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J&J resumes US rollout of single-dose COVID-19 vaccine

CDC and FDA recommended pause be lifted after ‘rigorous review’ of very rare blood clots

Rollout of Johnsons & Johnson’s (J&J) COVID-19 vaccine is primed to resume in the US after the US Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) recommended lifting the temporary pause on the jab.

The CDC and FDA recommended the pause following six reported cases in the US of a rare and severe type of blood clot – known as cerebral venous sinus thrombosis (CVST) – observed in individuals after receiving the single-dose J&J vaccine.

In these cases, the rare blood clots were seen in combination with low levels of blood platelets, known as thrombocytopenia.

According to the CDC and FDA, nearly all reports of these events were observed in adult women younger than 50 years old.

Following its review, the regulators said that at this time, the vaccine’s benefits outweigh its risks, although they added that women under the aged of 50 should be aware of the rare but increased risk of very rare blood clots with low platelets.

“We have concluded that the known and potential benefits of the [J&J] COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older,” said acting FDA commissioner Janet Woodcock.

“We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider,” she added.

On 20 April, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) also confirmed that the overall benefit-risk profile of Johnson & Johnson’s (J&J) COVID-19 vaccine is positive.

The PRAC concluded, however, that a warning regarding unusual blood clots with low blood platelets should be added to the product information for the vaccine, after finding a possible link between the rare adverse events and the jab.

A ‘plausible’ explanation for the combination of blood clots and low blood platelets observed following vaccination could be an immune response, according to the EMA.

This leads to a condition that is similar to heparin induced thrombocytopenia (HIT) that can be seen in patients treated with the anticoagulant heparin.

“As the global pandemic continues to devastate communities around the world, we believe a single-shot, easily transportable COVID-19 vaccine with demonstrated protection against multiple variants can help protect the health and safety of people everywhere,” said Paul Stoffels, chief scientific officer of J&J.

We will collaborate with health authorities around the world to educate healthcare professionals and the public to ensure this very rare event can be identified early and treated effectively,” he added.

Article by
Lucy Parsons

26th April 2021

From: Regulatory

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