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Normalcy Means Using Existing Tools Against COVID, Former FDA Chief Says

Dr. Mark McClellan, director of the Duke-Margolis Center, briefs media

News Tip: Normalcy Means Using Existing Tools Against COVID -- Vaccines, Tests, Treatments, Former FDA Chief Says

DURHAM, N.C. -- Americans anxious for life to return to normal should prepare for occasional future COVID-19 outbreaks in the same way they ready themselves for significant weather events and similar disruptions, a Duke expert said Tuesday.

Though COVID cases finally appear to be declining, there will be future flare-ups, and people need to be ready to mask back up and make other small sacrifices if need be, said Dr. Mark McClellan, a physician and economist who directs the Duke-Margolis Center for Health Policy.

A former commissioner of the U.S. Food and Drug Administration, McClellan spoke to journalists Tuesday in a virtual media briefing about the current COVID trends, the new treatments available, and what a vaccine for kids under age 5 would do to move the nation out of the pandemic. Watch the full briefing on YouTube

Here are excerpts.

On ICU occupancy and COVID case numbers

“We are past the peak of the omicron wave of cases in this country. We had been up around 800,000, 900,000 per day on average, and that’s just the ones counted. The best estimates were literally at millions of cases per day earlier in this wave. That is coming down in different parts of the country and different places. North Carolina, the surge was a little bit behind some of the earliest areas on the east coast and Florida, but coming down here.”

“I expect that’s going to translate into a gradual reduction in ICUs and then in deaths. We’re really at sort of the peak and it’s a disturbing level of peak deaths happening now, around 2,500 or more per day associated with the omicron surge. So we are definitely not back to normal now.”

“If we’re able to continue the decline in surge at the rate that’s been happening in the last week, I do see some real opportunities for relaxing mask mandates, for relaxing our activities, just within the next month. Not too far off at all.”

On turning a corner

“Governments and a lot of individuals are exhausted with COVID and ready to move on. So I think the most important decisions ahead for both our federal and local governments and for Americans are how do we get through what will hopefully be a new normal? It’s clear COVID is unlikely to be gone. The omicron variant and the new BA2 variant are just extremely contagious.”

“We do know immunizations, especially with a booster, are very protective against serious illness, and they also have an important protection, maybe a 50 percent reduction, in getting infected or transmitting covid at all.”

“We also know the vaccines aren’t perfect and COVID isn’t one and done. The future ahead is going to see some background rate of cases. The question is how high are those rates going to be, and how consequential will they be for our daily lives. The things that will matter there are whether we are able to respond when there is a local surge – maybe going back to putting on more masks or being a little bit more cautious about distancing, whether it’s in your school or in your workplace or in your community.”

“It’s also going to depend on how well we use all the other tools we have in addition to vaccination to keep us in something like normalcy in the future. We now have more widespread availability of tests, including rapid tests, which are not perfect but are very helpful.”

“And we also have treatments that work now, both intravenous treatments and, increasingly, oral treatments. Part of the future may be each American kind of having a plan, just like you do for a hurricane or a bad weather event, for what you do if there is a surge, to help keep you safe, help keep your family safe and help keep your community safe.”


On vaccine approval for children under 5

“It’s very important. If you look at our population right now, about two-thirds of people who are eligible for vaccines have been fully vaccinated. That’s highest for adults, especially very high rates for older adults, and then it kind of declines from there. High rates for people over 18 – over 80 percent there, then lower rates when we get to lower age groups for kids. Only about 30 percent of kids who are eligible for vaccines in the 5-11 age group have been vaccinated. And obviously the biggest unvaccinated group is that population under 5, and unfortunately, with this omicron spread we’re seeing more cases of severe illness in that group, including hospitalizations and some deaths. The overall rates fortunately are very low, but with so much risk of infection, so much transmissibility … kids are at risk if they haven’t been vaccinated.”

“The good news with the vaccine studies to date is that the vaccine two-dose version that has been quite extensively tested for Pfizer, does appear to show a very good immune response. Maybe not as high as we saw in older age groups, especially for kids age 2 and younger, but a significant immune response that does provide that protection, especially against serious illness.”

“I do expect FDA to keep looking at the data there and just like we’ve seen in other age groups, probably authorize a booster dose a couple months after that second dose. That would get this last remaining important segment of our population, which has been at risk from COVID. … It would give them opportunity for vaccination.”

“But that’s not going to be the end of the story. Most of the kids age 5 to 11 today in the United States have not been vaccinated. So clearly some important questions that parents have there, an important need to keep looking very closely at all the safety data. We now have safety data on millions of kids in that age range.”

“We have growing data showing that it really does prevent these serious complications from COVID, and also long-term complications from COVID. So some important issues around engaging the public.”


On current antiviral treatments

“Effective treatments are there, they’re just in limited supply. There is one monoclonal antibody authorized in the United States that works effectively against the omicron variant. We’re seeing about 500,000 doses of that per week, shipped, maybe 600,000 shipped over the next month or so, so that means a limited amount of supply relative to the number of people who could benefit.”

“Also coming are oral treatments for COVID.”

“Not all these drugs are widely available; not all of them are easy to use. Some of them, as I said, require an infusion, not just a pill you can take. But over the coming weeks they are going to become more widely available.”

“Even for people who have been vaccinated, if you are in a higher-risk group, if you’re in an older age group, if you have a serious chronic disease, it’s definitely worth talking to your doctor or pharmacist from here on out, about getting tested if you have symptoms, and about considering treatment as these treatments become more widely available. That’s going to keep you from having more significant consequences, it can help reduce transmission, and it can really help keep the burden on our health care system down.”

“We have the capabilities going forward, with the combination of vaccination and rapid access to testing, and treatments that really work, to never have to see these big surges and serious complications, hospitalizations and deaths again. IF we can achieve that, that’s the best path to normalcy in the long term.”


On importance of a global vaccination effort

“The probability of another variant is very high. The main questions are just how different it will be. Omicron was a very different variant than delta that came before.”

“With so many opportunities for continuing infection around the world, it increases the likelihood that some combination of variants is going to come along that actually does make the virus either easier to transmit or cause more serious harm.”

“The best way to slow down the progression of additional variants, and the best way to get us all back to normal … is to get vaccination rates up and to take other steps to prepare for this next endemic phase of the pandemic in the rest of the world. It’s still pandemic in many parts of the world where vaccination rates are under 20 percent or under 10 percent.”


On the vetting of a new commissioner for FDA

“It’s a critical agency right now … the FDA’s timely review of the data from Pfizer, on the vaccine for kids under 5, could have a big impact on where the pandemic goes from here. That agency has been really stretched in the pandemic. It hasn’t had a permanent leader really since the beginning of 2021.”

“While the staff there has been working really hard, it does make a difference having someone in charge. Rob Califf, who ... is very connected with Duke, a very widely respected clinician, an expert on medical evidence and things like vaccine safety and effectiveness of treatments – it’s what the agency needs right now. Along with a number of my former colleagues from both Democratic and Republican administrations, we strongly endorsed Rob Califf for FDA commissioner and I hope the politics can come together enough to get him through Congress as soon as possible.”

Faculty Participant
Dr. Mark McClellan
Dr. Mark McClellan is a physician and economist who directs the Duke-Margolis Center for Health Policy, where he works on strategies and policy reforms to improve health care. He was commissioner of the U.S. Food and Drug Administration and administrator of the Centers for Medicare & Medicaid Services.

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