Buoyed by overwhelming support from the US government, a small US company Novavax on Monday announced the results of clinical trials of its COVID-19 vaccine in the United States and Mexico, which found that its two-shot vaccination was effective against the coronavirus. Provides powerful protection against .
In a trial of 29,960 people, the vaccine demonstrated an overall efficacy of 90.4 percent, which is comparable to vaccines made by Pfizer-BioNtech and Moderna, and higher than the one-shot vaccine from Johnson & Johnson. The Novavax vaccine showed 100 percent efficacy in preventing moderate or severe disease.
Despite these impressive results, the future of the vaccine in the United States is uncertain and there may be a greater need in other countries. Novavax says it cannot seek emergency authorization from the Food and Drug Administration until the end of September. And with a plentiful supply of three other authorized vaccines, it’s possible that the agency could ask Novavax to apply for a full license — a process that could require several additional months.
The company’s chief executive, Stanley Erk, acknowledged in an interview that Novavax would probably win its first authorization elsewhere. The company is also applying in the UK, EU, India and South Korea.
“I think the good news is that the data is so compelling that it gives everyone an incentive to pay attention to our filings,” Mr. Erck said.
By the time Novavax gets the green light from the US government, it may be too late to contribute to the country’s first wave of vaccinations. But many vaccine experts expect the country to need booster shots at some point, with weakened immunity and emerging forms. And the protein-based technology used in the Novavax vaccine may do a particularly good job of increasing protection, even if people have previously been vaccinated with a different formulation.
“They may actually be true to boosters,” Dr. Luciana Borio, who was acting chief scientist at the FDA from 2015 to 2017.
Last year, the Trump administration’s Operation Warp Speed Program awarded with Novavax signed a $1.6 billion contract for 100 million future doses. The company got this tremendous support Despite never bringing a vaccine to the market in more than three decades.
In January, Novavax announced that its 15,000-person trial in the UK found the vaccine had 96 per cent efficacy against the original coronavirus. Against alpha, a virus variant first identified in the UK, efficacy dropped slightly to 86 per cent. In South Africa, where Novavax ran a small trial on 2,900 people and the beta version was dominant, the company found an efficacy of only 49 percent.
But South Africa’s trial was complicated by the fact that many volunteers had HIV, which is known to hinder vaccines. Furthermore, the study was so small that it was difficult to estimate how much protection the vaccine provided to HIV-negative volunteers.
With the support of Operation Warp Speed, Novavax devised plans for even larger late-stage tests in the United States and Mexico. But manufacturing problems postponed its launch till December.
By then, the United States had authorized the Pfizer-BioNtech and Moderna vaccines. In February, with the Novavax trial still underway, the government authorized Johnson & Johnson.
As it awaited test results, Novavax partnered with other companies to begin manufacturing bulk quantities of its vaccine. In India, it joined forces with Serum Institute and SK Biosciences in South Korea. Novavax inked an agreement with the Vaccine Alliance, Gavi, to supply 1.1 billion doses to middle- and low-income countries.
But the company’s difficulties with scaling continued, and it needed more time to develop the specialized tests used to confirm the quality of its product.
The new results were based on 77 test volunteers who came down with Covid-19. Volunteers who received placebo shots were far more likely to get sick than those not vaccinated, a statistical difference that translated into an efficacy of 90.4 percent.
“This is a strong result,” said Natalie Dean, a biostatistician at the University of Florida. “It puts them at that high level.”
The vaccine showed similar efficacy in a group of high-risk volunteers — those who were over the age of 65, had medical risk factors or had jobs that exposed them to the virus.
Novavax sequenced the genomes of 54 of the 77 viral samples, and found that half were alpha, which became dominant in the United States this spring.
The side effects of the vaccine were relatively mild. Some volunteers reported fatigue, headache, and other minor symptoms. “This vaccine seems to be easy on the arms,” said John Moore, a virologist at Weill Cornell Medicine who volunteered in the Novavax trial.
Novavax will apply for authorization in the United States after developing the quality control test, according to its chief executive. “You have to test them by all means from Sunday to show that under any circumstances you get the same answer,” Mr. Erck said. “And it takes time.”
Mr. Erck said the company plans to make 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter.
With each passing week, the United States is manufacturing a larger supply of authorized vaccines from other companies, raising questions about whether the nation needs to be granted more emergency use authorizations, or EUAs.
“The law says that once you have an adequate dosage, there is no need for additional EUAs,” said Dr. Borio.
One sign that the FDA is changing its approach to COVID-19 vaccines came last week. A US company called Ocugen was seeking emergency authorization for Covaxin, a Covid-19 vaccine now in use in India. But on Thursday the company announced That the FDA recommended that they instead take the standard route to a full approval, known as a biologics license application, which takes several additional months.
But because Novavax has been consulting with the FDA about its trials since last year, Mr. Erck said the company may be able to continue with its plans to obtain emergency use authorization.
“So far, they have indicated that if you are in the process for the EUA, you can continue for the EUA,” Mr. Erk said. “Anyone can tell you that could change, but I don’t know how to predict it.”
Dr. Paul Offit, a University of Pennsylvania professor and member of the FDA’s Vaccine Advisory Panel, said Novavax’s highly effective vaccine would be welcome. “The more the merrier,” he said. “I think there’s room for many more vaccines, because we’re going to have to deal with this virus for years if not decades.”
Novavax is preparing for that future by testing how its vaccine might work as a booster. A new version of the vaccine contains proteins from the beta version that was first identified in South Africa.
Researchers gave beta boosters to baboons vaccinated with the original version of the Novavax vaccine in experiments a year ago. Researchers found that after this booster, baboons’ immunity against COVID-19 protected them from beta, alpha and the original version of the coronavirus.
“When you boost, you see a much higher recall response,” said Matthew Freeman, a virologist at the University of Maryland School of Medicine. new study. The study has not yet been published in a scientific journal.
Dr. Freeman said the new study offered encouraging evidence that the Novavax vaccine might work well as a booster. He also suggested that first-time vaccinated people might do well to get a mix of the original and beta versions to expand their protection against new variants.
“Novavax could be used as a booster in the US, but it would certainly be the first vaccine that a lot of people around the world are going to see,” he said.