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NIH Clinical Center

Cutting Ribbon for NIH Clinical Center Pharmacy

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It was great to take part in the ribbon-cutting ceremony and officially open the NIH Clinical Center Pharmacy. The fully renovated, 10,000-square-foot facility, located on the first floor of the building’s southeast wing, consists of three parts: the outpatient pharmacy, which dispenses medications to patients who visit the clinical center for periodic checkups or treatment as part of a clinical study; the unit-dose pharmacy, which prepares medications in small doses for patients while staying at the Clinical Center; and the intravenous admixture unit (IVAU), which formulates sterile products, as needed, for patients at the Clinical Center. The Clinical Center Pharmacy will perform all of the above with the help of state-of-the-art automation, including a robotic medication management system.

I’m third from the left in the ribbon-cutting line. To my right, scissors in hand, (l-r) are Richard DeCederfelt, the Clinical Center’s Acting Pharmacy Chief, and James Gilman, CEO of the Clinical Center. Cutting the ribbon to my left (l-r) are Alfred Johnson, NIH’s Deputy Director for Management, and Marilyn Farinre, the Clinical Center’s Pharmacy Operations Chief. Looking on just behind them (l-r) are Tara Schwetz, NIH’s Acting Principal Deputy Director, and Michael Gottesman, NIH’s Deputy Director for Intramural Research. The ribbon-cutting ceremony took place on May 18 in the Outpatient Pharmacy Waiting Room. Credit: NIH

A Special Thanksgiving Day Concert

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What an inspiring afternoon I spent at the NIH Clinical Center. Caesar Sant, a 13-year-old violinist and child prodigy whose family now lives in the Memphis area, gave a special Thanksgiving Day concert. I got to accompany on guitar, but the moment belonged to his amazing talent. Caesar was born in August 2008 with sickle cell disease. As a participant in an NIH clinical trial, Caesar recently received a bone marrow transplant in hopes of curing his disease. So far so good.


Accepting the COVID-19 Vaccine

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Francis Collins Vaccination
I was thrilled to roll up my sleeve and get the Moderna COVID-19 vaccine today at the NIH Clinical Center. As NIH Director, I’ve followed closely the development of these first vaccines, and I know they have been rigorously tested and found to be safe and effective. I encourage everyone to accept the vaccines when offered to you. It’s our best chance to turn the tide on the pandemic. Also receiving the vaccine today were Health and Human Services Secretary Alex Azar, Anthony Fauci, Director of NIH’s National Institute of Allergy and Infectious Diseases; Colleen McGowan, Director of NIH’s Office of Research Services; and six frontline healthcare workers at the NIH Clinical Center. Credit: NIH

Celebrating the Gift of COVID-19 Vaccines

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COVID-19 - Gift of the Vaccines
Credit: NIH

The winter holidays are traditionally a time of gift-giving. As fatiguing as 2020 and the COVID-19 pandemic have been, science has stepped up this year to provide humankind with a pair of truly hopeful gifts: the first two COVID-19 vaccines.

Two weeks ago, the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to a COVID-19 vaccine from Pfizer/BioNTech, enabling distribution to begin to certain high-risk groups just three days later. More recently, the FDA granted an EUA to a COVID-19 vaccine from the biotechnology company Moderna, Cambridge, MA. This messenger RNA (mRNA) vaccine, which is part of a new approach to vaccination, was co-developed by NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The EUA is based on data showing the vaccine is safe and 94.5 percent effective at protecting people from infection with SARS-CoV-2, the coronavirus that causes COVID-19.

Those data on the Moderna vaccine come from a clinical trial of 30,000 individuals, who generously participated to help others. We can’t thank those trial participants enough for this gift. The distribution of millions of Moderna vaccine doses is expected to begin this week.

It’s hard to put into words just how remarkable these accomplishments are in the history of science. A vaccine development process that used to take many years, often decades, has been condensed to about 11 months. Just last January, researchers started out with a previously unknown virus and we now have not just one, but two, vaccines that will be administered to millions of Americans before year’s end. And the accomplishments don’t end there—several other types of COVID-19 vaccines are also on the way.

It’s important to recognize that this couldn’t have happened without the efforts of many scientists working tirelessly behind the scenes for many years prior to the pandemic. Among those who deserve tremendous credit are Kizzmekia Corbett, Barney Graham, John Mascola, and other members of the amazing team at the Dale and Betty Bumpers Vaccine Research Center at NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

When word of SARS-CoV-2 emerged, Corbett, Graham, and other NIAID researchers had already been studying other coronaviruses for years, including those responsible for earlier outbreaks of respiratory disease. So, when word came that this was a new coronavirus outbreak, they were ready to take action. It helped that they had paid special attention to the spike proteins on the surface of coronaviruses, which have turned out to be the main focus the COVID-19 vaccines now under development.

