The lack of approval for COVID - 19 vaccines is hampering efforts

The lack of approval for COVID - 19 vaccines is hampering efforts

Moreover, the Food and Drug Administration has begun to slow down the process for full approval of the Pfizer-BioNTech COVID-19 vaccine, facing pressure from those who believe the lack of full approval is hampering efforts to get more Americans vaccinated.

'We recognize that for some, the FDA approval of COVID - 19 vaccines could bring additional confidence and encourage them to get vaccinated, Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, said in a statement on Aug. 4. 'Acknowledging the urgency related to the current state of the pandemic, we took an all-hands on deck approach, including identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities in order to complete our review to help combat this pandemic surge.

President Marks said last week that he expects a fully approved vaccine by the early fall, but Joe Biden wouldn't comment on the time frame.

Data show that being vaccinated dramatically reduces the risk of hospitalization or death in the aftermath of COVID - 19 infections. More than 192 million Americans have gotten at least one dose of the three vaccines that were given emergency use authorization in the U.S. by Pfizer-BioNTech, Moderna and Janssen Johnson Johnson, without widespread side effects, data show. However, the number of Americans fully vaccinated against COVID has started to stall with about 92 million people over age 12 unvaccinated, according to the U.S. Centers for Disease Control and Prevention. Meanwhile, the more contagious Delta variant of the virus is spreading rapidly amongst the unvaccinated population.

The spike in COVID - 19 cases in states that have low vaccination rates has threatened to claw the U.S. back into the worst of the pandemic, and it creates a looming political liability for Biden. On Aug. 3, Biden gave a sober speech from the East Room of the White House saying that the nation's 'best line of defense" against the virus is the vaccine. His vaccine is important, said he.

Aber as Biden attempts to mount more aggressive vaccination efforts to curb the spread of the highly transmissible Delta variant, the fact that FDA has yet to fully approve any of the vaccines is threatening to slow progress. About 30% of unvaccinated people say they would be more likely to get a shot with full FDA approval, according to recent polls from the Kaiser Family Foundation. While the pollsters are likely a proxy for more general concerns, some doctors and public health experts in areas with low vaccination rates say they frequently hear the FDA's emergency authorization cited as a reason people remain hesitant to get the shot.

The Biden Administration says that all civilian federal employees must be vaccinated against COVID-19 or submit to regular testing, and many hospital systems and universities, as well as a number of private employers like Walmart, Google, and Disney, have begun to follow suit.

The Justice Department's Office of Legal Counsel recently released an opinion that states federal law does not prohibit companies from requiring vaccines even if they are under emergency authorization, and courts have generally upheld vaccine mandates.

But some employers and organizations have been reluctant to make similar requirements while the vaccines are still under emergency authorization. A number of public education institutions — including the State University System of New York and Colorado State University Systems — said that they will mandate vaccination for students once a vaccine has been fully approved. In other parts of the country, Republican politicians have used the lack of full approval to block vaccine requirements from being put into place. For example, in Texas, Republican Gov. has suggested several GOP candidates for governor. Greg Abbott signed an executive order on 29 July to prevent any organization that receives state funds, including public universities, from requiring vaccines under emergency use authorization.

Health systems, also, have adopted mixed approaches. General Beaumont Health, which employs 80,000 workers in Michigan, said it would require employees to get vaccinated after the FDA issues its full approval for at least one of the vaccines as did Mass General Brigham (Mass.) Other large health systems like Cleveland Clinic, Intermountain Health, and Christus Health put no vaccination requirements in place and say they are still monitoring the situation.

'We need to see a full approval before we'll do another evaluation of thinking about a requirement in the future, says Dr. Sam Bagchi, executive vice president and chief clinical officer with Christus. He notes that the healthcare system is already facing 'unprecedented staffing challenges’ due to many health care workers quitting or taking early retirement during the Pandemic. If his hospitals ordered workers to get vaccinated now he fears it would push workers away at a time when they need more staff due to rising COVID - 19 cases.

Long-term care facilities are in a particular precarious position. LeadingAge, the non-profit trade group for national nursing homes and other aging services, called recently for its members to require employees to get vaccinated against COVID 19 as vaccination efforts have stalled in places where the virus devastated residents and staff last year. But Katie Smith Sloan, the group's president and CEO says she knows many of her member facilities can't afford to lose staff who aren't ready to get vaccinated. 'We already face acute shortages, specifically for nursing assistants and nurses in long-term care, home health, nursing homes, and assisted living, she says. She hopes that an FDA approval will make more workers volunteer to get vaccines and encourage more facilities to require it.

So and so is the American military still weighing what to do. It has not yet required that its 1.3 million senior military medical personnel be vaccinated and active duty medical officials are watching the FDA approval process closely. Secretary of Defense is consulting with medical experts and still weighing whether to ask permission from Biden to require vaccines, Pentagon spokesman John Kirby said on Aug. 3.

In six months, Pfizer normally ends a priority review, like it does for the FDA. Pfizer says it submitted a rolling application in May and Moderna — which manufactures one of the other approved COVID 19 vaccines — says it submitted a rolling application in June, which means both companies could turn in portions of their applications while continuing to collect data. The process is'moving forward as rapidly as possible in keeping with the high-quality complete assessment that our public expects from FDA Marks said.

The COVID -19 pandemic was the first time that the FDA granted emergency use authorization to a vaccine for widespread use. The EUA designation was developed after the Sept. 11 attacks and originally intended for potentially lifesaving medicines or other products during an emergency such as a terrorist attack or a more acute disease outbreak. To get an EUA for COVID-19 vaccines, manufacturers had to follow special guidelines that included submitting two months of clinical trial data, along with information about the quality and consistency of the vaccines. The FDA had to establish that the 'potential benefits outweigh the known and potential risks' of the vaccine.

For full approval, the FDA must review significantly more data and make a larger determination that a vaccine is ready to be licensed, according to Dr. Jesse Goodman, former chief scientist at the FDA and a professor at Georgetown University. This involves analyzing hundreds of thousands of pages of material about clinical trials, manufacturing processes and how the vaccines have worked in the real world since the agency authorized them for emergency use. Regulators will check the vaccine manufacturer's data and perform their own analyses to verify the vaccine's efficacy, how effective that efficacy might decline over time and any evidence of potential side effects. They also inspect resulting manufacturing plants to ensure high levels of quality control — a particularly complex job given that these vaccines used new technology, Goodman says. He notes that the FDA has historically been under-resourced' and that there are a limited number of people with the appropriate expertise to review these new vaccines.

While all that can take time, public health experts are calling for more transparency from the agency as the U.S. struggles to convince a significant portion of its population to take the lifesaving shot. "It has been a black box," says Dr. William Schaffner, infectious disease professor at Vanderbilt University Medical Center. 'Particularly since we're dealing with a pandemic and the taxpayers of the United States are paying for this vaccine, I think having the leadership of FDA be more explicit about what the process is, and why it takes so long, would at the very least be instructive.

But some worry that issuing approval process to everyone will backfire. Marks warned in a letter to the New York Times last month that "any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the F.D. A. s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy.

Dr. Arnold Monto, a professor of epidemiology at the University of Michigan who chairs the committee of outside experts that advises FDA on vaccines, including COVID- 19, agrees. They're trying as hard as they can, he says, 'given the constraints that they're working under'.