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Lamar Alexander: FDA approved COVID-19 Vaccine is the way to stop more deaths

U.S. Senator Lamar Alexander

U.S. SenateWashington, D.C. – I chaired a hearing in the Senate health committee on Tuesday to explore the remarkable progression science is making toward a COVID-19 Coronavirus vaccine, as well as to remind parents to have their children get their childhood vaccinations and encourage as many Americans as possible to get the flu vaccine this fall.

I received an update on Operation Warp Speed, which is working around the clock to develop, manufacture, and distribute safe and effective COVID-19 Coronavirus vaccines as rapidly as possible.

U.S. Senator Lamar Alexander
U.S. Senator Lamar Alexander

Some people incorrectly believe “warp speed” means cutting corners, but it refers to the extraordinary investment in research, development, and manufacturing scale-up for a COVID-19 Coronavirus vaccine.

Perhaps most significantly, the Biomedical Advanced Research and Development Authority has taken the unprecedented step to help speed up manufacturing for hundreds of millions of doses of vaccines early in the process by buying these doses in advance so they can be ready to distribute as soon as the new vaccines are approved by the U.S. Food and Drug Administration (FDA).

Despite the speed with which scientists are developing a COVID-19 Coronavirus vaccine, Dr. Stephen Hahn, the Commissioner of the FDA, said the agency is not skimping on its review of safety and efficacy: “This is going to be a science, medicine, data decision. This is not going to be a political decision,” Dr. Hahn has said.

At the hearing I addressed three questions that Americans have about vaccines: 1. Are they safe; 2. Are they effective; and 3. Is the doctor’s office safe during the COVID-19 pandemic?

  1.  Vaccines are reviewed and approved by the FDA. FDA can either license a vaccine or authorize a vaccine for use during a public health emergency – and the FDA’s stringent approval process is the gold standard for the rest of the world. The vaccines that are routinely given to children are specifically recommended by the Advisory Committee on Immunization Practices (ACIP), an outside group of experts that looks at all available scientific information about each vaccine. Medical associations like the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians work with ACIP to develop these recommendations.
  2.  Polio was one of the most dreaded childhood diseases of the 20th century. Following introduction of polio vaccines, the number of polio cases fell rapidly to less than 100 in the 1960s and fewer than 10 in the 1970s according to the U.S. Centers for Disease Control and Prevention (CDC). Thanks to a successful vaccination program, the United States has been polio-free since 1979.
  3.  The pandemic has made some parents leery of the doctors’ office. For parents who are worried about taking their children to the doctor during the pandemic, AAP says pediatricians are working to ensure their offices are as safe as possible for children to visit. According to the AAP’s Dr. Sean O’Leary, “Medical offices are among the safest places you can be right now given the really extensive measures they’ve taken to prevent spread of COVID-19 Coronavirus both to themselves and their patients. Parents shouldn’t be afraid to go to their doctor.”

 

 

Fortunately, thanks to an unprecedented effort by private sector and our government, as well as scientists around the world, there is likely to be a COVID-19 Coronavirus vaccine ready for the most vulnerable citizens by the end of the year and hundreds of millions of doses early in 2021.

Some of the challenges apart from developing a vaccine are: how to distribute it, to whom it should go first and how to persuade Americans that it is safe to take.

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