Amid the rising vaccine hesitancy in Americans despite the availability of concrete data in favor of the vaccination, the vaccine’s full approval can bring skeptics on board to a much greater extent.
In the United States, two coronavirus vaccine manufacturers that were approved for emergency use have applied to the Food and Drug Administration for full vaccination approval.
This will enable them to sell vaccines directly to consumers and possibly enhance consumers’ confidence in the vaccine for its safety and effectiveness.
Pfizer & BioNTech submitted their application for Food and Drug Administration (FDA) approval on May 7th, whereas Moderna submitted its application on June 1st.
Both the vaccinations are currently being administered under an emergency use authorization (EUA).
As Dr. Fauci evinced that the full approval of the vaccines is in the cards soon, it could curb the virus further in the states that are reluctant to implement effective vaccination drives.
With more than 353 million COVID vaccine doses administered in the United States, providing full vaccine coverage for over 167 million people or 50.8% of the population, little to no side effects have been measured, which is encouraging the FDA for vaccine full approval.
In a survey released by the Kaiser Family Foundation in June, 31% of unvaccinated individuals said they were more likely to get vaccinated if one of the present authorized for emergency use vaccines obtained full FDA approval.
Seeing the current data, if this 31% of people get vaccinated, the vaccination rates can rise much nearer to 100%.
Currently, the U.S. FDA is under pressure to permit a full vaccine authorization for COVID-19 injections due to the rapid spread of the Delta variant.
According to medical health experts, waiting for the approval of the vaccine can be risky and may prolong efforts to stop the spread of the virus.
Delaying the Vaccine’s Full Approval is Consequential to Global Health
Despite the fact that mRNA coronavirus vaccines are proven to be effective, experts say there is no reason why Pfizer-BioNTech and Moderna have not yet received full approval from the FDA.
The FDA approved the distribution of RNA coronavirus vaccines from Pfizer and Moderna, allowing faster treatment during a public health emergency.
The clinical trial of the vaccines included almost 70,000 individuals. This study found that vaccines are over 90% effective at preventing symptomatic illness.
Furthermore, research gathered from many countries revealed that mRNA vaccines had been found to be quite safe and efficient.
The FDA had approved the emergency use of vaccines seven months prior, examined some filings, and provided feedback to the manufacturers. However, it has yet to be fully approved.
Now, the data is sufficient to tell a convincing story, and there is no point in stopping the full approval.
As vaccines are proven efficient against all variants with very low hospitalization rates, now the full approval has no danger associated with it.
Emergency Use vs. Full Approval: The Data is Sufficient to Support Rapid Vaccination Drives
In order to fully approve or license a vaccine, the FDA must evaluate a lot of data, as well as its safety and several aspects of its manufacture. In other words, EUAs differ from full licenses just by the degree of usage.
A COVID-19 emergency use authorization permits the administration of the vaccine during the period of public health emergency associated with the coronavirus. EUAs are issued when companies submit to the FDA a minimum of two months of follow-up safety data, as well as information on their product’s effectiveness and manufacturing process.
A full FDA approval requires an in-depth assessment of effectiveness and manufacturing data by a team of experts. Additionally, clinical trial follow-up data for infectious diseases should be submitted by the companies for at least six months after the trial ends. The safety of a vaccine continues to be monitored even after it has been fully approved.
Vaccine’s Full Approval Can Bust COVID Skeptics
With final approval, Pfizer-BioNTech, and Moderna will be able to market and distribute the vaccines to the general public even after the state of emergency is lifted.
BioNTech and Pfizer are seeking authorization for their vaccines for use in people sixteen and above, while Moderna requests approval for people eighteen and older.
Full approval of vaccines could also affect vaccine mandates, as many employers have already mandated or asked their workers to receive COVID-19 vaccines, except those who can request medical or religious exemptions.
But complete FDA clearance might lead to increased mandates from employers, schools, and other organizations. For example, once the COVID-19 vaccine has been fully approved by the FDA, the U.S. military will consider a vaccine mandate.
As vaccination mandates are legal with no constitutional conflict, these mandates can go to a new limit after the vaccine’s full approval.
Approval by the FDA can have far-reaching consequences for businesses other than those who submit applications and help overcome vaccine apprehension.
To reach a conclusion for infectious disease, the agency must analyze all supporting paperwork related to an application for at least six months, if not longer.
After submission, FDA scientists will examine the clinical study data in detail, looking for any anomalies or safety issues.
The FDA has to conduct inspections of production sites and interact with corporate officials on a regular basis.
There are also political obstacles to overcome for the FDA to approve vaccines, and not just science and data.
Last year, the FDA was chastised by former President Donald Trump for requiring vaccine producers to submit emergency use safety data for at least two months.
He also accused the agency of plotting against him in the 2020 presidential race on several occasions. This political meddling generated mistrust in some circles, as individuals questioned the agency’s tactics, which are generally science-focused.