Food and Drug Administration on The Covid-19 vaccine developed by Novavax was approved on Wednesday, A Maryland biotechnology company that received a large amount of federal funding to create shots. Vaccines will be a new option for Americans as vaccination rates are stagnant.
After two years of development, the vaccine eventually overcame manufacturing problems and became the fourth shot to obtain approval in the United States.The advisor of the Centers for Disease Control and Prevention Meet next week And it is expected to discuss who should be vaccinated with the Novavax vaccine.
The double dose vaccine was initially approved as a primary immune series for adults, rather than a booster that is likely to limit the market. Earlier this week, the Biden administration announced that it would buy enough 3.2 million doses to fully vaccinate 1.6 million people in the United States. In announcing the purchase, the government said Novavax plans to complete quality testing “in the coming weeks”, a necessary step before the dose is announced.
Novavax hopes the vaccine will appeal to those who have spurred shots from Pfizer-BioNTech and Moderna using messenger RNA technology.about 22% of people In the United States, we do not receive a single dose of the Covid vaccine.
The Novavax vaccine is given at 3-week intervals and works differently than the mRNA vaccine. It provokes an immune response with nanoparticles composed of proteins from the surface of the coronavirus that causes Covid-19. Similar protein-based vaccines have been widely used around the world for decades.
However, modest demand for Novavax shots in other wealthy countries is unclear if the company’s forecast for the United States will be maintained.of EuropeOnly 12.6 million Novavax doses were distributed during December, when the vaccine was available. approved In contrast, over a billion Pfizer-BioNTech and Moderna vaccines have been distributed in Europe.
A Morning Consult poll released earlier this month suggests that Nuvaxovid may face a similar lack of enthusiasm in the United States. Only 10 percent A percentage of unvaccinated people contacted for polls said they would definitely or perhaps get a protein-based vaccine.
The approval warns that the Novavax vaccine is associated with an increased risk of heart inflammation known as myocarditis and pericarditis. In a review of Novavax dataFDA scientists have identified 6 cases of side effects in approximately 40,000 study volunteers.
Moderna and Pfizer-BioNTech mRNA vaccines have also been associated with an increased risk of these conditions, but that association did not appear until extensive use.
Prior to the pandemic, Novavax was a lesser-known biotechnology company with several vaccines in its research pipeline, but no approved products. It became noticeable when Operation Warp Speed, the federal government’s 2020 campaign to develop the coronavirus vaccine, chose it for assistance. The program initially agreed to fund the development of the vaccine and pay up to $ 1.6 billion to buy up to 100 million injections.
However, a series of production delays meant that shots were not available for the first vaccination surge in the United States in early 2021.
The predicament of the manufacturing industry continues to plague the company. Even after the FDA Advisory Board recommended approval of the vaccine in early June, it took weeks for the FDA to approve the vaccine, as it took more time to approve the Novavax manufacturing process. The Serum Institute of India, the world’s largest producer of vaccines, manufactures Novavax vaccines.
In many clinical trials, Novavax has found that the vaccine is highly protective against symptomatic infections. However, the original formulation appeared in November and is probably not effective against Omicron variants that bypass some of the protection provided by other companies’ approved vaccines.
Novavax is developing a new version of the vaccine that targets Omicron and its highly contagious subvariants. Preliminary data Laboratory and animal studies have shown that booster shots targeting the previous Omicron subvariety, BA.1, produce a strong immune response against the virus.Company Say it’s expecting The results of the clinical trial of the shot will be available in September and the dose will be prepared in the last three months of this year.
The company says it plans to accelerate research on shots specially tuned for two new versions of Omicron known as BA.4 and BA.5.
Trials have also shown that Novavax shots work well as boosters, and the company is expected to seek booster approval soon. That way, the company may be able to attract vaccinated people who want to switch to new options to protect against new variants.
Weill Cornell virologist John Moore said he sees Novavax as a good vaccine, but he’s still not sure that the Omicron-based booster will provide much better protection compared to the original version. “There is too little information,” he said.
Dr. Moore speculated that some people would switch to Novavax as a booster this fall because of the relatively low pain, malaise, and other side effects they pass through in clinical trials. It was his experience as a volunteer on one of the Novavax exams. “The next day, the only way to find out which arm I had the needle in was Band-Aid,” he said.
If Novavax was found to have a booster effect, Dr. Moore would be happy to return to another shot, he said.
