The Covid-19 vaccine produced by the biotechnology firm Novavax has received approval from the U.S. Food and Drug Administration for use in teenagers between the ages of 12 and 17 in an emergency situation.
The two-dose Covid-19 vaccine for individuals 18 and older received emergency FDA approval in July.
More adult and paediatric vaccine alternatives would “perhaps assist raise immunisation rates, particularly as we prepare for continuous spikes of Covid-19 with the start of fall and the back-to-school season,” according to Stanley C. Erck, president and chief executive officer of Novavax.
In the U.S. government’s race to create a Covid vaccine in 2020, Novavax was one of the original competitors and received $1.8 billion in taxpayer financing from Operation Warp Speed. The small Maryland biotech startup, however, struggled to set up manufacturing fast, and its clinical trial results were read out much later than those of competitors Pfizer or Moderna.
Senior FDA official Dr. Peter Marks has stated that the vaccine developed by Novavax may appeal to unvaccinated individuals who would prefer a shot that is not based on the messenger RNA technology utilised by Pfizer and Moderna.
What Makes Novavax Different
The Pfizer and Moderna vaccines are the first FDA-approved vaccines to use mRNA, whereas the Novavax shot is based on more traditional protein technology used for decades in hepatitis B and HPV vaccines.
To command human cells to create duplicates of a virus particle known as the spike protein, Pfizer and Moderna’s vaccines use mRNA, a molecule loaded with genetic instructions. These spike copies trigger the immune system’s reaction, which primes the body to combat the actual virus.
Novavax causes the virus to replicate outside of human cells. The moth cells that the spike’s genetic code is placed into make copies that are later removed and purified throughout the production process. A human immune response against Covid is induced by injecting the finished spike copies into the body.
To stimulate a more extensive immune response, the adjuvant, an additional component used in the Novavax vaccine, is collected and purified from the bark of a South American tree. The doses contain 50 micrograms of adjuvant and 5 mcg of spike copy.
Safety And Effectiveness
According to clinical study data from the United States and Mexico, two doses of the Novavax vaccine were 90% effective at preventing Covid disease overall and 100% effective at preventing severe sickness. However, the trial was carried out in the months before the omicron form gained dominance, from December 2020 to September 2021.
At the FDA committee meeting in June, Novavax did not offer any information regarding the effectiveness of the shot against the variant. As is the case with Pfizer and Moderna’s shots, the vaccine’s efficacy against omicron is anticipated to be lower. Omicron is sufficiently different from the initial Covid strain that Omicron is difficult for the vaccine-produced antibodies to identify and combat.
The third shot increased the immune response to levels comparable to the previous two doses, which had 90% efficiency against disease, according to data published by Novavax in December. The business intends to request that the FDA approve a third dose of its vaccine.
The U.S. is getting ready to alter Covid injections to target the omicron BA.4 and BA.5 strains to boost protection against the virus as the FDA approves Novavax’s vaccines. The vaccine produced by Novavax, like all the others, is based on the virus’s initial emergence in Wuhan, China. As the virus mutated, Covid vaccines’ effectiveness against mild illness plummeted, although they still typically provide protection against severe disease.
A third dosage of Novavax’s vaccine showed a potent immune response against omicron and its subvariants, according to data that the company presented at an FDA committee hearing in late June. The company’s data on omicron impressed the committee members.
Similar to Pfizer and Moderna’s doses, the Novavax vaccination appears to entail a risk of myocarditis and pericarditis, known as a heart inflammation, for younger men. Myocarditis and pericarditis are both inflammatory conditions of the heart’s muscle and outer membrane, respectively.
Four myocarditis and pericarditis instances from Novavax’s clinical trial in young males between the ages of 16 and 28 were flagged by FDA inspectors. The majority of Covid vaccination adverse effect sufferers are hospitalised for a few days as a precaution before making a full recovery.
The FDA has released a fact sheet for medical professionals warning that there may be an elevated risk of myocarditis with the Novavax vaccination, according to evidence from clinical trials. According to the FDA, people who experience chest pain, shortness of breath, or symptoms of their heart fluttering or thumping should visit a doctor right once.
The CDC has discovered that, in the case of the mRNA shots, the risk of myocarditis is higher from infection with Covid than from immunisation. Viral infections are frequently the cause of myocarditis.