The U.S. Food and Drug Administration (FDA) has addressed the risk of immune thrombocytopenia (ITP) with the Johnson & Johnson (J&J) COVID vaccine.
The FDA issued a letter to Janssen Pharmaceutical Companies – the developer of the J&J vaccine – on Tuesday, alerting it of the change.
The letter says, “Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of immune thrombocytopenia (ITP) during the 42 days following vaccination.”
ITP is a disorder that can lead to easy or excessive bruising and bleeding, according to Mayo Clinic. The bleeding results from unusually low levels of platelets – the cells that help blood clot.
The FDA noted that the risk of experiencing ITP after vaccination is low, but people with a history of ITP should consult their medical providers before receiving the J&J jab.
The agency said those who have already received the vaccine should seek medical attention right away if they experience any symptoms of unusual or excessive bleeding, easy or excessive bruising, or tiny blood spots under the skin, especially at the site of injection.
In December 2021, the Centers for Disease Control and Prevention (CDC) accepted advice from a group of experts to recommend the use of the m-RNA based Pfizer-BioNTech and Moderna COVID vaccines over the J&J jab due to growing concerns about rare blood clots.
However, the J&J vaccine will still be available to individuals who are not able or willing to get an mRNA vaccine.
Meanwhile, South Korea has approved the use of the Novavax vaccine (Nuvaxovid), which will be manufactured and marketed by SK bioscience, the company announced on Wednesday. Also, the country is preparing to distribute Pfizer’s anti-COVID pill Paxlovid in order to pre-empt a surge of Omicron infections.
Nuvaxovid is the first protein-based COVID vaccine authorized in South Korea, which will be recommended to people who are 18 and above. The company said SK bioscience already has an advanced purchase agreement with the government for 40 million doses.
Stanley Erck, Novavax CEO, said, “Novavax is proud to bring our COVID-19 vaccine to South Korea at a critical time in the pandemic as both the Delta and Omicron variants have taken hold.”
The European Medicines Agency (EMA) said of the approval, “Taken together, the results of the two studies show a vaccine efficacy for Nuvaxovid of around 90%.”
“The original strain of SARS-CoV-2 and some variants of concern such as Alpha and Beta were the most common viral strains circulating when the studies were ongoing,” it added. “There is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron.”
