RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2021 > 2 > Woodcock: FDA plans guidance to address new COVID-19 variants

Woodcock: FDA plans guidance to address new COVID-19 variants

Posted 05 February 2021 | By Jeff Craven 

Woodcock: FDA plans guidance to address new COVID-19 variants

Janet Woodcock, MD

The US Food and Drug Administration is actively monitoring and assessing how current vaccines, therapeutics, and diagnostics are impacted by emerging COVID-19 variants and will issue guidance for ongoing medical product development against these variants.
In a recent statement, US Food and Drug Administration (FDA) acting commissioner Janet Woodcock, MD, said FDA has been monitoring potential new coronavirus variants since the start of the COVID-19 pandemic, and the agency has been actively working with medical product sponsors and international partners to evaluate the impact new COVID-19 variants have on authorized medical products.
The agency is continuing to take an “all-hands-on-deck” approach to the pandemic, she said. “As the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to fight this pandemic.”
Several SARS-CoV-2 Variants of Concern (VOC) emerged at the end of 2020 and beginning of 2021, and are responsible for a sharp increase in COVID-19 across the globe, including variants identified in the United Kingdom (VOC 202012/01, lineage B.1.1.7), South Africa (Variant 501Y.V2, lineage B.1.351) and Brazil (Variant P.1, lineage B.1.1.28).
Since its discovery in October of 2020, the B.1.1.7 variant has become notable for its increased transmissibility and is now the dominant variant in the UK. As of 2 February, the B.1.1.7 variant has been detected in 80 countries, according to the World Health Organization’s COVID-19 Weekly Epidemiological Update. The B.1.351 variant, first detected in December, also exhibits increased transmissibility, and appears to have the ability to evade neutralizing antibodies. According to WHO’s update from 2 February, B.1.351 is present in 41 countries in all WHO regions. Variant P.1, discovered in January, is also suspected to be more transmissible than other variants and have the ability to escape neutralizing antibodies; as of 2 February, it has been detected in 10 countries across four WHO regions.
Tracking evolving infectious diseases is not new ground for the FDA, Woodcock said. The agency has experience with modifying annual influenza vaccines and diagnostics to predict dominant strains, and the regulatory processes to do so are already in place. “We will utilize our experience with influenza to help inform a path forward if SARS-CoV-2 variants emerge against which currently authorized vaccines are not sufficiently effective. Similarly, the FDA also has vast experience with HIV developing resistance to antiviral drugs and will follow regulatory pathways to quickly enable new antiviral drug development for resistant virus,” she said.
FDA has already been relaying information to medical product sponsors about new COVID-19 variants and is currently developing guidance for developers of COVID-19 vaccines, therapeutics, and diagnostics. There is debate and discussion within FDA about what data are needed to justify changes in vaccine composition as well as the development of streamlined clinical programs to demonstrate immune response to new COVID-19 variants.
Woodcock said FDA is also considering ways to expedite COVID-19 therapeutics, “particularly virus-targeting monoclonal antibodies,” which may include “appropriate regulatory flexibilities.” The agency is collaborating with developers on ways to accelerate development of drugs and antibodies that show promise against new COVID-19 variants. “Relying on our growing experience with this class of drugs, our teams are discussing approaches to the generation and evaluation of pre-clinical, clinical and chemistry, manufacturing and controls data,” she said.
The spread of new COVID-19 variants has given researchers the opportunity to study how existing authorized and approved vaccines and therapeutics match up. Pfizer’s COVID-19 vaccine, Comirnaty, recently demonstrated neutralization of the B.1.1.7 variant and the B.1.351 variant of SARS-CoV-2 in pre-print papers posted to bioRxiv. Moderna’s COVID-19 vaccine has shown no significant difference in neutralization of the B.1.1.7 variant, according to non-peer reviewed results, but had “reduced but still significant neutralization” against the B.1.351 variant. AstraZeneca’s vaccine also recently demonstrated in a pre-print with The Lancet to have a similar efficacy against the B.1.1.7 variant.
There is also evidence pointing to reduced effectiveness against some variants for monoclonal antibodies with FDA emergency use authorizations (EUA) for use against COVID-19. In a recent pre-print paper posted to bioRxiv, bamlanivimab was found to still effective against B.1.1.7, but showed “completely or markedly abolished” neutralization of the B.1.351 variant. In the same paper, the monoclonal antibody cocktail casirivimab and imdevimab neutralized both B.1.1.7 and B.1.351 variants.
Woodcock said the FDA is aware of current evidence that suggests vaccines authorized for use appear to be protective against new COVID-19 variants, while some monoclonal antibodies appear to be less effective against new variants.
“We do not believe there will be the need to start at square one with any of these products—we recognize we are in a pandemic and we need to arm health care providers with the most appropriate tools to fight this pandemic on the frontlines,” she said. “We do not want to create obstacles to getting these tools to the frontlines.”


© 2022 Regulatory Affairs Professionals Society.

Tags: coronavirus, FDA, US