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I have no doubt the efficacy is going to be much lower than 90% based on our experience with the mRNA vaccines. It is available to be used as a first and second dose to be given at least three weeks apart but at this stage isn't recommended as a booster (more on that later). 2023-03-04T17:17:57.571Z, How to stop dieting, according to people who have done it Offering another vaccine choice may help increase Covid-19 booster vaccination rates for these adults, said Stanley Erck, president and chief executive officer. The initial agreement covered 150 million doses. The grant of provisional registration of Nuvaxovid by the TGA reflects Novavax increasing momentum around the globe, Erck said in a press release about the drugs approval in Australia. There was an error saving your display name. 1. All trademarks, names, and logos of partner organizations/entities are owned by such organizations/entities and are being used by Novavax solely for informational purposes. 2023-03-04T16:05:34.578Z. 2023-03-04T16:41:46.053Z, A UN official calls for holding the Israeli occupation accountable for its crimes against the Palestinians The company also finalized on 4 August an advance purchase agreement with the European Union for up to 200 million There can be soreness and redness at the site of injection. Australias Novavax approval adds a fourth jab to the countrys vaccination drive, following approvals of mRNA shots from Moderna and Pfizer as well as the one-shot, viral vector jab from Johnson & Johnson. Far fewer know their real story, Anna called police to report an assault, but they took out a family violence order against her. We are a biotechnology company committed to help address serious infectious disease globally through the discovery, development, and delivery of innovative vaccines to patients around the world. Novavax, for its part, appears confident that it has ironed out its manufacturing processes. Exclusive analysis of biotech, pharma, and the life sciences. Heres what leaders can do to fix that, CA Notice at Collection and Privacy Notice, Do Not Sell/Share My Personal Information. Total revenue rose 73% to $1.9 billion. Berkshire Country Day School is looking at ways to expand its enrollment; We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,Stanley Erck, Novavax CEO, said in a statement about Novavaxs FDA application. Full results from Nuvaxovid's pivotal phase III trial were published in December 2021. Novavax will market its Nuvaxovid vaccine in the U.S., Europe, South Korea, Australia, and other wealthier economies. Novavax is proud to be recognized by the 2021 Top Workplaces USA, reflecting our dedication to an exceptional work culture. This is still a big unknown, and we certainly don't have any data from the U.S. on this. The age dependence will be much scrutinized - other vaccines have shown that younger patients (teenagers) seem at most risk, and several of the Novavax cases were in young men. Offers may be subject to change without notice. Novavax Johnson & Johnsons Janssen (J&J/Janssen) (CDC recommends that the J&J/Janssen COVID-19 vaccine only be considered in certain situations, due to safety concerns.) For insights into the vaccine, its development and manufacturing, and what impact it might have on vaccination in the U.S., the Johns Hopkins Bloomberg School of Public Health reached out to William Moss, executive director of the International Vaccine Access Center. Novavax has demonstrated its ability to quickly produce viable vaccine candidates for emerging infectious diseases such as COVID-19. The Novavax vaccine can be stored in standard refrigerator temperatures. There is still a question as to whether the Novavax vaccine would have benefit as a booster dose for people who received a primary series with an mRNA vaccine, or even a primary series plus a booster, but the current emergency use authorization under FDA consideration is just for the primary series, not for a booster dose. It has struggled mightily to produce its product since it entered the race to develop a Covid vaccine, only earning FDA authorization for its vaccine in July, a full 19 months after Pfizer and Moderna. The many various DTaP vaccines (diphtheria, tetanus, and pertussis) are all proteins plus adjuvant as well. 2023-03-04T17:11:35.648Z, Larreta traveled to Rosario to meet with Javkin: "It is not true that the battle against drug trafficking was lost" 2023 American Association for the Advancement of Science. I am unsure how much of a difference this [vaccine] is going to make. The Novavax vaccine is made using a different approach, employing recombinant nanoparticle technology. And the company's extended manufacturing problems seem to have led to another complication: as Branswell noted earlier today, the FDA has now stated that the manufacturing situation "does not allow for a determination of comparability between the vaccine product used in these three studies and the vaccine product intended for use under EUA", which is quite something. This is a different type of vaccine than what we currently have under EUA here in the United States. Australias government reports that as of Thursday over 95% of its population above the age of 16 has gotten at least one dose of a COVID-19 vaccine, while 92.8% of the population has been fully vaccinated. 