Amid another coronavirus surge, and facing pressure over everything from testing access to school closures, top Biden administration health officials are headed to Congress Tuesday for a hearing on the Covid-19 pandemic.
The hearing, held by the Senate Health Committee, is framed around SARS-CoV-2 variants, but it will also be a chance for senators to pull information from the witnesses about the state of the pandemic and grill them over problems — legitimate or political ones — in the U.S. response.
The witnesses are Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases; Rochelle Walensky, the director of the Centers for Disease Control and Prevention; acting Food and Drug Administration Commissioner Janet Woodcock; and Dawn O’Connell, the assistant health secretary for preparedness and response.
The hearing may at times descend into political fights — Republican Sen. Rand Paul of Kentucky and Fauci have a history at these hearings of sparring over the severity of the coronavirus — but STAT is hoping the senators use the occasion to ask sharp questions that yield insightful answers about the pandemic’s future and how the world is responding. To help them with that task, we’ve outlined a baker’s dozen of questions and issues below that we would like to hear the witnesses address.
Will the U.S. Omicron wave look like South Africa’s?
For as much chaos as the Omicron variant is causing, one positive is that, in other countries whose waves preceded the U.S. surge, their spikes came crashing down as quickly as they skyrocketed. That’s inspired the hope that the country just needs to get through a few awful more weeks, and then there will be a reprieve.
U.S. modeling suggests as much, but even with Omicron causing less severe disease on average at the individual level, there could still be reasons why our Omicron wave might be more damaging than what other countries have experienced. While we have a more vaccinated population than South Africa’s, we also have a much older population. It’s also winter here, which seems to give the coronavirus an additional transmission boost, and we were contending with a Delta surge when Omicron took off, unlike South Africa. And compared to some European countries, we have lower vaccination rates and booster uptake, including among the oldest age groups – leaving the country more susceptible to higher numbers of hospitalizations and deaths.
All that’s to say, lawmakers should ask the health officials if our Omicron wave is tracking others, or if we’re faring worse.
How can you improve your communication on Covid-19?
This is a question that should be directed to Walensky, who has had to walk back several of her statements on Covid recommendations throughout her tenure. Just in the past few weeks, she’s been under fire for the CDC’s isolation guidelines and for seeming to trivialize the deaths of people who have comorbidities and remain vulnerable to severe Covid-19 after vaccination. Even Democratic Sen. Patty Murray, who chairs the panel, plans to address the “confusing and frustrating” communication from the CDC at the hearing, according to excerpts from her prepared remarks. CNN reported last week that Walensky has been receiving media training for months, and Tuesday will be an opportunity to put that into use.
When will the 500 million free rapid tests the president promised last month become available?
For many Americans, tests are still nearly impossible to find, and sometimes too expensive.
In an effort to fix the testing crisis, Biden promised last month that his administration would soon make 500 million rapid tests available to any American who wanted them — all they’d have to do was type their address into a new government website. The White House says they’re coming soon, but it’s not clear how many tests will be available by the end of January, whether there will be a limit on how many individuals can request, and whether they’ll arrive in time to make a difference during the worst of the Omicron surge.
What is the FDA doing to address concerns that rapid tests aren’t working as well to detect Omicron?
The FDA announced in late December that certain rapid Covid-19 tests were less sensitive in detecting infections from the Omicron variant than previous variants of concern. In the weeks since, a preprint study has also suggested that certain tests are less likely to detect the variant before infected people can transmit the virus to others, and scientists have been scrambling to figure out why. Americans, meanwhile, are taking to swabbing their own throats in hopes it’ll improve the accuracy of rapid tests, despite the FDA’s warnings against the practice.
Amid all this confusion, lawmakers would be smart to ask the agency for an update on what regulators have learned in the weeks since releasing that December statement, and what it plans to do to make sure Americans can still rely on results from rapid tests.
Lawmakers need to get specific: They should ask the FDA whether each test on the market is still able to meet the agency’s standard of detecting at least 80% of positive Covid-19 cases, a measure known as sensitivity. If Janet Woodcock, the acting FDA commissioner, says she doesn’t have that data, lawmakers should get firm assurances on when that data will be available. And if Woodcock says any test does have a sensitivity rating below 80%, lawmakers need to press her on whether the agency plans to pull that test off the market.
Why don’t we know yet whether a positive rapid antigen test indicates infectiousness?
