SOPA Images/LightRocket via Getty ImagesThis is a tedious and time-consuming process that requires a lot of data. The agency also wants to restore trust after being under attack by the Trump Administration.Although nearly 190 million Americans have had at least one dose of Covid-19 vaccine, 57% of those aged 12 or older have not received it. Despite a national campaign encouraging vaccination, the federal government has not yet approved Covid-19 vaccines. The vaccines are only currently approved for emergency use. This distinction is important to some people, particularly those who might be hesitant about getting vaccinated. Although there is growing clinical evidence that vaccines are safe for adults aged 12 and over, the word emergency raises questions about safety.It was easy to get the shots in the hands of Americans who wanted the vaccine. Now, the FDA is being criticized for not giving full approval. This could help to swing people who aren't yet vaccinated. There is also concern that vaccine trust could be eroded if too fast decisions are made, given how politicized the pandemic response by former President Donald Trump.What is the difference between full approval and emergency authorization?In January 2020, the Health and Human Services secretary declared a U.S. emergency. He didn't know the full extent of Covid-19's threat. The FDA was granted special authority to approve medicines, vaccines, and tests that could be used by the American public in an emergency situation to combat the virus. This allowed them to quickly authorize the use of the drugs, vaccines, and tests without having to go through the lengthy approval process. FDA can decide how much data is required to issue an EUA (an emergency use authorization).According to Nicholson Price, Nicholson Price is a professor of law in health at the University of Michigan Law School, Ann Arbor. The FDA will consider the following when granting emergency authorization. Also, the medicine or vaccine must be original. There cannot be any other approved alternative. He says that manufacturers had to submit safety data for vaccines that was closer to what companies would need to approve the vaccine. He explains that FDA required emergency authorization to have two months worth of safety data, while six months is needed for full approval.Pfizer/BioNTech was granted emergency authorization in December 2020 for its vaccine. Moderna followed a week later, and Johnson & Jonson in Feb 2021. Price says it is almost incontrovertible that the EUA process has made a significant difference in fighting COVID-19, at least in vaccines. This allowed people to get shots as soon as possible, rather than waiting for approval. Those months made a huge difference.What is the FDA approval process?It can take up 10 months to get FDA approval for a vaccine. Moderna and Pfizer have both applied for special designations that allow them to expedite approval for serious or unmet medical needs. This could mean it could take up to 6 months. Johnson & Johnson is yet to submit their application but will do so in 2021.A company must submit a Biologic License Application (BLA), which includes hundreds of pages of documentation. This includes preclinical and clinical information, manufacturing processes, facilities, safety reports, and many more. Some companies can request a rolling review to allow them to hand parts of their application to FDA when they become available. This is because it takes so much time to gather all this data. Moderna and Pfizer both use the rolling review program. This involves regularly meeting with FDA regulators to keep them informed about new clinical trial data, and manufacturing developments."I think many of us are puzzled why the FDA takes so long," Ashish Jha (dean of Brown University School of Public Health)Pfizer submitted their application on May 7, and was granted special priority status for review on July 16. According to a press release, Pfizer stated that the decision on whether or not to approve the vaccine must be made by January 2022. According to other reports, Pfizers approval could be sooner than expected. Moderna submitted its application June 1, but has not been granted priority review. A statement from an FDA official stated that the FDA acknowledges vaccines as being crucial to ending the COVID-19 epidemic and is working to quickly review all applications for approval. While an FDA authorization does not constitute FDA approval, each vaccine was subject to a rigorous scientific review by the FDA. This allows the FDA to assure the public that they meet FDA's strict standards for safety, effectiveness and manufacturing quality.Why does the process take so long?The agency takes at most six months to review all supporting documentation for an application in order to make a decision. Although clinical trial data is closely scrutinized as you would expect, the agency has to review more than just data experts. FDA also inspects manufacturing plants and meets with executives many times. Experts say that the FDA is not moving fast enough despite the labor-intensive process. Ashish Jha, Dean