Coronavirus vaccine: When will it be ready and will it be safe? – WFLA

by: Marni Hughes and Michael Geheren and Nexstar Media Wire

WASHINGTON (NewsNation Now) Its the topic on the minds of many Americans: When will we have a vaccine and will it be safe?

NewsNation sat down at the White House for anin-depth interview with three of the top officials on the front lines of Americas fight against the COVID-19 pandemic: Dr. Deborah Birx, the White House coronavirus response coordinator, Health and Human Services Secretary Alex Azar and Surgeon General Jerome Adams.

Hughes asked three members of the White House Coronavirus Task Force: Whats ahead?

WatchMarni Hughes full interview in the player above.

Hughes:The vaccine is critical Im not telling you anything you dont already know. The biggest question that I hear from people is: When will the vaccine be ready and will it be safe for me and my family to take?

Azar:So in terms of the vaccine timelines, we have two products that are almost fully enrolled in clinical trials,PfizerandModernasvaccines. We havesix vaccines total that we have invested in or contracted with, four in phase three final stage of clinical trials these two that are almost fully enrolled. We cant predict when well get data from them, because unlike just a therapeutic where you have someone whos sick and within a couple of days you can look at a clinical outcome to see if theyve gotten better and gotten out of the hospital, with the vaccine youre looking at preventing them getting the virus or lessening the disease progression in them if they do get the virus. And so that means you vaccinate thousands and thousands of people in each of these trials. Thirty-thousand people, half of them get the vaccine, half of them get a placebo and you have to then wait until a certain number of people get coronavirus and symptoms in that trial.

When we get that data that will be an independent process, therell be an independent, its called the data and safety monitoring board that will determine that pre-specified statistical endpoints have been met. That will then go to the drug companies and the FDA. The drug companies will determine whether the data meets their ethical standards to submit for FDA approval, will go to the FDA. FDA will consider that data against public guidance that theyve already laid out saying what the standards are to hold that to. They will use a public advisory committee process to get external input and the FDA career scientists will make the call as to whether the vaccine meets the FDAs legal and regulatory science and data standards for approval.

So, we dont know the timing of when well see the data, but Pfizer CEO of the worlds leading global biopharmaceutical companyhas publicly said that they think that we can see data from their trial as early as late October, so next week. And they have said that as once they get that data will take some time to clean up the data and be ready to submit and they would submit by late November. Stop and think about that. Thats 10 months from the entry of this virus to the United States. This is historic and unprecedented achievement thanks to President Trumps leadership and vision of Operation Warp Speed.

Hughes:No one will deny that 10 months is fast for a vaccine to come to market, but there is a saying you cant rush science. So can you address those concerns that are valid, that people do have, given what youve already stated about the process and the approval?

Dr. Birx:I think its really important for everyone to understand, the reason this is faster is because they moved everything consecutively. In many cases, you have large delays in between but pharmaceutical companies need to make money. And so they investigate whats the utility of that drug or vaccine will be. Will it be acceptable? How will it be used? And then they determine the market impact of that vaccine. That was all taken off the table, because the federal government said if this vaccine is safe and effective, were going to make the decision right now to manufacture it. And so no shortcuts were taken in the science and the safety. What it did do was cost a lot more, and I think that was an investment made by the federal government to say it is worth it with this kind of pandemic to make to those kind of investments.

Dr. Adams:There were horrific things done to people in this country, particularlypeople of color in the name of science, historically. We need to acknowledge that. We need to help everyone understand that there are protections now in place. TheOffice of Human Research Protectionswhich the Secretary (Azar) oversees. Independent data safety monitoring board which has unblinded the data before it even gets to the FDA and FDA process which is recognized around the globe is the safest in the world, in the safest of all time. And probably the most reassuring thing I can tell the Americans, is that as a Black man, the surgeon general of the United States, as a practicing physician, as someone with a masters in public health I will be getting a COVID vaccine when they tell me its been authorized or approved, and that I can get one, and my family will get it a COVID vaccine when they are told that they can get one because I trust the process. Were in the midst of a social justice movement right now. I think one of the greatest injustices in the world are the people who are pushing misinformation out there that is causing minorities in particular to disproportionately be harmed by vaccine-preventable diseases. Fifty percent of Americans get a flu shot in a given year. Only 40% of Hispanics and African Americans and Native Americans get their flu shot in a given year. That results in tens of thousands of people of color dying every year because of a lack of vaccine confidence, because we havent done enough to make it easier.

Watch the exclusive interview with White House Coronavirus Task Force members Secretary Alex Azar, Surgeon General Dr. Jerome Adams, and Dr. Deborah Birx on NewsNation on WGN America.

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Coronavirus vaccine: When will it be ready and will it be safe? - WFLA