Even with two other vaccines authorized, Novavax is having no trouble recruiting volunteers for its U.S. trial. If all goes well, the U.S. could see 110 million doses in June.
As recently as December, the vaccine maker Novavax appeared to once again be on the brink of failure.
Manufacturing troubles had forced the little-known Maryland company, which in its 34-year history had never brought a vaccine to market, to delay the U.S. clinical trial of its experimental Covid-19 inoculation, jeopardizing its $1.6 billion contract with the federal government. And two Covid-19 vaccines made by its competitors were already shipping around the country, leaving some to wonder whether Novavax would ever catch up.
But the picture has significantly improved. The company announced last week that its vaccine showed robust protection in a large British trial and also worked, although not nearly as well, in a smaller study in South Africa against a contagious new variant.
And the scarcity of the two vaccines authorized in the United States, made by Moderna and Pfizer, seems to have made it easier for Novavax to recruit volunteers in its trial here. That speedy enrollment has put the company on track to have results this spring, with possible government authorization as early as April. If all goes right — and nothing is guaranteed — that would mean an influx of 110 million vaccine doses, enough for 55 million Americans at two doses each, by the end of June.
The potential success of Novavax’s candidate carries global implications. Unlike Pfizer’s and Moderna’s shots, the Novavax vaccine can be stored and shipped at normal refrigeration temperatures. The company is setting up plants around the world to produce up to 2 billion doses per year.
As contagious variants circle the globe, more vaccines are desperately needed.
“I would say, the more the merrier at this point,” said Saad Omer, a vaccine expert at Yale University.
Novavax has signed up more than 20,000 people so far in its late-stage trial in the United States and Mexico, two-thirds of its goal of 30,000 participants. If it keeps enrolling volunteers at the same pace, it will complete recruitment more quickly than the Pfizer and Moderna trials did last year.
“It’s going fabulously well, frankly,” said Dr. Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center and a leader of the Covid-19 Prevention Network, which is helping to oversee the trial.
Dr. Thomas Campbell, who is overseeing the trial site at UCHealth in Colorado, said he has received more than 2,000 emails and hundreds of calls from would-be volunteers. He said excitement over the Pfizer and Moderna vaccines has stoked interest in getting immunized, but their scarcity is leading some people to investigate other options. The news about Novavax’s trial in Britain has also boosted enthusiasm: 224 people have enrolled so far at his site.
“Being in a clinical trial of an experimental vaccine gets them to a vaccine sooner, potentially, than they would otherwise,” he said.
If Novavax is successful, the new vaccine could add to a widening portfolio of shots in the United States by late spring. Moderna and Pfizer have deals with the United States to supply 400 million doses, enough to fully vaccinate 200 million people, by the middle of the year, and both companies are in talks to supply an additional 100 million doses each after that.
Johnson & Johnson, which recently reported that its one-dose vaccine was effective in a large U.S. trial, could receive authorization this month, but may not be able to supply the United States in significant numbers until April. AstraZeneca’s U.S. trial is also underway, and that company has a deal to supply Americans with 300 million doses of its two-shot vaccine.
But any number of obstacles could trip up Novavax’s progress. As other vaccines become more widely available, participants in Novavax’s trial could drop out of the trial. Even though its results in Britain were promising, the U.S. study could yield different results. Or the company could fail to prove to regulators that it can reliably manufacture its vaccine on a large scale. Given the likelihood that the United States may soon have three authorized vaccines available to the public, the company is under pressure to move quickly, or risk losing ground to competitors.
Novavax, based in Gaithersburg, Md., had struggled for years to bring a successful product to market, and in 2019 its stock was trading so low that it risked being delisted from the Nasdaq. Then, last spring and summer, two big deals rescued it from going under. In May, the Coalition for Epidemic Preparedness Innovations awarded the company up to $388 million to make its Covid vaccine available globally. In July, it was selected by the federal government’s Operation Warp Speed program to develop and sell its vaccine to the United States. Later in the summer, the company reported encouraging results in preliminary studies.
But the company struggled last fall to begin the U.S. trial by its earlier goal of October. Novavax has placed a big gamble on manufacturing, setting up plants around the world. But making these vaccines is a finicky and unpredictable process even for seasoned drug makers, and Novavax had trouble scaling up beyond the smaller batches needed for early trials.
“Things happen — small things happen,” said Stanley C. Erck, Novavax’s president and chief executive. “And so small things happen, and you lose weeks.”
Before the vaccine is authorized by the Food and Drug Administration, the company will have to show that it can consistently mass-produce the shots to the same quality as those used in its clinical trials, a high bar.
