FDA authorizes emergency use for Novavax Covid-19 vaccine for ages 12 to 17

A field of the Novavax Covid-19 vaccine organized at a pharmacy in Schwenksville, Pennsylvania, US, on Monday, Aug. 1, 2022.

Bloomberg | Bloomberg | Getty Images

Biotechnology firm Novavax introduced on Friday that its Covid-19 vaccine has been approved for emergency use by the U.S Food and Drug Administration for adolescents between the ages of 12 and 17.

In July, Novavax’s two-dose Covid-19 vaccine for adults ages 18 and over bought its emergency approval from the FDA.

Having extra vaccine choices for adults and kids will “hopefully help increase vaccination rates, particularly as we prepare for ongoing surges of Covid-19 with the start of fall and the back-to-school season,” Stanley C. Erck, president and CEO of Novavax, mentioned in an announcement.

Novavax was one of many unique individuals within the U.S. authorities’s race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. However, the small Maryland biotech firm struggled to shortly get manufacturing in place and its scientific trial knowledge learn out a lot later than rivals Pfizer or Moderna.

Dr. Peter Marks, a senior FDA official, has mentioned that Novavax’s vaccine would doubtlessly enchantment to unvaccinated individuals who would favor a shot that’s not based mostly on the messenger RNA expertise utilized by Pfizer and Moderna.

How Novavax is totally different

The Novavax shot relies on extra typical protein expertise used for a long time in hepatitis B and HPV vaccines, whereas Pfizer and Moderna are the primary FDA-approved vaccines to use mRNA.

Pfizer and Moderna’s vaccines use mRNA, a molecule encoded with genetic directions, to inform human cells to produce copies of a virus particle known as the spike protein. The immune system responds to these copies of the spike, which prepares the human physique to assault the precise virus.

Novavax makes copies of the virus spike outdoors human cells. The genetic code for the spike is put into an insect virus that infects moth cells, which produce copies which are then purified and extracted in the course of the manufacturing course of. The completed spike copies are injected into the human physique, inducing 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 broader immune response. The pictures encompass 5 micrograms of the spike copy and 50 micrograms of the adjuvant.

Effectiveness and security

Two doses of the Novavax vaccine have been 90% efficient at stopping sickness from Covid throughout the board and 100% efficient at stopping extreme sickness, in accordance to scientific trial knowledge from the U.S. and Mexico. However, the trial was carried out from December 2020 by way of September 2021, months earlier than the omicron variant grew to become dominant.

Novavax didn’t current any knowledge on the shot’s effectiveness towards the variant on the FDA committee assembly in June. However, the vaccine will doubtless have decrease effectiveness towards omicron as is the case with Pfizer and Moderna’s pictures. Omicron is so distinct from the unique pressure of Covid that the antibodies produced by the vaccines have bother recognizing and attacking the variant.

Novavax printed knowledge in December exhibiting {that a} third shot boosted the immune response to ranges comparable to the primary two doses which had 90% effectiveness towards sickness. The firm plans to ask the FDA to authorize a 3rd dose of its vaccine.

FDA authorization of Novavax’s vaccines comes because the U.S. is getting ready to replace Covid pictures to goal the omicron BA.4 and BA.5 variants to improve safety towards the virus. Novavax’s vaccine, like all the opposite pictures, relies on the unique model of the virus that first emerged in Wuhan, China. The effectiveness of Covid vaccines towards delicate sickness has slipped considerably because the virus has developed, although they nonetheless usually defend towards extreme illness.

Novavax introduced knowledge at an FDA committee assembly in late June demonstrating {that a} third dose of its vaccine produced a powerful immune response towards omicron and its subvariants. (*17*) members have been impressed by the corporate’s knowledge on omicron.

The Novavax vaccine additionally seems to carry a danger of coronary heart irritation for youthful males, often called myocarditis and pericarditis, related to Pfizer and Moderna’s pictures. (*12*) is an irritation of the center muscle and pericarditis is irritation of the outer lining of the center.

FDA officers flagged 4 circumstances of myocarditis and pericarditis from Novavax’s scientific trial in younger males ages 16 to 28. People who develop coronary heart irritation as a aspect impact of Covid vaccines are normally hospitalized for a number of days as a precaution however then get well.

The FDA has issued a truth sheet for health-care suppliers warning that scientific trial knowledge signifies there may be an elevated danger of myocarditis with the Novavax vaccine. People who expertise chest ache, shortness of breath and emotions of a fluttering or pounding coronary heart ought to instantly search medical consideration, in accordance to the FDA.

In the case of the mRNA pictures, the CDC has discovered that the danger of myocarditis is increased from Covid an infection than vaccination. (*12*) is normally attributable to viral infections.


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