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We Tried to Improve COVID Vaccine Labeling — the FDA Said ‘No Thanks’
Healthcare providers rely on product labeling for accurate, unbiased and up-to-date information on medical products. But current Food and Drug Administration (FDA)-approved labels for the Pfizer and Moderna COVID-19 vaccines are obsolete, misleading and out of touch with regulators elsewhere. Whatever one thought of the initial shots, people are now getting boosted indefinitely with little reliable information about scientific developments.
Take the ongoing uncertainty over whether vaccines reduce viral transmission. We asked the FDA to clarify in labeling that there isn’t substantial evidence that mRNA vaccines reduce viral transmission. This was an easy ask — the FDA has repeatedly stated that effectiveness against transmission remains unproven. The agency said so in December 2020, when vaccines were first authorized, and again in August 2021, when it fully approved Pfizer’s vaccine. The agency still states on its website today: “While it is hoped this will be the case, the scientific community does not yet know if Comirnaty will reduce such transmission.”
Viral transmission is just one of the multiple vaccine-related issues for which the FDA has not updated product labeling. In January, a group of us — current and former FDA advisers and academics from around the country — tried to fix this problem by asking the FDA to make critical changes to official product labels. But four months later, in a 33-page response letter, the agency denied almost every single request.
The FDA also failed to warn about the documented risk of sudden death, even though myocarditis is now a well-recognized side effect, particularly among young men. To support adding “sudden death” to product labeling, we pointed to multiple autopsy studies on lethal vaccination-associated myocarditis.
Diabetes Med Metformin Might Help Prevent Long COVID
A safe, generic diabetes pill can help people avoid long COVID, a new clinical trial shows. Metformin cut the risk of long COVID by about 40% for patients who received a two-week course of the drug while battling their infection, the researchers reported.
The results were even more dramatic if COVID-19 patients began taking metformin soon after infection. Starting on the drug within three days of symptom onset cut long COVID cases by more than 60% in those folks.
This is the first clinical trial to suggest that any drug taken during COVID-19 infection might reduce the risk of long COVID, the study authors noted.
CDC Comes Under Fire for Inadequate Information About Its COVID Response
Republicans aren’t impressed with the Centers for Disease Control and Prevention’s reorganization plan, or its efforts to explain it.
The embattled public health agency late Tuesday sent answers to a set of GOP lawmakers’ questions on its “Moving Forward”’ reform, announced last spring amid building criticism of its COVID-19 response. The agency in February announced a reorganization plan that would eliminate 20 offices and add 16 new ones and has shared summary reports from its internal review, but not shared staff or external groups, much to Republicans’ chagrin.
Government watchdogs are having challenges getting answers from CDC on its COVID-19 response, an official told a House panel Wednesday. “We do need more information,” Mary Denigan-Macauley, director of the Government Accountability Office’s public health unit, told the panel.
Since assuming control of the committee earlier this year, Energy and Commerce Oversight and Investigations Subcommittee Chair Cathy McMorris-Rodgers (R-Wash.) and other Republicans have put the spotlight on science agencies’ pandemic response and overall spending, turning their ire not just on the CDC but the National Institutes of Health and former top infectious disease official Anthony Fauci. Rodgers, Morgan Griffth (R-Va.) and others last week asked that one of Fauci’s deputies, a longtime pox researcher, sit for an interview on controversial pathogen research.
White House COVID Response Coordinator Ashish Jha to Leave His Post
His departure was reported first by the Wall Street Journal, which said Jha will be the last of the Biden administration’s rotating COVID response coordinators. Jha plans to leave June 15 and return July 1 to his previous position as dean of Brown University’s School of Public Health, the newspaper reported.
After the removal of the post of the COVID response coordinator, the director of the White House’s nascent Office of Pandemic Preparedness and Response Policy, who has not been named, will advise the president and coordinate federal responses to various biological and pandemic threats, the newspaper said.
COVID Cases Trend Down in All World Regions
Except for a few hot spots, COVID-19 activity over the past month declined in all six world regions, the World Health Organization (WHO) said in its weekly update today.
The pattern follows several weeks of a mixed picture, which saw rising cases in some parts of the globe.
Though two of the countries reporting rising cases — Australia and China — are both in the WHO’s Western Pacific region, cases in the area declined 5% over the past 28 days.
Mysterious COVID Lineages in U.S. Sewers Could Offer Clues to Chronic Infections
As COVID-19 testing and other coronavirus tracking efforts peter out in the United States, wastewater surveillance has become the primary method to monitor early community spread of the virus. And there’s some evidence that a close investigation of the findings could also help unravel some of the mysteries of long COVID.
Genetic sequencing of wastewater samples from sewer systems across the country has uncovered dozens of unique strains of the coronavirus, with multiple mutations in unusual combinations.
One possible explanation for these “cryptic lineages” is that they can be traced back to people who have been living with a chronic — and serious — COVID-19 infection for years.
In a recent preprint study, about two dozen researchers set out to understand the origin of these cryptic lineages by closely examining the evolution of one from Wisconsin. The lineage was linked to a single facility that served 30 people and was persistently present for more than a year. Additional data has told similar stories.
Your Risk of COVID-Linked Smell Loss Is Much Lower Now: Study
One of the signature symptoms of COVID-19 infection in the early months of the pandemic was a loss of sense of smell. Now, new research finds that is no longer the case, thanks to the new variants that have been circulating more recently.
The risk of losing a sense of taste or smell is now only about 6% to 7% of what it was during the pandemic’s early stages, according to researchers at Virginia Commonwealth University (VCU) School of Medicine in Richmond, Va.
The findings were published recently in the journal Otolaryngology — Head and Neck Surgery.
Researchers don’t know why fewer people are now losing their sense of smell with infection, but higher immunity to the virus could be a factor.
China Approves World’s First XBB-Specialized COVID Vaccine as Second Wave Nears End by June
A recombinant trivalent COVID-19 trimeric protein vaccine developed by WestVac Biopharma and West China Medical Center at Sichuan University, effective against the most recent XBB variants, has received emergency use approval in China.
This marks the world’s first approved XBB-targeting vaccine, highlighting China’s leading position in COVID-19 vaccine research and development, WestVac Biopharma announced on Thursday.