Politics, elections 'will play no role in the approval' of COVID-19 vaccine, health secretary says

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Friday, September 11, 2020
Health secretary explains when we could see COVID-19 vaccine
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ABC7 News had a candid conversation with Health and Human Services Secretary Alex Azar about the development of a COVID-19 vaccine.

SAN FRANCISCO (KGO) -- ABC7 News had a candid conversation with Health and Human Services Secretary Alex Azar about the development of a COVID-19 vaccine.

Question: Where are we on a vaccine?

Answer: We now have six vaccine candidates that we've selected, that we've contracted with. Three of them are in phase three clinical trial, which are the latest stage of development of proving safety and efficacy. Each of those involve 30,000 patients. Those are some of the largest vaccine trials ever. We believe now that it is credible that we will have in the high tens of millions of doses of FDA gold standard vaccine by the end of this year and many hundreds of millions of doses of FDA aproved vaccine as we enter into next year. We're playing this by the book, we're going to work to deliver safe, effective vaccines according to the FDA standards.

Question: The president has suggested a vaccine could be available before the November election and as early as October. How do you balance that suggested timeline with making sure the vaccine is both safe and effective?

Answer: We're going to get a safe and effective vaccine when the data shows we have a safe and effective vaccine. The vaccine in a clinical trial is given to half the participants, 15,000, the other 15,000 get what's called a placebo injection and then you simply have to have enough people in that trial get the disease, get coronavirus that it hits a pre-specified statistically significant end point that you look at the data to say have you seen enough of a different impact in those who got vaccine from those who didn't get vaccine, that's evaluated by that data and safety monitoring board, that's when they unblind the information. If there are enough cases we could see data by October on a couple of these trials and if not, we see data when we see it.

Question: What about people who will choose not to get the vaccine?

Answer: I just hope that all of the people who talk publicly aren't doing anything to fuel this really pernicious anti-vax movement generally that we see in the country. We have so many preventable diseases that unfortunately not enough people do get their vaccines and our work is going to be to try and convince them through transparent information to have a discussion with their healthcare provider and make a decision about what's right for them.

Question: What do you want to say to Californians to assure them political pressure is not influencing the release of a vaccine?

Answer: Politics and elections will play no role in the approval and authorization of a vaccine by the food and drug administration. It will be based on data, science, evidence and the appropriate legal and regulatory standards and we will follow a transparent process so that people can know that that is indeed the basis of the approval of the vaccine.

Question: What is the biggest challenge here?

Answer: Probably the most difficult part is the manufacturing at large scale of these vaccines quickly. It will often take years to be able to develop the capacity to manufacture at large scale. What we're doing is leveraging the different vaccine distribution systems we have in the United States.

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