Latest news with #Novavax
Health Line
2 days ago
- Health
- Health Line
What Are the Side Effects of the COVID-19 Vaccine?
According to the World Health Organization (WHO), healthcare professionals have given more than 13 billion COVID-19 vaccine doses since 2021, saving an estimated 14.4 million lives. These vaccines can also help prevent hospitalizations and serious illness caused by COVID-19. Researchers carefully track the side effects of the COVID-19 vaccine. Side effect considerations were an important part of clinical trials before the Food and Drug Administration (FDA) approved the vaccines, and will remain in consideration as people continue to get the vaccines. Here's what you should know about COVID-19 vaccine side effects. What are the common side effects of the COVID-19 vaccine? As with all vaccines, side effects may occur after getting the COVID-19 vaccine. Currently, two types of COVID-19 vaccines are available: mRNA vaccines from Pfizer-BioNTech and Moderna and protein subunit vaccines from Novavax. Each type of vaccine has the potential for side effects. Here are the more commonly reported side effects for each type of COVID-19 vaccine: Side effects mRNA vaccines subunit vaccines pain, soreness, redness at injection site √ √ fatigue √ √ headache √ √ muscle pain √ √ joint pain √ √ chills √ √ fever √ √ nausea and vomiting √ √ in infants: irritability or crying, decreased appetite, and sleepiness √ According to the Centers for Disease Control and Prevention (CDC), even if you've had side effects from a COVID-19 vaccine, you can likely still have that vaccine at the next recommended vaccination dosage. However, if your healthcare professional suspects your reaction was an allergic reaction, you may need to see a doctor who specializes in treating allergies (allergist or immunologist) for a consultation before having another COVID-19 vaccination of that type. What are the chances of getting serious side effects from the COVID-19 vaccine? Serious COVID-19 vaccine side effects are very rare. According to the CDC, researchers have identified four adverse event types that have occurred. These include: Anaphylaxis: This is a severe and potentially life threatening allergic reaction that can cause breathing problems, hives, and low blood pressure. The CDC reports that Anaphylaxis affects approximately 5 individuals per one million people who receive a dose of the COVID-19 vaccine. Guillain-Barré syndrome (GBS): GBS is a rare side effect that can cause the immune system to attack healthy nerve cells. Symptoms include muscle weakness and sometimes paralysis. Myocarditis and pericarditis: These heart conditions are rare COVID-19 vaccine side effects. Myocarditis occurs when the heart muscle becomes inflamed, and pericarditis occurs when the tissue surrounding the heart swells and becomes inflamed. According to the CDC, though rare, these side effects most often affect young adult males within 7 days of their second mRNA COVID-19 vaccine dose. Currently approved mRNA vaccines include Moderna and Pfizer-BioNTech. Thrombosis with thrombocytopenia syndrome (TTS): TTS is a very rare side effect, affecting approximately 4 individuals per 1 million Johnson & Johnson Janssen COVID-19 vaccines given. It's associated with the now-discontinued Johnson & Johnson's Janssen COVID-19 vaccine. TTS can cause blood clots or increased blood clotting, which can potentially be life threatening. Once reports of individuals with TTS following the Johnson & Johnson's Janssen COVID-19 vaccine were studied, this vaccine was removed from the market in the United States. As of June 1, 2023, the FDA changed the Emergency Use Authorization (EUA) granted to the Johnson & Johnson vaccine, limiting authorization. This decision follows an analysis of the safety concerns regarding thrombosis with thrombocytopenia syndrome (TTS). The (Johnson & Johnson) Janssen COVID-19 Vaccine is no longer given in the United States. Federal agencies continue to track and investigate both mild and severe side effects of COVID-19 vaccines. Optum Perks is owned by RVO Health. By clicking on this link, we may receive a commission. Learn more. Do the side effects vary by age? COVID-19 vaccines are now FDA-approved for people ages 5 and up. Here are some of the side effects reported by age. Children Research suggests that children who receive the Pfizer-BioNTech (BNT162b2) have mainly mild and