2023-03-04T18:05:58.217Z, Smotrich apologizes for his call to "delete Hvara": "I tripped over my tongue" - voila! The vaccine, which is stored at fridge temperature, is given as a primary series as two doses administered three weeks apart. About two-thirds are fully vaccinated, and of those eligible, only 50% have gotten a booster dose. Since December, Novavax and Serum have shipped millions of Covavax doses to Indonesia and the Philippines because the countries governments approved the Covavax doses before the World Health Organization. Britain has approved Novavaxs Covid-19 vaccine for use in those 18 years of age and older. "But with Novavax, it's a protein-based vaccine, so you simply make those spike proteins in the laboratory.". Choose your country to see content specific to that location, Global vaccine approval/authorization map. WebAs of January 2022, approximately 300 million people worldwide have been infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19). Not necessarily in the U.S., but in low- and middle-income countries that just don't have the capacity for the cold storage that the mRNA vaccines require. This is a big unknown about the Novavax vaccine: How will it stand up, particularly when used in the primary series against the omicron variant? But studies into its use for both are ongoing. If this had been the first one to hit back in 2020, the world would have jumped for it, but those days are gone. 2023-03-04T16:05:45.456Z, The Agricultural Show closes its doors due to an excessive influx of visitors When the FDA approves a vaccine, they look not only at the result of the trialssafety and efficacythey carefully consider the manufacturing process and that's where things are getting delayed. Can the dogs of Chernobyl teach us new tricks when it comes to our own survival? That was during a time when the alpha and beta variants were circulating in the U.S., before delta and omicron. Sherpa are world famous for their work, which is synonymous with their name. All of these have something in common: one way or another, they relay on the vaccinated patients cells to make the viral antigen Spike protein that set off the immune response. 2023-03-04T17:41:47.056Z, Formula 1: Verstappen and Checo Prez achieved 1-2 in the Bahrain qualifying and Red Bull maintains its dominance By Paul R. La Monica, CNN. Novavax has conducted clinical trials outside of the U.S., but because the manufacturing process was different, the results of those studies were not considered by the FDA. Subscribe to STAT+ for less than $2 per day, Unlimited access to essential biotech, medicine, and life sciences journalism, Subscribe to STAT+ for less than $2 per day, Unlimited access to the health care news and insights you need, Experts weigh in on potential health hazards posed by, Experts weigh in on potential health hazards posed by chemicals in Ohio train derailment, The X-waiver for buprenorphine prescribing is gone. The Gaithersburg, Maryland-based company said WebAs of January 2022, approximately 300 million people worldwide have been infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19). Then it goes to the Advisory Committee of Immunization Practices at the CDC, and the CDC director signs off on it. 2023-03-04T16:54:13.313Z, Austria: Why the SP remains the strongest force in the state elections in Carinthia But despite Novavaxs success in clinical trials, the company struggled to make progress through the spring and summer of last year. The latest data from the CDC shows that just over 35,000 doses of the vaccine have been administered. In the past two months, Novavaxs vaccine has earned approval from the World Health Organization, the European Medicines Agency, Indonesia, the Philippines, India, Australia, and South Korea. The purified protein antigens in the vaccine cannot replicate and cannot cause COVID-19. could be sentient says Microsofts chatbot feels like watching the A cruise company is making a big play for remote workers to sail around the world for just $30,000 a year, CA Notice at Collection and Privacy Notice, Do Not Sell/Share My Personal Information. "The global need for them is vast.". To 5 February 2023, over 241,000 doses of Nuvaxovid (Novavax) have been administered in Australia. 