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FDA Sets Review Criteria for Covid-19 Vaccines



30 June 2020. The Food and Drug Administration issued its standards that developers need to meet in evidence submitted for review of vaccines to prevent Covid-19 infections. The guidance document outlines FDA’s requirements for Covid-19 vaccines covering the drugs’ chemistry, manufacturing, animal tests, human clinical trials, and follow-up studies after a vaccine is approved.

The Covid-19 pandemic, now resurgent in the U.S., generated a global race to produce therapies to treat and vaccines to prevent infections from the SARS-CoV-2 virus. An industry dashboard tracking progress of these drug candidates shows, as of today, 150 Covid-19 vaccines in development, with 26 of those candidates in clinical trials. FDA says the guidance document issued today reflects its current thinking on vaccines, but also advice given to companies and academic researchers over the past several months.

The agency says it expects clinical trials to show vaccines are effective in preventing infections in at least half of the cases inoculated by the candidate vaccine, with the prevention of Covid-19 infections among a clinical trial’s primary efficacy measures, called endpoints. Those primary efficacy endpoints can be measured by infection detection tests, using nasal swabs or saliva samples, or blood tests looking for SARS-CoV-2 antibodies. Other efficacy measures can include reports of common Covid-19 infection symptoms, such as fever or coughing, or depending on the vaccine’s chemistry, measure severity of infection with antibodies in blood samples combined with symptom severity.

Safety endpoints, says FDA, should be based on data from samples large enough to provide reliable breaks between younger and older individuals. Study teams are expected to report adverse effects for at least seven days following vaccination, as well as any adverse events affecting participants for 21 to 28 days after vaccination. Follow-up monitoring should continue for at least one year, and developers should expect FDA to ask for post-marketing follow-up studies, and mechanisms for tracking signs of any adverse effects for extended periods.

In addition, vaccine developers need to account for special circumstances, including pregnant women and  women of child-bearing age, looking for evidence of effects of vaccine candidates on fetuses or births. FDA also expects vaccine developers to monitor trial participants for vaccine-associated enhanced respiratory disease, an immune-system reaction to some vaccinations, with criteria specified in advance for stopping trials if signs of these reactions occur.

FDA will allow vaccine developers to design clinical trials with alternatives to classic randomized samples evenly divided between treatment and placebo groups. Adaptive clinical trials that enable study teams to change treatments or modify the study design based on earlier collected data will be considered, as well as seamless trials that allow for combining early- and mid-stage trials, if these approaches can produce solid data without compromising the quality of results.

Likewise, FDA encourages clinical trial samples to include a wide range of racial and ethnic groups to accurately represent the larger population, vulnerable populations such as older-age individuals and those with chronic diseases, and children to assess their effects and responses to vaccines compared to adults.

“In this particular crisis in which there is so much at stake, we need to help expedite vaccine development as much as we can without sacrificing our standards for quality, safety, and efficacy,” says Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research in an agency statement. “We firmly believe that transparency regarding the FDA’s current thinking about the scientific data needed to support approval of safe and effective Covid-19 vaccines will help build public confidence in the FDA’s evaluation process, which will be critical in ensuring their use.”

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