President-elect Joseph R. Biden Jr. has asked Dr. David Kessler, a former head of the Food and Drug Administration, to oversee the effort to accelerate the development, manufacture and distribution of coronavirus vaccines.
Dr. Kessler, a pediatrician and lawyer who headed the F.D.A. during the presidencies of George Bush and Bill Clinton, has been a key adviser to Mr. Biden on Covid-19 policy and is co-chair of the transition team’s Covid-19 task force.
He will replace Dr. Moncef Slaoui, a researcher and former drug company executive. Dr. Kessler will share top responsibilities for the initiative with Gen. Gustave F. Perna, who will continue as chief operating officer, according to a Biden transition spokesman. The incoming administration has decided to phase out the Trump administration’s name for the program, Operation Warp Speed, a spokeswoman for Mr. Biden, Jen Psaki, said Friday.
“OWS is the Trump team’s name for their program,” Ms. Psaki wrote on Twitter, using the program’s initials. “We are phasing in a new structure, which will have a different name than OWS.”
Ms. Psaki added that the Biden Covid response would be run out of the White House. Dr. Bechara Choucair, a former commissioner of Chicago’s health department, will “oversee vaccinations efforts,” Ms. Psaki said, including working to fulfill Mr. Biden’s promise of getting “100 million Covid vaccine shots into the arms of the American people” by his 100th day in office.
Although Operation Warp Speed is widely credited with making possible the development of two highly effective coronavirus vaccines in record time, it has been much less successful at actually delivering the shots to the public — a complex task it shares with numerous federal, state and local authorities.
The Trump administration had vowed to vaccinate 20 million people by the end of 2020, but as of Thursday, just over 11 million inoculations had been given, according to the Centers for Disease Control and Prevention.
At some vaccination sites, long lines of elderly people have queued up for hours waiting for a vaccine; at others, a lack of willing recipients is forcing providers to offer the shots to random passers-by, before the doses expire.
In the late fall, Dr. Kessler warned Mr. Biden that Operation Warp Speed was not prepared for getting the shots into people’s arms. The transition team said last week that the president-elect intended to create vaccination sites in high school gyms, convention centers and mobile units to reach high-risk populations. Details of the plans are expected on Friday.
In addition to working to speed delivery of vaccines throughout the country, Dr. Kessler is expected to increase the emphasis on development of treatments, and he plans to begin a major antiviral development program for treatment of Covid-19, according to transition officials. He also wants to build U.S. capacity for manufacturing vaccines against the coronavirus as well as leading known pathogens.
While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.
Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.
Yes, but not forever. The two vaccines that will potentially get authorized this month clearly protect people from getting sick with Covid-19. But the clinical trials that delivered these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. That remains a possibility. We know that people who are naturally infected by the coronavirus can spread it while they’re not experiencing any cough or other symptoms. Researchers will be intensely studying this question as the vaccines roll out. In the meantime, even vaccinated people will need to think of themselves as possible spreaders.
The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection won’t be any different from ones you’ve gotten before. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. But some of them have felt short-lived discomfort, including aches and flu-like symptoms that typically last a day. It’s possible that people may need to plan to take a day off work or school after the second shot. While these experiences aren’t pleasant, they are a good sign: they are the result of your own immune system encountering the vaccine and mounting a potent response that will provide long-lasting immunity.
No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.
Dr. Kessler is close to Dr. Anthony Fauci, the nation’s top infectious disease doctor who became the leading governmental voice on the coronavirus pandemic. The two worked closely to speed the development and approval of drugs that changed the course of the AIDS epidemic in the 1990s.
When George Bush appointed him to lead the F.D.A. in 1990, AIDS was raging in the United States. During Dr. Kessler’s tenure, the F.D.A. issued new rules designed to speed drug approval. The pharmaceutical industry developed a class of antiviral drugs to treat AIDS/H.I.V., called protease inhibitors, some of which were approved within 40 days.
“Every one of those drugs I did with Tony,” Dr. Kessler said of Dr. Fauci in an interview. “We did it together. We approved more than a dozen antivirals plus antibiotics. We accelerated the approval, but we did it the right way.”
As commissioner, Dr. Kessler was also known for his battle against the tobacco industry, which until then had been considered sacrosanct in American politics.
Under his direction, and with significant help from the investigator Jack Mitchell, the F.D.A. proved that the tobacco industry knew for 50 years that nicotine was an addictive drug and that cigarette companies could control the levels of nicotine in their products.
That work set the stage for the landmark Master Settlement Agreement in 1998, which forced the tobacco industry to pay an estimated $206 billion in damages to the states, and to change the way they advertised and sold tobacco products. It also led to the 2009 passage of the Family Smoking Prevention and Tobacco Control Act, which finally gave the F.D.A. the authority to regulate tobacco products.
Dr. Kessler’s other big focus in government was improving American diets. As F.D.A. commissioner, he developed modern-day nutrition facts labels that are easy to read and include basic nutritional information that was often previously omitted.
After leaving the F.D.A., Dr. Kessler served as dean of the Yale School of Medicine, followed by a stint as dean and vice chancellor of the University of California, San Francisco Medical School. After blowing the whistle on financial irregularities at the university, he was dismissed as dean, but after an independent auditor concluded he was correct, the university apologized and he stayed on as a professor.
In 2018, Dr. Kessler became chairman of the board of the Center for Science in the Public Interest, a food and health watchdog group that is often critical of federal health policy.
He has served on the board of Immucor, a provider of transfusion and transplantation diagnostics products, for several years. In 2020, he joined the board of Ellodi Pharmaceuticals, a spinoff from Adare Pharmaceuticals, specializing in gastroenterology-focused drugs.
This week, he resigned from all three boards and is divesting his stock in the businesses. He said he did not own any stock in vaccine-related or pharmaceutical companies.