www.washingtonpost.com
Open in
urlscan Pro
96.16.159.126
Public Scan
Submitted URL: https://apple.news/AJbnBCWN1QwSy-Bv8p2G1HA?articleList=ArWGMAgBPSW-pnyRP2eJhzw
Effective URL: https://www.washingtonpost.com/health/2022/06/05/novavax-coronavirus-vaccine-fda/
Submission: On June 07 via api from US — Scanned from DE
Effective URL: https://www.washingtonpost.com/health/2022/06/05/novavax-coronavirus-vaccine-fda/
Submission: On June 07 via api from US — Scanned from DE
Form analysis
1 forms found in the DOMGET https://www.washingtonpost.com/newssearch/
<form id="search-form" method="get" class="search-form dn flex-ns items-center relative" action="https://www.washingtonpost.com/newssearch/" role="search"><label for="query" aria-labelledby="searchTitle"><input type="text" id="query"
autocomplete="off" name="query" class="no-shadow text-input brad-4 font-xxxs pa-0 b-none dn hidden" style="width:0;height:34px;line-height:20px;transition:all 0.25s cubic-bezier(0.49, 0.37, 0.45, 0.71)" placeholder="Search" aria-label="search"
value=""></label><span id="searchTitle" class="dn">Search Input</span><button type="submit" name="btn-search"
class="wpds-c-gNHrZC wpds-c-gNHrZC-jJaDHd-variant-secondary wpds-c-gNHrZC-biynoz-density-compact wpds-c-gNHrZC-hGNJMA-icon-center wpds-c-gNHrZC-iktOLlB-css focus-highlight dn dib-ns btn-show-search-input" aria-label="search"><svg
xmlns="http://www.w3.org/2000/svg" viewBox="0 0 16 16" fill="currentColor" aria-hidden="true" focusable="false" role="img" class="wpds-c-erhKsy ">
<path d="M7 11.52A4.5 4.5 0 1 1 11.52 7 4.51 4.51 0 0 1 7 11.52Zm0-8A3.5 3.5 0 1 0 10.52 7 3.5 3.5 0 0 0 7 3.52Z"></path>
<path d="m9.653 10.36.707-.708 3.995 3.996-.707.707z"></path>
</svg><span class="wpds-c-iSKIAI">Search</span></button></form>
Text Content
Accessibility statementSkip to main content Search InputSearch MenuSections MenuSections Democracy Dies in Darkness Try four weeks free ProfileSign in ProfileSign in Next articles Coronavirus pandemic Asia China’s university entrance exams are already stressful. Now add covid. Health A more traditional coronavirus shot on the way for some unable to wait Asia Making sense of N. Korea’s coronavirus mystery — and its menace Health White House says coronavirus shots for kids under 5 could begin June 21 Opinions Your questions about covid-19, answered by Dr. Leana Wen Middle East Turkey today, Türkiye tomorrow: U.N. okays country’s request for change Monkey Cage • Analysis Taiwan is moving away from ‘zero-covid.’ That’s harder than it seems. Health Pfizer seeks authorization of coronavirus shot for children under 5 Health There’s still no HIV vaccine. The science behind coronavirus shots may help... By The Way Everything you need to know about traveling to Italy By The Way Italy lifts all pandemic entry restrictions Asia After months of lockdown, people and traffic return to the streets of Shang... Asia Tom Cruise in Japan? Okay. Ordinary tourists in Japan? Not okay. Health How fast omicron’s BA.2 variant is spreading around the world Health Covid was vanishing last Memorial Day. Cases are five times higher now. By The Way Japan to welcome back tourists after 2-year pandemic shutdown Opinions Should parents boost their children now? There’s no straightforward answer. Health Vaccines may not prevent many symptoms of long covid, study suggests Letters to the Editor • Opinion Stop ignoring long covid Asia It’s not easy staying green: Keeping out of China’s covid lockdown Advertisement Close The Washington PostDemocracy Dies in Darkness Coronavirus U.S. cases and deaths by state World map Variant tracker Vaccine tracker Second booster 1 million deaths Health A MORE TRADITIONAL CORONAVIRUS SHOT ON THE WAY FOR SOME UNABLE TO WAIT By Carolyn Y. Johnson June 5, 2022 at 7:00 a.m. EDT Novavax developed a coronavirus vaccine with a more traditional approach than earlier shots. (Matt McClain/The Washington Post) Listen 11 min Comment on this story Comment Gift Article Share More than a year after people began rolling up their sleeves for cutting-edge coronavirus shots, a new vaccine, this one based on a classic decades-old technology, is expected to begin rolling out in the United States this summer. WpGet the full experience.Choose your planArrowRight Advisers to the Food and Drug Administration are scheduled to debate Tuesday whether a shot developed by the Maryland biotechnology company Novavax, an underdog in the vaccine race, is safe and effective. If the shot gets the green light, it will become the fourth coronavirus vaccine in the nation. For most people, some already on their third or fourth messenger RNA coronavirus shot from Moderna or Pfizer-BioNTech, it looks like a puzzle: A new vaccine? Why bother? But for a small contingent of holdouts who have closely tracked the progress of the Novavax vaccine, this is a moment of truth. “Some people