[약업신문]EMA reaffirms effectiveness of corona vaccine outperforms risk

“The expected effectiveness of vaccination exceeds the risk.”

The safety management committee (PRAC) under the European Medicines Authority (EMA) held an extraordinary meeting on the 18th, and some people who received AstraZeneca’s’Corona 19′ vaccine’COVID-19 vaccine AstraZeneca’ had symptoms of thrombosis and A related preliminary review was conducted.

On this day, PRAC once again confirmed its position that while the threat from’Corona 19′ is still spreading, the efficacy expected from vaccination exceeds the risk of accompanying side effects.

In addition, PRAC said that AstraZeneca’s’Corona 19′ vaccine was not associated with an increased risk of thrombosis in vaccinated subjects.

He explained that there was also no evidence to support that the problem originated from the particular batch or place of manufacture of the vaccine.

However, he noted that the’Corona 19′ vaccine appears to be accompanied by symptoms of thrombosis related to thrombocytopenia, with or without bleeding very rarely.

He added that there were rare cases of cerebral sinus thrombosis (CVST) that were accompanied by thrombosis symptoms.

As of March 16, a total of 20 million people in the UK and the European Economic Area (EEA) had been vaccinated against AstraZeneca’s’Corona 19′ vaccine. It was revealed that the review was conducted on 18 cases of disseminated intravascular coagulation (DIC) and cerebral sinus thrombosis.

In the case of such side effects, he stressed that the causal relationship was not proven.

However, it is possible that there is a correlation, so it seems that further analysis is needed, he added.

On this day, PRAC experts participated in the review process, and in this process, countries including the Medicines and Medical Device Safety Management Bureau (MHRA) under the UK Ministry of Health overseeing AstraZeneca’s’Corona 19′ vaccination to a total of 11 million people so far. He said it has worked closely with health authorities in the country.

When looking at the number of thromboembolic symptoms, including test cases made before approval and cases reported after entering the vaccination campaign, all cases were reported after vaccination, but compared to the level expected in the general public. PRAC evaluated that it corresponds to.

Accordingly, PRAC confirmed that overall risk of thrombosis did not increase.

Nevertheless, he noted that rare cases in younger patients appear to need to be monitored.

According to PRAC, as a result of a review by experts, disseminated intravascular coagulation and cerebral sinus thrombosis were reported in EU member states, and nine of the reported cases died.

Most of these were in the age group under the age of 55, and the proportion of women was high.

PRAC pointed out that it is difficult to estimate the mortality rate if they were not vaccinated, as reported cases are rare and’Corona 19′ itself does not cause thrombotic disorders.

However, the original estimate stated that among the vaccinations under 50 years of age as of March 16, less than one disseminated intravascular coagulation was expected within 14 days after vaccination, whereas five cases were reported.

Similarly, it was recalled that in the case of cerebral sinus thrombosis, an average of 1.35 cases were expected to accompany in the same age group, while 12 cases occurred at the time of cutoff.

In contrast, he added that this imbalance was not noticeable in the elderly who received the vaccine.

PRAC, however, made it clear that the proven efficacy of vaccination in preventing hospitalization or death due to’Corona 19′ outweighs the possibility of accompanying disseminated intravascular coagulation or cerebral sinus thrombosis in some very rare cases.

However, vaccinators were reminded that the possibility of such problems could not be ruled out, and when signs of thrombosis appeared, they requested that medical personnel be notified and treated immediately.

Meanwhile, PRAC plans to conduct additional reviews on the risks associated with other types of’Corona 19′ vaccines.