“Tens of millions of Americans will get vaccinated once this is approved,” said Eric Topol, director and founder of the Scripps Research Translational Institute.
Topol argues that full approval will reduce vaccine hesitancy and make it easier for employers, universities and the military to mandate vaccines. The lack of authorization, he said, “is the singular thing holding us back as a country right now.”
Ashish Jha, dean of the Brown University School of Public Health:
But the FDA has given little sign of when to expect full authorization.
The three coronavirus vaccines in use in the United States were approved under the FDA’s emergency use authorization last winter.
The companies behind two of those products have since requested full authorization: Pfizer and BioNTech submitted data for full approval of their vaccine on May 7, while Moderna followed suit on June 1. Johnson & Johnson, which received emergency use authorization later than the other vaccine makers and has since faced troubles with its manufacturing operations, is further behind.
So far, the FDA has not given a timeline for when it plans to pursue full authorization. At a recent news briefing, Anthony S. Fauci, President Biden’s chief medical adviser, refused to speculate.
“We don’t want to get ahead of the FDA. They have their process where they need to cross all the t’s and dot all the i’s,” Fauci said.
Those pushing the FDA to move faster say full approval could be game-changing.
A Kaiser Family Foundation poll in May found that nearly a third of unvaccinated Americans said they would be more likely to get the shot once it was fully approved. That response dwarfs the portion of unvaccinated people who said they would be swayed by time off work or free incentives.
Other people may get the vaccine because they are required to do so. The U.S. Army has indicated that it will make coronavirus vaccines mandatory starting in September, if they have full FDA approval. And full approval would also make it easier for employers and schools to mandate vaccines.
Dorit Rubinstein Reiss, a professor at the University of California Hastings College of the Law, argues that employers should be able to legally mandate vaccines that are under emergency use authorization, but she admits they’ll have an easier time of it with full approval.
“The anti-vaccine movement has been working to scare people from covid-19 vaccinations long before the emergency use authorization. … They’re not going to stop,” Reiss said. “However, it will make litigation against mandates significantly harder because the [emergency use authorization] is one of the few things that hasn’t been litigated before and that has some legal uncertainty behind it.”
Calling the vaccines “experimental” has become a scare-tactic.
Anti-vaccine groups have seized on the emergency use authorization to portray the coronavirus vaccines as experimental, but experts say that’s inaccurate.
While it’s true that the emergency use designation can be used to authorize drugs or other products with a lower standard of evidence — some experts point to the brief approval of hydroxychloroquine under the Trump administration — that’s not the case with the coronavirus vaccines.
The clinical trials for the coronavirus vaccines are larger than other historic vaccine trials used to support full FDA approval, according to Joseph Ross, a physician and expert in FDA approvals at the Yale School of Medicine.
While some centers of the FDA allowed for lower standards for emergency use in the early days of the pandemic, Ross said, the center in charge of vaccine approvals, known as the Center for Biologics Evaluation and Research (CBER), set a high standard.
“I think to our good fortune, the center on vaccines, CBER, said we can’t misstep with the vaccines and set high authorization standards, almost what you need for a full approval,” Ross said.
Since then, more than 300 million doses of mRNA vaccines have been distributed with great success.
“There’s never been a vaccine in history that’s had this scrutiny,” Topol said.
But the process of approving a vaccine is not usually quick.
A study of novel vaccine approvals over the past decade by Ross and his colleagues at the Yale School of Medicine found the median FDA review period was 12 months.
In addition to reviewing clinical data, regulators also inspect and gather data about the facilities producing the vaccines.
“Seven weeks is not a lot of time,” said Reiss, the University of California professor. “I expect they will try to move faster than the typical 12-month average, but I think we are still looking at months and not weeks.”
Reiss said that in the long-run, it behooved the FDA to be “careful, thorough and conservative.”
Critics say the FDA should move faster.
Topol argues that the May 7 filing from Pfizer was the culmination of six months of conversations, which should have given the agency time to get ahead on the momentous task of reviewing data for approval.
“This is a global crisis. We’re starting to head into another phase that’s not good,” Topol said. “I think it’s irresponsible that they haven’t even made a public statement, giving us a timeline.”
Ahh, oof and ouch
AHH: President Biden is heralding the U.S. emergence from the pandemic.
“This holiday weekend, Biden set out to present himself as an avatar of a nation that is once again open for business and leisure — and to take credit for a moment where lockdowns and masks have largely been replaced by ballgames and family barbecues,” The Washington Post’s Sean Sullivan and Matt Viser report.
“We are emerging from the darkness of . . . a year of pandemic and isolation, a year of pain, fear and heartbreaking loss,” Biden said.