can’t take the mRNA vaccines, and it is important to have a choice,” said Victoria Dawson, 74, of New York, who is allergic to an ingredient in the mRNA shots. She received a Johnson & Johnson shot and booster but hopes her next shot will be from Novavax. “I’m being very cautious. I’m staying around my apartment complex and not eating in restaurants,” she said. “I get up in the morning and just stress the minute I get up.” Even though Novavax lost the race to be first, company executives argue that their shot will help fill in the margins of the pandemic vaccination campaign and play an important role in helping people live alongside the virus into the future. They argue their vaccine, which can stay stable at refrigerator temperatures longer and may be better tolerated than alternatives, will have key advantages once the exigencies of the pandemic recede. Advertisement Story continues below advertisement But hopes were dashed Friday that the vaccine would offer an alternative for people worried about rare heart inflammation associated with mRNA vaccines. An FDA review found that there were five cases of inflammation, mostly in men, within two weeks of being vaccinated in Novavax trials, “raising concern for a causal relationship.” Novavax, a biotech company in Gaithersburg, Md., uses recombinant protein technology to create its coronavirus vaccine. (Video: John Farrell, Brian Monroe/The Washington Post) The Novavax vaccine is poised to hit the U.S. market as more than three-quarters of people 18 and older are already fully vaccinated. Among the unvaccinated, some may be waiting for another option, but others may not be interested at all. Novavax plans to seek expanded authorization for use of the shot in adolescents and as a booster. The rollout is likely to be slower than that of earlier coronavirus vaccines, which were available days after FDA advisers met. An agency review released Friday said testing and submission of manufacturing information about the vaccine were “still in process” and would be essential “to ensure the vaccine’s quality and consistency for authorization.” Advertisement Story continues below advertisement A meeting of Centers for Disease Control and Prevention vaccine advisers, a critical step before a vaccine becomes available, has not been scheduled yet. The company plans to have shots ready to supply “within a very short period of time,” a few weeks after the FDA authorizes the shot, said John Trizzino, chief commercial officer at Novavax. Despite the late arrival of their vaccine, Novavax executives remain confident it will fill a need. “If you would have asked anybody in the space 12 months ago what would be happening in the pandemic now, they would have said, ‘Oh, by now we’d be long past the pandemic,’” Trizzino said. TINY VACCINE FACTORIES In a brightly lit laboratory in Gaithersburg, Md., a cloudy, yellowish broth swirls inside Erlenmeyer flasks. The glass containers, shaking back and forth inside two incubators, are teeming with cells from a pest known as the fall armyworm moth. Advertisement Story continues below advertisement Those moth cells are tiny vaccine factories, churning out coronavirus spike proteins found in the newest omicron subvariants, BA.4 and BA.5. Even as Novavax scientists wait for their first-generation vaccine to be authorized, based on earlier versions of the virus, they are working on new formulations to be ready for wherever the pandemic swerves next. The winding path to this moment, a vaccine on the cusp of authorization a year after it was shown to be 90 percent effective, underscores the speedy development of the first vaccines. The lag for the Novavax vaccine reflects a combination of factors, including the more time-consuming technology used in its coronavirus shot, the growing pains of a small company that had to expand quickly and manufacturing delays. What makes the Novavax vaccine attractive to some people is that it is an older and more familiar technology. That is also what made it trail other shots. Protein-based shots are tried and true. They are used against influenza, hepatitis B and shingles. However, the timeline to develop them is longer. The newer mRNA vaccines instruct cells inside the body of vaccine recipients to build the coronavirus spike protein. The Johnson & Johnson vaccine uses a harmless virus to spur cells to churn out the spike protein. Novavax, by contrast, manufactures and purifies the coronavirus spike proteins in a laboratory. Novavax scientists start with a baculovirus, which in nature infects insects. It is engineered to carry genetic instructions for building the coronavirus spike protein. The baculovirus, with its genetic instructions, is then introduced into cells taken from the fall armyworm moth. Advertisement Story continues below advertisement In progressively larger vessels, researchers