Novavax's stock slides 23% after FDA details myocarditis cases for COVID-19 vaccine candidate https://www.marketwatch.com/story/n...ses-for-covid-19-vaccine-candidate-2022-06-03 Shares of Novavax Inc. NVAX, -24.91% tumbled 22.9% in trading on Friday after the Food and Drug Administration published a report that detailed the agency's assessment of the clinical data for the company's COVID-19 vaccine candidate. There were at least four instances of myocarditis, a type of heart inflammation, in the clinical-trial participants. "If causally associated, the risk of myocarditis following NVX-CoV2373 could be higher than reported during post-authorization use of mRNA COVID-19 vaccines," the FDA said. No cases of myocarditis were reported in clinical trials for either of the approved mRNA vaccines, which were developed by Moderna Inc. MRNA, -3.12% and BioNTech SE [sbntx] and Pfizer Inc. PFE, 1.02%. The first reports about myocarditis came after the mRNA vaccines had already been authorized. The FDA report was released in advance of next Tuesday's meeting of the Vaccines and Related Biological Products Advisory Committee. The two-shot vaccine has a 90% efficacy rate against mild to severe symptomatic COVID-19. Novavax's stock is down 70.0% this year, while the broader S&P 500 SPX, -1.57% has declined 12.3%.
From a global analysis of over 100 Million people... Three jabs best for preventing Covid infections, global analysis finds Number of doses, not vaccine combinations, key to boosting immunity, according to largest study of its kind https://www.theguardian.com/world/2...ctions-global-analysis-finds-vaccine-immunity Three doses of the same Covid-19 vaccine or a combination of jabs work equally well in preventing infections, according to the largest study of its kind. While the effectiveness of individual coronavirus vaccines is well known, the evidence around combinations of jabs has been less clear, especially for particular groups such as older people and those who are immunocompromised. Now a global analysis of data from more than 100 million people confirms the number of doses is the key to boosting immunity rather than jab combinations. The findings have been published in the BMJ. Three doses of either the same vaccine or a combination of different types work comparably well in preventing Covid-19 infections, even against different variants, according to the study. Despite a rapid decline in Covid-19 infections and deaths, concerns about waning vaccine immunity and new variants makes it important to understand which vaccine combinations are most effective, the BMJ said. The Chinese University of Hong Kong (CUHK) searched 38 World Health Organization Covid-19 databases for published studies and preprints on a weekly basis from 8 March 2022. They identified 53 studies involving 100 million people with 24 combinations of Covid vaccine courses. Receiving three doses of the same vaccine is known as a homologous regimen, while receiving a third dose that differs from those given as two primary doses is called a heterologous regimen. After taking account of differences in study design and quality, CUHK researchers found that three doses of any mRNA vaccine appear to be most effective (96%) against non-severe Covid-19 infections and most effective (95%) in reducing Covid-19 related hospital admissions. But the results also show that any three-dose regimen – heterologous or homologous – induces higher immunity in all age groups, even in the over-65s, than a two-dose homologous regimen. And the study found that in immunocompromised patients, a third mRNA booster dose, as part of a heterologous or homologous regimen, also greatly improves protection compared with two doses. The effectiveness of three-dose vaccine regimens against Covid-19 related death remains uncertain. The researchers acknowledged some of the study’s limitations, including that they didn’t evaluate the optimum time interval for prime boost or boosting regimens, owing to limited information. “An mRNA booster is recommended to supplement any primary vaccine course,” the researchers concluded. “Heterologous and homologous three dose regimens work comparably well in preventing Covid-19 infections, even against different variants.”
