The European Medicines Agency (EMA) said in a July 14 update: "The product information of [the] Nuvaxovid [vaccine] will be updated with severe allergic reaction and unusual or decreased feeling in the skin as new side effects." It added that following the assessment of the EMA's Pharmacovigilance Risk Assessment Committee, "anaphylaxis (severe allergic reaction) will be included in the EU product information as a side effect of Nuvaxovid."
According to the EMA, "a few cases" of anaphylaxis linked to the Novavax shot were reported – but the regulator refused to disclose the actual figure.
"Generally, cases reported spontaneously by a patient or healthcare professional concern suspected side effects – i.e. medical events that have been observed after vaccination – but which are not necessarily related to or caused by the vaccine."
The Epoch Times contacted the Maryland-based vaccine maker for comment, but did not receive a response as of writing.
According to The COVID Blog, the Novavax sub-unit protein vaccine delivers the SARS-CoV-2 spike protein using an insect virus. It also utilizes saponin from the soap bark tree (Quillaja saponaria) native to South America to trigger an immune response in the body.
Meanwhile, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) to the Novavax COVID-19 vaccine on July 13.
"Authorizing an additional vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death," FDA Commissioner Dr. Robert Califf said in a statement. He added that the EUA gives people another vaccine choice that meets the agency's "rigorous standards for safety, effectiveness and manufacturing quality."
The July 13 EUA issued by the regulator permitted the use of the two-dose vaccine, with an interval of several weeks, on adults aged 18 and up. In petitioning the FDA for an EUA, Novavax said it would market its vaccine to individuals who did not want to get the COVID-19 vaccines already authorized in the United States. Currently, the two-dose mRNA vaccines from Pfizer and Moderna and the single-dose adenoviral vector vaccine from Johnson & Johnson are authorized for use.
The vaccine's product label in the U.S. warned against injecting it to people with a history of allergic reactions to any of its components. But even before it was granted EUA, staffers at the FDA pointed out that the vaccine increased the risk of myocarditis. (Related: FDA warns of CARDIAC INFLAMMATION risk linked to the Novavax COVID-19 vaccine.)
In documents released June 3, staff members at the regulator cited four events of myocarditis – inflammation of the heart muscle – that occurred during clinical trials of the vaccine. Novavax conducted trials of its sub-unit protein vaccine on almost 30,000 patients between December 2020 and September 2021.
"These events raise the concern for a causal association with this vaccine, similar to the association documents with mRNA COVID-19 vaccines," they noted.
"Data from passive surveillance during post-authorization use in other countries also indicate a higher than expected rate of myocarditis and pericarditis [heart lining inflammation] … associated with the vaccine. Further evaluation is needed to inform the risk of myocarditis and pericarditis, and their outcomes, as additional data emerge over time."
Watch the video below as Dr. Jane Ruby warns against the dangers of the Novavax COVID-19 vaccine.
This video is from the Truth or Consequences channel on Brighteon.com.