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EU medicines regulator finds doable hyperlink between AstraZeneca Covid vaccine and blood clots

EU medicines regulator finds possible link between AstraZeneca Covid vaccine and blood clots

Syringes are filled with Astrazeneca’s vaccine in the pharmacy.

Christopher Neundorf | Image Alliance | Getty Images

LONDON – Europe’s Medicines Agency announced on Wednesday a possible link between the coronavirus vaccine developed by AstraZeneca and Oxford University and rare blood clotting problems in adults who received the shot.

It comes after a review of all currently available evidence in extremely rare cases of unusual blood clots in some vaccinated individuals.

Emer Cooke, executive director of the European Medicines Agency, said in a televised press conference that the regulator’s safety committee “has confirmed that the overall benefits of the AstraZeneca vaccine in preventing Covid-19 outweigh the risks of side effects.”

“A plausible explanation for these rare side events is an immune response to the vaccine that is similar to that seen in heparin-treated patients,” said Cooke, noting that it was heparin-induced thrombocytopenia.

The EMA has commissioned further research to investigate the link between the vaccine and blood clots, and said its safety committee had concluded that unusual blood clots with low platelets should be listed as “very rare” side effects of the shot. It also drew the public’s attention to other possible side effects that are flagged as adverse drug reactions on the product information of the vaccine.

The European Medicines Agency said it was “of great importance” that health professionals and those receiving the Oxford-AstraZeneca vaccine are aware of these risks and look out for possible symptoms, typically in the first two weeks after vaccination occur.

“These include, for example, shortness of breath, chest pain, swelling in the leg, persistent abdominal pain, neurological symptoms such as severe or persistent headaches or blurred vision and skin bruises beyond the injection site,” said Dr. Sabine Straus, chair of EMA’s security committee, said at the same press conference.

AstraZeneca’s shares fell nearly 1% during afternoon trading in London.

The Oxford-AstraZeneca shot has been followed by safety concerns in recent weeks, and several European countries temporarily stopped using the vaccine last month.

The EMA said on March 31 that it had found the shot to be safe and effective, but added that it could not rule out the possibility of a causal link between the vaccine and coagulation events, so the investigation will continue.

The World Health Organization, the UK Medicines Agency and the International Society on Thrombosis and Hemostasis have all stated that the benefits of administering the Oxford-AstraZeneca shot far outweigh the risks.

AstraZeneca previously said that its studies didn’t find a higher risk of blood clots as a result of its vaccine.

Most countries have since resumed the use of the shot, but many have suspended vaccinations for certain age groups.

A senior European Medicines Agency official said Tuesday that there was a clear “link” between the Oxford-AstraZeneca vaccine and very rare blood clots in the brain, although the direct cause was not yet known.

In an interview with the Italian newspaper Il Messaggero published on Tuesday, Marco Cavaleri, chairman of the EMA’s vaccine evaluation team, said: “In my opinion, we can now say that there is a link to the vaccine, but we are still me don’t know what is causing this reaction. “

The EMA then denied in a statement to Agence France-Presse that it had made a connection between the Oxford-AstraZeneca shot and rare blood clots.

UK vaccine study in children paused

The drug and health products regulator, which approved the Oxford-AstraZeneca vaccine for use in the UK, examined the data after a handful of reports – in both the UK and continental Europe – of serious but rare blood clots, some of which were fatal .

A UK study of the Oxford AstraZeneca vaccine in children has already been paused while the drug agency investigated a possible link between the shot and the bleeding disorders, particularly cases of blood clots in veins in the brain known as cerebral venous sinus thrombosis (CVST) as well Thrombocytopenia (low levels of platelets in the blood that help blood to clot).

The UK government noted that as of March 24th inclusive, there were 22 reports of CVST and 8 reports of other low platelet thrombosis events totaling 18.1 million doses of the AstraZeneca vaccine (one shot with two doses). given up to this date.

People are waiting in a vaccination center in Cologne on April 5, 2021.

Marius Becker | Image Alliance | Getty Images

“We need to know more about those affected and understand exactly how the diseases came about while many other questions remain open,” said Adam Finn, professor of pediatrics at Bristol University, UK, ahead of the announcement on Wednesday.

“There are some things that are very clear, however. The first is that these cases are indeed very rare. The second is that the vaccines available and used in the UK are very effective in preventing COVID,” said Finn.

“In short, if you are currently offered a dose of Oxford AstraZeneca vaccine, your chances of staying alive and staying healthy will go up if you take the vaccine and go down if you don’t.”

– CNBC’s Holly Ellyatt contributed to this report.

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Medical Marijuana Is Not Regulated as Most Medicines Are

Medical Marijuana Is Not Regulated as Most Medicines Are

Another marijuana-based drug, Nabiximole (Sativex), is available in Canada and several European countries to treat spasticity and nerve pain in patients with multiple sclerosis.