First head-to-head comparison of four COVID-19 vaccines https://knowridge.com/2022/06/first-head-to-head-comparison-of-four-covid-19-vaccines/ Scientists from La Jolla Institute for Immunology reported the first analysis of how four types of COVID-19 vaccines prepare the body to fight SARS-CoV-2. Their in-depth look at how T cells, B cells, and antibody levels shift in the six months following vaccination is critical for the understanding of how to protect people in the ongoing pandemic. The research is published in Cell and was conducted by Professor Alessandro Sette et al. In the study, the team examined human immune responses to an mRNA platform (Pfizer-BioNTech and Moderna vaccines), a recombinant protein-based adjuvanted vaccine platform (Novavax), and a viral vector-based platform (Janssen/J&J). All four vaccines in this study were designed to prepare the immune system to fight the same target, called the SARS-CoV-2 Spike protein. Their key findings included: Antibodies: After six months, those given Moderna had highest levels of neutralizing antibodies, followed by those given the Pfizer-BioNTech and Novavax vaccines. The Janssen/J&J vaccine led to the lowest neutralizing antibody levels. B cells: Participants given the Janssen/J&J vaccine had the highest percentage of memory B cells after six months. CD4+ T cells: All participants retained a similar percentage of memory CD4+ “helper” T cells against the virus. CD8+ T cells: The Novavax vaccine led to the lowest levels of CD8+ “killer” T cells. A higher CD8+ response was seen in those given Pfizer-BioNTech, Moderna, or Janssen/J&J vaccines. Overall, after six months, only 60 to 70 percent of participants retained memory CD8+ T cells. The study confirms that most people retain some immune response to SARS-CoV-2, regardless of which vaccine they receive. The researchers caution that this immune memory may not prevent infection, but it appears to help fight severe disease. If you care about COVID, please read studies about why some people are less naturally resistant to COVID-19, and cannabis addiction may increase COVID-19 risk. For more information about COVID, please see recent studies that too much body weight may increase COVID-19 death risk, and results showing that lung maintains long-term memory of COVID infection.
We have known this for many months although I'm a little perplexed about why they would say "...it appears to help fight severe disease" instead of saying the hospital data shows that the vaccines in fact do minimize hospitalization and severe Covid illnesses in comparison to those not vaccinated. Recent Covid Comparisons here in Canada as of May 15th 2022: wrbtrader
FDA panel recommends Novavax COVID vaccine be the fourth allowed for use in US https://www.usatoday.com/story/news...cine-recommended-fda-panel-use-us/7542891001/ A federal advisory committee Tuesday recommended a fourth COVID-19 vaccine be authorized for use in the Unites States, this one from Novavax, a Gaithersburg, Maryland-based company. The vaccine, which was supported by $1.8 billion in taxpayer funding, relies on a more traditional approach than the vaccines from Moderna and Pfizer-BioNTech, which have been used by more than three-quarters of Americans. A third vaccine, from Johnson & Johnson, was used in more than 16 million people, but has now been recommended as a second choice, because of an extremely rare, but potentially lethal side effect. According to polling data, 73% of Americans want more vaccine choices. Dr. Peter Marks, head of the Food and Drug Administration's vaccine review division, opened Tuesday's meeting by saying that because of vaccine hesitancy – which has left about 23% of the public unvaccinated – the government should do everything within its power to offer more options. Before the vaccine can become available, the head of the FDA must agree with the advisory panel that the benefits of Novavax's vaccine outweigh its risks. Then, a Centers for Disease Control and Prevention Panel and the CDC's director must also sign off on the vaccine. That process is likely to take a few weeks at least. Novavax has said it has millions of doses available and ready to be shipped once it receives authorization. At this point, the Novavax vaccine would be authorized only for use in adults and only for the initial two doses. The company has already submitted a request, which the FDA is considering, to provide the same vaccine as a booster dose. The original two-dose Novavax vaccine was shown to be safe and 90% effective in a large study conducted in late 2020 and early 2021. New variants have emerged since the vaccine was tested, but Novavax officials said they are confident the vaccine will continue to be effective. "While we will be prepared to switch to a variant strain vaccine based on omicron, it is not yet clear if an omicron-specific vaccine will be required," the company said in a statement. "If an omicron-specific vaccine is required in the fall, we are confident we will be ready with our vaccine." Novavax is currently conducting research to see if an omicron-specific vaccine or a shot that protects against both the original strain and omicron would be more protective than the current formulation. The company is also prepared to "pivot" to protect against other variants as they emerge, according to the statement. The committee spent several hours Tuesday discussing the safety of the Novavax vaccine, particularly as it relates to myocarditis, an inflammation of the heart muscle that is seen after infections and also, less commonly, after some of the COVID-19 vaccines. Novavax officials said they don't think