WEBVTT

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Good afternoon and thank you for

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joining us . I'll turn to Dr Wolinski

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and DR Fauci in just a moment . First ,

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I want to start with a brief update on

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our efforts to help states that are

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battling surging cases driven by the

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delta variant , particularly those

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states that have also been hit by

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hurricane IDa . First our thoughts are

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with those who have been impacted by

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the hurricane And we're leveraging our

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COVID-19 surge response to help in any

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way that we can as part of our surge

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response effort . Over 350 emts ,

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doctors , nurses and other healthcare

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personnel happened providing emergency

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medical care , medical care on the

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ground in the gulf states of Louisiana ,

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Mississippi and Alabama . And since

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july we've sent ventilators ,

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therapeutics and ambulances to support

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the strained healthcare systems in

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these states as they respond to Delta ,

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our personnel remained on the ground as

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hurricane item made landfall and are

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mobilized in the aftermath of the storm ,

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augmenting the strong efforts of

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hardworking local health care personnel .

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We are providing critical clinical care ,

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conducting patient movements , relieve

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strained hospitals and continuing to

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administer treatment For COVID-19

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patients . At the same time , our

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whole of government effort to respond

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to help states With delta outbreaks

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continues in fact to date . COVID-19

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surge response teams are working with

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18 states , pulling in personnel

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resources supplies and expertise from

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across the federal government including

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from HHS CDC fema , D .

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O . D . And the via to address state

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specific needs . We've deployed more

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than 700 personnel surged . Critical

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supplies to health systems , expanded

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testing capacity and importantly

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expanded the use of lifesaving

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therapeutics . In fact , in the month

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of August we shipped more than 670,000

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courses of therapeutic treatments .

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That's six times as many as we shipped

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in July . These therapeutics prevent

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hospitalization and save lives .

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Our message to all states , tribes and

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territories is clear . We stand ready

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to help you in any way we can to

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respond to the delta variant as we

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respond to surge as we remain laser

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focused on getting more shots and arms

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and we continue to build momentum Back

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in mid July we were averaging 500,000

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vaccinations per day . Today we're

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averaging 900,000 . That's an 80%

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increase in the number of shots were

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getting into arms each and every day .

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Last week we got over six million shots

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The biggest weekly total since July

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five importantly , we've accelerated

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the pace of first shots In August .

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We got over 14 million . That's almost

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four million more first shots in August

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compared to the prior month , July

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we continue to push for more

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vaccination progress , including

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through vaccination requirements .

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The President first adopted vaccination

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requirements for federal workers last

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month And now over 800 colleges and

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universities , Over 200 healthcare

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employers , small and large businesses

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across the country and dozens of state

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and local governments and school

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districts have stepped up to follow the

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President's lead . Tens of millions of

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americans are now covered by

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vaccination requirements and these

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requirements are already working to get

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more people vaccinated in Washington

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state . The weekly vaccination rate

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jumped 34 after the state announced

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vaccination requirements for state

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employees , teachers and school staff ,

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health care workers and colleges and

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universities . Businesses are seeing

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strong results On August three

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when Arkansas based Tyson Foods

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announced its employees would need to

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be vaccinated No later than November

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one . Only 45% of its workforce

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had gotten a shot Today . That number

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stands at 72% . That's a 60%

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increase in less than a month .

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Notably the share of job postings that

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require vaccinations are up 90

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according to indeed dot com . A popular

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job search site . Bottom line

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vaccination requirements work . They

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drive up vaccination rates and we need

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more businesses and other employers ,

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including healthcare systems , school

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districts , colleges and universities

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to step up and do their part to help

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end the pandemic faster . We need more

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individuals to step up to . As people

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across the country prepare for labor

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day weekend . It's critical that being

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vaccinated as part of their pre holiday

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checklist . Getting vaccinated is free .

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It's easy and convenient . It's safe

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and effective and it's never ever been

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more important . So please if you are

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not fully vaccinated . Don't put it off

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any longer visit vaccines dot

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gov Or texture ZIP code

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2438

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8-9438

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89 . That will enable you to find a

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site near you . Do your part , get

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your shot today for yourself and your

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loved ones for your community and our

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country . With that . I'll turn it over

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to Dr walensky , Doctor Wolinski .

