When will the FDA give full Approval to COVID-19 vaccines?
Share on Pinterest Two vaccine manufacturers have applied for full approval of their COVID-19 vaccines. Ben Hasty / MediaNews Group / Reading Eagle through Getty Images Two vaccine manufacturers have applied for full approval of their COVID-19 vaccines, but the FDA has not yet indicated when a decision will be made. COVID-19 vaccines have been authorized for emergency use in the United States but have not yet been fully approved. So far, the FDA has shown no indication of when it will grant full approval for these vaccines. Experts say full approval could help boost vaccination rates. It has been almost 7 months since the Food and Drug Administration (FDA) issued the first emergency authorization for a COVID-19 vaccine: the Pfizer-BioNTechs mRNA vaccine. In the following months, two other COVID-19 vaccines, the Modernas mRNA vaccine and the Johnson & Johnsons vector adenovirus vaccine, were authorized for urgent use. Since the first authorization, more than 182.7 million Americans 55 percent of the general population has received at least one dose, according to the Centers for Disease Control and Prevention (CDC). During the vaccination campaign, most people received an mRNA vaccine either because it was more available or preferred an mRNA vaccine. Moreover, a number of peer-reviewed studies have been published that support the safety and effectiveness of mRNA vaccines seen in initial clinical trials. However, so far the FDA has not indicated any indication of when it will give full approval. However, the lack of full approval has not limited the availability of vaccines. Right now, anyone 12 years of age or older can be vaccinated against COVID-19 in the United States. The place also has plenty of doses to go around. For one, full approval can help convince people in the waiting and viewing group that vaccines are safe and effective. Full approval can provide greater assurance that vaccine safety and efficacy have been more thoroughly studied and may reduce existing vaccine reluctance, he said. Melissa Tice, PhD, Assistant Professor of Clinical Research and Leadership at George Washington University. This could also lead to more employers and schools requiring COVID-19 vaccination for their staff and students. Both of these can help resume the stagnant vaccination program in the country. Which can prevent hospitals from congestion by COVID-19 patients, something that is still happening in parts of the country more than a year into the pandemic. Dr. Eric J. Topol, a professor of molecular medicine at the Scripps Research Translational Institute, wrote in a recent one New York Times opinion article that given the months of data now available, the FDA needs to move quickly to give full approval to mRNA vaccines. Little did any biologists (vaccines, antibodies, molecules) have considered their safety and efficacy at this scale, he wrote. In other words, RNA vaccines have been proven to be overwhelmingly safe and effective from clinical trials, independent research, and the experience of millions of people around the world who received them, he added. The FDA has not indicated when full approval of mRNA vaccines may occur. However, Pfizer and BioNTech and modern have already submitted applications for full approval of their vaccines officially recognized as a Biological License Application (BLA) to the FDA on May 7, 2021 and June 1, 2021, respectively. These submissions kicked off the clock in the FDA regulatory review. In the first 60 days, the agency checks the application to make sure it is complete and decides what kind of review will take place. Tice said given the urgent need for COVID-19 vaccines, the FDA is likely to give applications priority review. The purpose of the agencies for this type of review is to make a decision within 6 months of submission. This means that the FDA would decide on the full approval of the Pfizer-BioNTech vaccine by January 2022 and February 2022 for the Moderna vaccine. This is the maximum review deadline. A decision can come faster thanks to the work done for EUAs. The FDA has already reviewed initial clinical trial data from both companies and production aspects to give the EUA, Tice said, so full approval of these vaccines could occur in less than 6 months. FDA emergency approval is a less rigorous review process reserved for public health emergencies for which a pandemic clearly qualifies. There was still strong evidence that the vaccines were safe as they were based on clinical data involving tens of thousands of study participants, which is the same size test that a drug or vaccine was expected to receive full approval. EUAs for COVID-19 vaccines were given based on an average of 2 months of safety monitoring data. Tice said the full review requires companies to submit long-term data on vaccine safety, along with additional data on how well the vaccine protects against infection and serious illness. This will give a better picture of the benefits and risks of the vaccine. According to a poll last month by the Kaiser Family Foundation (KFF), about a third of unvaccinated adults said they would be more likely to be vaccinated if one of the COVID-19 vaccines received full FDA approval. About half of the waiting and viewing vaccination group said the same thing. This group which accounted for about 10 percent of the adults surveyed includes a large number of Black and Hispanic adults and younger adults. Many incentives have been offered to encourage this hedge group to get vaccinated, including millions of dollars in lotteries, free donuts and free beer, with mixed success. The KFF survey also found that about 6 percent of adults say they will only be vaccinated if required, such as by an employer or school, or to travel. For them, the stimulus towards vaccination may have to come from mandates. Even without the full approval of COVID-19 vaccines by the FDA, some employers have already begun to require vaccination for employees. For example, Morgan Stanley is banning workers who are not fully vaccinated from most of its New York offices. Also, the Houston Methodist health system in Texas imposed a COVID-19 vaccine mandate on its employees. More than 150 workers resigned or was terminated as a result of this new policy, even though it was a small fraction of the more than 20,000 workers who obeyed. A group of employees challenged the mandate in court, but one judge fired their lawsuit. This court decision, and federal law, supports the right of employers to request that employees be vaccinated. However, some employers may expect the FDA to grant full approval before deciding on their vaccine mandate. This includes the US military, which has encouraged, but is not required to, its active members to vaccinate. Partial vaccination rate in the military range from 58 percent for the Marine Corps to 77 percent for the Navy. However, the military has suggested that once the vaccine is fully approved, it may make vaccination a medical readiness requirement for service members. Even if federal employment law allows vaccine mandates, businesses in certain states may find it more difficult by requiring their employees to be vaccinated. Many states have introduced or passed law restricting the use of employer COVID-19 vaccine mandates or vaccination certification.