Update: On Monday, August 23, the FDA approved the Pfizer/BioNTech COVID-19 vaccine, making it the first officially licensed vaccine against the coronavirus. In a briefing call on Monday, acting FDA Commissioner Dr. Janet Woodcock said that Americans should now feel fully confident in vaccination efforts going forward. "While this and other vaccines have met the FDA's rigorous scientific standards for emergency use authorization, as the first FDA approved COVID-19 vaccine, the public can be confident that this vaccine meets the FDA's gold standard for safety, effectiveness and manufacturing quality that we require for an approved product," Woodcock said.
While this is the fastest vaccine approval in the agency's history, coming nearly four months after Pfizer filed for licensing, experts have ensured that the speedy approval is merely a reflection of scientists working day and night on data analysis and risk-benefit assessment. This approval will now last indefinitely, unlike the emergency approval, and the agency hopes it will convince more Americans to pursue inoculation.
This story was originally published on August 6, 2021.
Due to the numerous COVID-19 variants that are believed to be more resistant to vaccines, and an alarming rise in COVID cases and hospitalizations, the Federal Drug Administration (FDA) is accelerating their vaccine approval process for the two-shot Pfizer vaccine. While President Joe Biden said the process was initially set to be completed by the fall, people familiar with the administration’s plan say the unofficial approval deadline is Labor Day — if not sooner.
Currently, the two-shot Pfizer and Moderna vaccines, as well as the one-shot Johnson & Johnson vaccine, have an FDA-granted emergency use authorization. This allows drug manufacturers who have met a series of scientific and regulatory criteria to provide lifesaving medicines, like vaccines, that have not been fully approved to be used in the event of a public health emergency. Once emergency use authorization is granted, the FDA puts in place a series of “existing vaccine safety monitoring systems” during the post-authorization and approval period, as per the administration’s website. Multiple studies have shown that all three of the COVID-19 vaccinations distributed in the United States are both safe and effective, even among the COVID variants.
And now that cases are rising in all 50 states and the country is experiencing thousands of new cases a day, due in no small part to the Delta variant — as well as other mutations of the virus, like Delta Plus and the Lambda variant — there’s an even greater need to get as many Americans who are eligible for the vaccine inoculated.
Currently, Mississippi and Louisiana have some of the worst vaccination rates per state in the entire country, and as a result have seen the number of positive COVID cases jump more than 132% and are experiencing a weekly average of 910 new cases per day. The number of Americans hospitalized with COVID-19 has increased by 60% — a frightening statistic, given that a recent study found that when every bed is full in an ICU unit, patients’ risk of dying from COVID increase by 92%.
Still, some have been hesitant to get vaccinated as the vaccines have not been fully approved. A recent Kaiser Family Foundation poll found that three out of every 10 people who have yet to receive their first dose of a vaccine said they would be more likely to get a shot if the vaccines were fully approved, which is why the FDA is hoping to speed up the process. In a written statement, FDA leaders “recognized that approval might inspire more public confidence and had taken an all-hands-on-deck approach” to the work, as reported by The New York Times.
“As we know, a lot of people are potentially on the fence waiting for that to happen,” Dr. Mark Steele, executive chief clinical officer at Truman Medical Centers/University Health in Kansas City, told local news network and NBC affiliate KSHB-TV. “If that were to occur I think that would be hopefully a big boost to getting more people vaccinated.”
Once the Pfizer vaccine is fully approved, the FDA will likely fully approve the additional available vaccines as well, making it that much easier for businesses, federal government agencies, and other institutions to mandate employees and patrons be fully vaccinated — edging us ever closer to herd immunity and the chance of protecting more people, including those too young to receive a vaccine yet or those who are immunocompromised, from this deadly virus. But for now, unvaccinated people are still urged to reconsider waiting for a piece of paper to protect themselves from spreading COVID to family, friends, and neighbors.