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Thank you , Jeff and good afternoon

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let's begin with an overview of the

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data . Our seven day average of cases

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is about 129,000 cases per day . Our

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seven day average of hospital

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admissions is about 11,500 cases per

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day . And our seven day average of

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daily deaths has increased to 896 per

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day as we prepare for more of our

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Children to return to school after

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labor day . C . D . C . Has strong and

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detailed guidelines that should be

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implemented to promote our Children's

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safety in the classroom . Let me

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reiterate what they are . Most

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importantly , CDC recommends that

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everyone eligible for vaccination be

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vaccinated before school starts . If

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you or your vaccine eligible child is

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not yet vaccinated , it is never too

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late to begin your vaccine series .

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Next , universal masking is critically

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important in schools for students .

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Teachers , staff and visitors

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regardless of vaccination status . C .

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D . C . Also recommends school employ

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additional key strategies in school to

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keep kids safe , including improved

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ventilation , physical distancing and

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establishing screening programs for

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students and teachers . Federal

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resources have been made available to

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help schools implement these

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recommendations . Parents should

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educate themselves on the CBC's

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recommendations for K through 12 .

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School operations . Parents can ask

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questions of their school

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administrators and learn how these

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steps will be implemented in their

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district . Parents should encourage

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their Children to wear masks when in

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public indoor settings . And finally ,

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and perhaps most importantly , parents

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can protect their Children by getting

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vaccinated themselves . This will

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create a protective bubble around their

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Children who are not yet eligible for

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their own vaccine . As we approach the

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labor day holiday weekend , I want to

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share ways that americans can keep

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their families and themselves safe over

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the long holiday weekend . First , if

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gathering with family and friends

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remember that spending time outside

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with others who are vaccinated will

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help to prevent transmission throughout

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the pandemic . We have seen that the

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vast majority of transmission takes

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place among unvaccinated people

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enclosed indoor settings . Second ,

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when in public indoor settings , please

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wear a mask vaccinated or unvaccinated

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as I've said before , masks are not

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forever , but they are for now given

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the high transmissibility of the delta

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variant and the significant community

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transmission in this country wearing a

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mask is the easiest way for anyone ,

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regardless of your vaccination status

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to slow the spread of disease . Third

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talk with family and friends who are

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still unvaccinated about the benefits

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of the vaccine and continued , consider

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taking them to get vaccinated over the

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long holiday weekend just yesterday

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CDCs advisory committee on immunization

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practices reviewed the recent FDA

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decision to approve the Pfizer Covid

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vaccine and we have updated our

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recommendations . I'm delighted to say

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that we now have a fully FDA approved

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CDC recommended vaccine available For

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anyone who's been waiting to get

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vaccinated until we had more evidence

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on safety and effectiveness . I hope

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yesterday's announcement will have you

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joined the more than 170 million people

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who have decided to protect themselves

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against COVID-19 by getting vaccinated

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yourself . Thank you . I'll now turn

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things over to Dr . Fauci . Okay ,

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thank you very much . Doctor Wolinski .

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I would like to now update you on

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COVID-19 vaccination in pregnancy .

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Next slide . It is very clear now as

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I'll show you in a moment That there

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are severe adverse outcomes for mother

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and baby during COVID-19

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infection . Therefore it is extremely

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important for pregnant women and women

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planning to get pregnant to get

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vaccinated . Next slide , let's look at

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these adverse events that I mentioned a

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moment ago from this C . D . C

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mmwr from over a year ago . If you look

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at the analysis of about 400,000 women

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and look at the risk ratio of things

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like intensive care admission ,

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invasive ventilation , Extracorporeal

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membrane oxygenation or ECMO or death ,

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they all have an increased risk ratio .

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Next slide , if you look at total

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numbers total number of cases of

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pregnant women with COVID-19 from

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January 2022 , August 2021 . There have

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been about 110,000 cases . About 19,000

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hospitalizations and 131 deaths .

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Indeed , Covid 19 in pregnancy is

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serious . Next slide . Let's take a

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look at some of those risk factors

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which increase the possibility and

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probability of severe illness . One is

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age , 25 years of age and older

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occupation , pre pregnancy , obesity

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and chronic diseases like lung disease ,

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hypertension and pre gestational

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diabetes mellitus . Next slide , What

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about the safety of COVID-19 vaccines

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and pregnant women In over 35,000

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participants that were followed in the

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v safe . There were no obvious safety

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signals among pregnant women who

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received an M . R . In a covid 19

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vaccine . Next slide . And if you look

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at the immunogenicity in pregnant and

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lactating women , you see potent

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anybody and T cell responses as well as

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cross reactive immune response against

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a number of arians . Next slide , if

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you look then at breast milk , another

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advantage of getting a pregnant woman

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vaccinated is that when that woman

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breast feeds , it passes by passive

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immunization , a specific IGA and

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IgG antibodies in breast milk . That

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was seen in a study with a six week

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follow up period . Again , anybody is

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found in breast milk show strong

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neutralization of virus protecting your

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newborn baby . Next slide . And so if

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you look at the strong statement of 23

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leading organizations who strongly urge

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all pregnant individuals as well as

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recently pregnant planning to become

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pregnant . Well lactating and other

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eligible individuals to be vaccinated .