self-limiting side effects, such as discomfort at the injection site. Clinical trials in which researchers tested the vaccines in children also revealed no serious side effects, according to 2021 research. The most common side effects from the study were similar to those of adults. These included pain at the injection site, fatigue, chills, and headache. The most common symptom in children was a mild to moderate fever. Young adults A 2021 study of vaccine side effects published in JAMA found that younger adults were more likely to have adverse side effects than older adults. Another 2021 study found young adults and adolescent males were the most likely to experience myocarditis as a vaccine side effect. The study found that 79% of reported myocarditis events were in men. Older adults A 2024 survey of over 200,000 older adults who had between one and three COVID-19 vaccinations and boosters found that older adults who had COVID-19 vaccination had no increased risk of emergency hospital visits or hospitalization when compared to unvaccinated older adults. The participants reported common symptoms that rarely required medical assessment and resolved. Do the side effects vary by vaccine brand? The FDA has approved two COVID-19 vaccine brands in the United States: Pfizer-BioNTech and Moderna for mRNA vaccines and Novavax for protein subunit vaccines. The side effects of the two different types of vaccines are very similar. However, if you have a severe allergic reaction after getting a COVID-19 vaccine, the CDC recommends that you avoid getting another dose of the same vaccine type. For example, if you have an allergic reaction to the Pfizer-BioNTech vaccine, avoid the Moderna vaccine (and vice versa) since they work in the same way. Individuals are seven times more likely to experience myocarditis after infection with the virus that causes COVID-19 than after a COVID-19 vaccination. The CDC reports 80% of patients who were diagnosed with myocarditis at least three months before participating in a survey study had fully recovered or likely fully recovered as determined by their cardiologists. What does a lack of side effects from the COVID-19 vaccine mean? Some people will experience mild side effects from the COVID-19 vaccine, while others may have none. Your side effects (or lack thereof) don't mean the vaccine will work better for you than another person. The vaccine can help protect you regardless of your body's response. How to cope with the side effects of the COVID-19 vaccine If you experience side effects from the COVID-19 vaccine, here are some measures that may help: Apply cold compresses to the injection site. Drink plenty of fluids. Perform light stretches to relax your arm muscles. Take over-the-counter pain relievers like acetaminophen, ibuprofen, or aspirin (but only for those older than age 18). Rest and give your body time to recover. Side effects are generally mild and usually resolve within a few hours to a few days – less than a week. If you experience a significant side effect of the COVID-19 vaccine, report it to the Vaccine Adverse Event Reporting System (VAERS). This resource can also be used to report any new side effects you haven't heard mentioned before. How effective is the COVID-19 vaccine? At the start of the COVID-19 pandemic, there were no readily available protections or treatments for the coronavirus. Since then, researchers have found that the COVID-19 vaccinations have been highly effective at reducing the death rate from COVID-19 while finding no indication of increased risk of non-COVID mortality after vaccination. The COVID-19 vaccine has helped protect people against the coronavirus. According to the CDC, people who are unvaccinated have higher diagnosis and death rates than people who are vaccinated. People who are vaccinated, especially those ages 65 and older, can further reduce their risk by receiving a booster dose. Takeaway All vaccines have the potential for side effects. However, very few adverse events have been reported for the COVID-19 vaccine, and many worldwide health groups are monitoring side effects closely. Given the recommendations for COVID-19 vaccinations for people at increased risk, you may want to speak with your doctor or a healthcare professional to see if you have any health conditions that put you in the high risk category and if you are recommended to get a COVID-19 vaccination.