The two vaccines currently authorized for administration in the United States work in a unique way. Their centerpiece is a small, non-infectious snippet of mRNA. Our cells constantly produce thousands of mRNAs, which provide the instructions needed to make proteins. When someone receives an mRNA vaccine for COVID-19, it tells the person’s own cells to make the SARS-CoV-2 spike protein. The person’s immune system then recognizes the viral spike protein as foreign and produces antibodies to eliminate it.

This vaccine-spurred encounter trains the human immune system to remember the spike protein. So, if an actual SARS-CoV-2 virus tries to infect a vaccinated person weeks or months later, his or her immune system will be ready to fend it off. To produce the most vigorous and durable immunity against the virus, people will need to get two shots of mRNA vaccine, which are spaced several weeks to a month apart, depending on the vaccine.

Some have raised concerns on social media that mRNA vaccines might alter the DNA genome of someone being vaccinated. But that’s not possible, since this mRNA doesn’t enter the nucleus of the cell where DNA is located. Instead, the vaccine mRNAs stay in the outer part of the cell (the cytoplasm). What’s more, after being transcribed into protein just one time, the mRNA quickly degrades. Others have expressed concerns about whether the vaccine could cause COVID-19. That is not a risk because there’s no whole virus involved, just the coding instructions for the non-infectious spike protein.

An important advantage of mRNA is that it’s easy for researchers to synthesize once they know the nucleic acid sequence of a target viral protein. So, the gift of mRNA vaccines is one that will surely keep on giving. This new technology can now be used to speed the development of future vaccines. After the emergence of the disease-causing SARS, MERS, and now SARS-CoV-2 viruses, it would not be surprising if there are other coronavirus health threats in our future. Corbett and her colleagues are hoping to design a universal vaccine that can battle all of them. In addition, mRNA vaccines may prove effective for fighting future pandemics caused by other infectious agents and for preventing many other conditions, such as cancer and HIV.

Though vaccines are unquestionably our best hope for getting past the COVID-19 pandemic, public surveys indicate that some people are uneasy about accepting this disease-preventing gift. Some have even indicated they will refuse to take the vaccine. Healthy skepticism is a good thing, but decisions like this ought to be based on weighing the evidence of benefit versus risk. The results of the Pfizer and Moderna trials, all released for complete public scrutiny, indicate the potential benefits are high and the risks, low. Despite the impressive speed at which the new COVID-19 vaccines were developed, they have undergone and continue to undergo a rigorous process to generate all the data needed by the FDA to determine their long-term safety and effectiveness.

Unfortunately, the gift of COVID-19 vaccines comes too late for the more than 313,000 Americans who have died from complications of COVID-19, and many others who’ve had their lives disrupted and may have to contend with long-term health consequences related to COVID-19. The vaccines did arrive in record time, but all of us wish they could somehow have arrived even sooner to avert such widespread suffering and heartbreak.

It will be many months before all Americans who are willing to get a vaccine can be immunized. We need 75-80 percent of Americans to receive vaccines in order to attain the so-called “herd immunity” needed to drive SARS-CoV-2 away and allow us all to get back to a semblance of normal life.

Meanwhile, we all have a responsibility to do everything possible to block the ongoing transmission of this dangerous virus. Each of us needs to follow the three W’s: Wear a mask, Watch your distance, Wash your hands often.

When your chance for immunization comes, please roll up your sleeve and accept the potentially life-saving gift of a COVID-19 vaccine. In fact, I just got my first shot of the Moderna vaccine today along with NIAID Director Anthony Fauci, HHS Secretary Alex Azar, and some front-line healthcare workers at the NIH Clinical Center. Accepting this gift is our best chance to put this pandemic behind us, as we look forward to a better new year.

Links:

Coronavirus (COVID-19) (NIH)

Combat COVID (U.S. Department of Health and Human Services, Washington, D.C.)

Dale and Betty Bumpers Vaccine Research Center (National Institute of Allergy and Infectious Diseases/NIH)

Moderna (Cambridge, MA)

Pfizer (New York, NY)

BioNTech (Mainz, Germany)


Music in the Atrium

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Music in the Atrium
On November 10, I took a break at lunchtime to pull out my guitar and play some bluegrass with the We RNA String Band. The hour-long performance was part of the NIH Clinical Center’s “Music in the Atrium” series. These frequent concerts are provided for patients, their families, and visitors to support the Clinical Center’s environment of care and healing. Jamming away, while physically distancing, are fellow bandmembers (l-r) William Sears on fiddle, Dominic Golec on mandolin, John Tisdale on bass, and Ivan Vujkovic-Cvijin on guitar. Credit: NIH

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