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The bottom line . Get vaccinated back

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to you , Jeff . Wonderful . Thank you

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doctors . Let's open it up for a few

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questions first question . We'll go to

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Yamiche Alcindor or at PBS .

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Hi , thanks so much for taking my

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question . Um I have a question about

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um because in some ways the worries

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that you have with back to school

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Children . Um is there anything that

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you're seeing now in the states ? Given

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the parents apprehensions and their

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kids back to school ? You can talk

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about as bubbling up given that some

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medical professionals are saying that

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they're seeing more Children be

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hospitalized . And I'm also wondering

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if you can speak at all to the idea

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that some some states are seeing um ICU

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bed shortages because of covid , Is

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there any sort of resources being

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shared to try to figure out what's

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going on there and to address it . Dr

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Wolinski . So are absolutely thank you .

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First of all we have , as I mentioned

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in my remarks , strict and detailed

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guidance as to how to keep our Children

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safe in school . This includes

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vaccination of everybody who is

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eligible wearing masks in school . And

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we are seeing in some school as well as

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uh distancing screening protocols . We

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are seeing schools that are not

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following these guidance specifically ,

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not masking , not having having lower

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rates of vaccination are dealing with

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outbreaks , especially in the context

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of this very transmissible delta

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variant . And we are encouraging those

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schools to follow our guidance and to

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follow our assistance as they manage

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those outbreaks to get their kids

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safely back into school with regard to

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pediatric hospitalizations . We know

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that there is an absolute number of

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Children because of this highly

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transmissible variant , an absolute

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number of Children that are infected

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now with SARS Kobe to and because of

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that absolute number , there's a larger

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number of Children in the hospital were

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also simultaneously dealing with an RSV

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outbreak that is occurring in Children .

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Now that's a typical for this season

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but is also leading to more . I can see

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of those pediatric hospital beds .

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Thank you . Hospital capacity . The

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last part of your question . Our surge

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response teams are in constant

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communication with governors , states

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and local health officials and as I

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mentioned , we have deployed 700

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federal personnel to support states in

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their search response and in their

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hospital staffing capacity . This

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includes doctors , nurses . Ems and

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others . And we stand ready to provide

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states with additional resources ,

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medical support teams , technical

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assistance , more supplies . And as

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we've talked about life saving

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therapeutics that can keep people out

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of the hospital and save lives . Next

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question Hoda Zeke Miller at the

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Associated Press . Thanks very My

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question . Um you mentioned the

16:12.540 --> 16:15.100
upcoming holiday weekend , given the

16:15.110 --> 16:17.040
surge in cases should americans

16:17.040 --> 16:19.780
reconsider travel this holiday weekend .

16:19.790 --> 16:21.901
And then more broadly we've seen from

16:21.901 --> 16:24.123
the State Department and CDC new travel

16:24.123 --> 16:26.720
warnings for countries that have uh

16:26.730 --> 16:28.730
that are doing better against covid

16:28.730 --> 16:31.400
than the United States . Why hasn't the

16:31.400 --> 16:33.567
administration taking a tougher stance

16:33.567 --> 16:35.678
in terms of advising americans not to

16:35.678 --> 16:37.900
travel the same way it is advising them

16:37.900 --> 16:40.067
not to travel to countries like Canada

16:40.067 --> 16:41.844
or places like Puerto , rico Dr

16:41.844 --> 16:45.030
Wolinski . Yeah . Um We um provide our

16:45.030 --> 16:47.230
travel health , we received travel

16:47.230 --> 16:49.910
health notices um and and and carefully

16:49.910 --> 16:52.300
watch those daily . There's look at um

16:52.310 --> 16:54.760
testing capacity as well as taste rates

16:54.760 --> 16:58.160
and we update our travel guidance uh by

16:58.160 --> 17:01.630
country um in real time . Um We have

17:01.630 --> 17:03.686
actually articulated that people who

17:03.686 --> 17:07.150
are fully vaccinated um and who are

17:07.150 --> 17:10.140
wearing masks can travel . Um Although

17:10.150 --> 17:11.970
given where we are with disease

17:11.980 --> 17:14.850
transmission right now , um we would

17:14.850 --> 17:17.017
say that people need to take their own

17:17.017 --> 17:18.517
these risks into their own

17:18.517 --> 17:20.406
consideration as they think about

17:20.406 --> 17:22.517
traveling first and foremost . If you

17:22.517 --> 17:24.239
are unvaccinated . Um we would

17:24.239 --> 17:26.572
recommend not traveling . Next question .