Medical cannabis is hardly a new therapeutic agent. It was widely used as a patent drug in the United States in the 19th and early 20th centuries and listed in the United States Pharmacopoeia until the passage of the Marijuana Tax Act in 1937 made it illegal.

Then a 1970 federal act made it a Schedule 1 substance that severely restricted access to marijuana for legitimate research. To make matters worse, plants like marijuana contain hundreds of active chemicals, the amounts of which can vary widely from batch to batch. Unless researchers can study purified substances in known quantities, conclusions about benefits and risks are highly unreliable.

As in Dr. Finn’s book, here are some expert conclusions about the role of medical marijuana in their respective fields:

People who use marijuana for pain relief do not reduce their dependence on opioids. In fact, Dr. Finn: “Narcotics patients who also use marijuana for pain say their pain level is still 10 on a scale of 1 to 10.” The authors of the chapter on pain, Dr. Peter R. Wilson, pain specialist at the Mayo Clinic in Rochester, Minnesota, and Dr. Sanjog Pangarkar of the Greater Los Angeles, VA Health Service concluded, “Cannabis itself does not produce analgesia and, paradoxically, it could interfere with opioid analgesia. “A 2019 study of 450 adults in the Journal of Addiction Medicine found that medical marijuana not only did not relieve pain for patients, it also increased the risk of anxiety, depression, and substance abuse.

Dr. Allen C. Bowling, a neurologist at the NeuroHealth Institute in Englewood, Colorado, noted that while marijuana has been extensively studied as a treatment for multiple sclerosis, the results of randomized clinical trials have been inconsistent. The studies overall showed some but limited effectiveness, and in one of the largest and longest studies, the placebo performed better in treating spasticity, pain, and bladder dysfunction, wrote Dr. Bowling. Most of the studies used pharmaceutical grade cannabis that is not available in pharmacies.

The study, which suggests that marijuana could reduce the risk of glaucoma, dates back to 1970. In fact, THC does lower the harmful pressure in the eye, but as Dr. Finny T. John and Jean R. Hausheer, ophthalmologists at the University of Oklahoma Health Sciences Center, wrote, “To achieve therapeutic levels of marijuana in the bloodstream for treating glaucoma, a person would have to smoke approximately six to eight times a day. At that point, the person would likely be physically and mentally incapable of performing tasks that require attention and focus, such as: B. Working and driving. The major medical eye care companies have thumbs down on marijuana as a treatment for glaucoma.

Allison Karst, a psychiatric pharmacy specialist at VA Tennessee Valley Health System who researched the benefits and risks of medical marijuana, concluded that marijuana can have “negative effects on mental health and neurological function,” including deterioration the symptoms of PTSD and bipolar disorder.

Dr. Karst also cited a study that showed that only 17 percent of edible cannabis products were accurately labeled. In an email, she wrote that the lack of regulation “creates difficulties in extrapolating available evidence to different products in the consumer market due to differences in chemical composition and purity”. She cautioned the public not to weigh “both potential benefits and risks,” which I would add a caveat to – buyers beware.

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European Medicines Company authorizes use in EU

European Medicines Agency authorizes use in EU

A healthcare worker holds a coronavirus disease (COVID-19) vaccine bottle at the Dignity Health Glendale Memorial Hospital and Health Center in Glendale, California, United States on December 17, 2020.

Lucy Nicholson | Reuters

The European Medicines Agency approved the Pfizer and BioNTech coronavirus vaccine for conditional use on Monday, opening the door to a vaccination program across the European Union.

The news comes less than two weeks after the vaccine developed in America and Germany was approved for use in the UK and US

Europe is well on its way to starting vaccinations within a week, regulators said, and authorities in several EU countries including France, Italy, Austria and Germany have announced they will start vaccinations on December 27.

The vaccine must be approved by the European Commission before it can be distributed. A decision is expected shortly.

The European Medicines Agency issued a statement on Monday that it had recommended that the vaccine be given conditional marketing authorization for people aged 16 and over.

“The EMA’s scientific opinion paves the way for the first authorization for the placing on the market of a COVID-19 vaccine in the EU by the European Commission with all associated protective measures, controls and obligations,” said the agency.

Vaccine approvals are picking up pace as European countries tighten their lockdowns in the face of a deadlier winter wave of viral infections.

A new and highly transmissible variant of the virus has been discovered in the UK, prompting Prime Minister Boris Johnson to impose strict lockdowns on some areas. It has resulted in a growing number of countries ceasing flights and transportation from the island.

The coronavirus pandemic has killed nearly half a million people across Europe since it began.

Governments scramble to put in place effective strategies to prevent further infections and keep the local economy alive as cases and deaths break new records during the holiday season.

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