of Brown University School of Public Health, urged the FDA to speed up Good Morning America's pace last week. He said, "I think many of us are baffled by why the FDA takes so long."The FDA faces political hurdles when approving vaccines. It is not just science and evidence that must be considered. Trump was critical of the FDA last year for requiring vaccine developers to submit safety data for emergency use within two months. Trump also accused the agency of conspiring against his in the 2020 presidential election. Some conservative circles were skeptical about the agency's tactics, which was normally science-focused.The FDA is aware of the stakes and has been working around the clock to address them.It doesn't help that the FDA made unpopular decisions recently, including approving the controversial Alzheimers drug Aduhelm despite scientists stating that there is no evidence it works. This approval led to an ongoing investigation by the Office of the Inspector General.It makes sense that the FDA would like to be more deliberate about vaccine approvals in order to regain public trust. Paul Offit, a pediatrician who heads the Vaccine Education Center at Children's Hospital Philadelphia, said, "I think the FDA understands what's at stake here, and theyre working around the clock to get it done."According to reports, the agency has expedited the process and even prioritized other projects to speed up the timeline. When President Biden was asked about the matter last week, he stated that he expected the agency to approve the Pfizers vaccine in full by the Fall, perhaps as soon as August.Why is vaccine approval necessary?There are many reasons why it is better for both the company and the public to have full approval of a vaccine. Full approval boosts public confidence because it shows that the vaccine has been through a rigorous process to ensure safety and effectiveness. Full approval, on the other hand, looks at more data over a longer time period. The company also has benefits: vaccines that are not approved for public health emergencies will be stopped from being sold after the time limit expires. The drug is fully FDA approved, which means that it can be used anytime for as long as the FDA approves.Many people get their Covid-19 vaccine news from cable news.To maximize their investment return, pharmaceutical companies also seek exclusivity. The FDA will not grant any new emergency use authorizations to similar products after a vaccine has been fully approved. Price says that unless they are selling a significantly different product, companies who want to enter the vaccine market will not be able obtain an EUA. Doctors have the option to prescribe approved drugs off-label, which is something doctors should consider. Price explained that there is currently no vaccine approved for children younger than 12. If the vaccine were fully approved doctors would be able to prescribe it to children under 12.Is full approval going to encourage more people getting vaccinated?Public health experts agree. Many public health experts believe so. As people are vaccinated more often, there is a growing number of people who either wait to see if they get the vaccine or reject it. Since December 2020, when the vaccines received emergency authorization, more than two-thirds of Americans have received at least one dose. According to the Henry J. Kaiser Family Foundation, the proportion of Americans who are waiting to see if they have received vaccines has decreased from 39% in December 2020 to 10% in June 2020. Ashley Kirzinger (associate director for public opinion research and survey research at Kaiser Family Foundation) says that friends and family were the most persuasive in persuading people to get vaccinated. She says it was watching their family members and friends get vaccinated without side effects or being pressured by family members to do so. Around 6% of the population has stated that they will not receive the vaccine, while 14% of those who have said they will get it have remained steady.She adds that this wait-and-see group is also most concerned about side effects and safety of the vaccine. The survey found that half of Americans were not sure about the status of vaccines in terms of emergency use versus full approval. However, it did indicate that some people would be more likely to choose to get vaccinated if full approval was granted. Nearly half the respondents in the wait-and-see group and 8 percent of those who said no to the survey believed they would be more likely than others to receive full vaccine approval. Kirzinger says that it still seems like a persuasive argument.The survey also revealed that vaccination messages are more effective when they are sent from doctors who are well ahead of the public regulators. Over 80% of those surveyed trust their doctor or their child's pediatrician. Only 69% trust the FDA. She says that although there is some news coverage about the Covid-19 vaccine via cable news, there is no doubt it will have an impact on people's trust in their doctor or child's pediatrician. However, doctors are still trusted messengers.
