Our Solutions

Commentary on FDA Guidance on Development and Licensure of Vaccines to Prevent COVID-19

It typically takes years to develop, test, and gain regulatory approval for a novel vaccine. In the era of COVID-19, academic labs, pharmaceutical companies big and small, non-governmental organizations, and federal governments are pulling out all stops to achieve what will hopefully be a record-shattering pace for the development and approval of a vaccine. As part of the U.S. government support of these efforts, the U.S. FDA issued Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry to provide its perspective on (and recommendations) for the CMC (chemistry, manufacturing, and control), nonclinical, and clinical aspects related to such vaccines. Considering the ongoing public health emergency, in an unusual action, the agency implemented this guidance without prior public comment.

To expedite the path to clinical trial for some vaccines, the FDA highlights that nonclinical safety studies may not be required prior to first-in-human (FIH) trials for vaccines developed with well-characterized platforms or other precedent. For example, those…

“…made using a platform technology utilized to manufacture a licensed vaccine or other previously studied investigational vaccines and is sufficiently characterized.”*

The vaccine currently being developed by AstraZeneca and the University of Oxford leveraged the university’s data on a vaccine for MERS (also a coronavirus), which was developed using the same platform. (*Note that this provision also applies to non-COVID vaccines).

With respect to novel COVID-19 vaccines that do not have such precedents, the FDA remains diligent in its focus on patient safety; the nonclinical requirements remain much the same as for a non-COVID vaccine. That said, some allowances are made to encourage certain activities normally studied sequentially, to be conducted concurrently. The FDA’s expectations for the nonclinical development of novel vaccines are aligned with those described by the World Health Organization (WHO guidelines on nonclinical evaluation of vaccines, WHO Technical Report Series No. 927, 2005).

According to Dr. Joseph Francisco, Chief Toxicologist at Altasciences:

“In my experience, the majority of COVID-19 vaccines target the virus’ spike protein. Even though mice are not susceptible to infection by this virus, and cannot be used in a challenge model to evaluate the protective effects of the vaccine against the virus, mice do generate a strong antibody response against the spike protein. These antibodies can protect against viral infection in vitro; therefore, mice have commonly been used for the nonclinical toxicity evaluation of these vaccines as they are considered a relevant species.”

This podcast, featuring Dr. Francisco, offers additional insight into the vaccine development process, the relevant guidelines, and how Altasciences can help you get your vaccine candidate to FIH and beyond.


This site uses cookies to store information on your computer and improve your browsing experience. By remaining on this site, you consent to the placement of these cookies. Read our Cookie Policy to learn more.


Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide comprehensive support research services and bioanalytical expertise.

Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.

Learn More

Working as a flexible, attentive extension of your team, we offer all you need to move your molecule forward.