2nd COVID-19 vaccine trial paused over unexplained illness
New Brunswick (US): A late-stage study of Johnson & Johnson's COVID-19 vaccine candidate has been paused while the company investigates whether a study participant's unexplained illness is related to the shot.
The company said in a statement on Monday evening that illnesses, accidents and other so-called adverse events are an expected part of any clinical study, especially large studies, but that its physicians and a safety monitoring panel would try to determine what might have caused the illness.
The pause is at least the second such hold to occur among several vaccines that have reached large-scale final tests in the US.
The company declined to reveal any more details about the illness, citing the participant's privacy.
Temporary stoppages of large medical studies are relatively common. Few are made public in typical drug trials, but the work to make a coronavirus vaccine has raised the stakes on these kinds of complications.
Companies are required to investigate any serious or unexpected reaction that occurs during drug testing. Given that such tests are done on tens of thousands of people, some medical problems are a coincidence. In fact, one of the first steps the company said it will take is to determine if the person received the vaccine or a placebo.
The halt was first reported by the health news site STAT.
Final-stage testing of a vaccine made by AstraZeneca and Oxford University remains on hold in the US as officials examine whether an illness in its trial poses a safety risk. That trial was stopped when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company has said. That company's testing has restarted elsewhere.
Johnson & Johnson was aiming to enroll 60,000 volunteers to prove if its single-dose approach is safe and protects against the coronavirus. Other vaccine candidates in the US require two shots.
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Karnataka govt directs municipal corps to regulate, prohibit pigeon feeding
Bengaluru (PTI): The Karnataka government has issued directions to municipal corporations across the state to regulate and prohibit feeding pigeons in public places, citing serious public health concerns.
Deputy Secretary to Government V Lakshmikanth has written to the Urban Development Department requesting it to issue directions to the Greater Bengaluru Authority (GBA) and all municipal corporations to take immediate steps to implement the measures.
In an official note dated December 16 issued by the Health and Family Welfare Department and released to the media on Wednesday, the department said uncontrolled feeding of pigeons in public places has resulted in large congregations of birds, excessive droppings and serious health concerns, particularly respiratory illnesses linked to prolonged exposure to pigeon droppings and feathers such as hypersensitivity pneumonitis and other lung diseases.
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"The commissioner, the Greater Bengaluru Authority and the Commissioners and chief officers of other municipal corporations shall take necessary action to mitigate the causes of dangerous disease spread by pigeon and enforce specified guidelines in their respective jurisdiction," the note said.
According to the department, these include a prohibition on feeding pigeons or causing pigeons to be fed in areas where it may cause nuisance or pose a health hazard to the public. Pigeon feeding shall be permitted only in designated areas in a controlled manner, subject to certain conditions.
"The designated areas may be selected in consultation with stakeholders. The responsibility for upkeep of the designated areas and compliance to the directions shall be taken up by some charitable organisation or an NGO. The feeding in designated areas shall be permitted only for some limited hours in the day," it said.
The note further stated that authorised officers of local authorities shall issue on-the-spot warnings and may impose fines for violation of the order, or lodge complaints to prosecute offenders under Sections 271 (Negligent act likely to spread infection of disease dangerous to life) and 272 (Malignant act likely to spread infection of disease dangerous to life) of the Bharatiya Nyaya Sanhita.
It also directed local authorities to conduct public awareness campaigns, including the display of signboards, banners and digital messages, explaining the health hazards associated with pigeon droppings and feathers, the content of the regulatory directions and penalties for violations, and alternative humane methods of bird conservation that do not endanger public health.
