HEALTH CARE BRIEFING: Vaccines May Struggle With Omicron Variant

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Moderna President Stephen Hoge said there’s a “real risk” that existing Covid-19 vaccines will be less effective against omicron, while U.S. medical adviser Anthony Fauci said the variant’s severity may be limited.

U.S. health officials said yesterday it’s still unclear how transmissible the latest Covid-19 variant is, how well existing vaccines work and whether it will lead to more severe illnesses. Hoge stopped short of comments by Moderna Chief Executive Officer Stephane Bancel that spooked markets last week, saying it’s too early to tell by how much omicron will degrade vaccines.

“I think that there’s a real risk that we’re going to see a decrease in the effectiveness of the vaccines,” Hoge said in an ABC interview. “What I don’t know is how substantial that is.”

An updated formulation probably would be needed if effectiveness is shown to drop significantly, he said.

“Are we going to see something more like a 50% decrease in efficacy, which would really mean we’d probably need to reboot the vaccines and update them?” Hoge said.

Data from South Africa, where omicron was first detected in November, suggest it may not cause more severe illness than the more widely circulating delta variant, Fauci said on CNN’s “State of the Union.” He cautioned that his conclusion was preliminary.

“Thus far, it does not look like there’s a great degree of severity to it,” Fauci said. “We feel certain that there will be some degree, and maybe a considerable degree, of protection against the omicron variant” with existing vaccines, he said. Read more from Tony Czuczka and Justin Sink.

The U.S. is reevaluating the travel ban on eight southern African countries as more information about the omicron variant and its spread becomes available, Fauci said yesterday.

“That ban was done at a time when we were really in the dark — we had no idea what was going on,” Fauci said in an interview with CNN’s “State of the Union.” U.S. medical advisers are evaluating the new restrictions on “a daily basis” and Fauci said he was hopeful “we’ll be able to lift that ban in a quite reasonable period of time.” Read more from Justin Sink and Aysha Diallo.

More on Omicron:

Molecular Covid-19 tests developed by Thermo Fisher Scientific, Alphabet’s Verily Life Sciences, and nearly two dozen other companies may be able to detect the omicron variant, the FDA announced Friday. Omicron reduces the sensitivity of one genetic target in several molecular tests, the FDA said in an update on its website. That target, which covers a portion of a spike gene, wouldn’t pick up the virus—signaling the presence of the new strain. Genetic sequencing would be needed to confirm the presence of omicron when tests identify this pattern, the agency noted. Read more from Celine Castronuovo.
More people under 40 are contracting Covid-19 as a fourth wave sweeps across South Africa, early data from the nation’s National Institute for Communicable Diseases show. As many as 68% of coronavirus hospital admissions in the Tshwane municipal area—that includes the capital Pretoria—were under 40. That compares with individuals over 50 accounting for 66.1% of hospitalizations during the first weeks of the third wave earlier this year, the institute said in a report on Friday. Read more from Loni Prinsloo and Antony Sguazzin.
South Africa’s daily number of confirmed Covid-19 cases almost quadrupled by Friday since Tuesday as the omicron variant spreads across the country. A South African study of infections since the start of the pandemic found that the risk of reinfection from the omicron coronavirus variant is three times higher than for any previous strain. Read more from Bloomberg News.

More on the Coronavirus Pandemic

Contractor Shot Mandate Under Assault in Texas, Georgia Hearings: Biden’s power to mandate Covid-19 vaccinations for federal contractors was under attack in two federal courtrooms Friday, with a pair of judges appointed by the Trump administration considering whether to up the tally of states where the measure is blocked. Attorneys for Texas and a seven-state coalition led by Georgia told the judges that Biden overstepped his authority with an intrusive policy for contractors that’s actually just cover for his real agenda of getting Americans vaccinated. Biden administration lawyers defended the president’s power to set the terms for federal contracts as long as its related to economic efficiency, as it is with ensuring contractor workers can perform instead of being sick with Covid-19. Read more from Robert Iafolla.

