In many U.S. regions, the Delta variant of SARS-CoV-2 has caused the COVID-19 pandemic to escalate again. Last week’s 7-day average of daily new cases increased almost 70%, to more than 26,000; Hospital admissions have increased by more than a third, according to the Centers for Disease Control and Prevention.
Part of the reason is that less than half of the U.S. population is fully vaccinated. Some researchers and doctors are concerned that the vaccine hesitation is driven by the fact that shots available in the United States – made by Pfizer-BioNTech, Moderna and Johnson & Johnson (J&J) – have been approved in an emergency, but are not yet fully proven. . Anti-vaccine activists, talk show hosts and right-wing extremist politicians have made the vaccines’ “experimental” nature a talk.
Full evidence from the Food and Drug Administration (FDA) can help win over skeptics, says Monica Gandhi, an infectious disease doctor at the University of California, San Diego. “It means something to people for it to be proven,” she says. “It just seems like the simplest and easiest thing we could do right now.”
Pfizer and Moderna have both requested full FDA proof for their jabs, but that could be months away. Here’s where things stand.
Why have the vaccines in the US not been proven yet?
All three vaccines have received an emergency use approval (EUA), which the FDA offers during crises as a quick way to give people access to potentially life-saving drugs. In the past, EUAs have typically been used for medication under “very catastrophic, immediate circumstances, like an anthrax attack,” says Jesse Goodman, a former FDA chief researcher who is now at Georgetown University. The COVID-19 pandemic marks the first time EUAs have been allocated new vaccines.
To receive an EUA, vaccine manufacturers had to follow one specifically set guidelines asked for safety and efficacy data from clinical trials involving tens of thousands of participants, as well as information on the quality and consistency of the vaccines. Pfizer and Moderna both received an EUA in December 2020; J & Js came in February. Based on the actual data they have been collecting since then, Pfizer requested the FDA full trial in early May and Moderna on June 1st. J&J is expected to follow soon.
What is the difference between a full trial and an EUA?
It’s a scale. The FDA will review much more data covering a longer period of time before providing full evidence. “It’s not a huge difference, but it’s a real difference,” Goodman said. The Agency will analyze additional clinical trial data and consider actual efficacy and safety data. It will inspect production facilities and ensure that quality control is very strict. “It’s an exhaustive review,” says Goodman.
The FDA is already aware of much of the data, however, for example about the very rare side effects caused by J&J and Pfizer vaccines that did not show up in clinical trials.
When can the vaccines be proven?
On July 16, the FDA accepted Pfizer’s duty “under priority review” – meaning it will move faster than during standard examinations, which typically take at least 10 months; the agency now has until January 2022 to review the materials. It seems like a long time, but last week was an FDA official told CNN that the decision is likely to come within two months. The review … has been ongoing, is among the Agency’s highest priorities, and the Agency intends to complete the review well in advance of [January] Date, ”an FDA press officer confirmed to Science in a statement.
The FDA has not formally accepted Moderna’s submission, possibly because the company has not yet submitted all of the required materials.
Why have there been calls for faster testing?
Full proval could help overcome the vaccine hesitation, wrote Eric Topol, director of the Scripps Research Translational Institute, in a recent op-ed. “Some people who understand that ‘E’ in ‘EUA’ stands for ’emergency’ are waiting for full FDA proof before getting a shot,” he wrote.
“I think it’s fair to say that any number of us who are clinically infectious doctors and in public health are honestly a little surprised at how long the process takes,” says William Schaffner, professor of infectious diseases at Vanderbilt University Medical Center.
“I want [FDA] to be careful. I also want them to move it forward, ”says Schaffner. “Honestly, I want them to work on the weekends. The people who vaccinate work on the weekends. The virus works on weekends. ”
Will proval really convince more people to get vaccinated?
About 30% of the unvaccinated say they were waiting for the vaccines to be fully tested, according to a 1888 adult study conducted in June by the Kaiser Family Foundation. But the report warns that for many people, FDA testing is likely to be “a proxy for general safety issues.” Not everyone who is now focused on proval may be able to get a vaccine, especially if they perceive the trial process as hasty or politically motivated.
“For those people who are really dying to get the vaccine at this point, I do not know that the FDA providing the full evidence will make a huge difference,” said Krutika Kuppalli, an infectious disease doctor at the Medical University of South Carolina. , who says many of her patients are wary of COVID-19 shots.
But full trial can swing some people. For members of groups that have been treated badly by the health care system, signing a consent form to be vaccinated – a requirement for vaccines with an EUA – can be a psychological barrier, says Gandhi: “Signing a consent that says ‘experimental’ and the phrase ‘experimental’ brings up experimental questions in black and brown societies. “
Will proval pave the way for mandatory vaccinations?
More than 500 U.S. universities and some high-profile hospitals have already issued vaccination mandates, meaning staff and students must be vaccinated.
But many schools and hospitals are reluctant to ask their staff to take what is technically still an experimental product and which is in full swing; so is the US military. Some states, including those with some of the lowest vaccination rates in the country, such as Alabama, Arkansas and Tennessee, have gone so far as to ban mandates in schools and colleges until vaccines are fully proven. (Conversely, a judge this week upheld Indiana University’s vaccine mandate after being challenged by a group of eight students.) Once a vaccine is proven, “I think it will be on a firmer footing for organizations and businesses. to mandate it, “Goodman said.
In France – where the hesitation of vaccination also runs high – more than 1 million people signed up for a vaccine after President Emmanuel Macron announced on July 12 that vaccination would become mandatory for health professionals and that “health cards” would be required to enter malls, bars, restaurants and other public places. But these measures also proved controversial: tens of thousands took to French streets Saturday in protest.
Could the FDA speed up its testing process?
Perhs, but the agency does not want to rush. “Any vaccine testing without completing the high-quality review and evaluation that the United States expects the agency to perform will undermine the FDA’s statutory responsibilities, affect public confidence in the agency, and do little to combat vaccine hesitation,” said FDA Peter Marks. wrote in That in response to Topol’s prayer for speed.
“Everyone claims that this takes a long time [are] almost like saying you do not want the FDA to do the normal, complete job it does, ”says Goodman. Regulatory rigor is especially important for messenger RNA vaccines that use a whole new technology, he adds.
II Is it safe to get a vaccine that has only one emergency proval, not full proval?
Any expert Science spoke with had the same message: The data collected so far show that the vaccines that get an EUA in the US are very safe and very effective. “It was really incredible to see how well these vaccines worked in the clinical trials,” says Gandhi.
“Vaccines are such a gift,” said Cody Meissner, a pediatrician at Tufts Pediatric Hospital who specializes in infectious diseases and a member of the FDA’s Vaccine Advisory Committee. “Every adult should get this vaccine.”