Novavax, a small U.S. company backed by generous support from the U.S. government, announced the results of clinical trials of the Covid-19 vaccine in the U.S. and Mexico on Monday, with two doses powerful against the coronavirus. Discovered to provide protection. ..
In a trial of 29,960 people, the vaccine was comparable to the vaccine manufactured by Pfizer-BioNTech and Moderna, showing an overall efficacy of 90.4 percent higher than the Johnson & Johnson one-shot vaccine. The Novavax vaccine has been shown to be 100% effective in preventing moderate or severe illness.
Despite these impressive results, the future of vaccines in the United States is uncertain and may be needed more in other countries. Novavax states that it will not be possible to seek an emergency permit from the Food and Drug Administration until the end of September. Also, due to the abundance of three other licensed vaccines, the agency may instruct Novavax to apply for a full license. This process can take several more months.
In an interview, the company’s CEO, Stanley Erck, confirmed that Novavax would probably get its first approval elsewhere. The company has also applied in the UK, European Union, India and South Korea.
“I think the good news is that the data is very compelling and gives everyone an incentive to pay attention to our submissions,” Elk said.
It may be too late for Novavax to contribute to the country’s first wave of vaccination by the time it gets a green light from the US government. However, many vaccine experts predict that at some point the country will need booster shots due to weakened immunity and the emergence of mutants. Also, the protein-based technology used in the Novavax vaccine may be particularly effective in enhancing protection, even if previously vaccinated with another formulation.
“They may be really right for boosters,” said Dr. Luciana Borio, who acted as FDA Chief Scientist from 2015 to 2017.
Last year, the Trump administration’s Operation Warp Speed program Award Novavax has a $ 1.6 billion contract for 100 million future doses.The company has gained this tremendous support Despite having never put a vaccine on the market In over 30 years.
In January, Novavax announced in a study of 15,000 people in the United Kingdom that the vaccine was found to be 96% effective against the original coronavirus. Efficacy was slightly reduced to 86% against alpha, the first viral variant identified in the United Kingdom. In South Africa, where Novavax conducted a small trial of 2,900 people and the beta version prevailed, the company found only 49% efficacy.
However, South African trials have been complicated by the fact that many volunteers are infected with HIV, which is known to interfere with the vaccine. In addition, the study was so small that it was difficult to estimate how much protection the vaccine provided to HIV-negative volunteers.
With the help of Operation Warp Speed, Novabax has planned for larger late trials in the United States and Mexico. However, due to manufacturing issues, the release was postponed until December.
By then, the United States had approved the Pfizer-BioNTech and Moderna vaccines. In February, the government approved Johnson & Johnson’s as the Novavax trial is still underway.
While waiting for the test results, Novavax has partnered with other companies to begin producing large quantities of the vaccine. In India, we worked with Serum Institute and in South Korea, we worked with SK Biosciences. Novavax has reached an agreement with its vaccine alliance, Gavi, to supply 1.1 billion doses to low- and middle-income countries.
However, the company’s scaling difficulties continued, requiring more time to develop special tests used to verify product quality.
The new results are based on 77 trial volunteers infected with Covid-19. Volunteers who received placebo shots were much more likely to get sick than volunteers who were vaccinated, and statistical differences were converted to 90.4 percent efficacy.
“This is a powerful result,” said Natalie Dean, a biostatistician at the University of Florida. “It puts them on top of that.”
The vaccine showed the same efficacy in a group of high-risk volunteers — people over the age of 65, who had medical risk factors or had jobs that were exposed to the virus.
Novavax sequenced 54 genomes out of 77 virus samples and found that half were Alpha. This is the variant that prevailed in the United States this spring.
The side effects of the vaccine were relatively mild. Some volunteers reported fatigue, headaches, and other minor symptoms. John Moore, a virologist at Weill Cornell Medicine, who volunteered for the Novavax trial, said:
According to the CEO, Novabax will apply for approval in the United States after completing the development of quality control testing. “We need to test them every way from Sunday to show that we get the same answer under all conditions,” Erck said. “It takes time.”
Erck said the company plans to administer 100 million doses a month by the end of the third quarter and 150 million doses a month by the end of the fourth quarter.
Every week, the U.S. is building more supplies of vaccines licensed by other companies, and whether the country needs to grant more emergency use authorization or EUA. I am raising a question.
“By law, if you have enough, you don’t need an additional EUA,” said Dr. Borio.
One sign came last week that the FDA is changing its approach to the Covid-19 vaccine. An American company called Ocugen was seeking an urgent permit for Covaxin, the Covid-19 vaccine currently used in India.But on Thursday, the company Announcement Instead, the FDA recommended that we follow the standard path to full approval, called a biopharmacy approval application. This will take a few more months.
However, Novavax has been discussing trials with the FDA since last year, and Erck said the company could continue its plans to seek an emergency use authorization.
“So far, they have shown that they can continue EUA if they are in the process of EUA,” Erck said. “Everyone could tell you that it could change, but I don’t know how to predict it.”
Dr. Paul Ofit, a professor at the University of Pennsylvania and a member of the FDA’s Vaccine Advisory Board, said Novabax’s highly effective vaccine would be most welcomed. “More fun,” he said. “We’ll be dealing with this virus for years, if not decades, so I think there’s room for more vaccines.”
Novavax prepares for the future by investigating how vaccines act as boosters. The new version of the vaccine contains the first beta mutant protein identified in South Africa.
Researchers gave a beta booster to baboons vaccinated with the original version of the Novavax vaccine in an experiment a year ago. Researchers have found that baboon immunity to Covid-19 surged after this booster, protecting it from beta, alpha, and the original version of the coronavirus.
“When boosted, we see a very high recall response,” said a virologist at the University of Maryland School of Medicine. New research.. This study has not yet been published in a scientific journal.
Dr. Freeman said the new study provided promising evidence that the Novabax vaccine may function well as a booster. He also said that first-time vaccinated people may be better off getting a blend of the original and beta versions to extend protection against new variants.
“Novavax could be used as a booster in the United States, but it will certainly be the first vaccine many people see around the world,” he said.
Novavax Offers US 4th Powerful Covid-19 Vaccine
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