The CDC has been hammered for recent changes to its isolation and quarantine policy that shorten the length of time people need to be out of circulation. The biggest bone of contention has been the fact that the new policy doesn’t require people to test negative before ending their isolation, i.e. after recovering from Covid.
At a briefing on Friday, Henry Walke, co-lead of CDC’s expanding testing and diagnostic work group, explained that rapid tests aren’t authorized for use to determine infectiousness.
“The significance of a negative antigen test, for example, late in the course of an illness, after you’ve become positive … it’s unclear what that means. And so, a negative antigen test doesn’t necessarily mean that there’s an absence of virus,” Walke said.
Why don’t we know this yet? Has the FDA asked rapid test manufacturers to generate those data? If not, why not? If so, when does the agency expect the data to be available? As the administration moves to make rapid tests available to all American households, shouldn’t we be trying to get the best possible use out of these tools?
Should Americans expect to need a fourth vaccine dose? And if so, when?
In recent weeks, countries like Israel and Chile have begun offering fourth vaccine doses to people with suppressed immune systems or other underlying vulnerabilities. Now, the same is true in the U.S.: Some at-risk Americans will become eligible for a fourth vaccine dose this week, according to CDC guidance. But it’s still a complete mystery whether or when the general population might be offered a fourth dose. Executives at Pfizer and Moderna, the country’s two largest vaccine makers, have said for months it’s likely that older people, if not everyone, will require a booster shot on an annual basis as long as Covid-19 remains a threat.
A fourth shot for all presents a number of challenges: Namely, equity. Many countries in the Middle East, Africa, and Latin America have yet to give half of their population a second dose. A fourth shot for citizens of the world’s richest countries could keep developing countries waiting even longer. It’s also unclear whether such a booster shot would be tailored toward the Omicron variant, specifically, or any future variants that may emerge in the months to come.
What will be the process for deciding whether to update the vaccine strain? Who makes that call?
With each variant that emerges, questions have arisen about whether the existing vaccines — which all target the spike protein from the original version of SARS-CoV-2, the Wuhan strain — will still be adequately protective. Manufacturers work to develop and test vaccines containing the new strains, but to date it’s been concluded that giving a booster shot of the original vaccine would be enough to increase antibody levels to protect against the mutated strains.
Given the rate at which SARS-2 has evolved, though, at some point the vaccine will probably need to be updated. But who gets to decide when that happens? Will the FDA determine the vaccines are no longer generating enough cross-protection and ask manufacturers to change their target strain? Will a manufacturer see an economic advantage to developing an updated vaccine and seize it?
And how will whoever makes the call determine what the vaccine strain should be changed to? Omicron, with its wild constellation of mutations, came at us from out of the blue; most experts predicted a Delta 2.0 variant would be the direction the virus would take. If the Wuhan strain is replaced by something that turns out to be off target, we could end up with a situation that sometimes occurs with flu vaccines — a vaccine that is mismatched to circulating strains. In that case, a change could lead to less protection, not more.
The World Health Organization would very much like this process to occur in a coordinated manner, with scientists and regulatory agencies weighing in on whether, when, and how to update the available vaccines. Leaving it to individual manufacturers would not best serve public health interests, Mike Ryan, head of WHO’s health emergencies program, told STAT recently.
“It can’t purely be the decision of one manufacturer to say, “Well, this is what we’re going to make, and this is what you’re going to buy,” Ryan said.
When is the earliest possible time for Covid vaccine authorizations for children under the age of 5? Why is it taking so long?
One of the characteristics of the Omicron wave in this country has been an increase in the number of young children being hospitalized for Covid. Children under the age of 5, though, still cannot be vaccinated. And it seems like that isn’t likely to change for a while.
Pfizer and BioNTech’s study of a lower dose of vaccine in children 2 to 4 years of age didn’t succeed; antibody levels in the children after their second dose were not comparable to those the vaccine achieved in older age groups. The companies have concluded that in young children this is probably a three-dose vaccine and they have given the children in their study a third dose at least eight weeks after the second.
Results from this amended trial aren’t expected until the end of March or early April, and, presuming the results are positive, it would be some weeks before the application to extend the vaccine’s emergency authorization could make it through the FDA process. So we might be looking at May.
