Novavax Requires Extra Warnings One Day After Receiving Emergency Use Authorization

After months of deliberation, the FDA granted Novavax Emergency Use Authorization as the fourth COVID-19 vaccine in the US and the second non-mRNA vaccine. A day later, though, the European Medicines Agency (EMA) required Novavax to add safety warnings to the product, including the risk of anaphylaxis, paraesthesia and hypoaesthesia, and myocarditis and pericarditis. 

America’s First Protein-Based COVID-19 Vaccine

The FDA announced on July 13 that it granted Emergency Use Authorization to Novavax’s adjuvanted COVID-19 vaccine. It is the first protein-based COVID-19 vaccine authorized for use in the US.

The Novavax COVID-19 vaccine contains the SARS-CoV-2 spike protein for the body to develop antibodies against COVID-19 with Matrix-M adjuvant to elicit a more robust immune response. Novavax makes the spike protein with genetically modified insect cells. 

The FDA based the EUA on the PREVENT-19 clinical trial, which enrolled about 30,000 patients from the US and Mexico. The Novavax vaccine demonstrated 90.4% efficacy among the participants with limited adverse reactions. 

Several companies looked to protein-based COVID-19 vaccines early on in the pandemic, but due to restrictions in the manufacturing process, protein-based vaccines were always projected to take longer to develop. Since then, companies like Medigen, Clover, and Sanofi have developed protein-based COVID-19 vaccine candidates, but none of them have proven as safe or effective as Novavax. 

Novavax is authorized for use throughout the European Union, Canada, Australia, New Zealand, Japan, South Korea, Indonesia, Thailand, Singapore, and Bangladesh. Its most recent approval in the US isn’t just another notch in its belt. It might be its most considerable notch in one of the biggest pharmaceutical markets in the world. 

President and CEO of Novavax, Stanley C. Erck, said, “This authorization reflects the strength of our COVID-19 vaccine’s efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues.”

The FDA’s statement noted that Novavax would continue to evaluate the vaccine’s safety, particularly regarding the risk of myocarditis and pericarditis. 

Related Article: FDA Panel Recommends Novavax To Be Fourth Authorized COVID-19 Vaccine in America

Additional Safety Warnings to Novavax COVID-19 Vaccine

The EMA issued a safety update on July 14 regarding all European-approved COVID-19 vaccines. Of the six approved vaccines, Novavax (marketed as Nuvaxoid in Europe), Spikevax (Moderna), and Vaxzevria (AstraZeneca) received additional safety updates. 

The first additional safety warning for Novavax regards a small number of anaphylaxis (severe allergic reaction) cases associated with the vaccination. Patients or healthcare providers ‘spontaneously’ reported a few cases of anaphylaxis after receiving a Novavax vaccination. ‘Spontaneous’ reports are medical events observed after administration of the vaccine but are not definitively caused by the vaccine. 

Novavax must also disclose the risk of paraesthesia and hypoaesthesia associated with vaccination. Paraesthesia is an unusual tingling or crawling sensation in the skin, and hypoaesthesia is marked by a decreased sensitivity or feeling, especially in the skin. Of the 1.5 million doses administered by May 31 this year, 189 reported cases of paraesthesia and 67 cases of hypoaesthesia were reported. The EMA said that generally, these cases were also ‘spontaneously’ recorded. Vaxzevria received a similar notice for the risk of paraesthesia and hypoaesthesia, which occurs in less than 1 in 100 people. 

The final safety update for Novavax is common among mRNA COVID-19 vaccines; the risk of myocarditis or pericarditis, inflammation conditions of the heart. Of 210,000 Novavax doses administered in the European Union and the European Economic Area by May 15 this year, 5 cases of myocarditis or pericarditis were reported after administration. 

The EMA is still assessing the risk of myocarditis and pericarditis and has not yet required a change to product labeling, but the Australian Therapeutic Goods Administration (TGA) added the risk of pericarditis to Novavax’s product label. The TGA decided after 160,000 doses of Novavax resulted in 12 cases “likely to represent pericarditis.” 

Novavax responded the same day but only responded to the anaphylaxis updates. The Maryland-based company said it received two reports of anaphylaxis cases that met “a probable/definite case definition.” Novavax said it reported no severe allergic reactions during the clinical development of its vaccine but agreed to update the label and continue monitoring the situation. 

After years of development, Novavax’s protein-based COVID-19 vaccine received FDA authorization, but it may still have some way to go to prove its safety for larger populations. As more doses are administered, safety trends will become clearer, and regulatory authorities and Novavax can adjust accordingly to keep the public safe. 

Author

Reed Slater