White House refuses to sign off on FDA guidelines for authorizing and monitoring the use of coronavirus vaccines

Senior officials working in the White House are strongly objecting to the standards put forward by the Food and Drug Administration (FDA) that will determine whether or not a Wuhan coronavirus (COVID-19) vaccine is ready for public distribution.

People familiar with the situation are telling news outlets like the Wall Street Journal that it is unlikely that the White House will sign off on the agency’s proposed guidelines. The officials have expressed unhappiness with several factors, including one proposal that would require companies to monitor trial subjects for side effects for at least two months after they receive the vaccine. This represents a serious breach of personal privacy, and the White House would like the FDA to scrap the plan altogether.

Among the officials that have raised concerns are White House Chief of Staff Mark Meadows and many officials and aides working for the Office of Management and Budget (OMB)

While there is a chance that Meadows, the OMB and the FDA can come to an understanding, recent talks between the White House and the FDA have failed to indicate that they have agreed on a resolution to the conflict.

The FDA has made it clear that they do not need the approval of the White House before proceeding. However, they do want the administration’s blessing in order to reassure Americans that the vaccines the FDA approves will meet the supposedly high standards that they have set for vaccine manufacturers.

Many Americans are already rightfully concerned about the arrival of coronavirus vaccines due to the speed with which corporations are trying to get them into public use. This is raising concerns about the safety of the shots. The fact that the FDA wants people who take them to be monitored for two months after the vaccination date will likely only bring in more skepticism to the whole affair.

It should also be concerning that many of the companies developing the leading COVID-19 vaccines, in a bid to ease public concerns regarding the safety of their future products, have indicated their support for the FDA’s requirements.

“We cannot allow a lack of transparency to undermine confidence in the vaccine development process,” said Dr. Michelle McMurry-Heath, president and CEO of the Biotechnical Innovation Organization (BIO), one of the trade groups pushing for the FDA’s new requirements.

“The public must have full faith in the scientific process and the rigor of the FDA’s regulatory oversight if we are to end the pandemic.” BIO’s member companies include many of those that are currently developing coronavirus vaccines.

Usually, companies that want to market their vaccine need to go through a very lengthy and supposedly very thorough approval process. However, due to the current state of the pandemic in the United States, the FDA is scrapping a lot of these requirements in favor of a faster review process which they believe can still ensure the safety and effectiveness of the vaccines.

There are over 180 vaccines currently being developed around the world. Four of them are already in the final stage of clinical trials in the United States, less than a year since research and development began.

Listen to this episode of the Health Ranger Report, a podcast by Mike Adams, the Health Ranger, as he talks about how, in states run by the Democratic Party, health officials will be going door-to-door to vaccinate people at gunpoint or kidnap them under the guise of medical necessity in order to take them to quarantine encampments.

Public divided over whether they will get a COVID-19 vaccine

According to a national survey conducted in September by the Pew Research Center, only around half of U.S. adults are saying that they will either definitely or probably get a COVID-19 vaccine once it becomes widely available. This is a very steep decline from a similar survey conducted back in May that said 72 percent of the population is planning to get the vaccine. The survey was conducted between Sept. 8 to 13 and it involved 10,093 American adults.

The study found that only 21 percent of adults will definitely get a vaccine, while another 30 percent will probably get it. Twenty-five percent said they probably will not and 24 percent said they definitely will not.

Back in May, 42 percent and 30 percent said they definitely and probably will get a vaccine. Only 16 and 11 percent said they probably and definitely will not get vaccinated.

Of those who stated that they probably or definitely would not get vaccinated to prevent COVID-19, a full 90 percent are concerned about the potential side effects, especially given the fact that all of the vaccines being developed in the United States have been rushed.

Eighty-five percent said they want to know more about how well the vaccine works before they take it, 32 percent said they are concerned that it will cost too much and a full 55 percent of those who do not intent to get vaccinated do not believe that they need it.

Furthermore, of those planning to get a vaccine, 57 percent of them said it is less likely that they will get their shot if they had to pay out of pocket to receive it and if they knew that a lot of people were experiencing side effects. (Related: Coronavirus vaccine trial subjects report extreme exhaustion, shortness of breath, day-long headaches and shaking so violently that one of them cracked a tooth.)

As of press time, the United States has over 7.3 million cases of coronavirus, including 208,716 deaths. President Donald Trump himself, along with First Lady Melania, have recently also tested positive for COVID-19.

Learn more about the ongoing pandemic, and of the many attempts by pharmaceutical corporations to develop vaccines for it by reading the articles at Pandemic.news.

Sources include:

WSJ.com

NYTimes.com

PewResearch.org

Coronavirus.JHU.edu

BBC.com