2023-03-04T18:11:47.491Z, Inclusion at the Wartenberg school: "Need very, very high" "We need more manufacturers producing more vaccines," said Dr. William Schaffner, an infectious diseases expert at Vanderbilt University Medical Center in Nashville, Tennessee. As of Sunday, more than 143 million people in the U.S. had been fully vaccinated, according to the CDC. We're seeing a very different process here: There's a delay between the recommendations from the FDA advisory group to the FDA actually making an EUA, and that's largely because of their continued investigations into the manufacturing process. Powered and implemented by Interactive Data Managed Solutions. (Pfizer-BioNTech didn't get funding from the program for its vaccine.). Follow @abchealth on Instagram, where we're busting myths and sharing practical, smart health advice. There has already been controversy about indicidents of myocarditis during the trials, which is quite interesting, because that's been an issue to some degree with several other vaccines as well. Novavax and the Serum Institute had previously pledged to supply COVAX with 1.1 billion vaccine doses over an unspecified time frame. Novavax ( NVAX) is facing serious headwinds going into 2023 with the pandemic demand waning and new leadership changes, even as it celebrates a historic milestone of $2 billion in revenue for 2022 with $1.3 billion cash on hand. This service may include material from Agence France-Presse (AFP), APTN, Reuters, AAP, CNN and the BBC World Service which is copyright and cannot be reproduced. Novavaxs stock price dropped 6.2% on Wednesday in New York. Novavax said it plans to apply to the Food and Drug Administration for emergency use authorization in the third quarter. Novavaxs COVID-19 vaccine, which goes by the brand name Nuvaxovid, still has one final regulatory hurdle to cleara review from the Australian Technical Advisory Group on Immunisationbut government officials expect to roll out the jab to the Australian public within weeks. What might the virus do next? The Novavax vaccine also has an adjuvant, an immune stimulant to get a better immune response. How did it come to this. A limited number of doses of Novavax 'sCOVID-19 vaccine are expected to be initially distributed. It has been a long time, pandemically speaking, much longer than they or anyone else wanted. I have [received] several hundred emails from individuals and groups who have said for whatever reason we would like to have [this] particular vaccine this just gives them further choice, Skerritt said. I hope that there is a sizable population who have been waiting and this is their opportunity, but I'm not that confident that this is going to happen. The dark horse vaccine company Novavax announced strong results today from a pivotal, 30,000-person trial of its pandemic coronavirus vaccine in the United States and Mexico. Almost 95 per cent of Australians aged 16 and older have received two doses of a COVID-19 vaccine, but the federal government hopes the introduction of Novavax will encourage those holding out to finally come forward. Storms threaten north-east United States after tearing through the south, leaving 10 dead, arrival of the first batches of the vaccine in Australia last week, 95 per cent of Australians aged 16 and older have received two doses of a COVID-19 vaccine, recommends Novavax for people aged 18 years and older, said after the vaccine received final ATAGI approval, when Australia's drug regulator approved Novavax, the Novavax vaccine contains the actual spike protein itself, A new bivalent COVID-19 booster rolls out next month. The booster shot is authorized for people 18 and older who, for medical or accessibility reasons, cannot take one of the bivalent messenger RNA Covid boosters, or who otherwise would not take a booster. All cases in the vaccine group were mild, meaning the vaccine was 100 percent effective against moderate to severe illness. It uses the same technology that has been used in vaccines for hepatitis B, HPV, and whooping cough a technology Novavax has described as a "tried and true" platform. In the Novavax clinical trial of about 40,000 people, there were six cases of myocarditis, or inflammation of the heart muscle, and one in the placebo group. I don't see a big rush to get vaccinated among those who have already decided not to. In a statement Tuesday, the company warned about "I think particularly in the United States, our vaccine is going to be most importantly used as a booster vaccine," Stanley Erck, Novavax's chief executive officer, said Monday during a call with investors. The company's partner in Japan, Takeda, said the country cancelled further purchases of Novavax's vaccine. Perhaps, that's where the real value of Novavax and other protein-based vaccines are: their familiarity as a vaccine platform and fewer logistical storage issues. The adjuvant in Shingrix is basically the same as in the Novavax vaccine, a blend of compounds from the Chilean soap tree and some bacterial surface antigens. The clinical trial data on the vaccine's efficacy looked good90% overall. To 5 February 2023, over 241,000 doses of Nuvaxovid (Novavax) have been administered in Australia. Novavax