By Ciara Linnane
One day after the U.S. Food and Drug Administration said it’s halting the use of antibody drugs as COVID-19 treatments because they don’t work on the highly contagious omicron variant, Pfizer and German partner BioNTech announced they are launching a trial to evaluate an omicron-oriented vaccine in healthy adults aged 18 to 55.
“While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” said Kathrin U. Jansen, Ph.D., senior vice president and head of vaccine R&D at Pfizer /zigman2/quotes/202877789/composite PFE +1.65% .
The study will enroll up to 1,420 participants for three cohorts; one will comprise people who received two doses of the current Pfizer and BioNTech /zigman2/quotes/214419716/composite BNTX -4.25% COVID vaccine 90 to 180 days prior to enrollment, with that group to receive one or two doses of the omicron vaccine; a second composed of people who received three doses of the existing vaccine and will get one dose of the current one or the omicron one; and a third group of “vaccine-naive” people, who will get three doses of the omicron vaccine.
On Monday, the FDA said the COVID antibody drugs from Regeneron /zigman2/quotes/203149337/composite REGN +1.44% and Eli Lilly /zigman2/quotes/200106384/composite LLY +3.50% should no longer be used as treatments and revoked its emergency-use authorization for both drugs. In a statement, the agency acknowledged that omicron now accounts for 99% of new cases, making it “highly unlikely” they would help people seeking treatment, as the Associated Press reported.
The companies themselves had said in December that the infusion drugs are less able to target omicron due to its mutations. Still, the federal action could trigger pushback from a number of Republican governors who have continued promoting the drugs against the advice of health experts.
Alternate therapies, including antivirals developed by Pfizer and Merck /zigman2/quotes/209956077/composite MRK +2.36% , are in short supply, as is an antibody drug from GlaxoSmithKline /zigman2/quotes/209463850/composite GSK +2.29% /zigman2/quotes/200381158/delayed UK:GSK +2.45% that remains effective in treating omicron.
The news comes as new cases in the U.S. are finally coming down from their recent peaks, even though they remain undesirably high at more than 668,000 a day, according to a New York Times tracker.
Hospitalizations remain above 156,000 a day but seem to be reaching a peak in many places. But deaths are still above 2,000 a day, meaning the U.S. is suffering casualties on the same scale as the terrorist attacks of Sept. 11, 2001, every two days.
Most deaths — roughly three out of four — are occurring in people above the age of 65, according to the Centers for Disease Control and Prevention. They are also mostly happening to unvaccinated people, who remain at high risk of developing severe disease or dying of omicron, which studies continue to show causes mostly milder symptoms in people who have been fully vaccinated and had a booster shot.
Geographically, states in the Northeast that were first to be hit by omicron surges are now seeing a steep decline in cases, the Times tracker shows. New York and New Jersey, for example, have seen cases fall by about two-thirds from their early January levels.
But cases remain at or near record levels in states including Alabama and North Dakota; in Kansas, they have climbed 65% from two weeks ago.
A New York state judge ruled Monday that the state’s face-mask mandate in public places is unconstitutional and now void, the New York Times reported, citing court documents.
Gov. Kathy Hochul enacted the mandate for all indoor public places including schools in December and later extended it to Feb. 1. But State Supreme Court Justice Thomas Rademacher ruled that Hochul and state health officials lacked the authority to enact the mask mandate without the approval of state lawmakers, despite their “well aimed” intentions. Hochul said she would appeal.
Other COVID-19 news you should know about:
• The European Union will relax travel rules for vaccinated residents and those who have recovered from COVID effective Feb. 1, according to a statement. Those people will no longer be required to quarantine or face additional testing as the 27-member trading bloc seeks to restore more normal conditions. The news comes a day after the World Health Organization’s regional head, Hans Kluge, said omicron offers plausible hope” for some semblance of a return to normalcy in the coming months. While cautioning that it’s too soon to drop mitigation measures, Kluge said in a statement that between vaccination and natural immunity due to infection, the variant could lead to stabilization over time.