After a six-week delay, the US Food and Drug Administration approved Novavax’s Covid-19 vaccine, according to a letter from the agency, but people over the age of 65 and above, and those over the age of 12 with at least one underlying condition, are at increased risk for severe illness.
“Market research and US CDC statistics show that older people and those with underlying conditions are the population most likely to seek Covid-19 vaccinations each season,” Novavax president and CEO John Jacobs said in a statement on Saturday. “This important milestone demonstrates our commitment to these populations and is an important step towards the availability of protein-based vaccine options.”
The Centers for Disease Control and Prevention in the US lists a wide range of conditions that can lead to severe illnesses due to Covid-19, including age, asthma, diabetes, lung disease, obesity, and pregnancy.
The Novavax Covid-19 vaccine, which uses traditional protein-based technology over Pfizer/BioNTech and Moderna mRNA vaccines, has been subject to emergency use permits since 2022.
The Novavax vaccine was on track to fully approve April 1, but the FDA delayed the decision while seeking more data, sources told CNN. A new approval issued Friday requires vaccine recipients to implement Novavax to consider the risk of inflammation of myocarditis and pericarditis – inflammation of the membranes surrounding the myocardium and heart.
These conditions have not been reported after receiving the Covid-19 vaccine, according to the U.S. Centers for Disease Control and Prevention. A small number of cases have been reported in Novavax vaccine trials, suggesting an increased risk, the CDC notes. However, the CDC and the Advisory Committee on Vaccination Practices have said the rare risk of cardiac inflammation in all groups recommended for vaccination outweigh the benefits of Covid-19 vaccination.
CDC’s vaccine advisors are considering changing the agency’s guidance for those who should win the annual Covid-19 shot. At last month’s meeting, the committee discussed recommendations focusing on older people, people with weakened immune systems, and perhaps people who are more likely to be exposed to the coronavirus.
Robert F. Kennedy Jr., a secretary to the U.S. Department of Health and Human Services and a longtime anti-vaxious activist, mistakenly referred to the vaccine as a vaccine because of “the most deadly vaccine ever made,” and recently issued a misleading statement about the safety of a massive vaccine in the heart of West Texas.
HHS did not respond to requests for comment regarding Novavax approval.