Not to submit vaccines for authorization only after at least five severe cases of Be Ready by Election Day COVID-19 have been seen in volunteers who got the placebo, according By Sarafina Wright complex biological products that are to the guidance. WI Contributing Writer intended to be administered to mil- “In addition to outlining our exlions of individuals, including healthy pectations for vaccine sponsors, we

The Food and Drug Administra- people in an effort to thwart the pan- also hope the agency’s guidance on tion (FDA) has issued guidance on demic. COVID-19 vaccines helps the pubemergency use authorization (EUA) “Being open and clear about the cir- lic understand our science-based defor COVID-19 vaccines to further cumstances under which the issuance cision-making process that assures prevent the spread of the disease of an emergency use authorization for vaccine quality, safety and efficacy for caused by the coronavirus. a COVID-19 vaccine would be ap- any vaccine that is authorized or ap-

The agency said these recom- propriate is critical to building public proved.” mendations apply, as of Oct. 9, to confidence and ensuring the use of The agency says an EUA is a difCOVID-19 vaccines, which are COVID-19 vaccines once available,” ferent standard than an approval, as

noted in the June guidance, however, in the case of an investigational vaccine developed for the prevention of COVID-19, both pathways require the submission of data demonstrating any vaccine’s safety and effectiveness.

The FDA added that the guidance reiterates that any assessment regarding an EUA will be made on a caseby-case basis considering the target population, the characteristics of the product, the preclinical and human clinical study data on the product and the totality of the available scientific evidence relevant to the product.

The guidance for EUA comes almost seven months after the outbreak of the novel coronavirus that has resulted in more than 37 million global cases and one million plus deaths, according to John Hopkins’ COVID-19 tracker. In the U.S., there have been more than seven million cases and 200,000 deaths.

The pandemic presents an extraordinary challenge to global health, according to the FDA.

The agency added there are currently no FDA-licensed vaccines to prevent COVID-19, and the EUA policy is intended to remain in effect only for the duration of the public health emergency related to the disease.

WI

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ADMISSION PRIORITY PASS Your ticket to better health. Open House Event Date: 10/19/2020 Time: 11:00 a.m. to 1:00 p.m. Location: Courtyard Washingtonian DC/U.S. Capitol 1325 2nd St NE Washington, DC 20002

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