brew a cloudy broth of moth cells capable of churning out the spikes. In a factory in India, where manufacturing takes place, there are 6,000-liter stainless steel vats teeming with the insect cells. To recover the key vaccine ingredient, the coronavirus spike proteins, scientists purify and filter out other cellular debris. Then, they add detergent to create a spike-covered soap bubble that looks similar to the virus itself. An adjuvant, a vaccine ingredient that revs up the immune system, is added. Gale Smith, chief scientist at Novavax, said he started working on the technology in the early 1980s as a graduate student. “I had this crazy idea when I was a graduate student,” Smith said, talking over the loud hum of lab equipment. “I knew it was important, and I can tell you, hardly anyone shared that opinion.” The advantage of “bug cells,” as Smith calls them, is that they are adept at making complex proteins. Advertisement Story continues below advertisement Still, cool science alone is not enough to get a vaccine across the finish line, and at the beginning of the pandemic, Novavax started out with disadvantages. The company had never launched a vaccine. Its staff had been slashed and key manufacturing capabilities sold off to keep the company afloat after efforts to develop a vaccine against respiratory syncytial virus foundered in 2016. The Novavax coronavirus shot was one of six candidates backed by Operation Warp Speed, the federal program established to accelerate vaccine development. The government invested $1.6 billion in the Maryland company to support development of the shots. Even with the influx of cash, the challenges to scale up were enormous. “We were not a developed company at that time. We started with 100 people in the United States, without any laboratory space at the time,” chief executive Stanley Erck said. “Starting Jan. 12, 2020, we had seven-day weeks for two years. Every day, we would work to get to the next experiment, to the next data point.” Advertisement Story continues below advertisement The Novavax workforce exploded during the past two years to 1,600 employees, and a new headquarters is under construction. The growth is visible in every department. In a glass corridor, scientists receive frozen patient samples from vaccine trials around the world. Last year, a staff of nearly 60 received and analyzed results from about 100,000 samples. So far this year, they have analyzed 87,000 and are looking to expand the lab to double their capacity by next year. The Serum Institute of India is manufacturing the Novavax vaccine, and U.S. regulators needed to inspect that plant, which added to the time it took to review the application for FDA authorization, Erck said. Story continues below advertisement Novavax also lost time in manufacturing because of difficulties with tests used to check the contents and quality of the vaccine. Vaccine makers must demonstrate to regulators that their product is consistent in every batch and every vial. Advertisement “That can take a long time to both get that process right and to the level of purity the FDA requires,” said Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine. The company filed for emergency authorization in January. WAITING FOR NOVAVAX With more than three-quarters of U.S. adults fully vaccinated, few people expect that a fourth shot will significantly boost vaccination rates. For Novavax executives, one of their selling points has been the promise of helping to close the vaccine hesitancy gap, but the experience in some European countries, where the shot is available, has not borne that out. Story continues below advertisement There is a niche group of people in the United States who connect on social media and who have been holding out for the shot because they can’t or won’t take the existing vaccines. But the true potential of the shot is global or as a booster. It has already been approved in more than 40 countries. And if it is eventually authorized in adolescents and children, that could also spur greater use. Advertisement “I still think there are quite a lot of people who are nervous about the mRNAs, all these people who haven’t gotten boosted. I think there is a niche there for people who feel safer with” the Novavax shot, said Kathryn Stephenson, a vaccine expert at Beth Israel Deaconess Medical Center in Boston who led a Novavax trial. With the virus continuing to throw curveballs, adding another option to the arsenal could be crucial for the future, experts said. Some people had hoped the protein shot might be an attractive option in a world in which there are choices, especially because mRNA shots have been associated with a risk of heart inflammation in younger men. But the five cases of heart inflammation identified recently “support a concern for causal relationship to vaccine,” FDA