More than 183 million doses of the Pfizer vaccine and 135 million doses of Moderna have been administered in the United States, according to the CDC, and their rollout has been correlated with a sharp drop in Covid-19 cases since January. The vast majority of Covid-related hospitalizations and deaths now occur among unvaccinated populations.
“It’s as good as it gets when it comes to data on safety and efficacy,” said Céline Gounder, an infectious disease specialist and epidemiologist at New York’s Bellevue Hospital. “We have it in real life ̵
It is still unclear how much full licensing of the vaccines will encourage unvaccinated Americans to get their shots. Voting released on June 30 by the Kaiser Family Foundation showed that nearly a third of unvaccinated adults – and about half of those who said they take a “wait and see” approach to the vaccine – said they were more likely would get it if the FDA fully approved one of the shots.
FDA spokeswoman Abby Capobianco said the agency is working quickly to assess companies’ applications, even though she refused to offer a timeline for approval.
“Although an approval is not an FDA approval, the FDA conducted a thorough scientific evaluation of each of the approved vaccines and can assure the public and the medical community that the vaccines meet the FDA’s strict standards of safety, efficacy and production quality,” she said .
Pfizer and Moderna each submitted their applications on an ongoing basis, which means they would submit sections to the FDA as they are finished as opposed to waiting for the entire document to be completed. Both companies request priority review, which means that the Agency’s objective would be to take a decision within six months of receiving the full application.
“It’s time for the agency to at least make clear what its timeline for approval is,” a former senior FDA official told POLITICO. “On the other hand, it takes two to tango. It is also up to the company to send all required and requested data to the agency. “
Pfizer has submitted its biological license application “in full” to the FDA, company spokesman Steve Danehy told POLITICO, though he would not comment on when the final documentation was submitted. Meanwhile, Moderna continues with the FDA’s rolling submission process, said spokeswoman Colleen Hussey.
Some warn that the FDA must be very careful not to make a decision that may be perceived as hasty or politically influenced. More transparency around the licensing process, they say, could help persuade Americans who have cited the vaccines’ current status as authorized for emergency use as a reason to delay immunization.
The FDA, which provides more details about its vaccine approval process and its timeline, could help counter speculation, the process was politicized, as seen when Pfizer’s shots were first approved for emergency use in December, Gounder said. Right-wing pundits questioned whether the conditional approval was intentionally delayed until after the presidential election, when regulators were really waiting for two months of follow-up data from participants in clinical trials.
“You can’t go through any of that science,” she said.
Topol claims that formal approval from the FDA will help – if not based solely on the science and benefits of the shots, he said, because more employers and schools are likely to start demanding that workers and students be either vaccinated or take certain measures in the workplace, like mask wearing or frequent testing if they refuse the shots.
“The people in the category who take the accommodation do not stick with the masks and nostrils every few days for very long,” he said.
Workplace mandates could also offer ways for the unvaccinated to change their status – 42 percent of workers who had not been given the shot said they would if their employers required it, according to the KFF, even though 92 percent of them are against such a mandate.
Full approval may alleviate some individuals’ concerns, but the reasons for rejecting the vaccine so far are numerous and vary based on cultural norms, perceptions of Covid risk and their level of mistrust in institutions, said Rachael Piltch-Loeb, associate researcher at NYU. School of Global Public Health with a focus on vaccine hesitation.
“The reality is that we need to have really local, individual conversations with people to hit the specific reason why they are not happy about getting the vaccine at this point,” she said.
Continued misinformation and hesitation about the vaccines as vaccination rates level off and the Delta variant becomes more dominant gives the FDA even greater urgency, giving formal blessing to the shots, Topol said.
“They just think you can trust the truth – it used to be relatively true, but we’ve learned in recent years that it’s completely out of the window,” he said. “You can no longer.”