is conducting studies of the vaccine as a booster dose. In an effort to get COVID-19 vaccines made in Canada, the federal government announced in February 2021 a deal between with Novavax to begin producing its vaccine in Montreal. Novavax's vaccine would be the third Operation Warp Speed candidate to get the green light from the FDA, along with those of Moderna and Johnson & Johnson. We had no idea when [Operation Warp Speed] started how well the mRNA vaccines would perform. IE 11 is not supported. According to the CDCs Novavax COVID-19 Vaccination Operational Planning Guide, healthcare officials should be able to begin ordering doses of Novavax the week of July 25, 2022. The company's partner in Japan, Takeda, said the country cancelled further purchases of Novavax's vaccine. We have two messenger RNA, or mRNA, vaccines and the Johnson & Johnson adenovirus vector vaccine. FORTUNE may receive compensation for some links to products and services on this website. Data from the CDC indicate that BA.5 remains the dominant virus strain at present, though a half-dozen or so other Omicron variants are starting to replace it. [The FDA] needs to be absolutely confident that the product being produced and delivered in the U.S. meets all the regulatory requirements and is the product that was tested, for which we have safety and efficacy data. Terms & Conditions. Sign up here. 2023-03-04T17:35:35.892Z, Mobile monitors in the test: You can see more with the second one 2023-03-04T16:23:40.262Z, A couple was killed by a light plane crash in the Negev, a minor injured by gunfire in the south of Mount Hebron: Shabbat news summary | Israel today I think it's useful to step back and ask: What would the ideal COVID vaccine look like? He told CNBC recently that Novavax expects the FDA to approve its vaccine this month. FORTUNE may receive compensation for some links to products and services on this website. Of those, it is estimated that almost 5.5 million people have died. Novavax is not responsible for the privacy policy of any third-party websites. The approval of Modernas vaccine, Spikevax, makes it the countrys second fully licensed vaccine to protect against SARS-CoV-2. A string of countries have approved vaccine maker Novavaxs long-awaited COVID-19 jab in recent weeks, giving their citizens a new vaccine that health officials say could win over people who were dissatisfied with past options. Many well-known vaccines use a similar approach delivering a specific part of the pathogen to the body to learn to recognize including the hepatitis B vaccine, the HPV vaccine and the shingles vaccine. Terms & Conditions. WebGlobal vaccine approval/authorization map | Novavax Science & technology Global vaccine approval/authorization map Global vaccine approval/authorization map Please select the country/region and language for vaccine authorization status. Novavaxs Covid vaccine showed highly favorable results in initial trials, with efficacy close to that shown by the mRNA vaccines. Prevention against severe disease varied from 87 per cent in the UK trial to 100 per cent in the US and Mexico trial. 2023-03-04T18:11:58.357Z, The controversial Chinese restaurant that rewards thin people and punishes the 'chubby' The vaccines' efficacy against mild disease in South Africa was 57% for J&J and 49% for Novavaxlower than in any other country they were tested. There are persistent questions about how this vaccine will fit into the current landscape (for example, does it qualify for "emergency use" when there are other vaccines available?) The Pfizer, Moderna and Johnson & Johnson vaccines all work by providing genetic instructions for the body to build the coronavirus's spike protein, which the immune system learns to recognize and fight. Novavax is producing its COVID-19 vaccine under two brand names, Nuvaxovid and Covavax. There might be people out there who have decided not to get an mRNA vaccine because it is a new platformalthough, we have more information on the mRNA vaccines because of how many people have been vaccinated here in the U.S. than probably any other vaccine. Novavax did not immediately respond to Fortunes request for comment on its current production capacity. The World Health Organization approved the Covavax vaccine on Dec. 17, opening the door for Novavax to supply the vaccine to COVAX, a global facility aimed at sending vaccines to lower- and middle-income countries. But after Australia announced its Novavax approval, shares rebounded 1.5% in after-hours trading. Indeed, "a lot of our first doses are going to go into low- and middle-income countries, as they should," Erck said. The initial agreement covered 150 million doses. The Nuvaxovid (Novavax) vaccine is provisionally approved for adults. "The Delta variant was was discovered in India is now one of the most common variants circulating the U.K. The company's partner in Japan, Takeda, said the country cancelled further purchases