the rate of myocarditis is any higher among trial participants than the general population, but FDA officials said it remains an open question. Panel members said they support some language on the vaccine label clarifying that most COVID-19 vaccines appear to increase the risk for myocarditis, particularly among young men. The Novavax vaccine is a protein-based vaccine and includes a adjuvant to boost its effectiveness. The protein-based technology has also been used in other vaccines. The spike protein found on the surface of the coronavirus that causes COVID-19 is manufactured in insect cells and then delivered, along with the adjuvent, inside a nanoparticle. The immune system learns to recognize this spike protein and attack it when seen again on the actual virus. The Moderna and Pfizer-BioNTech vaccines, instead, are based on so-called mRNA technology, which triggers the body to manufacture its own spike protein, which then trains the immune system. Although mRNA technology was being developed before the pandemic, it was first used at large scale against COVID-19. The J&J vaccine uses a harmless virus to deliver the same spike protein. The 22-member committee voted 21-0 in favor of authorizing the vaccine. One member, Dr. Bruce Gellin, chief of Global Public Health Strategy for The Rockefeller Foundation, said he didn't vote yes because he felt that the study data, collected in 2020-2021, was outdated for combatting the omicron variant and he wanted to see more recent real-world data. "We need insights into performance, not just science that tells about its promise," he said in explaining his vote. Dr. Michael Nelson, chief of the Asthma, Allergy, and Immunology Division at UVA Health and UVA School of Medicine in Charlottesville, Virginia, said he supports providing another vaccine option for people who are allergic to existing vaccines. He said he expects people will still need three doses of the Novavax vaccine to provide the same kind of protection seen after boosting with the mRNA shots. Dr. Cody Meissner, who directs the pediatric infectious disease unit at Tufts University School of Medicine in Boston, also supported the idea of providing another option to the public. "mRNA vaccines are a great gift to humanity," he said. But, he added "there's always an opportunity to improve."
Moderna will have an Omicron focused booster in the fall. Tests are showing this booster to be very effective. Moderna says new booster for fall could be 'turning point' in COVID fight The announcement comes as the U.S. battles a surge from omicron subvariants. https://abcnews.go.com/US/moderna-booster-fall-turning-point-covid-fight/story?id=85254442 With vaccine immunity waning, and concerns over a fall surge growing, officials from Moderna announced on Wednesday that data from its study on Omicron-containing bivalent booster, revealed that it offers superior antibody response against omicron – one month after injection - compared to the company's current vaccine. Moderna Chief Medical Officer Dr. Paul Burton told ABC News that he believes the company's "highly effective" updated COVID-19 bivalent vaccine could be a "turning point" in the nation's fight against the pandemic. "The data are definitely better than I had even hoped," Burton told ABC News that in an interview. "Given the magnitude of effect — that seven-fold increase in antibody levels — we could for the first time, be at a vaccine that is truly effective with once yearly dosing because we know those antibody levels will decay." Moderna plans to file its data with the Food and Drug Administration "as quickly as possible," and should the vaccine be authorized, the company will be ready to supply the shots to "as many people around the world as possible," Burton said. "These are very important data. It's an important announcement. And I think it has the potential to be a real turning point in this latter part second half of the pandemic," Burton said. The announcement comes as the U.S. continues to battle a secondary surge from omicron subvariants amid waning immunity, relaxed attitudes by many towards mitigation measures and fatigue and skepticism about vaccination and booster shots. After more than a year of persistent efforts and messaging from federal and local authorities, just under 71% of the eligible population aged 5 and over is fully vaccinated and less than half who have completed their primary series have had their first booster dose. Burton said the company hopes this new vaccine could, for the first time, provide a roadmap for annual COVID-19 vaccinations, rather than shots every few months. "I believe that we will be able to get to this once yearly dosing now because we have high levels now. That will probably even increase and mature over time, potentially giving people protection over a full year. We could finally get to that once yearly protection, so I think it's really important," Burton said. The variant adapted vaccine, which contains omicron mRNA, was found to be highly effective against omicron, Burton said. The company reported that this new bivalent vaccine combines the original shot and the omicron mRNA together in a single shot. "The original vaccine gives great protection against delta and other variants that we've seen still recently, and that really caused significant disease. Omicron does cause significant disease. It's definitely not mild, but it's super infectious. You need to combine the two together," Burton explained. Although it is still unknown how well the new vaccine will be able to prevent infections and severe illness, Burton said he is confident that the vaccine will "definitely