The EMA has included myocarditis and pericarditis as new side effects in the Novavax vaccine information. Here is what data the decision is based on
Nuvaxovid, Novavax's Covid vaccine has never been lucky from the start. Having arrived late compared to its competitors, it had to convince the undecided because it was made "the old way" with proteins and adjuvants and, instead, it remained in the refrigerators.
Now another cold shower. If it had not met the sympathies of the most skeptical before, the news of the European Medicines Agency (EMA) of a possible link between the Novavax vaccine and some cases of myocarditis and pericarditis will certainly not help.
WHAT THE EMA SAID
On Wednesday, the EMA Drug Risk Supervisory Committee (PRAC), based on a small number of cases of myocarditis and pericarditis reported following the administration of Nuvaxovid, determined that there may indeed be a link.
"The Committee – reads the safety update of the Ema Covid vaccines – therefore recommends including myocarditis and pericarditis as new side effects in the information on the Nuvaxovid product, together with a warning to raise awareness among health professionals and people who receive this vaccine ”.
"The Committee – continues the document – has also requested the holder of the marketing authorization to provide further data on the risk of the onset of these side effects".
THE CASES OF MYOCARDITIS AND PERICARDITIS
The EMA, in addition to evaluating the cases, noted that the Australian Therapeutic Goods Administration (TGA) had also recently added pericarditis to the product information as a side effect of "unknown frequency".
The TGA, the report reports, has received a small number of reports of suspected myocarditis and / or pericarditis in people given the Nuvaxovid vaccine. After evaluating them according to a series of internationally accepted criteria, it was found that 3 cases could represent myocarditis and 12 could represent pericarditis.
For the Prac, as of 31 May, out of approximately 210,000 vaccine doses administered in the EU, 5 cases of myocarditis and / or pericarditis were reported.
Along with the risk of myocarditis and pericarditis, anaphylaxis, a severe allergic reaction, will also be added to the new side effects of Nuvaxovid. Generally, cases reported by a patient or a healthcare professional involve suspected side effects, i.e. medical events observed after vaccination, but not necessarily related to or caused by the vaccine. Therefore, the frequency for anaphylaxis will also be defined as “unknown”.
The episodes of anaphylaxis, on July 14, had caused the shares of Novavax to drop by 26.2%.
PARESTHESIA AND HYPOESTHESIA
The same goes for other side effects such as paraesthesia (unusual skin sensation, such as tingling or crawling) and hypoesthesia (decreased sensation, especially of the skin).
So far, reports the EMA, 189 cases of paraesthesia and 67 of hypoesthesia have been reported worldwide for more than 1.5 million vaccine doses distributed as of May 31, 2022.
The Novavax vaccine side effect update comes one month after the European Commission's approval of the extended conditional marketing authorization for Nuvaxovid in adolescents in Europe aged 12 to 17 years.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/vaccino-novavax-che-succede-con-i-casi-di-miocarditi-e-pericarditi/ on Fri, 05 Aug 2022 12:19:21 +0000.