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Biden chooses former FDA chief to lead federal vaccine efforts

According to transition authorities, President-elect Joseph R. Biden Jr. has selected Dr. David Kessler to lead Operation Warp Speed, a program that accelerates the development of Covid-19 vaccines and treatments.

Dr. Kessler, a pediatrician and lawyer who headed the Food and Drug Administration during the presidency of George Bush and Bill Clinton, was Biden’s primary advisor to the Covid-19 policy and co-chaired the transition team Covid-. I am. 19 Task Force.

He will replace Dr. Moncef Slaoui, a researcher and former pharmaceutical company executive who will be a consultant for Operation Warp Speed. According to Biden’s transition spokesman, Dr. Kessler shares the initiative’s Chief Operating Officer with General Gustav F. Perna, who continues to be Chief Operating Officer. Dr. Kessler’s responsibilities cover the manufacture, distribution, safety and efficacy of vaccines and therapeutics.

“Dr. Kessler became a trusted advisor to the Biden campaign and President Biden at the beginning of the pandemic, and has probably briefed Biden 50 or 60 times since March,” said Anitadan, co-chair of the transition team. It was. “When the staff asks,’What do doctors say?’, We find that David Kessler is one of the doctors that President Biden expects to talk to us.

Dr. Kessler will participate in Operation Warp Speed ​​at a critical time. Although this program is widely accepted to have enabled the development of two highly effective coronavirus vaccines in record time, it has been far less successful in actually providing shots to the public. .. This is a complex task shared with many federal, state, and local governments.

The Trump administration has vowed to vaccinate 20 million people by the end of 2020, but as of Thursday, just over 11 million people had been vaccinated, according to the US Centers for Disease Control and Prevention.

At some vaccination sites, long lines of seniors line up for hours waiting for the vaccine. In other areas, a voluntary shortage of recipients has forced providers to provide shots to random passers-by before the dose runs out.

In late fall, Dr. Kessler warned Biden that Operation Warp Speed ​​wasn’t ready to put shots in people’s arms. The transition team said last week that President-elect intends to create vaccination sites in high school gymnasiums, convention centers and mobile units to reach high-risk people. Details of the plan are scheduled for Friday.

According to transition authorities, Dr. Kessler is expected to focus on the development of treatments in addition to working on the rapid delivery of vaccines nationwide, a key antiviral treatment for Covid-19. We are planning to start a virus development program. He also wants to build the US’s ability to produce vaccines against coronavirus and major known pathogens.

Dr. Kessler is near Dr. Anthony Fauci, the top infectious disease doctor in the United States, who has become the government’s main voice on the coronavirus pandemic. The two worked closely together to accelerate the development and approval of drugs that changed the course of the AIDS epidemic in the 1990s.

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Answers to vaccine questions

The exact order of vaccinated people may vary from state to state, but in most cases healthcare professionals and caregiver residents are the top priority. This article is useful if you want to understand how this decision is made.

Life will return to normal only if society as a whole has adequate protection against the coronavirus. Once the country has approved the vaccine, only a few percent of the population will be vaccinated in the first few months. The majority of unvaccinated people remain vulnerable to infection. More and more coronavirus vaccines show strong protection against getting sick. However, the virus can spread without knowing that it is infected, as it has only mild or no symptoms. Scientists still don’t know if the vaccine will also block the infection with the coronavirus. Therefore, for the time being, even vaccinated people should wear masks and avoid indoor congestion. Once a sufficient number of people are vaccinated, it becomes very difficult to find people who are susceptible to the coronavirus. Depending on how quickly we, as a society, reach that goal, life may begin to approach normal by the fall of 2021.

Yes, but not forever. Two vaccines that may be approved this month clearly protect people from illness caused by Covid-19. However, the clinical trials that produced these results were not designed to determine whether vaccinated people could spread the coronavirus without developing symptoms. It remains a possibility. We know that people who are naturally infected with the coronavirus can spread the coronavirus in the absence of coughing and other symptoms. As the vaccine is deployed, researchers will enthusiastically study this question. In the meantime, even vaccinated people need to think of themselves as possible spreaders.

Pfizer and BioNTech vaccines, like other common vaccines, are offered as shots in the arm. The injection is no different from what you got before. Tens of thousands of people have already been vaccinated and no one has reported serious health problems. However, some of them experience short-term discomfort, such as pain and flu-like symptoms that usually last for a day. After the second shot, you may need to plan for a break from work or school. These experiences are not fun, but they are good signs. These are the result of your own immune system encountering the vaccine and initiating a powerful response that provides long-term immunity.

No. Moderna and Pfizer vaccines use genetic molecules to stimulate the immune system. The molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily foam that can fuse with the cell and slide the molecule into it. Cells use mRNA to make proteins from coronaviruses that can stimulate the immune system. At any given time, each of our cells can contain the hundreds of thousands of mRNA molecules they produce to make their own proteins. When these proteins are made, our cells shred mRNA with a special enzyme. The mRNA molecules that our cells make can survive for only a few minutes. Vaccine mRNA is designed to withstand the cells’ enzymes a little longer, allowing the cells to make extra viral proteins and stimulate a stronger immune response. However, mRNA can last for at most a few days before it is destroyed.

AIDS was furious in the United States when George Bush appointed him to lead the FDA in 1990. During Dr. Kessler’s tenure, the FDA issued new rules designed to expedite drug approval. The pharmaceutical industry has developed a class of antiviral drugs for the treatment of AIDS / HIV called protease inhibitors, some of which have been approved within 40 days.

“All of those medicines I took with Tony,” Dr. Kessler said in an interview about Dr. Forch. “We did that together. We approved more than a dozen antivirals and antibiotics. We accelerated approval, but we did it the right way.”

As a commissioner, Dr. Kessler was also known for his fight against the tobacco industry, which was previously considered sacred in American politics.

Under his direction, and with the great help of investigator Jack Mitchell, the FDA states that the tobacco industry is a nicotine-addictive drug and that tobacco companies can control the level of nicotine in their products. Proved to have known for 50 years.

The work set the stage for the groundbreaking Master Settlement Agreement in 1998, forcing the tobacco industry to pay the state an estimated $ 206 billion in damages and change the way tobacco products are promoted and sold. It also led to the enactment of the Family Smoking Prevention and Tobacco Control Act of 2009, which ultimately empowered the FDA to regulate tobacco products.

Dr. Kessler’s major focus in other governments was to improve the American diet. As an FDA Commissioner, he developed a modern nutrition label that is easy to read and contains basic nutrition information that was often omitted before.

After leaving the FDA, Dr. Kessler was Dean of Yale University School of Medicine, followed by Dean and Vice President of the University of California, San Francisco Medical College. After whistling about the university’s financial deficiencies, he was dismissed as dean, but after the independent auditor determined that he was right, the university apologized and continued to teach.

In 2018, Dr. Kessler became chairman of the Center for Public Interest Sciences, a food and health surveillance group that is often critical of federal health policy.

He has been a board member of Immucor, a provider of blood transfusion and transplant diagnostic products, for several years. In 2020, he joined the board of directors of Ellodi Pharmaceuticals, a spin-off from Adare Pharmaceuticals, which specializes in gastroenterology-focused pharmaceuticals.

This week he has resigned from all three boards and is selling shares in the business. He said he does not own shares in vaccine-related or pharmaceutical companies.

Biden chooses former FDA chief to lead federal vaccine efforts

Source link Biden chooses former FDA chief to lead federal vaccine efforts

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