reviewers wrote. Novavax took issue with the FDA analysis, arguing that the rates of heart inflammation were exceedingly low and were the same in the vaccine and placebo groups. “We believe there is insufficient evidence to establish a causal relationship,” the company said in a statement. For Randy Cox, 42, of Ludington, Mich., the revelation that the same rare heart risk may exist with this vaccine as with mRNA vaccines comes as a major disappointment. Cox has been waiting on Novavax for months because he is fearful that mRNA vaccines, with their rare potential to cause heart inflammation in men, could exacerbate the large cyst on the right atrium of his heart. As much of the country was vaccinated, boosted and even boosted again with mRNA vaccines, Cox kept his mask on and continued wiping down his groceries. It “comes as quite a shock” to learn about heart inflammation associated with the Novavax shot, Cox said. He had been frustrated by the slowness of the regulatory review and watched with envy as other countries authorized the vaccine. When Canada authorized the Novavax shot, Cox applied for a passport, thinking he could make the five-hour drive, only to learn that people who were not Canadian citizens were not eligible to roll up their sleeves and get a shot. Now, Cox said he is going to have to dig into the data, watch the FDA meeting and think about whether he still wants Novavax or whether, if the risks are about the same, he would settle for the Pfizer-BioNTech vaccine that has been more widely used. “I’m really bummed,” Cox said. CORONAVIRUS: WHAT YOU NEED TO READ Vaccines: Will you need a fourth coronavirus vaccine? Officials have authorized a second booster shot for Americans 50 or older. A vaccine for young kids could also be available soon. Mask guidance: A federal judge struck down the mask mandate on transportation, but covid-19 cases are on the rise again. We created a guide to help you decide whether to keep wearing face coverings. Most experts say you should keep wearing on planes. Tracking the virus: See the latest coronavirus numbers and how the omicron variant has spread across the world. At-home tests: Here’s how to use at-home covid tests, where to find them and how they differ from PCR tests. New CDC team: A new team of federal health scientists has been formed to provide real-time data on the coronavirus and future outbreaks — a ‘National Weather Service’ to forecast what’s next in the pandemic. For the latest news, sign up for our free newsletter. Show more ChevronDown Comment 698 Comments GiftOutline Gift Article Loading... Advertisement Advertisement Loading... Advertisement Advertisement Company * About The Post * Newsroom Policies & Standards * Diversity and Inclusion * Careers * Media & Community Relations * WP Creative Group * Accessibility Statement Get The Post * * Become a Subscriber * Gift Subscriptions * Mobile & Apps * Newsletters & Alerts * Washington Post Live * Reprints & Permissions * Post Store * Books & E-Books * Newspaper in Education * Print Archives (Subscribers Only) * e-Replica * Today’s Paper * Public Notices Contact Us * Contact the Newsroom * Contact Customer Care * Contact the Opinions team * Advertise * Licensing & Syndication * Request a Correction * Send a News Tip * Report a Vulnerability Terms of Use * Digital Products Terms of Sale * Print Products Terms of Sale * Terms of Service * Privacy Policy * Cookie Settings * Submissions & Discussion Policy * RSS Terms of Service * Ad Choices washingtonpost.com © 1996-2022 The Washington Post * washingtonpost.com * © 1996-2022 The Washington Post * About The Post * Contact the Newsroom * Contact Customer Care * Request a Correction * Send a News Tip * Report a Vulnerability * Download the Washington Post App * Policies & Standards * Terms of Service * Privacy Policy * Cookie Settings * Print Products Terms of Sale * Digital Products Terms of Sale * Submissions & Discussion Policy * RSS Terms of Service * Ad Choices THE WASHINGTON POST CARES ABOUT YOUR PRIVACY We and our partners store and/or access information on a device, such as unique IDs in cookies to process personal data. You may accept or manage your choices by clicking below, including your right to object where legitimate interest is used, or at any time in the privacy policy page. These choices will be signaled to our partners and will not affect browsing data. WE AND OUR PARTNERS PROCESS DATA TO PROVIDE: Actively scan device characteristics for identification. Select basic ads. Store and/or access information on a device. Create a personalised ads profile. Select personalised ads. Create a personalised content profile. Select personalised content. Measure ad performance. Measure content performance. Apply market research to generate audience insights. Develop and improve products. View list of partners I accept Manage cookies