August 11, 2021 marks eight months since the Food and Drug Administration first issued an emergency use authorization (EUA) for the Pfizer vaccine. EUAs were also issued shortly after the Pfizer vaccine for Moderna and Johnson & Johnson’s versions. Since the vaccines were first distributed in December 2020, more than 160 million Americans have been inoculated.
However, no vaccines have been approved for permanent distribution. Tweets by acting FDA commissioner, Dr. Janet Woodcock, indicated that the FDA goal date for approving the Pfizer vaccine is January 2022. In the same series of tweets, Dr. Woodcock said the FDA intended to complete the review for the Pfizer vaccine “far in advance” of the goal date.
The January 2022 goal date for approving the Pfizer vaccine is still sooner than most drugs awaiting FDA approval. That’s because Pfizer applied for a priority approval, which means the FDA approves the drug in six months or less following application submission. Pfizer submitted their application for approval on July 16, 2021.
What’s the Difference Between an EUA and Priority FDA Approval?
Most vaccines take years or even decades to develop and receive approval from the FDA. But in the event of a nationwide medical emergency like the Covid-19 pandemic, the FDA can and will approve emergency use authorization for drugs that have shown scientific evidence that it could be an effective treatment.
Approval for distribution of EUA drugs lasts until the emergency is over or in the event that the drug is later proven to be ineffective or carries risks that outweigh the benefits. For example, EUAs were issued in March 2020 for chloroquine phosphate and hydroxychloroquine sulfate to treat Covid-19 symptoms. The FDA revoked the EUAs for these drugs after they were proven ineffective and carried dangerous side effects.
Priority FDA approval of drugs begins with the submission of a Biologic License Application, a lengthy, pages-long report including documentation of preclinical and clinical data, manufacturing processes and facilities, safety reports, and other data. Since this information can take years to collect, drug companies are allowed to apply for a rolling review when they want priority approval. Both Pfizer and Moderna are using the rolling review program to hasten approval of their vaccines, which requires them to meet regularly with FDA regulators to update them on clinical trials and developments in the study of their vaccines.
Despite the growing need for effective vaccines against the coronavirus, the FDA still has the duty of ensuring the drugs they approve for permanent distribution are safe for use. That’s why the vaccines must undergo the same process as any other drug seeking approval even under a priority application. The FDA’s number one goal is to protect Americans while providing effective medicine.
So far, EUAs for covid-19 vaccines remain in place because they have been proven to be effective and the benefits still outweigh the risks. A new wave of increased covid-19 diagnoses has hit Mississippi. The current covid-19 vaccines have proven to protect the vaccinated against serious illness and hospitalizations due to covid-19. However, vaccinated people can still carry and pass along covid-19 to others. This is why it is important to wear a mask in public, socially distance, wash or sanitize your hands frequently, and isolate yourself immediately if you are exposed or test positive for covid-19. We encourage you to get vaccinated to help reduce your risk of serious illness or hospitalization from this contagious disease.
EliteCare offers covid-19 vaccinations seven days a week. No appointment is needed but you can dial 662-348-3342 or click here to request a visit.