Another one of the approved vaccines may be dangerous to your health
The vaccine has stopped being used in the United States. What will Canada do?
On April 13, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) called for an immediate halt to Johnson & Johnson vaccine because of reports of blood clots in at least 6 vaccinated individuals.
Later the same day, Johnson & Johnson announced that it would suspend all clinical trials until guidelines for vaccine researchers and patients are updated. In addition, the company intends to postpone mass vaccination with its drug in Europe. Johnson & Johnson's vaccine has been approved by the European Union, but countries have yet to begin administering the vaccine.
Six cases of a rare condition, cerebral venous sinus thrombosis (CVST), which is combined with thrombocytopenia (low blood platelet counts), have been reported in the USA. All 6 patients turned out to be women between 18 and 48 years of age. One of them died and one was hospitalized in critical condition.
Experts from the USA admitted that cases of thrombosis are very rare. About 7 million doses of Johnson & Johnson vaccine have been administered in the country.
"I want to emphasize that such effects are extremely rare," said Janet Woodcock, FDA inspector. — But the safety of COVID-19 vaccines is a top priority for the federal government, so we are very strict about all reports of side effects."
Dr. Anthony Fauci, chief spokesman for the U.S. Division of Infectious Diseases, says those who have been vaccinated have no cause for concern, as side effects occurred within 6 to 13 days of vaccination.
Dr. Ann Schuchat, chief deputy director of the Centers for Disease Control and Prevention, said the suspension of Johnson & Johnson will help the health system prepare for identifying and treating patients, as well as recording other side effects that may be seen in vaccinated individuals.
Peter Marks, director of the Center for Biologics Evaluation and Research, notes that standard therapies used for thrombosis are not appropriate in this situation and may even cause harm to the patient or be fatal.
And while calls to suspend vaccination with Johnson & Johnson are advisory, Marks is hopeful that vaccine use in the U.S. and other countries will be suspended. People who experience severe headaches, abdominal pain, leg pain, or shortness of breath within three weeks of vaccination are advised to see a doctor.
Canada is in no hurry to take decisive action, but will monitor its southern neighbor's situation. On March 5, Canada approved the Johnson & Johnson vaccine and has placed a pre-order for 10 million doses with an option to order up to 28 million more doses. But deliveries aren't expected until late April, and Procurement Minister Anita Anand believes the doses won't be ready for use until early May. Prime Minister Justin Trudeau said Canada is still waiting to receive a shipment of Johnson & Johnson vaccine.
"But we are closely following developments in the United States, and we can assure you that the Department of Health will put the health of Canadians first in any decisions," Trudeau said.
Health Canada is working with the vaccine manufacturer, FDA and other regulatory agencies while side-effect data is analyzed.
The problem with the Johnson & Johnson vaccine is very similar to the situation with AstraZeneca, which uses the same technology but a different formula. Cases of vaccine-induced prothrombotic immune thrombocytopenia have been reported in some countries among those vaccinated with AstraZeneca, with one case occurring in Canada. As a result, European countries rejected the vaccine, and Canada's National Advisory Committee on Immunization (NACI) recommended not to use the drug for people under 55 years old.