17:27.540 --> 17:29.590
Go to MEg Tyrell at CNBC .

17:31.940 --> 17:34.430
Thank you . I'm hoping you can comment

17:34.430 --> 17:36.541
on these reports we've seen today and

17:36.541 --> 17:38.708
the FDA confirming that two of the top

17:38.708 --> 17:42.010
regulators in the vaccine uh unit there

17:42.020 --> 17:44.110
are retiring in october and november

17:44.110 --> 17:46.610
Marianne , Gruber and Phil Kraus , a

17:46.610 --> 17:48.721
number of organizations are reporting

17:48.721 --> 17:51.770
that in part they're resigning because

17:52.140 --> 17:54.340
uh the FDA hasn't been as involved in

17:54.340 --> 17:56.690
the booster discussion that C . D . C .

17:56.700 --> 17:58.756
In some ways is front running them .

17:58.756 --> 18:00.700
And in some ways the White House's

18:00.700 --> 18:02.589
front running discussion . I know

18:02.589 --> 18:04.811
you've addressed this before Jeff ? But

18:04.811 --> 18:06.533
if you could tell us , are you

18:06.533 --> 18:08.367
concerned in general about these

18:08.367 --> 18:10.589
resignations affecting trust in the FDA

18:10.589 --> 18:12.756
and the vaccine process and also about

18:12.756 --> 18:14.700
the ability for the FDA to quickly

18:14.700 --> 18:16.700
review vaccines , especially as the

18:16.700 --> 18:18.700
review for kids is coming up around

18:18.700 --> 18:20.860
that time . Okay , thank you for the

18:20.860 --> 18:23.082
question . As the as the president said

18:23.082 --> 18:26.740
last week , FDA is the gold standard

18:26.820 --> 18:28.730
and we are all grateful for the

18:28.740 --> 18:31.710
tireless work of the senior team and

18:31.710 --> 18:34.810
the whole staff at EFTA , especially

18:34.810 --> 18:37.080
during the pandemic . The FDA has

18:37.080 --> 18:39.550
strong leadership in Dr Woodcock and Dr

18:39.550 --> 18:42.270
Peter Marks at the Center for biologics

18:42.280 --> 18:44.220
evaluation and research and their

18:44.220 --> 18:47.040
critical work continues as we work to

18:47.040 --> 18:49.690
get safe and effective vaccines to the

18:49.690 --> 18:52.390
american people . You know the booster

18:52.390 --> 18:54.557
decision which you referenced as we've

18:54.557 --> 18:57.080
talked about . That decision was made

18:57.090 --> 19:00.200
by and announced by the nation's

19:00.200 --> 19:01.978
leading public health officials

19:01.978 --> 19:04.810
including Dr Wolinski Dr Fauci surgeon

19:04.810 --> 19:08.150
General Vivek Murphey Dr Janet Woodcock ,

19:08.160 --> 19:11.090
the FDA acting commissioner Dr Francis

19:11.090 --> 19:13.930
Collins . Dr Kessler and others . And

19:13.930 --> 19:16.490
as our medical experts laid out having

19:16.490 --> 19:19.070
reviewed all the available data , it is

19:19.070 --> 19:21.650
in their clinical judgment that it is

19:21.650 --> 19:24.830
time to prepare americans for a booster

19:24.830 --> 19:26.830
shot . We announced our approach in

19:26.830 --> 19:29.260
order to stay ahead of the virus gives

19:29.260 --> 19:32.540
states and pharmacies time to plan and

19:32.540 --> 19:34.540
to be transparent with the american

19:34.540 --> 19:37.920
people . Ask the latest data and expert

19:37.920 --> 19:40.020
clinical judgments from the team to

19:40.020 --> 19:42.353
give them time to do their own planning .

19:42.353 --> 19:44.242
We have been also been very clear

19:44.242 --> 19:47.190
throughout that this is pending FDA

19:47.200 --> 19:49.910
conducting an independent evaluation

19:49.920 --> 19:52.720
and CDCs panel of outside experts

19:52.730 --> 19:55.260
issuing a booster dose recommendation .

