FDA says that many people who had shots of Novavax Vaccine developed some cardiac complications like myocarditis and endocarditis (inflammation of the muscles of the heart)
Since the start of the Coronavirus or Covid-19 pandemic in 2020, the scientific understanding of the disease, its transmission, prevention, and treatment (like monoclonal antibodies therapy) has evolved and is still growing.
In continuation of the evolution of Covid-19 vaccines, there are questions around the efficacy of the Covid-19 vaccines and the complications after administration of these vaccines.
The brand names of Novavax Vaccine are Nuvaxoid and Covovax. Unlike mRNA and Vector vaccines, Novavax Covid-19 Vaccine is a protein adjuvant vaccine.
It contained the spike protein of coronavirus and takes a different approach by strengthening the immune response of the body.
However, other vaccines trick the body’s cells into creating the virus and trigger the immune system.
Novavax Inc. claims 90% effectiveness against lab-confirmed symptomatic infection and 100% against moderate to severe disease in phase 3 trials results released in the month of December 2021.
Now the Novavax Vaccine is in the news because Food and Drug Administration has expressed concern that six people have myocarditis and pericarditis (inflammation of heart muscles).
However, the effectiveness of the Novavax Covid-19 Vaccine was claimed ~90% during the trials. But this performance came before the spread of the Omicron variant which eluded vaccines more than earlier strains.
Novavax Covid-19 Vaccine is effective but Signals Safety Worry
FDA has raised concern about the safety of the Novavax Covid-19 Vaccine and its after-effects. Agency has released its evaluation of Novavax’s Covid19 Vaccine ahead of the meeting of outside advisers who are scheduled to discuss Novavax’s submission and whether the agency should recommend authorization and approval of the vaccine shot.
The FDA staff’s appraisal advised the vaccine could face many rounds of questioning from advisers on the efficacy of the vaccine against the Omicron strain and with a potentially high risk of myocarditis and other heart health conditions.
A total of 6 people developed myocarditis and endocarditis a kind of inflammation of heart muscles, out of 40,000 people who had taken Novavax’s shot during various studies which is a big cause of concern.
One person who had gotten the placebo also developed the symptoms of myocarditis, the FDA said.
But of the six myocarditis and pericarditis cases among Novavax Vaccine recipients, five had developed myocarditis within two weeks of vaccination. All 5 patients required hospitalization, FDA said.
What Does Novavax Company Say?
The Novavax company said that there is not enough data and evidence to prove the FDA claim that its shot caused myocarditis and endocarditis.
The vaccine is already approved in more than 40 countries worldwide and has shown good results but the authorization in the United States was delayed due to manufacturing challenges.
Approved Covid-19 Vaccines in the United States of America
Three coronavirus vaccines are approved in the United States of America, including mRNA, or RNA, vaccines from Pfizer, BioEntech SE, and Moderna.
Pfizer – BioNTech (Brand Name: Comiranty)
It was granted full Food and Drug Administration in August 2021 for ages 16 and above, this is an mRNA vaccine, which is relatively a new technology. Pfizer vaccine to be stored at freezer level temperature.
Moderna (Brand Name: Spikevax)
The FDA granted full approval to the modern vaccine in January 2022 for people 18 and older, upgrading the vaccine’s EUA, which was given in December 2020. It also uses mRNA technology and had similarly high efficacy. It also requires a freezer level temperature to store and transport.
Johnson & Johnson (Brand Name: Janssen)
It was approved by FDA in February 2021. This is a virus vector or carrier vaccine, a type of vaccine which has already been used before for Flu. Johnson & Jonson vaccine is a one-shot vaccine and full effectiveness comes after two weeks of shot.