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AstraZeneca (AZN) COVID-19 Jab's New Side Effect Stated by EMA

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The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) issued a recommendation that people who have previously suffered from capillary leak syndrome should not be inoculated with AstraZeneca’s AZN COVID-19 vaccine, Vaxzevria. The committee also recommended adding capillary leak syndrome as a side effect on Vaxzevria’s product label to increase awareness of this risk.

Capillary leak syndrome is a rare disorder characterized by massive leakage of plasma from blood vessels, which swells up arms and legs and results in low blood pressure, thickening of the blood and low blood levels of albumin.

The PRAC reviewed six cases of capillary leak syndrome in people, mostly women, given Vaxzevria. Three of the six people had a history of the condition while one of the persons died.

This year so far, AstraZeneca’s shares have risen 17.5% compared with an increase of 8.7% for the industry.

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The latest recommendation adds to AstraZeneca’s woes surrounding its vaccine’s use. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and EMA in April found a possible link between AstraZeneca’s AZN COVID-19 vaccine and rare blood clot events in the brain of adults who have received the shot.

The PRAC, back then, had recommended to list the unusual blood clots with low blood platelets as a rare side effect of the vaccine.

Though MHRA said that benefits of vaccination continue to outweigh any risks, the U.K’s Joint Committee on Vaccination and Immunisation (JCVI) recommended that individuals below 30 years of age should opt for an alternative vaccine available in the country.

Reportedly, on Jun 13, leading EU drugs regulator recommended that AstraZeneca’s shot should be avoided in people over the age of 60. Italy’s government on Friday suspended use of AstraZenecas vaccine in people under 60 years of age.

We remind investors that in March, many European countries, including Germany, France and Italy had temporarily paused vaccinations with AstraZeneca’s jab following some reports of blood clots in people who had received the shot. However, the PRAC, concluded there was no increase in the overall risk of blood clots with the use of AstraZeneca’s vaccine. Germany, France, Italy and some other European nations later resumed using AstraZeneca's COVID-19 vaccine after EMA’s report. Some countries however restricted its use in younger people.

AstraZeneca’s vaccine is approved for temporary/conditional use in more than 50 countries including the European Union. However, it has not yet received authorization from the FDA.

At present, Pfizer PFE-BioNTechs BNT162b2 and Moderna’s MRNA mRNA-1273 and J&J’s JNJ single shot vaccine are available in U.K and EU countries. J&J’s vaccine has also been linked to such rare blood clot events.

Meanwhile the PRAC continues to review cases of myocarditis and pericarditis, both conditions of heart inflammation, which have been mainly linked to people vaccinated with mRNA vaccines, Pfizer’s Comirnaty (brand name of BNT162b2 in EU) and Moderna’s mRNA-1273

AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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AstraZeneca PLC (AZN) : Free Stock Analysis Report

Johnson & Johnson (JNJ) : Free Stock Analysis Report

Pfizer Inc. (PFE) : Free Stock Analysis Report

Moderna, Inc. (MRNA) : Free Stock Analysis Report

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