prevent hospitalization and death." "It's highly effective," Burton said, adding that the safety profile is also "very robust," and "reassuring." Should another variant of concern emerge, one drastically different than omicron and the already existing variants, scientists at Moderna will be prepared to reevaluate and readapt the shot to address the new threat. "If something again really drastic occurs, Well, we'll have to look at that. But I would say again, what I think we've been able to show here, is that we can adapt very quickly. We were able to make this new booster in weeks and get it into testing. I think we can even speed that up now. So, I think we were well prepared for that," Burton said. [9:45 in] Burton said he remains worried about the growing population of "unprotected" and "under-vaccinated" Americans, who will be vulnerable to more severe disease. "But by the fall, here, and around the world, we're gonna have many people who are unvaccinated and under- vaccinated and they're going to be very vulnerable," Burton said. "By Autumn, we know that waning occurs. Even people who got boosted in the new year, come the autumn of this year, they're going to have low levels of antibody. They're going to be unprotected, under-vaccinated and they're going to be very vulnerable." The sentiment of booster fatigue among some Americans is another concern for Burton, he said. "The fatigue and just the eagerness of all of us... to kind of put COVID behind us has led to apathy and a real reduction in boosting," Burton said. As Moderna also prepares for the FDA to consider authorizing its pediatric vaccine for children under six years-old, Burton said he hopes the youngest Americans will also have access to this updated shot as well, in the fall, once they receive their primary series. "I think the issue for the littlest kids is that they have no protection right now, they have had no primary vaccination they're under protected," Burton said. "I would propose that parents, caregivers get their little kids vaccinated now, They'll be ready to go back to school with Moderna. We know that two doses will give them protection... I think it's likely that they will need an additional boost at some point. And I would propose, and I think we all would imagine, that this is then the booster for them to get in the autumn of this coming year." The company is conducting studies to look into safety and efficacy of the shots in young children, and scientists are expected to have data later in the year, Burton said.
The F.D.A. authorized Moderna and Pfizer vaccines for children as young as 6 months. If the C.D.C. signs off, shots could be available next week. https://www.nytimes.com/2022/06/17/us/politics/pfizer-moderna-vaccines-kids-fda.html Friday, June 17, 2022 10:14 AM ET An advisory panel to the Centers for Disease Control and Prevention is meeting Friday and Saturday on whether to recommend the vaccines for the age group. Afterward, the C.D.C.’s director, Rochelle P. Walensky, will issue her own recommendation, the final step before doses are rolled out. (More at above url)
Fully signed off. The Covid vaccine is now available for younger children. COVID vaccine: US opens Pfizer, Moderna shots for kids under 5 CDC Director Dr. Rochelle Walensky gives final signoff https://abc11.com/covid-vaccine-children-vacccine-cdc-pfizer-moderna/11974069/
Pfizer and BioNTech say updated Covid-19 boosters show increased immune response against Omicron variant https://www.cnn.com/2022/06/25/health/pfizer-booster-results/index.html Two Pfizer and BioNTech Covid-19 vaccine boosters updated to target the Omicron variant show a substantially higher immune response than the current Covid-19 vaccine, the companies said Saturday. The companies tested a vaccine that targets Omicron BA.1 subvariant and bivalent booster – which targets two strains – that includes the current Pfizer/BioNTech Covid-19 vaccine and a vaccine candidate that targets Omicron. The study looked at two different dose levels – 30 micrograms and 60 micrograms – in more than 1,200 adults age 56 and older. The current primary and booster dosage for this age group is 30 micrograms. The study showed that, across both dose levels, a fourth booster with the Omicron-modified vaccine candidates resulted in a substantially higher immune response against the variant. One month after the shot, the monovalent vaccine showed a 13.5- and 19.6-fold increase in Omicron-fighting antibodies, depending on the dose. The bivalent vaccine showed a 9.1 and 10.9-fold increase in antibodies. Preliminary results from studies in the lab also suggest the vaccines could neutralize the Omicron BA.4 and BA.5, the companies said. The BA.4 and BA. 5 subvariants are increasingly circulating in the United States. Both vaccine candidates appeared to be safe and well-tolerated. The results were shared in a news release and have not yet been peer-reviewed or published. “Based on these data, we believe we have two very strong Omicron-modified candidates that elicit a substantially higher immune response against Omicron than we’ve seen to date,” Pfizer Chairman and Chief Executive Officer Albert Bourla said in a news release. Earlier this month, Moderna reported its bivalent Covid-19 vaccine booster that contained a vaccine targeting Omicron showed a stronger immune response against the variant. The company said its updated booster also showed a “potent” response against the BA.4 and BA.5 subvariants. The companies will present their data on Tuesday, when the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee meets to vote on updated coronavirus vaccines for the fall.