But the nation fell short of the president’s goal of ensuring that 70 percent of American adults had received at least one vaccination shot by Sunday. Biden referenced these challenges in his speech, while still striking a note of optimism. “Today, while the virus hasn’t been vanquished, we know this: It no longer controls our lives,” he said.
“At the same time, strategists from both parties said they believe the pandemic — the issue that propelled Biden into the White House and has won him high marks from Americans during his first six months as president — is starting to fade as the dominant political topic. As conditions improve, the door is opening for polarizing debates over crime, immigration and border security to seize more attention as next year’s midterm elections draw near. Those issues do not play in Biden’s favor, polls show,” our colleagues write.
OOF: The Supreme Court will take up a case on the 340B program and Medicare drug payments.
The case stems from a dispute between hospitals and the federal government over reimbursements for drugs at hospitals covered by the 340B program.
The 340B program requires pharmaceutical manufacturers to sell drugs at a discounted price to certain hospitals and clinics that serve vulnerable populations. The program has come under criticism from drug companies who say the savings from the discounted drugs are not passed down to patients.
In 2017, the Trump administration announced plan to cut the amount of Medicare reimbursement going to 340B hospitals based on the argument that the government should not reimburse hospitals for more than the cost they were spending to acquire the drugs. The American Hospital Association sued to stop the cuts, and lower courts split on the case.
“The [Supreme Court] decision could create a headache for the Biden administration, as its rule determining pay rates for discounted drugs is under White House review,” Stat’s Rachel Cohrs reports. “Department of Health and Human Services Secretary Xavier Becerra has already had to backtrack in attempts to mediate a separate conflict between drugmakers and hospitals over the same drug discount program.”
OUCH: Almost all recent coronavirus deaths are among the unvaccinated.
Anthony S. Fauci on Sunday said that 99 percent of the people who died of covid-19 in June were unvaccinated.
The director of the National Institute of Allergy and Infectious Diseases called the loss of life “avoidable and preventable” during an appearance on NBC’s “Meet the Press.”
“If you look at the number of deaths, about 99.2 percent of them are unvaccinated. About 0.8 percent are vaccinated. No vaccine is perfect. But when you talk about the avoidability of hospitalization and death, Chuck, it’s really sad and tragic that most all of these are avoidable and preventable,” Fauci said.
Around 55 percent of eligible Americans have received at least one dose of a coronavirus vaccine, according to The Washington Post’s vaccine tracker. And while death rates have fallen dramatically, around 10,000 Americans died of the virus in June.
More in coronavirus news
- Covid wards in the D.C. area are almost empty, as vaccinations drive down cases, especially among the most vulnerable, The Post’s Rachel Chason reports.
- Nearly 15 million Americans have missed their second dose of a coronavirus vaccine, The Post’s Caroline Anders reports. As of June 16, nearly 11 percent of people had not gotten their second shot within 42 days of the initial jab. The recommended interval is three weeks after the first Pfizer-BioNTech shot and four weeks after the first Moderna shot.
The ongoing Alzheimer's drug controversy
The FDA’s Alzheimer’s drug approval is reigniting debates about the disease.
In opting to approve a controversial new Alzheimer’s treatment, the FDA relied on the evidence that the drug, called Aduhelm, was effective at removing amyloid clumps in the brain. A long-standing hypothesis holds that these toxic clumps are the main driver of Alzheimer’s.
The FDA determined that the drug’s success in reducing these clumps meant there was a “reasonable likelihood” the drug would help patients. But with little convincing evidence of direct clinical benefit, lawmakers and doctors have worried about the drug’s $56,000 a year price-tag and its potential to wreck Medicare’s finances.
“But within the scientific community, it is the argument over the amyloid hypothesis that has set off some of the biggest fireworks and could have a sweeping impact on the future of Alzheimer’s treatment. The tumult in the field and within the FDA — where internal memos show staffers had sharply differing views of the drug — reflects fundamental disagreements over the role of amyloid beta. To some, logic and science dictate that getting rid of it is an important goal. To others, that notion is a costly distraction,” The Post’s Laurie McGinley reports.
The approval also comes as some scientists are pushing back against the amyloid hypothesis — arguing that its prominence has crowded out investigation into other factors that might drive the cognitive decline in Alzheimer’s and might be easier to target for treatment.
“Even if amyloid does cause Alzheimer’s disease, it does not necessarily mean you can cure the disease by removing it,” neurologist Matthew S. Schrag told The Post. “If someone came to the emergency room with a stab wound, just removing the knife wouldn’t cure them either.”