Health Highlights, April 21, 2021
Multiple Violations at Baltimore Plant Making COVID-19 Vaccines: FDA
Improper disinfection and not following contamination prevention protocols are among the nine violations found by U.S. Food and Drug Administration inspectors at a Baltimore plant that had to discard up to 15 million doses of Johnson & Johnson's coronavirus vaccine and was ordered to temporarily halt all production.
The inspection at the Emergent BioSolutions plant -- a subcontractor of Johnson & Johnson -- was conducted after reports that workers had contaminated a batch of Johnson & Johnson vaccine doses with the harmless virus used to deliver AstraZeneca's vaccine, which is also made at the plant, according to The New York Times.
The violations included: not properly disinfecting the factory and its equipment; not following procedures meant to prevent contamination of doses and to ensure the strength and purity of the vaccines made at the plant; improperly trained employees; and problems with the design of the building, according to the inspection completed Tuesday.
The FDA said it has not authorized Emergent to distribute any Johnson & Johnson vaccine doses, and that no vaccine made at the plant has been released for use in the United States, the Times reported.
AstraZeneca's vaccine hasn't been approved for use in the United States and all the Johnson & Johnson doses used in the country so far were made in other countries.
"We will not allow the release of any product until we feel confident that it meets our expectations for quality," Dr. Janet Woodcock, the FDA's acting commissioner, and Dr. Peter Marks, the agency's top vaccine regulator, said in a statement.
The agency said it was working with Emergent to fix the problems. Earlier this month, the FDA said the AstraZeneca vaccine could no longer be made at the plant to reduce the risk of cross-contamination with the Johnson & Johnson vaccine, the Times reported.
In a statement, the Emergent said that "while we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them."
Johnson & Johnson said in a statement that it's stepped up oversight of Emergent and that it would "ensure that all of FDA's observations are addressed promptly and comprehensively," the Times reported.
Too Little Sleep May Increase Dementia Risk: Study
People who get too little sleep in middle age may have an increased risk of dementia when they're older, according to a new study.
Researchers tracked nearly 8,000 people in Britain for about 25 years, beginning when they were 50 years old, The New York Times reported.
Those who consistently slept an average of six hours or less on weeknights were about 30% more likely to be diagnosed with dementia at an average age of 77 than those who regularly got seven hours of sleep a night.
There was no general difference between men and women, according to study published in the journal Nature Communications.
"It would be really unlikely that almost three decades earlier, this sleep was a symptom of dementia, so it's a great study in providing strong evidence that sleep is really a risk factor," Dr. Kristine Yaffe, a professor of neurology and psychiatry at the University of California, San Francisco who was not involved in the study, told the Times.
But one other expert expressed some doubt.
"It's always difficult to know what to conclude from these kinds of studies," Robert Howard, a professor of old age psychiatry at University College London, wrote in one of several comments submitted about the study to the journal.
"Insomniacs -- who probably don't need something else to ruminate about in bed -- shouldn't worry that they are heading for dementia unless they get off to sleep immediately," he added.
J&J COVID-19 Vaccine Should Be Used, But Carry Blood Clot Warning: European Agency
A warning about a possible link to rare blood clots should be added to the Johnson & Johnson/Janssen single-dose COVID-19 vaccine, the European Union's drug regulator said Tuesday.
But the European Medicines Agency also said the vaccine's benefits still far outweigh its risks and it did not recommend that member nations avoid using the vaccine, The New York Times reported.
"The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects," the agency said in a statement about its non-binding recommendation.
The rare clots associated with the Johnson & Johnson vaccine are "very similar" to those associated with the AstraZeneca vaccine, for which the EMA made a similar recommendation, the Times reported.
"Health care professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination," the agency advised.
It said an immune response may be one possible explanation for the rare blood clots.
The Johnson & Johnson vaccine has already been given to nearly eight million people in the United States. However, U.S. regulators last week paused use of the vaccine due to concerns about six cases of the rare blood clots. That led Johnson & Johnson to delay the vaccine's rollout in the EU's 27 member states, the Times reported.
U.S. health officials said Monday they're investigating"a handful" of new, unconfirmed cases that have emerged since use of the vaccine was paused.
Previously, the nation's leading infectious disease expert, Dr. Anthony Fauci, said he anticipated a decision about whether to resume use of the Johnson & Johnson vaccine this Friday, when an expert panel advising the Centers for Disease Control and Prevention is scheduled to meet, the Times reported.