Biden administration readies battle plan as Covid variants reach the U.S.

Biden’s quest to beat back the pandemic is at a critical juncture. The number of new cases has started plateauing and even falling in some areas, and millions more vaccine doses are expected to become available within weeks. But news that the more transmissible variants have reached the U.S. reduces the government’s margin for error — potentially making it harder to continue bringing down the number of new infections, and drawing resources away from the president’s goal of inoculating hundreds of millions of Americans by summer.

“We need better genetic surveillance of all the variants out there … but you can’t snap your fingers and get it,” said Ezekiel Emanuel, a bioethics expert at the University of Pennsylvania who served on Biden’s Covid-19 advisory board during the transition. Manufacturers also need to develop vaccines capable of protecting against multiple strains — much as flu shots do — and easy-to-administer medicines to treat the virus, he added.

That’s on top of the pressing need to vaccinate much of the country. Biden’s team “already are pushing as hard as they can, but you have to push as hard as possible to get as many people vaccinated as possible,” Emanuel said.

In some ways the current situation resembles March 2020, when the U.S. was dangerously behind in testing to monitor the virus’ movements and reliant almost entirely on other basic public health measures to limit its reach. Although the U.S. has two vaccines available and more in development, their slower-than-expected rollout has officials looking for ways to buy time, and protect already stretched health care systems, while they beef up their pandemic battle plans.

“You’re going to hear me say this a lot, so here it is: Wear masks. Stay six feet apart. Avoid crowds and poorly ventilated spaces. Also, now is not the time to travel,” CDC Director Rochelle Walensky said Friday at a White House briefing before describing the agency’s “dramatically” scaled-up efforts to expand variant surveillance and testing over the past 10 days — including partnerships with testing companies and research labs across the country.

But even with the boosted effort, “We need to be treating every case as if it is a variant in this pandemic right now,” Walensky said.

The strains that have emerged from South Africa, Brazil and the United Kingdom present a mammoth challenge, said University of Minnesota infectious disease expert Michael Osterholm, who also advised Biden on the pandemic during the transition. “This is, to me, one of the most humbling moments in my scientific career of 45 years. I am certain I know less about SARS-CoV-2 today than I did six months ago. The more I learn, the less I know,” he said.

Adding to the difficulty, every new infection gives the virus a chance to mutate; over time, small mutations can converge in ways that change the virus’s behavior, giving rise to additional variants.

The CDC earlier this month partnered with commercial labs and universities to sequence at least 6,000 samples a week, a fraction of what testing experts say is needed to understand the full extent of how the virus is spreading and which strains are present. The U.S. needs to analyze 10,000 of positive test samples a day to get that picture, Phil Febbo, chief medical officer of testing giant Illumina, said in early January.

“We’re doing some sequencing and are working with the CDC as well. CDC has expanded their capacity, and so our state lab is very much tied in with the network of state labs working with CDC,” said Jinlene Cha, acting deputy secretary of public health services for the Maryland Department of Health.

The emerging variants have not shifted the state’s immunization goals, Cha said. “We have not yet made any specific changes to our overall strategy: the goal being just to get more vaccines and vaccinate as many people as we can, and prioritizing those who are at highest risk.”

In the meantime, federal health officials are urging people to wear masks religiously. But only 37 states currently have mask rules.

The variants have also spurred vaccine developers to begin work on booster shots to to heighten protections against the latest strains. Moderna has already started human trials for one “out of an abundance of caution” while others, including Pfizer, say they are researching the impact the strains have on their shots.

FDA’s top vaccine regulator, Peter Marks, said Friday that the agency is working on guidelines for quickly revising existing Covid-19 vaccines, and evaluating the safety and efficacy of those tweaks, in the face of new virus variants.

The agency is “working with industrial partners to put together a playbook for how this will look if we need to switch over to a different sequence,” Marks said during an event Friday held by the American Medical Association. The process of revising and evaluating existing vaccines will likely be “pretty streamlined” compared to their initial development and could involve clinical trials with only a few hundred people. The agency has so far required Covid-19 vaccine developers to conduct late-stage trials with at least 30,000 participants.

A J&J executive argued during a call with investors Friday morning that the company’s data reflects how the pandemic has evolved since last fall, when Pfizer and Moderna published their Phase III trial results. “Because there are a large number of these variants running around … you really cannot compare our 72 percent in the United States to a 94 percent done at a different time,” said Mathai Mammen, global research and development head for J&J’s pharmaceutical arm, Janssen.

The J&J results reflect the difficult new reality facing the country’s pandemic response.

“This is a wake-up call to all of us,” top federal infectious disease expert Anthony Fauci said in a White House press briefing Friday, adding that the government and vaccine manufacturers must be “nimble” in adjusting shots to protect against different strains.

That quick action is not limited to constructing an altered vaccine, but also switching production lines, churning the updated shots out, getting them authorized for use and distributing to millions. It could be a Herculean task on top of the already complicated vaccine rollout nationwide.

Congressional funding for those efforts will be critical in the next relief package, White House senior adviser Andy Slavitt, an Obama-era health official, told reporters. “We want to turbocharge our efforts at sequencing, which I believe should be a shared bipartisan perspective, we can do that,” he said in the White House briefing. “What we need is the Congress to quickly pass the American rescue plan.”

In the meantime, common-sense public health measures are critical. Osterholm predicts a case surge in the U.S. over the next six to 14 weeks, driven by the more transmissible strains and a general pandemic fatigue that is loosening public health measures at the worst time. “We’re really good at pumping the brakes after we’ve wrapped the car around the tree,” he said.

Rachel Roubein, David Lim and Brianna Ehley contributed to this report.



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