Meanwhile, hopes that Moderna’s vaccine could soon be available for young children have been hit with some cold water. The company was previously asked by the FDA to expand the size of its trial; the lead researcher for one of the trial sites has said the data will likely be ready to be submitted to the FDA at the end of March.
So young children are going to have to weather the Omicron wave without vaccine. Did the process of developing vaccines for the youngest children need to take this long?
When does the FDA expect to fully approve Moderna’s Covid-19 vaccine? Why is it taking so much longer than Pfizer’s?
Lawmakers need to ask Woodcock what’s going on with Moderna’s application for full approval of its Covid-19 vaccine. After all, Moderna submitted its application back in August, but the FDA still isn’t done reviewing it. That’s much longer than it took the FDA to review Pfizer’s application, which was approved by the FDA this summer roughly three months after submission.
There are no signs that there’s anything wrong with Moderna’s application or with its vaccine, which has now been administered to millions of Americans without raising major safety concerns. But lawmakers should ask the question we at STAT have been wondering: What is taking so long?
Do we need to reframe our strategy of fighting the coronavirus?
The Biden administration has framed its goal as defeating the virus. But the real “end” of the pandemic will come as SARS-CoV-2 becomes a seasonal pathogen, one that continues to evolve and causes some amount of disease and death but doesn’t disrupt society. Some scientists have been calling on the Biden administration to shape its response around that reality, including, in a series of JAMA editorials last week, a number of experts who advised the Biden transition. It seems that President Biden himself is increasingly alluding to that future, saying last week that “having Covid in the environment, here and in the world, is probably here to stay, but Covid as we’re dealing with it now is not here to stay.” We’ll be paying attention to how the witnesses talk about the endgame of the pandemic and how the response is geared toward that.
Will the federal government issue clearer guidance about which masks are most effective at preventing Covid? Why are cloth masks still so prevalent?
At over 700,000 cases per day, the U.S. is experiencing an all-time high in Covid cases, nearly three times as many new infections as compared to the devastating surge almost exactly one year ago. Despite the Omicron wave, though, if you walk into a restaurant, gym, or airport, many people are still wearing the cloth face coverings that first became popular during the early weeks of the pandemic, way back in March 2020.
By now (or really, by midway through 2020), the science is clear: Professional-grade masks, like N95s, KN95s, or surgical masks, are dramatically more effective at preventing the spread of viral particles and stopping infection. Still, though, there’s no national standard for mask quality, and key leaders like Biden, Fauci, or Walensky haven’t done much to discourage use of outdated cloth face coverings, or to facilitate government programs that distribute the higher-quality masks that could put a major dent in Covid transmission.
Is the administration declaring defeat in its fight with Moderna over vaccine access?
This fall, Biden administration officials were signalling they were going to take extraordinary actions to force Moderna to share its vaccine technology with the developing world. But it’s been several months and Moderna still isn’t sharing its vaccine technology. Lawmakers should press the witnesses on why the Biden administration seems to have given up the fight.
Lawmakers would be smart to ask the officials specifically about whether the Biden administration thinks Moderna is now doing enough to vaccinate the rest of the world in light of its recent efforts to sell more doses to the developing world through Covax, and to pen a separate deal with the African Union.
If the witnesses say Moderna should still do more, lawmakers should press the witnesses on whether the administration is still considering using the Defense Production Act to mandate Moderna send doses of vaccine to the developing world. If the witnesses reveal the administration is no longer considering that option, they should get concrete details on what changed since David Kessler, Biden’s chief scientific officer for the federal Covid-19 response, said the law was “probably the strongest authority” at the administration’s disposal, and would “give the president the authority to allocate doses” to the developing world.
Is there a silver lining to Omicron?
There’s this notion that, for all the havoc Omicron is wreaking, there could be a silver lining to this wave: so many people are gaining immunity or an additional layer of protection to the coronavirus that the new variant is going to accelerate our transition to endemicity.
When this topic comes up in conversations with scientists, many try to avoid touching it, so as not to minimize the damage that Omicron is leaving in its wake. They also rightfully note that another variant could surprise us and reshape the landscape. But the issue remains an important component of the scientific debate about the future of the pandemic. Still, if any of the witnesses are asked this, you can bet they’ll likely shift to discussing the harms of Omicron and why people need to take it seriously instead of saying anything that could frame the situation as a positive.
https://www.statnews.com/2022/01/11/13-big-questions-omicron-congress-fauci-walensky/