of Novavax's vaccine. Derek Lowes commentary on drug discovery and the pharma industry. "The more ways that we have at getting at this virus, and the more ways that we have at providing protection to people, the better off we are," he said. Novavax vaccine trials run in South Africa and the UK indicate that its efficacy in the UK was 89% at least seven days after individuals had received two doses of vaccine. Novavax's clinical data are (almost entirely) from before the Delta and Omicron eras of coronavirus, which makes you wonder how it's holding up under the current conditions (a constant problem with this constantly evolving virus). There's still a huge need, great inequities, and many vulnerable populations in many countries who need to be vaccinated. 2023-03-04T18:05:36.393Z, "I issued order 8 to myself": Amir began a hunger strike in front of the president's residence in order to bring about negotiations Israel today Novavax COVID-19 vaccine 3 weeks (or 21 days) after the first dose. The government was trying to diversify the vaccine platforms and not put all of its eggs in one basket. But the trials were conducted before the emergence of the Omicron variant, and the company says it's conducting further studies on the efficacy of the vaccine against newer variants. (The company's findings were presented in a news release and still must be submitted for peer review.). Home COVID tests 'need overhaul' after study finds inconsistent results, First batch of the Novavax COVID vaccine arrives in Australia here's what happens next, These COVID vaccines will get you into Australia when the international border reopens, Novavax gets final green light, becomes fourth COVID vaccine option, Timely reminder: How to respond if you test positive to COVID-19. The Novavax COVID-19 vaccine is available in limited quantities at Pima County Health Department clinics and mobile vaccination units. Novavax ( NVAX) is facing serious headwinds going into 2023 with the pandemic demand waning and new leadership changes, even as it celebrates a historic milestone of $2 billion in revenue for 2022 with $1.3 billion cash on hand. What's behind Biden's booster vaccine plan? I hope I'm wrong. All rights reserved. The information provided on this website is intended for members of the general public in only. 2023-03-02, Four Emirati planes arrive at the airports of Damascus, Latakia and Aleppo, carrying relief aid Clinical trials in this age group were conductedwhen the Delta variant was predominantly circulating. All rights reserved. 1. But even if a vaccine is available only under an EUA, manufacturers must receive FDA approval before making changes to the product. Novavax said the vaccine was 93 percent effective against what the Centers for Disease Control and Prevention has defined as variants of concern or variants of interest, including the Alpha variant, or B.1.1.7, first found in the U.K., which was the predominant variant seen in the U.S. trial. Novavaxa biotech company in Gaithersburg, Maryland, that had not brought a vaccine product to market beforereceived $1.8 billion from the U.S. government under Operation Warp Speed. How long it takes to build immunity: In clinical trials, one dose of the Moderna vaccine was 80.2% effective a month after vaccination. COVID-19 Boosters Updated Boosters Last fall, multiple outlets including Politico and the New York Times reported that Novavax vaccines produced at U.S. plants were not meeting purity standards. Prior to the pandemic Novavax was seen as a company with a promising technology, but no proven track record having never brought a vaccine to market and no production facilities of its own. Novavax creates transformational vaccines that help address some of the worlds most pressing infectious diseases. Back when the blog was sort of all-vaccines all-the-time, various vaccines and adjuvant combinations came up constantly. It will depend on what the FDA finds out about the manufacturing processes. 2023 Fortune Media IP Limited. Never miss a story: Follow your favorite topics and authors to get a personalized email with the journalism that matters most to you. We're three years into the COVID-19 pandemic. 2023-03-04T16:35:45.962Z, Arslan renews his solidarity with the occupied Syrian Arab Golan Novavax said it has already filed for authorization of the vaccine in the United Kingdom, European Union, Canada, Australia, India and the Philippines. "With the mRNA vaccines like Pfizer and Moderna, we inject the [genetic] instruction to make the spike protein," infectious diseases physician Paul Griffin told ABC News Radio. They were a relatively small biotech company, and they didn't partner with the big vaccine manufacturers. 1. Novavax, it must be said, disputes that there is a relationship with its vaccine, saying that there is not enough data, but the signals seem stronger than were seen with the other vaccines, so we'll see how that argument flies. 