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FILE PHOTO: Oxford / AstraZeneca COVID-19 vaccine vials are displayed at a vaccination center in Bierset, Belgium, on March 17, 2021. REUTERS / Yves Herman
FRANKFURT / PARIS – Europe’s drug watchdog is reviewing a small number of reports of bleeding, blood clots, and low platelet counts in people who have received the AstraZeneca coronavirus vaccine.
The European Medicines Agency (EMA) has said that so far it has not found a causal link between the vaccine and the incidents. The World Health Organization has also said that there is no proven link and that people should not panic.
At least 13 EU member states, including Germany, France and Italy, have suspended the use of the injection pending the outcome of the EMA investigation.
This is what we know so far:
WHAT HAS HAPPENED?
More than 45 million COVID injections have been given from all manufacturers in the EU and the European Economic Area since vaccinations began almost three months ago.
The EMA is investigating reports of 30 cases of unusual blood disorders from 5 million people who received the AstraZeneca vaccine in the EU.
The focus and main concern of EMA is cases of blood clots in the head, a rare and difficult-to-treat condition called cerebral venous thrombosis (CVT).
In Germany, seven people between the ages of 20 and 50 have been diagnosed with CVT up to 16 days after vaccination according to Monday, according to the national vaccine authority Paul Ehrlich Institute (PEI). Based on the known rate of CVT in the general population, the PEI would have expected one case in every 1.6 million.
WHAT HAVE OTHER COUNTRIES AND ASTRAZENECA SAID?
Britain has administered more than 11 million doses of the AstraZeneca vaccine, and reports of blood clots were no greater than would have occurred naturally. The UK drug regulator has urged Britons to keep getting their vaccines, including the AstraZeneca injection.
Canada has said that health experts are confident that all COVID-19 vaccines administered in the country are safe, including that from AstraZeneca.
AstraZeneca said on Sunday that a review of the safety data of more than 17 million people vaccinated in the UK and the European Union with its vaccine had shown no evidence of an increased risk of blood clots.
WHAT IS THE EMA RESEARCHING?
EMA researchers are testing whether the incidence rate is higher in the vaccinated population than normal history rates.
The normal frequency is taken from public health statistics or insurance records. This would be combined with a medical analysis of each case and knowledge of the scientific literature.
EMA’s head of security monitoring, Peter Arlett, added that CVT’s rarity meant that the watchdog would have to rely more on case-by-case analysis than on sparse statistical data.
A spokeswoman for Germany’s vaccine authority, which is part of the investigation, said the EMA would not rule on causation.
Instead, the EMA will assess the likelihood of an increased risk of the condition and compare it to the benefits of fighting COVID-19 and providing relief to healthcare systems.
For example, the vaccines developed by Pfizer and Moderna have been linked to an increased risk of anaphylaxis, but are still recommended because the benefits outweigh the risks of the side effect, which can be treated.
The regulator has said that, for now, it remains “firmly convinced” that the benefit of the product outweighs any risk.
WHAT DID THE CLINICAL TRIALS SHOW?
AstraZeneca and European regulators have said that concerns about blood clotting disorders did not arise during human trials.
Monitoring safety after approval is key because extremely rare side effects, or those that affect only a small subset of the population, are nearly impossible to identify during clinical trials, according to PEI.
ARE THERE A PRECEDENT OF VACCINE SAFETY ISSUES?
In Japan, a government recommendation for the use of the human papillomavirus (HPV) vaccine to prevent cervical cancer has been suspended since June 2013, due to media reports of a suspected pain syndrome. This has drawn criticism from the WHO.
A study published in The Lancet Public Health last year concluded that a continued suspension would lead to thousands of cancer deaths over the next several decades.
In Ukraine https://www.reuters.com/article/us-health-measles-ukraine-insight-idUKKBN1XE15T, deep mistrust of vaccines has allowed measles to become an epidemic. Doubts about vaccines are rooted in corruption and mistrust of authority, but also in a temporary suspension from the government in 2008, when a 17-year-old died shortly after receiving the measles and rubella vaccine.
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