The U.S. Food and Drug Administration (FDA) accomplished a large milestone amidst the ongoing pandemic.
On August 23rd, 2021, the FDA approved the Pfizer-BioNTech COVID-19 vaccine, the first vaccine to be approved for COVID-19.
The vaccine is now marketed under its proprietary name, Comirnaty, for the prevention of coronavirus in people 16 years of age and older.
The vaccine is also still available under emergency use authorization (EUA) for those 12 through 15 years of age, and for immunocompromised individuals receiving a third dose.
This approval is for the product’s biologics license application (BLA), which builds on the extensive data submitted for the EUA.
This information includes overwhelmingly positive preclinical and clinical data and inspections of quality and manufacturing processes.
Up until today, all available COVID-19 vaccines have been authorized under an EUA.
While these three vaccines have all met the FDA’s high standards for safety and effectiveness under an EUA, some of the public has been hesitant to get vaccinated before official FDA approval.
Health experts hope that the FDA’s full vaccine approval will instill confidence in the millions of people in the U.S. who have had apprehensions about getting vaccinated.
According to a Kaiser Family Foundation survey, about 3 in 10 unvaccinated adults stated they would be more likely to get vaccinated if one of the products received full approval.
With a change in the dynamic amongst the hesitant, the hope is that there will be an additional wave of individuals choosing to get vaccinated.
Vaccination has become as important as ever with the spread of the COVID-19 delta variant into areas with low vaccination rates.
The U.S. has entered a deadlier phase of the pandemic as the COVID-19 delta variant continues to surge and remains the most prominent variant.
Data suggests that the delta variant is more infectious, leads to increased transmissibility, and causes more severe disease compared to other coronavirus strains.
Even fully vaccinated individuals can become infected with Delta variant through breakthrough infections and spread the virus.
However, unvaccinated persons remain the greatest concern and are most susceptible to infection by the variant.
With the danger of the new variant and resurgence in COVID-19 cases, the U.S. may have to return to some of the restrictions set in place during the original height of the pandemic.
Cases and hospitalizations are on the rise once again, and vaccination is one of the only things stopping the U.S. from taking a turn for the worst.
It is incredibly important that all individuals who are able to receive the vaccine get vaccinated. Even with the delta strain, vaccines significantly decrease a person’s chances of infection.
The two authorized and one approved vaccine are incredibly effective in preventing the development of severe disease, hospitalization, and death even with the delta variant.
Even those who are vaccinated who develop breakthrough infections will typically be infectious for a shorter period of time.
Written by: Emmanuel J. Osemota