Biden Picks Former F.D.A. Chief Kessler to Lead U.S. Vaccine Efforts

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Biden Picks Former F.D.A. Chief Kessler to Lead U.S. Vaccine Efforts

President-elect Joseph R. Biden Jr. has appointed Dr. David Kessler, a former head of the Food and Drug Administration, asked to oversee efforts to accelerate the development, manufacture and distribution of coronavirus vaccines.

Dr. Kessler, a pediatrician and attorney who passed the F.D.A. During the presidencies of George Bush and Bill Clinton, he was a key advisor to Mr Biden on Covid-19 policy and is co-chair of the Covid-19 task force of the transition team.

He will be Dr. Replace Moncef Slaoui, a researcher and former CEO of a pharmaceutical company. Dr. Kessler will share primary responsibility for the initiative with General Gustave F. Perna, who will continue to serve as chief operating officer, according to a Biden interim spokesperson. In-depth administration has decided to phase out the Trump administration's name for the program, Operation Warp Speed, a Mr Biden spokeswoman Jen Psaki said Friday.

"OWS is the name of the Trump team for its program," Ms. Psaki wrote on Twitter using the program's initials. "We are introducing a new structure that will have a different name from OWS."

Ms Psaki added that Biden Covid's response would come from the White House. Dr. Bechara Choucair, a former Chicago Health Department commissioner, will "oversee vaccination efforts," said Ms. Psaki, including work to fulfill Mr Biden's promise to "get 100 million Covid vaccine shots into the arms of the American people" his 100th day in office.

While Operation Warp Speed ​​is largely responsible for enabling two highly effective coronavirus vaccines to be developed in record time, it has been much less successful in actually getting the shots out to the public – a complex task they have with numerous federal, state – and local authorities shares.

The Trump administration had promised to vaccinate 20 million people by the end of 2020, but by Thursday just over 11 million vaccinations had been given, according to the Centers for Disease Control and Prevention.

At some vaccination sites, long lines of elderly people have lined up for hours waiting for a vaccine. For others, a lack of willing recipients forces vendors to offer the shots to random passers-by before the cans expire.

In late fall, Dr. Kessler told Mr. Biden that Operation Warp Speed ​​was not prepared to get the shots into the arms of the people. The transition team announced last week that the president-elect intends to set up vaccination sites in high schools, convention centers and mobile units to reach populations at risk. Details of the plans are expected on Friday.

Dr. In addition to working to accelerate vaccine delivery across the country, Kessler will also focus more on developing therapies. According to transitional officials, he plans to launch an extensive antiviral development program to treat Covid-19. He also wants to build capacity in the United States to manufacture vaccines against the coronavirus as well as against leading known pathogens.

Covid19 vaccinations>

Answers to your vaccine questions

If I live in the US, when can I get the vaccine?

While the exact order of vaccine recipients may vary from state to state, most doctors and residents of long-term care facilities will come first. If you want to understand how this decision is made, this article will help.

When can I get back to normal life after the vaccination?

Life will not return to normal until society as a whole receives enough protection against the coronavirus. Once countries approve a vaccine, they can only vaccinate a few percent of their citizens in the first few months. The unvaccinated majority remain susceptible to infection. A growing number of coronavirus vaccines show robust protection against disease. However, it is also possible for people to spread the virus without knowing they are infected because they have mild or no symptoms. Scientists don't yet know whether the vaccines will also block the transmission of the coronavirus. Even vaccinated people have to wear masks for the time being, avoid the crowds indoors and so on. Once enough people are vaccinated, it becomes very difficult for the coronavirus to find people at risk to become infected. Depending on how quickly we as a society achieve this goal, life could approach a normal state in autumn 2021.

Do I still have to wear a mask after the vaccination?

