The US Food and Drug Administration (FDA) is working “as quickly as possible” to learn more about the omicron variant of the coronavirus, according to FDA acting commissioner Dr. Janet Woodcock. Woodcock also encouraged Americans to get vaccinated and get booster shots as soon as possible.
Here is the full statement:
“As we have done with previous emerging variants of COVID-19, the U.S. Food and Drug Administration is actively working with our federal partners, international regulators, and medical product companies to quickly address any potential impact of the new omicron variant in tools to fight the pandemic”.
“The agency is working as quickly as possible to assess the potential impact of this variant on currently available diagnostics, therapies and vaccines. We are monitoring the situation closely and are committed to communicating with the public as we learn more. we’ll learn more.”
“Historically, the work to obtain the genetic information and patient samples for the variants, and then perform the necessary tests to assess their impact, takes time. However, we expect most of this work to be completed in the coming weeks. .”
“The FDA has been actively monitoring the possible emergence of SARS-CoV-2 variants since the start of the pandemic and has worked with medical product developers when a new variant (or mutation) emerges that could affect product performance” .
“With industry guidelines in place in February and contingency plans already in place, we are well positioned and committed to working with companies to quickly assess and address the potential impact of future and emerging viral mutations on covid-19 tests, therapies and vaccines”.
“We have taken a number of steps to account for variants emerging so far in the pandemic, such as requiring companies to actively monitor and assess the impact of variants on their products as a condition of authorization, and that ‘they quickly take action’.
“The agency previously limited the scope of use of certain monoclonal antibodies based on variants circulating in certain regions, updated fact sheets for healthcare providers with information on the impact of variants known about certain therapies, and communicated with the public about tests affected by viral mutations.”
“We expect to have more information about the ongoing evaluation of whether, and how well, the current vaccines work against this variant in the coming weeks. If modification of the current vaccines is necessary, the FDA and the companies will work together to develop and test such changes quickly.”
“In a preliminary review, we believe that the high-volume polymerase chain reaction (PCR) and antigen (rapid) tests that are widely used in the United States show a low likelihood of being affected and continue to work. However, the FDA will continue to closely review and adjust the course as necessary.”
“The FDA is committed to continuing to use all tools to fight this pandemic, including pivoting as the virus adapts, to arm us with the best available diagnostics, lifesaving therapies and vaccines to combat this virus.” .
“Current vaccines remain highly effective in preventing COVID-19 and the serious clinical consequences associated with COVID-19 infection, including hospitalization and death. In addition, currently available data from our international partners and vaccine manufacturers that have been evaluated by the FDA, suggest that an additional booster injection after completion of a primary vaccination course (six months for Pfizer-BioNTech and Moderna and two months for Janssen (Johnson & Johnson) offers better protection against covid-19 infection”.
“Getting vaccinated or receiving a booster dose with one of the currently available vaccines is the best thing you can do right now (in addition to standard precautions like wearing a mask) to protect yourself and your family and friends.”