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FDA Will Not Require Clinical Trial Data to Authorize Redesigned COVID Boosters — Official
The U.S. Food and Drug Administration will not require companies to submit clinical trial data on COVID-19 vaccines modified to protect against the BA.4 and BA.5 versions of Omicron in order to authorize those shots, a top FDA official said on Thursday.
Dr. Peter Marks, head of the agency’s Center for Biologics Evaluation and Research, told Reuters the agency will rely on data from clinical trials vaccine makers have run on shots designed to combat the BA.1 lineage, as well as manufacturing data, for emergency use authorization submissions before the fall.
The FDA on Thursday recommended COVID-19 vaccine manufacturers change the design of their booster shots beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 sublineages.
U.S. Orders 2.5 Million More Doses of Bavarian Nordic’s Vaccine for Monkeypox
The shot has already been cleared for both smallpox and monkeypox in the United States, where it is called Jynneos.
The U.S. government is ramping up its efforts to fight monkeypox by sending hundreds of thousands of vaccine doses to states in the coming months, expanding access for those most at risk and increasing supply to areas with high case numbers.
Globally, there have been more than 3,400 cases of monkeypox and one death since the outbreak began in May, according to a World Health Organization tally.
A Viral Reprise: When COVID Strikes Again and Again
For New York musician Erica Mancini, COVID-19 made repeat performances. March 2020. Last December. And again this May. “I’m bummed to know that I might forever just get infected,” said the 31-year-old singer, who is vaccinated and boosted. “I don’t want to be getting sick every month or every two months.”
But medical experts warn that repeat infections are getting more likely as the pandemic drags on and the virus evolves — and some people are bound to get hit more than twice. Emerging research suggests that could put them at higher risk for health problems.
Several public figures have recently been reinfected. The U.S. Health and Human Services Secretary Xavier Becerra and Canadian Prime Minister Justin Trudeau said they got COVID-19 for the second time, and U.S. Sen. Roger Wicker of Mississippi said he tested positive a third time. All reported being fully vaccinated, and Trudeau and Becerra said they’d gotten booster shots.
NYC to Offer Pfizer’s COVID Drug at Mobile Test-to-Treat Sites
New York City will start offering Pfizer Inc.’s COVID antiviral Paxlovid at “first of its kind” mobile test-to-treat sites across the city, providing immediate treatment for those who test positive for the virus.
People who test positive for COVID and qualify for Paxlovid will be able to get a prescription on the spot, which they can take to a nearby pharmacy to pick up the drug. By the end of the summer, officials plan to bypass pharmacies entirely, offering Paxlovid directly through the mobile sites.
Earlier on Thursday, Pfizer asked U.S. regulators for full approval of Paxlovid for people at high risk of developing severe disease, bringing the drugmaker one step closer to securing a formal clearance that would allow it to sell and market the antiviral outside of the public health emergency.
The Secrets of COVID ‘Brain Fog’ Are Starting to Lift
New research in the journal Cell is shedding some light on the biological mechanisms of how COVID-19 affects the brain. Led by researchers Michelle Monje and Akiko Iwasaki, of Stanford and Yale Universities respectively, scientists determined that in mice with mild COVID-19 infections, the virus disrupted the normal activity of several brain cell populations and left behind signs of inflammation.
They believe that these findings may help explain some of the cognitive disruption experienced by COVID-19 survivors and provide potential pathways for therapies.
For the past 20 years, Monje, a neuro-oncologist, had been trying to understand the neurobiology behind chemotherapy-induced cognitive symptoms — similarly known as “chemo fog.” When COVID-19 emerged as a major immune-activating virus, she worried about the potential for similar disruption.
Clue Found in Search for Cause of Long COVID, Canadian Researchers Say
For some people who get COVID, their symptoms are mild. Others have had it but never even knew. But a small batch of people who’ve contracted the virus end up with something called long COVID.
Researchers have been trying to figure out why some people get long COVID.
Now, new research in a Canadian trial “has identified a potential key culprit causing some people to continue experiencing breathing issues months after contracting COVID-19,” according to a new report.
WHO Says Monkeypox Cases Triple in Europe in Two Weeks, Urgent Action Needed to Contain Spread
The World Health Organization on Friday warned that urgent action is needed to contain the spread of monkeypox in Europe, as cases have tripled over the past two weeks.
Europe is the center of a global outbreak of the virus with 90% of confirmed monkeypox cases reported there, according to the WHO. New infections have tripled since June 15 with 4,500 confirmed cases across 31 European nations.
Henri Kluge, the head of WHO Europe, called on governments to ramp up efforts to prevent monkeypox from establishing itself on the continent, warning that time is of the essence.
COVID Cases up by More Than 30% in Britain Last Week
Data released by Britain’s Office for National Statistics showed that more than 3 million people in the U.K. had COVID-19 last week, although there has not been an equivalent spike in hospitalizations. The number of COVID-19 deaths also fell slightly in the last week.
British officials said the latest wave of COVID-19 infections was likely caused by Omicron subvariants BA.4. and BA.5.
Moderna Seeks Health Canada Nod for New Double-Protection COVID Booster
Patricia Gauthier, president and general manager for Moderna Canada, says the application for its combination shot, known as a bivalent vaccine, was submitted to the Canadian regulator Thursday.
If approved quickly, doses could be ready for Canadians as early as September, she said.
Denmark’s COVID Mass Mink Cull Had No Legal Justification, Says Report
The Danish government lacked legal justification and made “grossly misleading” statements when it ordered a mass mink extermination two years ago, according to an official inquiry into Europe’s first compulsory farm sector shutdown, which has cost taxpayers billions in compensation to farmers.
In November 2020, Denmark, the world’s largest mink producer, announced it would kill its entire farmed mink population of 15 million animals, because of fears that a COVID-19 mutation moving from mink to humans could jeopardize future vaccines.
The extermination plan was fraught with problems, including reports of mink rising from mass graves, pollution risks from buried carcasses and fears that escaped mink might infect those in the wild and create a permanent virus reservoir from which new variants might infect humans.