COVID-19 Vax: Politics has no effect, FDA officials say

Washington-FDA Commissioner of Medicine Stephen Hahn worked hard to reassure Senators that one of his government decisions on the COVID-19 vaccine was and will not be a political motive. I did.

Hahn said in the Senate Health, Education, Labor and Pensions Committee that “I assure you that all the decisions we have made have been made by FDA scientists based on politics and data, not science. I want to emphasize it. ” Hearing on federal response to COVID-19.. “The FDA will not approve or approve the COVID-19 vaccine until it meets stringent expectations for safety and efficacy … The decision to approve or approve such a vaccine or treatment is the FDA’s dedicated career. The staff will do it thoroughly. The process will be reviewed and science will guide our decisions. “He added,” The FDA does not allow pressure from anyone to change it … I above all. Also prioritizes the interests of Americans. “

Questions about the timeline

Senator Mitt Romney, Utah, attempted to clarify his thoughts on the approval of the COVID-19 vaccine or the appropriate timeline for approval, but failed. “The process can take weeks, or even months, depending on the complexity of the data we’re looking at,” Hahn replied. “We feel the urgency of the moment and take the responsibility to save the lives of Americans very seriously. We will not be late, but we will not cut corners in the process.”

Dr. Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, was more specific when distributing approved or approved vaccines.

Currently, if all the vaccines pre-manufactured by some companies are included in the total, “probably 50 million in November and another 100 million plus 1 million by December. Let’s … by April, we’ll have a total of about 700 million. “

“So if you’re talking about who will be vaccinated in December or November, it won’t be the majority of the population,” Forch continued. “It’s mainly people who have priorities, probably health care providers, and are likely to be vulnerable to potential conditions, according to the Advisory Board on Immunization Practices. But I We do not have all doses, for example, they will be available by the end of December. As the months go by, they will be introduced sequentially. “

Redfield addresses mask issues

CDC Director Robert Redfield (MD) Suppresses The Caused Riot At the Senate hearing last week When he said that masks are more effective than vaccines in controlling the virus. “I’m completely confident in the importance of the vaccine, and in the end it will be the vaccine that will bring us back to life. But if the vaccine elicits an immune response in only half of the people, half People are not protected from the vaccine, “so wearing a mask is still very important.

He also touched on issues with the vaccine timeline. “It is expected to be given about 700 million times by April or late March, but this is enough to vaccinate 350 million people because it requires two doses,” said the second. Late or early next year’s third quarter, before the entire population is vaccinated.

Other senators had pet issues that they wanted to discuss. Dr. Senville Cassidy (R-La.) Said that patients are guaranteed to be free of vaccine costs, but providers will bear the costs associated with vaccination. He asked if those costs would also be covered. “I think healthcare providers will be expensive,” said Major Brett Guilloir (MD), Deputy Secretary of Health for the Department of Health and Human Services (HHS). “The government is committed to ensuring that patients have no out-of-pocket costs, whether for the vaccine itself or for the administration of the vaccine.”

Cassidy also expressed concern about the level of antibody response provided by the vaccine. “For people at higher risk [emergency department] A nurse or clerk gives people [ED], Do I need antibody serology after vaccination? Are there enough serological tests to do this? “

“There are still no data linking clinical outcomes to antibody development, so it is unlikely that antibody testing will be needed in such situations,” Hahn said in the first few trials. If such data becomes available, in subsequent tests.

Paul, Fauci Spar, Mortality

Senator Rand Paul (R-Ky.) Seems to be pushing the idea of ​​herd immunity, and the government’s first goal of “flattening the curve” means slowing down the coronavirus. It does not reduce the total number of deaths, as it causes deaths that remind everyone to be alone. “Our hospital isn’t overwhelmed because lockdowns were meant to mitigate the proliferation of viral deaths, but the same number of people are likely to die with or without lockdowns.” He said. “The media, and frankly, government officials seem to have forgotten this important warning,” he said.

“We have reached the highest mortality rate in the world,” Paul said, saying that Sweden, which imposed some powers and instead used voluntary guidelines, showed about one-third the mortality rate of New York and New Jersey. One million … The mortality rate in the United States is fairly comparable to the underdeveloped world where social distance is virtually impossible. This poses an important problem: people. Can the course of the infectious disease be changed through crowd control? Claim the echoing “no”

Forch vigorously opposed Paul’s conclusion. “Comparing Sweden’s mortality rate to other comparable Scandinavian countries-worse,” Forch said. “I don’t think it’s appropriate to compare us to Sweden … the only way we could stop the outbreak of infection is essentially the physical separation and kind of recommendations we have. Made without regrets that it was to have a matter. “

Senator Susan Collins (R-Main) is HHS Secretary Alex Azar He proclamation that he must sign off All rules related to medical products and devices, including vaccines. “Such changes can slow progress and make Americans doubt that the protocol is being followed,” she told Giroir. “Can you explain why these changes are being made and whether they could affect the new medical treatment of COVID-19?”

“As I understand, this was a secretary’s administrative decision, because the authority to create rules for institutions with 90,000 people is widespread,” Giroir replied. “I don’t think it interferes with the process … this is the management process to gain control so there aren’t hundreds of different ways to create rules at this very important time. did.”

Collins replied: “Thank you for your guarantee, but if everything had to flow to the secretary, it seems inevitable that it would create delays and suspicions, and we’re in this pandemic. Neither is useful when dealing with it. “