Sen. Marshall Calls on FDA to Fully Approve COVID Vaccines and Booster for Vulnerable People

(Washington, D.C., August 2, 2021) – Today, U.S. Senator Roger Marshall, M.D. called on the Food and Drug Administration (FDA) to grant full authorization of the current vaccines currently under Emergency Use Authorization (EUA). This approval would help combat vaccine hesitancy and unleash physicians to provide elderly Americans and those with underlying health conditions a third COVID-19 vaccine booster shot. According to the Kaiser Family Foundation, 44 percent of unvaccinated Americans are waiting to see the FDA grant full approval for COVID vaccines. Additionally, in order to address vaccine hesitancy, Senator Marshall is urging the FDA to give traditional non mRNA vaccines, such as Novavax and AstraZeneca a final thumbs up or down for EUA. Senator Marshall believes the focus right now should be on the 20 percent of American adults without immunity, and the FDA can impact this more than all the meaningless jawing coming out of Washington, D.C. Senator Marshall issued this statement:

“Recent inconsistent mask mandates are especially punishing children, those who have been fully vaccinated, and those who had COVID, and will only lead to more vaccine hesitancy. That said, full FDA approval of the vaccines will help combat the hesitancy and provide our doctors with the tools necessary to protect the most vulnerable among us by giving them a third dose. Real world science shows us this virus disproportionately impacts senior citizens and those with underlying health conditions, but not healthy children. Thus, we need to focus on maximizing our high risk group’s immunity,” said Senator Marshall. “As cases increase, now is the time to talk to your doctor about getting vaccinated if you haven’t yet and about the possibility of getting a third booster shot if you are at higher risk. Science shows us our vaccinations and/or natural immunity provide exceptional defense for the low risk group against the Delta variant and all variants, and that we don’t need to revert back to draconian mask mandates and lockdowns.”

Senator Marshall was recently on FOX News to discuss the FDA fully approving the COVID vaccine as well as the need for COVID booster shots for vulnerable Americans. You may click HERE or on the image below to watch the interview.

Background:

Federal agencies are using a misguided one-size-fits all vaccine approach. As a result, the recent mask mandates are harming those who are significantly protected from severe disease and death of COVID-19 via infection-acquired and/or vaccine-acquired immunity.

There is data suggesting a third shot could improve immunity for our most vulnerable populations. FDA and CDC need to utilize this real-world evidence that patients are generating every day here in America and abroad.

For example, the Israel health ministry approved a plan to give booster shots, starting last weekend. Initial data shows a booster dose – after being fully vaccinated – is promising in further powering your level of protection.

The United Kingdom launched the first clinical trial in the world on boosters. They claim that millions of vulnerable people in the UK will need to get a booster. And they’re ahead of the U.S. in trying to understand the long term immunity of the vaccines by measuring t-cell response. The UK is doing this because they want to be specific on how many shots are required to generate a level of protection that people need from all COVID variants. Earlier last week, Senator Marshall penned an op-ed for The Hill highlighting the importance of COVID-19 immune response research and the important role T-cell tests can play in decisions on vaccinations. The Senator said in part,

“We need to prioritize vaccine-acquired and infection-acquired immune response research to understand the who, what, when, where, how, and why for future vaccination efforts, including clinical appropriateness. In doing so, federal agencies need to take a deeper dive into T-cells (and B-cells) as they play an essential role in reducing the severity of symptoms and help prevent infection…The clock is ticking as parents inch closer to the fall semester and return their children to the classroom. Every parent and physician I’ve talked to has told me if they knew their patient or child’s level of immune response, it would make sense to amend the standard on dosing and administration to meet clinical appropriateness. This would impact their benefits versus risk model. From what I’ve heard on how states and stakeholders are debating what to require and what not to require for its K-12 schools, we need real answers and the precision that comes from it. We can go beyond our narrow understanding of COVID-19 immunity. HHS agencies need to better prioritize and collaborate efforts to develop what our next steps should really be for the short and long term, and natural immunity should be considered part of the equation. And thanks to Congress, they certainly have the resources to pull it off.”

In April, Senator Marshall led a group of Republican doctors and other health care providers in Congress to launch a public service campaign to boost COVID-19 vaccine participation saying in part, “Operation Warp Speed brought us safe and effective vaccines in record time… The FDA did not skip any steps. Instead, they cut bureaucratic red tape – not corners – and they got the job done in record time… The beauty of living in this great nation is however, that we have the option to choose whether or not we get vaccinated. When the time comes for you to make that decision, talk it over with your doctor or your pharmacist and consider their recommendation… I hope you’ll join me, along with over 100 million Americans, in choosing to receive the vaccine so we can throw away our masks and live life as free as we did before.” You may click HERE or on the image below to watch the PSA.

###