A field of Novavax Covid-19 vaccine is organized at a pharmacy in Schwanksville, Pennsylvania, United States, on Monday, August 1, 2022.

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Biotechnology firm Novavax introduced Friday that its COVID-19 vaccine has been approved by the US Meals and Drug Administration for emergency use for adolescents aged 12 to 17 years.

In July, Novavax’s two-dose COVID-19 vaccine for adults 18 years of age and older acquired emergency approval from the FDA.

Having extra vaccine choices for adults and youngsters will “hopefully assist improve vaccination charges, particularly as we put together for the continuing COVID-19 surge with the beginning of fall and the back-to-school season.” do,” Stanley C. Erk, President and CEO Novavax, stated in a press release.

Novavax was one of many authentic contributors within the US authorities’s race to develop a COVID vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Velocity. Nevertheless, the small Maryland biotech firm struggled to start out manufacturing shortly and its medical trial information had been learn a lot later than rivals Pfizer or Moderna.

A senior FDA official, Dr. Peter Marks, has stated that Novavax’s vaccine will doubtlessly attraction to individuals who haven’t been vaccinated who would like a shot that’s based mostly on messenger RNA know-how utilized by Pfizer and Moderna. Not there.

How is Novavax Completely different?

The Novavax shot relies on the extra conventional proteinase know-how used for many years within the hepatitis B and HPV vaccines, whereas Pfizer and Moderna are the primary FDA-approved vaccines to make use of mRNA.

Pfizer and Moderna’s vaccines use mRNA, a molecule encoded with genetic directions, to inform human cells to make copies of a virus particle known as a spike protein. The immune system reacts to those copies of the spike, getting ready the human physique to assault the precise virus.

Novavax makes copies of the virus spike exterior human cells. Spike’s genetic code is put into an insect virus that infects insect cells, which produces copies which are then purified and extracted in the course of the manufacturing course of. The ready spike copies are injected into the human physique, triggering an immune response towards COVID.

The Novavax vaccine additionally makes use of an extra ingredient known as an adjuvant, which is extracted and purified from the bark of a tree in South America, to induce a broad immune response. Photographs include 5 µg of spike copy and 50 µg of adjuvant.

effectiveness and security

Based on information from medical trials within the US and Mexico, two doses of the Novavax vaccine had been 90% efficient in stopping illness from COVID throughout the board and 100% in stopping extreme illness. Nevertheless, the trial was carried out from December 2020 to September 2021, months earlier than the Omicron model went into impact.

Novavax offered no information on the shot’s effectiveness towards the variant at an FDA committee assembly in June. Nevertheless, the vaccine’s effectiveness towards Omicron will likely be low, as is the case with photographs from Pfizer and Moderna. Omicron is so completely different from the unique pressure of Covid that the antibodies produced by the vaccines have bother recognizing and attacking the variant.

Novavax revealed information in December displaying {that a} third shot boosted an immune response in comparison with the primary two doses, with 90% effectiveness towards the illness. The corporate plans to ask the FDA to authorize a 3rd dose of its vaccine.

The FDA authorization of Novavax’s vaccines comes because the US prepares to replace the COVID photographs to focus on the BA.4 and BA.5 variants of Omicron to extend safety towards the virus. Novavax’s vaccine, like all different photographs, relies on the unique model of the virus that first emerged in Wuhan, China. The effectiveness of COVID vaccines towards gentle illness has largely decreased because the virus has advanced, though they nonetheless usually defend towards extreme illness.

Novavax offered information at an FDA committee assembly in late June displaying {that a} third dose of its vaccine produced a stronger immune response towards Omicron and its subtypes. Committee members had been impressed by the corporate’s figures on Omicron.

The Novavax vaccine additionally raises the chance of coronary heart irritation for younger males, often known as myocarditis and pericarditis, just like photographs from Pfizer and Moderna. Myocarditis is irritation of the center muscle and pericarditis is irritation of the outer layer of the center.

FDA officers flagged off 4 circumstances of myocarditis and pericarditis from a medical trial of Novavax in younger males aged 16 to twenty-eight. Individuals who develop coronary heart irritation as a aspect impact of COVID vaccines are often hospitalized for a number of days as a precaution, however then get well.

The FDA has issued a reality sheet for well being care suppliers warning that medical trial information point out an elevated threat of myocarditis with the Novavax vaccine. Based on the FDA, folks experiencing chest ache, shortness of breath and emotions of fluttering or pounding coronary heart ought to search medical assist instantly.

Within the case of mRNA photographs, the CDC has discovered that the chance of myocarditis is bigger with COVID an infection than by vaccination. Myocarditis is often attributable to a viral an infection.

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