Biden’s mission to combat the pandemic is at a critical juncture. The number of new cases has started to stagnate and even drop in some areas, and millions more doses of vaccine are expected to be available within weeks. But news that the most communicable variants have reached the United States reduces the government’s margin of error – potentially making it more difficult to continue reducing the number of new infections and withdrawing resources from the president’s goal of inoculating hundreds of millions of Americans until the summer.
“We need better genetic surveillance of all the variants out there … but you can’t snap your fingers and understand,” 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 that can protect against various strains – just like flu vaccines – and easy-to-administer drugs to treat the virus, he added.
This is in addition to the urgent need to vaccinate much of the country. Biden Team “They are already pushing as hard as they can, but it is necessary to push as hard as possible to vaccinate as many people as possible,” said Emanuel.
In some ways, the current situation resembles March 2020, when the U.S. was dangerously late in testing to monitor the virus’s movements and relied almost entirely on other basic public health measures to limit its reach. While the United States has two vaccines available and more in development, its slower-than-expected launch causes authorities to look for ways to save time and protect already overburdened health systems, while reinforcing its pandemic battle plans.
“You will hear me say this a lot, so here it is: Wear masks. Stay two meters away. Avoid agglomerations and poorly ventilated spaces. Besides, now is not the time to travel, ”said CDC director Rochelle Walensky on Friday at a briefing at the White House before describing the agency’s efforts to expand surveillance and testing of variants in the past 10 days – including partnerships with testing companies and research labs across the country.
But even with the increased effort, “We need to treat each case as if it were a variant of this pandemic now,” said Walensky.
The strains that emerged from South Africa, Brazil and the UK present a huge challenge, said University of Minnesota infectious disease specialist Michael Osterholm, who also advised Biden about the pandemic during the transition. “This is, for me, one of the most humble moments in my 45-year scientific career. I’m sure I know less about SARS-CoV-2 today than I did six months ago. The more I learn, the less I know,” he said.
To increase the difficulty, each new infection gives the virus a chance to mutate; over time, small mutations can converge in ways that change the behavior of the virus, 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 United States needs to analyze 10,000 positive test samples a day to obtain this image, said Phil Febbo, medical director at testing giant Illumina, in early January.
“We are doing sequencing and working with CDC as well. The CDC has expanded its capacity and therefore our state laboratory is closely linked to the network of state laboratories that work with the CDC, ”said Jinlene Cha, Maryland State Department of Health’s acting undersecretary for public health services.
The emerging variants have not changed the state’s immunization goals, Cha said. “We haven’t made any specific changes to our overall strategy yet: the goal is just to get more vaccines and vaccinate as many people as we can, and prioritize those who are most at risk.”
Meanwhile, federal health officials are encouraging people to wear masks religiously. But only 37 states currently have masking rules.
The variants also encouraged vaccine developers to start working on booster doses to increase protection against the latest strains. Moderna has already started testing in humans for an “over-caution”, while others, including Pfizer, say they are researching the impact that strains have on their vaccines.
FDA’s top vaccine regulator, Peter Marks, said on Friday that the agency is working on guidelines to quickly review existing Covid-19 vaccines and assess the safety and effectiveness of these adjustments in the face of new variants of the virus.
The agency is “working with industry partners to put together a manual of what it will look like if we need to move to a different sequence,” said Marks during an event on Friday held by the American Medical Association. The existing review and evaluation process Vaccines are likely to be “greatly simplified” compared to their initial development and may involve clinical trials with just a few hundred people. The agency has so far required Covid-19 vaccine developers to conduct final stage tests with at least 30,000 participants.
A J&J executive argued during an investor call on Friday morning that the company’s data reflects how the pandemic has evolved since last fall, when Pfizer and Moderna published the results of the Phase III tests. “As there are a large number of these variants circulating … you really can’t compare our 72 percent in the United States to 94 percent done at a different time,” said Mathai Mammen, global head of research and development for the J&J pharmaceutical arm. , Janssen.
The results of J&J reflect the difficult new reality faced by the country’s response to the pandemic.
“This is a wake-up call for all of us,” federal infectious disease expert Anthony Fauci said at a press conference at the White House on Friday, adding that the government and vaccine manufacturers must be “nimble” in adjusting vaccines for protection against different strains.
This quick action is not limited to building an altered vaccine, but also switching production lines, turning over updated vaccines, authorizing their use and distributing to millions. It can be a Herculean task in addition to the already complicated implementation of vaccines across the country.
Congressional funding for these efforts will be critical in the next aid package, senior White House aide Andy Slavitt, an Obama-era health worker, told reporters. “We want to boost our sequencing efforts, which I believe must be a shared bipartisan perspective, we can do that,” he said at the White House briefing. “What we need is for Congress to quickly approve the American rescue plan.”
In the meantime, common sense public health measures are critical. Osterholm predicts an increase in cases in the United States in the next six to 14 weeks, driven by more transmissible strains and general pandemic fatigue that is easing public health measures at the worst time. “We are very good at putting on the brakes after wrapping the car around the tree,” he said.
Rachel Roubein, David Lim and Brianna Ehley contributed to this report.