Biden Shot-or-Test Litigation Denied Fast-Track Schedule: A federal appeals court in Cincinnati rejected the Biden administration’s request to move up deadlines in the legal challenge to its emergency shot-or-test rule that would accelerate consideration of lifting an order that froze the rule. The U.S. Court of Appeals for the Sixth Circuit didn’t explain why it turned aside the administration’s petition to move up the briefing schedule on its motion to dissolve the Fifth Circuit’s stay. The Sixth Circuit said in its order issued late Friday that it “reserves judgment” to set deadlines for reviewing the merits of the emergency rule. Read more from Robert Iafolla.

Answers Wanted on OSHA Health-Care Covid-19 Rule: Time is running out for OSHA’s original Covid-19 health-care emergency temporary standard. The standard is set to expire Dec. 21, six months after it was enacted June 21. While the Occupational Safety and Health Administration issued the rule saying the mandate would be replaced with a permanent one within six months, as of Friday, OSHA hasn’t said when that permanent standard will be issued or how the measure will differ from the temporary version. Asked for guidance regarding the release, a Department of Labor spokeswoman said Friday that OSHA “does not have an update at this time.” Read more from Bruce Rolfsen.

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Happening on the Hill

Oversight Plans Drug Pricing Hearing: The House Oversight and Reform Committee scheduled a hearing Thursday to reveal findings in the panel’s three year investigation into pharmaceutical pricing and business practices. The hearing will also look at the need for structural reforms for the industry.

Senators Ready Bill to Overturn Biden Vaccine Mandate: The Occupational Safety and Health Administration’s Nov. 5 rule requiring private sector employers to enforce Covid-19 vaccination or testing policies would be overturned by S. J. Res. 29. The resolution appears to have enough votes for Senate passage after Sen. Joe Manchin (D-W.Va.) stated his support on Thursday. Minority Leader Mitch McConnell (R-Ky.) said he expects a vote this week. If the Senate does pass the resolution, it would likely stall in the Democratic-controlled House, Bloomberg Government Analyst Adam M. Taylor writes.

BGOV Bill Summary: S. J. Res. 29, Block Covid-19 Vaccine Mandate

Aging Research, Advocacy Group Launches with Gingrich Help: A group trying to elevate age-related conditions and promote research into making humans live longer is getting help from former House Speaker Newt Gingrich, a long-time advocate for expanding the government’s research portfolio, Alex Ruoff reports.

The Alliance for Longevity Initiatives—a nonprofit backed by several research organizations and companies—is hoping to make inroads in Congress to expand what the government spends on aging research and to make it easier for companies to gain approval for medicines meant to help people live longer lives, Dylan Livingston, the group’s president and founder, said. “This is about keeping in better health for a longer period of time,” Livingston said. The group wants to work with the Food and Drug Administration to create a special pathway for therapies in the “longevity medicine” space and increase the budget for the National Institute on Aging, part of the National Institutes of Health, Livingston said.

The Alliance on Thursday will host a talk with Gingrich and former Rep. Steve Israel (D-N.Y.). Gingrich is connected to the group by Joseph DeSantis, who is chief strategy office for Gingrich 360, a consultancy formed by Gingrich, and sits on the board of directors for the Alliance.

What Else to Know

Telehealth Visits in Medicare Soar: Medicare telehealth visits increased 63-fold from roughly 840,000 in 2019 to 52.7 million in 2020 as the Covid-19 pandemic caused beneficiaries to forgo in-person doctor visits in favor of virtual encounters, according to an HHS study. Ninety-two percent of telehealth visits—which allow patients and providers to interact live via computer, tablet, or smartphone—took place from beneficiary homes, which was not allowed by Medicare before the pandemic. The massive increase in telehealth visits occurred while overall in-person visits to clinicians fell by 11% from 2019 to 2020. Read more from Tony Pugh.

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To contact the reporters on this story: Michaela Ross in Washington at mross@bgov.com; Alex Ruoff in Washington at aruoff@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com

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