WASHINGTON (NEWS10) — Full approval of a COVID-19 vaccine is inevitable. Approval rests squarely on the shoulders of the U.S. Food and Drug Administration (FDA), and it's only a matter of time.
The FDA granted priority review status to Pfizer's COVID vaccine application—for use in people 16 and older—on July 16, giving them six months to review Pfizer's clinical trial information. Although they said they don't intend to prolong the process, approval could be held up until January of 2022.
"The Prescription Drug User Fee Act (PDUFA) Goal Date of January 2022 reflects the PDUFA deadline for Priority Review and does not mean approval will not happen before that time. Quite to the contrary, the review of this BLA (Biologics License Application) has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the PDUFA Goal Date," according to the FDA.
Passed in 1992, the PDUFA was an attempt to speed up the approval of new drugs, according to Pharmaceutical Research and Manufacturers of America. Since it passed, the time it takes for the FDA to approve new drugs went from two years to 10 months.
Pres. Joe Biden reaffirmed the FDA's statement, telling CNN on Wednesday that he expects the agency to fully approve the vaccine sometime before the end of this year. "They're not promising me any specific date, but my expectation, talking to the group of scientists we put together—plus others in the field," he said, "is that sometime—maybe in the beginning of the school year, at the end of August, beginning September, October—they'll get a final approval."
The way the FDA's vaccine program is designed should help it in its efforts to expedite the full approval of COVID vaccines. This is because manufacturers with COVID vaccines approved for emergency use—Johnson & Johnson, Moderna, and Pfizer—had to follow the same FDA guidelines used for all vaccines.
Full approval for Moderna's COVID vaccine is likely to follow a few months after Pfizer's. Pfizer announced that it had applied for full approval of its vaccine for people ages 16+ on May 7. It did not receive priority status from the FDA until two months later.
Moderna applied for full approval of its vaccine in people age 18 and up on June 1. As of Thursday, the FDA has not yet granted Moderna priority review. Based on the Pfizer timeline, that's not likely to happen until sometime in August. That marks the PDUFA goal date around February or March 2022 for Moderna's version.
Moderna and Pfizer have been submitting clinical trial information on a rolling basis to the FDA, allowing the FDA to review information for specific age groups over time, both manufacturers said. Full approval will follow the same trend as emergency use approval, given by age group (adults, adolescents, children, and infants).
Overall, a little under half of Americans are fully vaccinated (48.8%). The percentage among Americans ages 18 or older is better (59.6%), according to the Centers for Disease Control and Prevention. Either way, the percentage falls short of the estimated 70% to 90% needed to reach herd immunity.
Could full approval from the FDA bolster support from vaccine-hesitant people? Possibly, according to a survey from the Kaiser Family Foundation (KFF). A combined 30% of people polled who have not gotten vaccinated said it was for reasons that could be assuaged by full FDA approval including:
Other reasons or concerns for why people remain unvaccinated from the KFF survey are less likely to be alleviated by approval:
The U.S. Census Bureau estimates that an average of 10.8% of Americans are probably or definitely not going to get the vaccine. New York is below that average at 8.1%. In three states, the estimate is more than two times the average. That according to the Census Bureau's Household Pulse Survey COVID-19 Vaccination Tracker, published July 14, putting North Dakota at 22.2%, West Virginia at 22.4%, and Wyoming at 25.6%.
Findings of the Census Bureau's survey are in line with KFF's survey. The most popular reason for not getting vaccinated is because of side effects (50.6%), followed by not trusting the vaccine (47.6%), thinking it's not needed (34.9%), and not trusting the government (34.4%).
