NewsWorldMinute by minute: concern, restrictions and uncertainty about the...

Minute by minute: concern, restrictions and uncertainty about the omicron variant


Dr. Janet Woodcock, Acting Commissioner of the FDA. Photo: (Tom Williams / CQ-Roll Call / Getty Images)

The US Food and Drug Administration (FDA) is working “as quickly as possible” to find out more about the omicron coronavirus variant, according to Acting Commissioner Dr. Janet Woodcock. agency. Woodcock also encouraged Americans to get vaccinated and boosted as soon as possible.

Here, the full statement:

“As we have done with previous emerging variants of COVID-19, the US Food and Drug Administration is actively working with our federal partners, international regulators, and medical products companies to quickly address any potential impacts. of the new omichronic variant in the tools to combat 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 closely monitoring the situation and are committed to communicating with the public as we 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 next few weeks.”

“The FDA has been actively monitoring the possible emergence of SARS-CoV-2 variants since the beginning of the pandemic and has collaborated with medical product developers when a new variant (or mutation) emerges that could affect product performance.” .

“With industry guidance established in February and contingency plans already in place, we are well positioned and committed to working with companies to rapidly assess and address the potential impact of emerging and future viral mutations on tests, therapies and covid-19 vaccines “.

“We have taken a number of steps to adapt to emerging variants so far in the pandemic, such as requiring companies to actively monitor and assess the impact of variants on their products as a condition for authorization, and to take prompt action. Measures”.

“The agency has previously limited the scope of use of certain monoclonal antibodies based on variants circulating in certain areas, updated fact sheets for healthcare providers with information on the impact of known variants on certain therapies, and it has communicated with the public about the tests affected by the viral mutations. “

“We anticipate having more information from the ongoing evaluation of whether, and to what extent, current vaccines work against this variant in the coming weeks. If a modification of the current vaccines is necessary, the FDA and the companies will work together to develop and test such a modification quickly. “

“In a preliminary review, we believe that the high-volume (rapid) antigen and polymerase chain reaction (PCR) tests that are widely used in the United States show a low probability of being affected and continue to work. However, 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 ourselves with the best available diagnostics, and life-saving therapies and vaccines to fight this virus.” .

“At this time, current vaccines remain highly effective in preventing COVID-19 and the serious clinical outcomes associated with COVID-19 infection, including hospitalization and death. Additionally, data currently available from our international partners and of vaccine manufacturers that have been evaluated by the FDA, suggest that an additional booster injection after completion of a primary vaccination (six months for Pfizer-BioNTech and Moderna and two months for Janssen (Johnson & Johnson) provides greater protection against a covid-19 infection “.

“Getting vaccinated or getting a booster dose with one of the currently available vaccines is the best thing you can do right now (in addition to the usual precautions like wearing a mask) to help protect yourself, your family and your friends.”


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