Yeah, but not forever. The two vaccines that may be approved this month clearly protect people from contracting Covid-19. However, the clinical trials that produced 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 with the coronavirus can spread it while they don't have a cough or other symptoms. Researchers will study this question intensively when the vaccines are introduced. In the meantime, self-vaccinated people need to think of themselves as potential spreaders.

Will it hurt What are the side effects?

The vaccine against Pfizer and BioNTech, like other typical vaccines, is delivered as a shot in the arm. The injection is no different from the ones you received before. Tens of thousands of people have already received the vaccines, and none of them have reported serious health problems. However, some of them have experienced short-lived symptoms, including pain and flu-like symptoms that usually last a day. It's possible that after the second shot, people will have to plan to take a day off or go to school. While these experiences are not pleasant, they are a good sign: they are the result of your own immune system's encounter with the vaccine and a strong reaction that ensures lasting immunity.

Will mRNA vaccines change my genes?

No. Moderna and Pfizer vaccines use a genetic molecule to boost the immune system. This molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse with a cell, allowing the molecule to slide inside. The cell uses the mRNA to make proteins from the coronavirus that can stimulate the immune system. At any given point in time, each of our cells can contain hundreds of thousands of mRNA molecules that they produce to make their own proteins. As soon as these proteins are made, our cells use special enzymes to break down the mRNA. The mRNA molecules that our cells make can only survive for a few minutes. The mRNA in vaccines is engineered to withstand the cell's enzymes a little longer, so the cells can make extra viral proteins and trigger a stronger immune response. However, the mRNA can last a few days at most before it is destroyed.

Dr. Kessler is Dr. Anthony Fauci, the nation's leading infectious disease doctor who became the leading government voice on the coronavirus pandemic. The two worked closely to expedite drug development and approval that changed the course of the AIDS epidemic of the 1990s.

When George Bush made him head of the F.D.A. In 1990 AIDS raged in the United States. During the tenure of Dr. Kessler was the F.D.A. issued new rules to speed up drug approval. The pharmaceutical industry developed a class of antiviral drugs called protease inhibitors to treat AIDS / H.I.V., some of which were approved within 40 days.

"Each of these drugs that I took with Tony," said Dr. Kessler in an interview about Dr. Fauci. “We did it together. We approved more than a dozen antivirals and antibiotics. We expedited approval, but we got it right. "

As commissioner, Dr. Kessler was also known for his fight against the tobacco industry, which until then was considered sacrosanct in American politics.

Under his direction and with considerable help from investigator Jack Mitchell, the F.D.A. proved that the tobacco industry knew for 50 years that nicotine was an addictive substance and that cigarette companies can control the nicotine levels in their products.

This work formed the basis of the landmark 1998 Framework Settlement Agreement that forced the tobacco industry to pay states an estimated $ 206 billion in damages and to change the way they advertise and sell tobacco products. It also resulted in the passage of the Family Smoking Prevention and Tobacco Control Act of 2009, which eventually led to the F.D.A. the Authority for the Regulation of Tobacco Products.

Dr. Kessler's other major government focus was improving the American diet. As F.D.A. Commissioner, he developed modern nutrition labels that are easy to read and contain basic nutritional information that was previously often left out.

After leaving the F.D.A. was Dr. Kessler Dean of the Yale School of Medicine, followed by a position as Dean and Vice Chancellor of the San Francisco Medical School of the University of California. After whistling at the university for financial irregularities, he was dismissed as dean, but after an independent examiner concluded he was right, the university apologized and he remained a professor.

In 2018, Dr. Kessler chairman of the board of the Center for Science in the Public Interest, a monitoring group for nutrition and health, which often criticizes the health policy of the federal government.

For several years he was on the board of directors of Immucor, a provider of transfusion and transplant diagnostic products. In 2020, he joined the board of directors of Ellodi Pharmaceuticals, a spin-off from Adare Pharmaceuticals that specializes in gastroenterological drugs.

This week he stepped down from all three boards and is selling his shares in the companies. He said he didn't own any vaccine or drug company stocks.

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