Mr. Erck said that the company is now on track to produce the 2 billion doses it has promised annually, which he acknowledged was an ambitious goal. “Some would say we’re crazy — I won’t say that, though we’re doing something that’s unprecedented,” he said.
But by the time the company had ironed out the kinks in its manufacturing, the vaccines from Moderna and Pfizer had already been authorized. Because of this, Mr. Erck said, it knew it had to approach its trial a little differently in order to encourage people to sign up, given that other vaccines were becoming available.
Instead of splitting volunteers into two equal groups — one receiving a vaccine and one a placebo — it has designed the study so that two-thirds of the participants receive the vaccine.
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Answers to Your Vaccine Questions
Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area
You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available.
Probably not. The answer depends on a number of factors, including the supply in your area at the time you’re vaccinated. Check your state health department website for more information about the vaccines available in your state. The Pfizer and Moderna vaccines are the only two vaccines currently approved, although a third vaccine from Johnson & Johnson is on the way.
That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data.
Employers do have the right to compel their workers to be vaccinated once a vaccine is formally approved. Many hospital systems, for example, require annual flu shots. But employees can seek exemptions based on medical reasons or religious beliefs. In such cases, employers are supposed to provide a “reasonable accommodation” — with a coronavirus vaccine, for example, a worker might be allowed to work if they wear a mask, or to work from home.
If you have other questions about the coronavirus vaccine, please read our full F.A.Q.
That was an attractive prospect for Ray Garcia, a web developer in San Diego, who signed up for the trial last month. “I was like, those are really good odds,” he said. “I just went for it.”
The company has also been granted approval from the F.D.A. to change the trial to a so-called crossover design, in which participants will receive a second round of shots if the vaccine is shown to be safe and effective. Under the plan, anyone in a placebo group would then get the vaccine in the second round, and those who received a vaccine would get a placebo. That will help reassure potential volunteers that they will eventually receive the vaccine even if they were in the placebo group.
Trial investigators have also said that they have a frank conversation with potential participants, explaining that they can drop out of the study if they are offered an opportunity to be vaccinated in the community. Some have done so, the investigators said, but not enough to jeopardize the trial.
Dr. Benjamin Luft, the principal investigator of the Novavax trial at Stony Brook University, said some volunteers dropped out after New York State opened eligibility to everyone 65 and older. “Initially, I think, our patients responded to that, and now, as time goes on, they are seeing the reality of not being able to get the vaccine,” he said.
Novavax, like other vaccine makers, has sought to diversify its pool of volunteers by focusing recruitment on groups that have been disproportionately affected by the virus, including people who are older, Black or Latino.
But a history of discrimination and unethical experimentation has made some people who belong to racial or ethnic minorities reluctant to participate in clinical trials.
“You hear about these stories and you’re like no, I’m not going to participate in any of this,” said Darnella McGuire-Nelson, who is Black and signed up for Novavax’s trial in late December.
Ms. McGuire-Nelson, who works at the U.S. Patent and Trademark Office, said she learned about the trial in December while listening to the radio in her car, waiting to pick up her mother at a doctor’s appointment at Howard University Hospital. On the radio, she heard about an upcoming round table of experts, including Howard’s president, Dr. Wayne A. I. Frederick and Dr. Anthony S. Fauci, the nation’s top infectious disease doctor, who would be discussing the upcoming Novavax trial, and about the hesitancy of many Black people to take a vaccine or participate in studies. After Ms. McGuire-Nelson learned that Howard University, her alma mater, was participating in the trial, she decided to sign up. Howard is one of a handful of historically Black colleges and universities that are participating in the Novavax trial.
“How do we know if the therapy or vaccine is going to work on Black people if we don’t have enough people who represent that group in the clinical trial?” she said. “We’re the group, Blacks and Hispanics, who are dying disproportionately.”
As of late January, about 17 percent of those who have enrolled in the Novavax trial are over 65, 13 percent are Black and 16 percent are Latino. By comparison, about 16.5 percent of the country is 65 and older, 13 percent are Black and 18 percent are Latino. Dr. Corey, from the clinical trials network, said the trial is largely meeting its goals.
Mr. Garcia said he was also motivated to sign up to ensure his community is represented because Latinos are one group that has been most affected by Covid-19. “If you get a flu shot every year, this shouldn’t be any different, but then again, just the word trial or clinical study scares people,” he said. “I wanted to contribute something, like, why not help science?”
Noah Weiland and Sharon LaFraniere contributed reporting.
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