Senator Romney: The US Must Have the Capacity to Manufacture a Large Number of Coronavirus Vaccines

At a Senate Health, Education, Labor and Pensions (HELP) Committee Hearing titled "An Emerging Disease Threat: How the U.S. Is Responding to COVID-19, the Novel Coronavirus," Senator Romney (R-Utah) asks witnesses from the CDC, FDA, and Administration about our country's preparedness for the Coronavirus.

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Romney: I appreciate the work that’s been done by the public health community in our country to delay the arrival of the COVID-19 in the United States. It's really quite remarkable to me that while other countries have seen so many cases, whether it's Italy, or Iran, South Korea, Japan, that we’ve been able to delay it. Clearly you can’t keep it away forever, and we already have the community transmission which you predicted. I want to turn to another issue however, which is whether we as Congress and Administrations—Republican and Democrat—have done enough to prepare protective equipment for our medical professionals and for our public at large. What percent of what would be needed by medical professionals, if we were to have a full-blown pandemic, and I hope we don’t, but if we were to have one—what percentage of what we would need for our medical professionals is in the strategic national stockpile?

Dr. Kadlec: Sir, I can give you a rough order of magnitude. It depends what kind of, like you said a severe pandemic, ten percent of what we need right now. If it were to be a severe event, we would need 3.5 billion N-95 respirators. We have about 35 million.

Romney: That’s an area where I’ve been most concerned that it strikes me that we should have substantially more than ten percent that what would be needed for a substantial pandemic we should have that in stock. I can’t believe that we Congress, I’m not blaming the Administration, this is Congress in appropriating and it’s prior Administrations as well, that should be in place. Do masks help for the general public? Let’s say we have a major pandemic and people are concerned, they’re going to the grocery store, they know other people there might be infected. Do masks actually help? Do they prevent or reduce the likelihood of being exposed to the disease Dr. Fauci?

Dr. Anthony Fauci: It depends on the mask. If you look at the N-95 mask, they’re much better than those sort of floppy masks...The most important thing for a mask would be if someone is infected to prevent them from infecting others. The other is the health care provider, to protect them. The general public who could wear them, that could certainly prevent gross droplets from going when someone sneezes and coughs on you. But it doesn’t provide the kind of protection that people think it does. So therefore, there are some downsides because people keep fussing with the masks...

Romney: Turn to aircraft. If someone on an aircraft is infected and sneezes, how many people are going to be exposed to that disease? Is it just a couple of people—the people sitting next to them—is it the whole aircraft?

Dr. Schuchat: For this kind of virus, we’re thinking just the couple rows around it. For other types of infections, it might be broader.

Romney: Let’s say we do get a vaccine it tests positively and so forth, and goes through phase one and phase two clinical trials. What does it take to get major production done? How long does it take to actually kick the production up, and how long goes that take, and who does that? Who is doing the manufacturing once we know this is a vaccine that works?

Dr. Fauci: That was one of the things that was discussed yesterday when the President and Vice President brought in the CEOs of a number of companies and that’s really important because when I was talking about a year to a year and a half, if you don’t have the production capacity to make tens and tens of millions of doses, it may take even longer. And the ones who can do that essentially are the pharmaceutical companies. The federal government is not going to be able to make hundreds of millions of doses, it’s going to have to be partnership with the private sector.

Romney: Do we have that capacity in the United States, is this capacity outside the US? And I guess the question I’m looking for is whether legislatively or from an appropriations standpoint, we should provide funding to have the capacity to make large number of vaccines? We should have that capacity in the US and have it ready to go in case—if this isn’t the pandemic that we’re worried about, if another one comes down the road—is this something that we should have ready to go?

Dr. Kadlec: Yes sir and in fact, right now the only capacity we have is really egg production which wouldn't be relevant to the vaccine candidate or the candidates that we at BARDA are pursuing. So we would have a longer than a six-month wait to basically produce vaccines on scale.

Romney: I want to underscore that that is an area we ought to consider making an investment in.