19:55.270 --> 19:57.400
So the bottom line this virus has

19:57.400 --> 20:00.090
proven to be unpredictable and we want

20:00.090 --> 20:02.257
to stay ahead of it and plan for every

20:02.257 --> 20:04.368
scenario And that's been our approach

20:04.368 --> 20:06.423
from day one and will continue to be

20:06.423 --> 20:08.670
our approach . Next question . Cheyenne

20:08.670 --> 20:09.850
Hazlitt abc

20:12.540 --> 20:14.900
Hi thanks for taking my question . Um

20:14.910 --> 20:17.077
there are comments at yesterday's Asep

20:17.077 --> 20:19.299
meeting that the administration doesn't

20:19.299 --> 20:21.410
seem to have enough data to recommend

20:21.410 --> 20:23.354
boosters . I'm wondering if you're

20:23.354 --> 20:25.299
confident that enough data will be

20:25.299 --> 20:27.188
available by September 20 . Um to

20:27.188 --> 20:29.190
reassure and back that decision dr

20:29.190 --> 20:33.050
Wolinski happy to take that . So um we

20:33.060 --> 20:35.160
uh the A . C . I . P . Reviewed data

20:35.160 --> 20:37.150
yesterday that was the day that we

20:37.150 --> 20:39.261
reviewed um just a few weeks ago that

20:39.261 --> 20:41.520
looked at increased waning with regard

20:41.520 --> 20:43.353
to the vaccine effectiveness for

20:43.353 --> 20:46.100
infection and some suggestion that

20:46.100 --> 20:48.267
there was an increased way new vaccine

20:48.267 --> 20:51.270
effectiveness against hospitalization .

20:51.440 --> 20:54.450
The did not review international data

20:54.460 --> 20:56.460
that actually has led us to be even

20:56.460 --> 20:58.750
more concerned about increased risk of

20:58.750 --> 21:01.200
vaccine effectiveness waning against

21:01.200 --> 21:03.340
hospitalization , severe disease and

21:03.340 --> 21:05.860
death . They will be reviewing that as

21:05.860 --> 21:08.860
well . But that is um it is our own

21:08.860 --> 21:11.390
data as well as international data that

21:11.390 --> 21:13.390
has led us to be concerned that the

21:13.390 --> 21:15.557
waning we're seeing for infection will

21:15.557 --> 21:17.860
soon lead to waning that we would see

21:17.860 --> 21:20.027
for hospitalization severe disease and

21:20.027 --> 21:22.280
death which is why it's so critical now

21:22.290 --> 21:24.380
to plan ahead to remain ahead of the

21:24.380 --> 21:27.780
virus . Next question , this will be

21:27.780 --> 21:29.836
our last question will go to Jeannie

21:29.836 --> 21:31.750
Bowman at Bloomberg .

21:34.140 --> 21:36.500
Hi , thank thank you so much for taking

21:36.500 --> 21:38.722
my question . I'm wondering if you have

21:38.722 --> 21:40.778
any idea how many unused doses there

21:40.778 --> 21:43.120
are in areas that have been impacted by

21:43.130 --> 21:45.310
IDA and what the plan is to either

21:45.310 --> 21:47.366
prevent or minimize those doses from

21:47.366 --> 21:49.610
spoiling due to power outages and cold

21:49.620 --> 21:51.564
in the cold storage requirements .

21:52.340 --> 21:55.490
Think about The # one concern right now

21:55.490 --> 21:58.260
is we talked earlier is about those who

21:58.270 --> 22:01.290
have suffered losses and are in danger

22:01.290 --> 22:03.401
from the hurricanes . Our thoughts go

22:03.401 --> 22:05.401
out to them . I know our operations

22:05.401 --> 22:07.700
team is working very closely with all

22:07.700 --> 22:11.490
of the states to provide any um support

22:11.490 --> 22:13.670
they can , including to make sure that

22:13.680 --> 22:16.280
the vaccines continue to be stored

22:16.280 --> 22:18.058
safely and administered . Where

22:18.058 --> 22:21.520
appropriate . So where the team is all

22:21.520 --> 22:23.576
over that . Doing anything we can to

22:23.576 --> 22:26.590
help with the hurricane including

22:26.600 --> 22:28.489
protecting the vaccines and where

22:28.489 --> 22:30.656
appropriate , continuing to administer

22:30.656 --> 22:33.500
vaccinations . Thank you for today .

22:33.510 --> 22:35.677
We'll look forward to a briefing later

22:35.677 --> 22:36.760
in the week . Thank you everybody