2023-03-04T17:59:52.710Z, The Israeli occupation arrested 480 Palestinians, including 62 children, during February Novavax says Covid-19 vaccine shows 90.4% overall efficacy in US/Mexico Phase 3 trial. Across these trials, approximately 27,000 people received two doses of the vaccine, and approximately 17,000 received a placebo. Novavax has been gaining wider global acceptance in recent weeks, winning approvals from the World Health Organization, the European Commission, South Korea, India, and the Philippines in recent months. For an optimal experience visit our site on another browser. The Food and Drug Administration announced Wednesday that it has authorized a booster shot for Novavaxs Covid-19 vaccine. Hes worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimers, diabetes, osteoporosis and other diseases. Click "Continue" only if you are a medical professional. Todays$1.6 billioninvestment supports theNovavaxcandidateall the way through to manufacturing 100 million doses for the American people, Alex Azar, former U.S. Health and Human Services secretary, said at the time. In an effort to get COVID-19 vaccines made in Canada, the federal government announced in February 2021 a deal between with Novavax to begin producing its vaccine in Montreal. Two doses brought efficacy up to 95.6%. S&P Index data is the property of Chicago Mercantile Exchange Inc. and its licensors. The Covavax jab will go to lower- and middle-income countries, in line with the equitable distribution pledge Novavax made as part of its partnership with the Coalition for Epidemic Preparedness Innovations (CEPI), a global vaccine development foundation. For now, Australia will offer Novavaxs jab in two-dose regimens for people over age 18 who have not yet been vaccinated. The Novavax jab, which is a protein subunit vaccine, is produced by genetic engineering and grown in moth cells. The situation reported by Novavax comes despite having posted huge sales gains in the last three years during the heyday of the | Economy | CNN. Complete and submit reports to VAERS online. Here are the briefing documents, and here is the FDA's analysis slide deck. Recombinant, protein-based nanoparticle vaccine, Diversity matters: Inclusivity in clinical trials, From pandemic to endemic: Why COVID-19 may be here to stay, Standing on the shoulders of giants: How a Novavax vaccine is developed, Recombinant nanoparticle vaccine technology, Global authorization site of Novavax COVID-19 Vaccine (recombinant, adjuvanted), Ask medical questions, report adverse events, and product quality complaints, Pay Transparency Nondiscrimination Provision. Its believed that there are a good number of people who would prefer to take something like the Novavax vaccine over the less-established techniques like mRNA and adenoviruses. 2023-03-04T17:11:51.998Z, 38 vehicles were vandalized in Safed - a resident of the city was arrested on suspicion of acts Israel today Novavax produces the Covovax version of the vaccine with the Serum Institute of India, the worlds largest vaccine maker by volume, which also manufactures a version of AstraZenecas COVID-19 vaccine. EUAs still apply to COVID-19 vaccines produced by Johnson & Johnson and Novavax. The protein is made outside of the human body and then injected into us, and that induces the immune response. FORTUNE is a trademark of Fortune Media IP Limited, registered in the U.S. and other countries. FDA advisers greenlight Novavax COVID-19 vaccine, Novavaxs long-awaited COVID-19 vaccine authorizations offer an alternative to mRNA, Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays. 2023-03-04T17:11:46.527Z, Trump seeks to block Pence's grand jury testimony in 2020 election interference investigation "With AZ, we put those same instructions in a harmless virus and deliver them where they need to go. Last So which ones are best? John Skerritt, head of the TGA, said in a press conference that there has been strong public interest in the vaccine because it relies on older technology than mRNA jabs from makers Pfizer and Moderna. 2023-03-04T18:06:03.676Z, Migrant from Ghana: She made it to Italy and shortly afterwards returned to Africa That would add a fourth vaccine to the U.S. arsenal. [Because] this was seen as a potential adverse event in the clinical trials, which is a much smaller group of vaccine recipients, some FDA advisors thought that there should be a warning should Novavax receive an EUA. Its time, The X-waiver for buprenorphine prescribing is gone. Past that, though, this is going to be a difficult decision. ", Executive director, International Vaccine Access Center, Vaccine expert Bill Moss discusses the national vaccine booster plan announced by President Joe Biden and beginning in late September, Global health expert Ruth Karron discusses the work currently taking place at laboratories around the country to develop a vaccine for COVID-19, What you need to know about the Novavax vaccine.