According to a letter from the US Food and Drug Administration, the Covid-19 vaccine from Novavax has been approved after a six-week delay, but only for individuals aged 12 and up and those 65 and over who have at least one underlying disease that increases their chance of developing a serious illness.
In a statement released on Saturday, Novavax President and CEO John Jacobs stated, “Market research and US C.D.C. statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out Covid-19 vaccination seasonally.” “This important milestone is a major step towards the availability of our protein-based vaccine option and demonstrates our commitment to these populations.”
According to the US Centres for illness Control and Prevention, a number of factors, such as advanced age, diabetes, asthma, lung illness, obesity, and pregnancy, can increase a person’s risk of developing a serious case of COVID-19.
Since 2022, emergency use authorisation has been granted for the Novavax Covid-19 vaccine, which employs a more conventional protein-based technology than the mRNA vaccines produced by Pfizer/BioNTech and Moderna. The FDA has approved Pfizer and Moderna’s vaccines for use in individuals aged 12 and older, and they are still available for youngsters as young as six months under emergency use authorisation.
According to a source who spoke to CNN, Novavax’s vaccine was scheduled for complete approval on April 1st, but the FDA postponed the decision while requesting additional evidence. According to the updated approval letter sent on Friday, Novavax must carry out postmarketing research examining the risk of myocarditis and pericarditis, which are inflammations of the heart muscle and surrounding membrane, in vaccination recipients.
The US Centres for Disease Control and Prevention report that these problems have been documented infrequently following Covid-19 immunisation. According to the CDC, a small number of instances were documented during the Novavax vaccine’s trials, indicating a higher risk. But according to the CDC and its Advisory Committee on Immunisation Practices, in all populations that are advised to get vaccinated, the advantages of the Covid-19 vaccine exceed the infrequent risk of heart inflammation.
Changes to the CDC’s recommendations for who should receive a yearly Covid-19 vaccination are being considered by the agency’s vaccine advisors. The committee reviewed a recommendation at its meeting last month that targeted older folks, people with compromised immune systems, and maybe others who are more susceptible to coronavirus exposure.
In the midst of a widespread outbreak centred in West Texas, Robert F. Kennedy Jr., the secretary of the US Department of Health and Human Services and a long-time opponent of vaccinations, has wrongly referred to Covid-19 vaccines as “the deadliest vaccine ever made” and, more recently, made false claims regarding the safety of the measles vaccine.
A request for comment on the approval of Novavax was not answered by HHS.
