Although a number of EU countries have halted the use of the AstraZeneca vaccine, the company along with a number of health experts insist that it is safe.
AstraZeneca said in a statement on Monday that there were 15 deep vein thrombosis (DVT) events and 22 pulmonary embolism (PE) cases among 17 million people in the EU and UK who have received at least one AstraZeneca vaccine dose.
“This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines,” the pharmaceutical company said.
The company pointed out that in the clinical trials, “even though the number of thrombotic events was small, these were lower in the vaccinated group. There has also been no evidence of increased bleeding in over 60 000 participants enrolled.”
The European Medicines Agency (EMA) reiterated that there is no indication that the vaccine was responsible for these adverse events. The organisation is currently reviewing the vaccine, and more information is expected in its monthly safety report due during the week. They are currently scheduled to meet on Tuesday.
There are however concerns that slowing the pace of vaccinations will result in more lives lost and fuel vaccine hesitancy.
“I do worry that some people will not be able to differentiate between an unrelated or coincidental VTE [venous thromboembolism] occurrence (due to DVT/PE being so common in the general population) and a causative relationship,” Stephan Moll, MD, of the division of haematology at the University of North Carolina at Chapel Hill, said to MedPage Today.
WHO chief scientist Soumya Swaminathan, MD, noted that it has happened before: Norway early on raised concerns about deaths among the elderly getting vaccinated, but then clarified it was only the expected rate of death.
She pointed out that of the 300 million-odd doses of all COVID vaccines administered globally, not one death has been documented as having been caused by vaccination, “We do not want people to panic. We would for the time being recommend that countries continue vaccinating with AstraZeneca.”
Canada, meanwhile, has said that it will continue to use the AstraZeneca vaccine. The company is likely to seek emergency use authorisation from the United States for its jab when it clears its Stage III clinical trials in that country.
“This does not necessarily mean these events are linked to vaccination, but it’s routine practice to investigate them,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus at a press briefing Monday. “It shows that the surveillance system works and effective controls are in place.”
Source: MedPage Today