Yahoo
3 days ago
- Business
- Yahoo
Citi initiates coverage on biotech amid improving sentiment in sector
-- Citi initiated coverage on small- and mid-cap biotechnology companies on early signs of improving sentiment in a sector weighed down this year by policy uncertainty and weak investor interest. The brokerage launched with Buy ratings on Acumen, Amylyx, Arcellx, NewAmsterdam Pharma, and Protagonist Therapeutics (NASDAQ:PTGX), and a Sell rating on Novavax (NASDAQ:NVAX). It pointed to deep pipelines and catalysts expected in the second half of 2025 as reasons for optimism in selected stocks despite broader sector underperformance. Biotech shares have lagged the broader market, with the SPDR S&P Biotech (NYSE:XBI) ETF down over 9% year-to-date, while the S&P500 has gained nearly 3%. Citi said persistent concerns around U.S. drug pricing policy have weighed on the group but noted signs of "policy fatigue" among investors and a shift back toward company fundamentals. While large-cap biopharma names such as Eli Lilly (NYSE:LLY), Vertex (NASDAQ:VRTX) and Gilead (NASDAQ:GILD) have led recent gains, Citi said small- and mid-cap stocks may begin to benefit if sentiment continues to recover. Recent deal activity and partnerships suggest a pickup in business development interest, and expectations of a U.S. interest rate cut in September could support further momentum, it added. Citi emphasized the potential of U.S.-based biotechs in areas such as immunology, cardiology, oncology, and rare neurological diseases. It cautioned against companies focused on respiratory vaccines, citing seasonality and political risk. Related articles Citi initiates coverage on biotech amid improving sentiment in sector MS starts coverage of at Equal-Weight on balanced risk-reward Caterpillar's E&T segment is likely a core driver to the next EPS cycle: BofA Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
The Hindu
13-06-2025
- Business
- The Hindu
Novavax's COVID-flu combo vaccine shows strong immune response in trial
Novavax's experimental COVID-19-influenza combination and standalone influenza vaccines generated a strong immune response in adults aged 65 and older, similar to already approved shots against the viruses in a late-stage trial. Both the vaccine candidates were well tolerated with no new safety concerns, the biotech said on 11 June 2025. . Its shares rose 1.3% to $7.29 in premarket trading. The study, which involved about 2,000 participants, tested the safety and immune response of the COVID-influenza combination and standalone flu vaccines compared to its COVID-19 shot Nuvaxovid and Sanofi's flu shot Fluzone HD, respectively. Novavax said the study was not designed to show statistically significant results. The data will be used to design a future late-stage study, which can be submitted for regulatory approval, it said. The Maryland-based biotech, which is shifting its focus to commercialising its candidates through partnerships, said it continues to look for partners that can advance further development of these experimental vaccines. It had signed a licensing deal with Sanofi worth up to $1.2 billion last year to commercialize and further develop its COVID-19 vaccine, Nuvaxovid. Nuvaxovid gained the U.S. approval last month after the Food and Drug Administration missed an April 1 target to approve the shot. The approval, however, limited its use to older adults and at-risk individuals over the age of 12. The traditional protein-based shot offers an alternative to its messenger RNA-based rivals from Pfizer/BioNTech and Moderna. Earlier this week, health secretary Robert F. Kennedy Jr., a long-time vaccine skeptic, fired all members of a U.S. Centers for Disease Control and Prevention panel of vaccine experts — a move public health experts said could undermine confidence in currently available shots.
Yahoo
13-06-2025
- Business
- Yahoo
Novavax's COVID-Flu Combo Shot Shows Strong Immune Response
Novavax NVAX announced encouraging results from an initial cohort of a late-stage study evaluating its experimental COVID-19-influenza combination (CIC) and stand-alone influenza vaccine candidates. Results showed that the CIC and flu vaccines generated 'robust immune responses' across three flu strains (H1N1, H3N2 and B) and the SARS-CoV-2 strain in adults aged 65 and older. Per Novavax, these responses were similar to those seen with its own approved COVID-19 vaccine, Nuvaxovid, and Sanofi's SNY influenza vaccine, Fluzone HD. Novavax emphasized that this study was not designed to demonstrate statistical significance but to provide preliminary immunogenicity data. It intends to use these findings to design another late-stage study, which could potentially support regulatory submissions, if successful. NVAX is also exploring strategic collaborations to finance further development and potential commercialization of both candidates. This is part of the company's recent strategic shift focused on expanding its