With the world entering its second year of lifewith the widespread impact of COVID-19, agencies like the US Food and Drug Administration (FDA) are keeping busy with monitoring emerging variants, weighing approval of new products, and offering guidance to R&D experts and others working on solutions.
With life-sciences professionals, public officials and civilians all expressing concern about the COVID-19 variants popping up around the globe, the FDA (via acting commissioner Janet Woodcock) recently issued a statement advising that the agency remains on top of developments and will work to ensure that Americans have the diagnostics, treatments and vaccines necessary to fight the virus.
“We understand the need to adapt and pivot to support modification or development of these lifesaving tools as new variants of coronavirus are identified,” Woodcock said in the statement. “The FDA continues to monitor the identified and emerging variants circulating globally, as well as their detection in the US.”
As have researchers in other parts of the world, FDA researchers have been assessing the impact of new strains on already authorized products, Woodcock commented. What’s more, she said, the agency will continue drawing upon its vast repository of infectious disease knowledge to work toward solutions that can be used to effectively protect the public from the virus.
Janssen vaccine update
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will gather to discuss a possible emergency use authorization (EUA) for the COVID-19 vaccine candidate from Janssen Biotech.
According to Woodcock, the committee members will publicly discuss data submitted in support of the vaccine candidate, in order to insure citizens understand the scientific data the FDA will review when deciding whether to grant authorization for the vaccine.
“The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines, so that the American public and medical community have trust and confidence in FDA-authorized vaccines,” she remarked.
The VRBPAC’s independent, scientific and public health experts members offer advice to the FDA. However, the authority to grant EUAs for vaccines lies with the FDA itself.
Clinical trial guidance
In the face of continuing challenges around conducting clinical studies, the FDA again has updated its Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency” guidance.
The updated document includes a new question-and-answer section about whether the agency considers receipt of medical products authorized under an EUA for use in clinical care (such as a vaccine or a monoclonal antibody to treat COVID-19) to be receipt of “investigational” medical products. Such information could be relevant if sponsors are weighing eligibility criteria that exclude patients from enrolling in clinical trials if they have received certain medical products.
Compounded COVID-19 treatment warning
The agency is alerting healthcare providers and compounders that there may be risks tied to compounding remdesivir drug products, and its members recommend against compounding the COVID-19 treatment.
Compounded drugs are not approved by the FDA. As a result, the agency does not verify the safety, effectiveness, or quality of compounded drugs, and it advises that such drugs only be used in patients whose needs cannot be met by an FDA-approved drug.