Biden administration prepares battle plan as Covid variants reach US



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Biden’s quest to fend off the pandemic is at a critical time. The number of new cases has started to level off and even decline in some areas, and millions of additional doses of the vaccine are expected to be available within weeks. But news that the most transmissible variants have reached the United States reduces the government’s margin of error – potentially making it harder to continue to reduce the number of new infections and divert resources away from the goal of the government. president to vaccinate hundreds of millions of Americans by the summer.

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

This is in addition to the pressing need to immunize much of the country. Biden’s team “Already growing as hard as you can, but you have to do as much as you can to get as many people as possible vaccinated,” Emanuel said.

In some ways, the current situation resembles that of March 2020, when the United States was dangerously behind in testing to monitor the virus’s movements and was almost entirely dependent on other basic public health measures to limit its scope. While the United States has two vaccines available and more are in development, their slower-than-expected roll-out is prompting officials to look for ways to save time and protect already strained health systems, while strengthening their pandemic plans.

“You’re going to hear me say that a lot, so there you go: wear masks. Stay six feet apart. Avoid crowds and poorly ventilated spaces. Plus, now is not the time to travel, ”CDC Director Rochelle Walensky told a White House briefing on Friday before describing the agency’s intensified efforts to expand surveillance and testing of variations over the past 10 days – including partnerships with testing companies and research labs across the country.

But even with the heightened effort, “we have to treat every case as if it were a variant of this pandemic right now,” Walensky said.

The strains that have emerged from South Africa, Brazil and the UK present a gigantic challenge, said Michael Osterholm, an infectious disease expert at the University of Minnesota, who also advised Biden on the pandemic during the transition. . “It was, for me, one of the humblest moments of my 45-year scientific career. I’m sure I’m less familiar with SARS-CoV-2 today than I was six months ago. The more I learn, the less I know, “he said.

Adding to the difficulty, each new infection gives the virus a chance to mutate; over time, small mutations can converge to alter the behavior of the virus, giving rise to additional variants.

Earlier this month, the CDC partnered with commercial labs and universities to sequence at least 6,000 samples per week, a fraction of what testing experts deem necessary to understand the full extent of the spread of the virus. viruses and strains present. The United States has to analyze 10,000 positive test samples per day to get that picture, said Phil Febbo, chief medical officer of testing giant Illumina, in early January.

“We do sequencing and also work with the CDC. The CDC has expanded its capacity, so our state lab is closely linked to the network of state labs working with the CDC, ”said Jinlene Cha, acting deputy secretary of public health services at the Department of Health. Maryland.

The emerging variants did not change the state’s immunization goals, Cha said. “We haven’t made any specific changes to our overall strategy yet: the goal is simply to get more vaccines and vaccinate as many people as possible, and prioritize those who are most at 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 prompted vaccine developers to start working on booster shots to boost protections against the latest strains. Moderna has already started human trials “out of caution” while others, including Pfizer, say they are researching the impact of the strains on their injections.

The FDA’s main vaccine regulator, Peter Marks, said Friday the agency was working on guidelines to quickly review existing Covid-19 vaccines and assess the safety and effectiveness of those adjustments, in the face of the news. virus variants.

The agency “is working with industry partners to develop a manual on what it will look like if we have to switch to a different sequence,” Marks said at an event hosted by the American Medical Association on Friday. The process of reviewing and evaluating what exists Vaccines will likely be “quite streamlined” from their initial development and may involve clinical trials with only a few hundred people. The agency has so far asked developers to Covid-19 vaccines to conduct advanced stage trials with at least 30,000 participants.

A J&J executive argued on an investor call on Friday morning that the company’s data reflected the evolution of the pandemic since last fall, when Pfizer and Moderna released the results of their Phase III trial . “Because there are so many of these variations out there … you really can’t compare our 72% in the US to 94% done some other time,” said Mathai Mammen, global head of research and development. development for the pharmaceutical branch of J&J. , Janssen.

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

“It’s a wake-up call for all of us,” top federal infectious disease expert Anthony Fauci said at a White House press briefing on Friday, adding that the government and vaccine makers must be “nimble. To adjust injections to protect against different strains.

This swift action is not limited to building a modified vaccine, but also changing the production line, producing the updated shots, clearing them for use, and distributing them to millions of people. This could be a Herculean task on top of the already complicated national rollout of the vaccine.

Congressional funding for these efforts will be critical in the next relief plan, senior White House adviser Andy Slavitt, an Obama-era health official, told reporters. “We want to energize our sequencing efforts, which I think should be a shared bipartisan perspective, we can do it,” he said at the White House briefing. “What we need is for Congress to quickly adopt the US bailout.”

In the meantime, common sense public health measures are essential. Osterholm predicts an increase in cases in the United States over the next six to 14 weeks, due to the most transmissible strains and general pandemic fatigue that is easing public health measures at the worst time. “We’re really good at pumping the brakes after wrapping the car around the shaft,” he said.

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

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