pipeline and exploring partnership opportunities for the same. Shares of Novavax have underperformed the industry year to date, as seen in the chart below. Image Source: Zacks Investment Research The above announcement came just under a month after it received the long-awaited FDA approval for Nuvaxovid, albeit with a narrower label than initially expected. While the agency granted full approval to the vaccine for use in older adults aged 65 and above, it restricted the use in individuals aged 12-64 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. This latest approval aligns with the FDA's recently issued guidance for COVID-19 vaccine boosters. As part of this guidance, COVID vaccine makers will be required to conduct randomized, placebo-controlled clinical studies demonstrating the real-world benefit of yearly COVID vaccine boosters in individuals aged under 65 years. Starting this year, Sanofi has acquired exclusive rights to market Nuvaxovid globally, except in certain territories where Novavax maintains existing partnership agreements. This arrangement is part of a multi-billion-dollar deal signed last year, wherein Sanofi assumed commercial responsibility for the vaccine. The company is also eligible for ongoing tiered royalties on future sales of COVID-19 vaccines. Apart from Novavax, Pfizer PFE and Moderna MRNA are also developing their respective COVID/flu combination vaccines using mRNA technology. Despite the recent regulatory setback, Moderna remains ahead of its competitors with the development of its investigational COVID-19/flu vaccine candidate, mRNA-1083. Moderna had to voluntarily withdraw its FDA filing for mRNA-1083 to accommodate the agency's request for additional efficacy data on the flu component of the vaccine. Moderna intends to resubmit the filing later this year. Pfizer suffered a major setback in this space last year when it reported data from a phase III study on its investigational mRNA-based COVID-19/flu combination vaccine. The study missed one of its two primary immunogenicity objectives. Pfizer is currently evaluating adjustments to its combination vaccine program to improve immune responses against influenza B and plans to discuss the next steps with health authorities. Pfizer is developing this vaccine in collaboration with BioNTech. Novavax's deal with Sanofi also allows the latter to combine its own influenza vaccines with Nuvaxovid. Sanofi is currently testing multiple COVID-19/flu combination vaccine candidates under this arrangement. Last year, the FDA granted fast-track designation to two of Sanofi's experimental combination vaccines, both being evaluated in separate phase I/II studies. While the first combination uses the Fluzone HD vaccine with Nuvaxovid, the second pairs Novavax's COVID-19 shot with Flubok. Novavax, Inc. price | Novavax, Inc. Quote Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Moderna, Inc. (MRNA) : Free Stock Analysis Report Novavax, Inc. (NVAX) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Business Insider
12-06-2025
- Business
- Business Insider
Novavax Stock (NVAX) Gets a Boost from ‘Robust Immune Responses'
Novavax (NVAX) stock jumped on Wednesday after the vaccine maker released results from a Phase 3 clinical trial of its COVID-19-Influenza Combination (CIC) and stand-alone flu vaccine. The initial cohort results from this study included 'robust immune responses' for the CIC and flu vaccine that were comparable to licensed rivals Nuvaxovid and Fluzone HD. Confident Investing Starts Here: Additionally, Novavax noted that the two vaccines were well tolerated. Almost all of the adverse events, greater than 98%, that were experienced by patients were mild or moderate in severity. The trial includes roughly 2,000 patients aged 65 or older. Novavax stated that it will continue to seek partners to further the development of its CIC and stand-alone flu vaccines. The results from this study provide it with the data it needs for discussions with potential partners. NVAX Stock Movement Today While NVAX stock had soared more than 2% in pre-market trading, the company couldn't maintain those gains. As a result, the stock is only up 0.56% as of Wednesday morning. Investors will also note that shares are down 8.83% year-to-date and 54.6% over the past 12 months. The Phase 3 clinical trial data also failed to attract investor interest today. Trading volume was muted at 1.38 million shares, compared to a three-month daily average of roughly 11.29 million units. Is Novavax Stock a Buy, Sell, or Hold? Turning to Wall Street, the analysts' consensus rating for Novavax is Hold, based on one Buy, two Hold, and a single Sell rating over the past three months. With that comes an average NVAX stock price target of $11.25, representing a potential 55.39% upside for the shares. Spark, TipRanks' AI analyst, highlighted 'strong revenue growth and profitability improvements' but warned of 'negative equity and cash flow challenges.'
