Pfizer/BioNTech and Moderna vaccines have only emergency use authorization in the country at present. The companies say that they are working to request FDA to grant them full approval. And health professionals want it to happen at the earliest. Their vaccines have been in use in the country since mid-December. And real-world data shows that these vaccines work against the viruses that cause COVID 19. Experts hope that these vaccines are given full approval as soon as possible. They also expect that the FDA will work in this direction as fast as possible as and when the applications come in. Moving from emergency use authorization to full approval will help vaccine manufacturers to market their products directly to consumers. It will also lead to the required changes in the vaccine mandates. It may also help experts fight off vaccine hesitancy.
Full FDA Approval For Coronavirus Vaccines Will Boost Fight Against Vaccine Hesitancy
The path to full approval is not that easy. The three vaccines available in the country today are not approved, but authorized. The manufacturers applied for EUA due to the dire situation the pandemic created in the country. Besides, the process of application for this is relatively faster.
Emergency Authorization is the same as its name suggests. A product receives temporary authorization to be used during an emergency. When the emergency gets over, such a license will become invalid. Thus the vaccine-manufacturers should submit a separate application to the FDA for full approval. The general process for full approval from FDA involves the following steps:
- Lab research
- Pre-clinical trial; these has been completed when it comes to coronavirus vaccines.
The Food and Drug Administration also requires vaccine-makers to submit data to support the process of manufacturing, facilities, processes, characterization of the product and demonstrations. The company has to prove that the manufacturing of the vaccines will be consistent and reliable. Upon completion of the trials and the submission of related data, the manufacturer can submit a biologics license application to the agency. When doing so, a manufacturer is seeking permission to directly market its products in the country.
FDA analyzes the data to evaluate the data provided is proof that the product is effective and safe. It also tries to understand if the information on the manufacturing and facilities ensure consistency and excellence of quality of the product. Upon completion of this analysis, the agency takes a decision with regard to its full approval or license for use in the US. If it designates an application as “priority review”, a decision will be taken in a time period of six months. A standard review, on the other hand, is a lengthy process.
Giving formal approval to a product requires that the authority has to observe many things. The most prominent among them is safety. This is excellent in 100 million people who have received at least one dose of these vaccines.
The pandemic is on the decline in the country. And the situation of emergency will be lifted within no time. In such an instance, the FDA has to give another green light for the vaccines to be used in the country. The authority maintains the highest standards when it comes to safety. And it is one among the finest regulatory bodies all over the world.
Authorized, but the unapproved vaccine is one of the primary reasons for vaccine hesitancy. If one can believe history, hesitancy or complete mistrust always happens with unapproved vaccines. In 2009, the US declared a public health emergency due to the H1N1 influenza outbreak. Later, the WHO declared it to be a pandemic.
A study done among 1500 US adults came up with the following insights:
- 77% of the population will be concerned of an unapproved vaccine.
- 63% flatly refused to receive it.
The type of health professional; public/private too influenced a decision in this regard.