FDA: Coronavirus Vaccines Must Protect >50% Vaccinated Individuals

June 30, 2020

New recommendations are intended to aid biomedical firms in achieving licensure of a safe and effective vaccine.

The US Food and Drug Administration (US FDA) has provided new guidance on development of vaccines against the disease caused by SARS-CoV-2, COVID-19. The new recommendations are intended to aid biomedical firms in achieving licensure of a safe and effective vaccine, according to a press release.

Identifying a key target, the FDA advised that they would expect a COVID-19 vaccine to prevent disease or decrease its severity in at least 50% of individuals who are vaccinated.

The FDA statement was careful not to pick favorites among the many biotech companies which have thrown their hat in the vaccine ring.

“FDA has the scientific expertise to evaluate any potential COVID-19 vaccine candidate regardless of the technology used to produce or to administer the vaccine. This includes the different technologies such as DNA, RNA, protein and viral vectored vaccines being developed by commercial vaccine manufacturers and other entities,” the statement reads.

The guidance, titled “Development and Licensure of Vaccines to Prevent COVID-19,” provides an overview of standards for quality, chemistry, manufacturing, and for post-licensure safety evaluation. The FDA also encouraged the inclusion of diverse populations in research, including populations disproportionately impacted by COVID-19, particularly ethnic minorities, as well as (in late phase trials) of elderly individuals and those with comorbidities.

Further elaboration also emphasized the import of ensuring clinical trials are large enough to demonstrate the safety and effectiveness of a vaccine.

FDA Commissioner Stephen M. Hahn, MD, explained the agency’s motivations.

“We recognize the urgent need to develop a safe and effective vaccine to prevent COVID-19 and continue to work collaboratively with industry, researchers, as well as federal, domestic, and international partners to accelerate these efforts. While the FDA is committed to expediting this work, we will not cut corners in our decisions and are making clear through this guidance what data should be submitted to meet our regulatory standards. This is particularly important, as we know that some people are skeptical of vaccine development efforts,” Hahn said.

“We have not lost sight of our responsibility to the American people to maintain our regulatory independence and ensure our decisions related to all medical products, including COVID-19 vaccines, are based on science and the available data. This is a commitment that the American public can have confidence in and one that I will continue to uphold.”

Related Coverage:

Moderna Ramps Up SARS-CoV-2 Vaccine Productive Capacity

According to a recent statement, Moderna is building the capacity to deliver about 500 million doses of its investigational SARS-CoV-2 vaccine, with a 2021 target of “up to 1 billion 100 μg doses per year.”

Read more.

Goals of Operation Warp Speed

Patrick Soon-Shiong, MD, describes goals and expectations for the accelerated coronavirus vaccine program “Operation Warp Speed.”

Watch here.

What Can Benefit COVID-19 Vaccine Research

In an interview with Contagion, William Schaffner, MD, of the Vanderbilt University Medical Center, discussed the strategy of participant age-stratification being practiced by at least 1 team of investigators for a potential COVID-19 vaccine. He also explained the difficulty of properly representing minority patients in vaccine research, and how that may influence development timelines.

Watch here.