Novavax spikes ahead of presentations on COVID-19 vaccine portfolio https://seekingalpha.com/news/38901...f-presentations-on-covid-19-vaccine-portfolio Novavax (NASDAQ:NVAX) shares ended a three-day losing streak Monday to rise ~9% after the biotech announced that it would share new data from its COVID-19 vaccine pipeline at the World Vaccine Congress (WVC) Europe, scheduled to be held Oct. 11 – 14, 2022. The NVAX presentations lined up for Wednesday include an oral presentation on new data from the company’s first Phase 1/2 dose-finding study for the COVID-Influenza Combination vaccine candidate. Another presentation will contain new data for NVAX protein-based vaccine as a booster in adults aged 18 and older and adolescents aged 12 - 17 from the Phase 3 PREVENT-19 trial and Study 307. In Q3 2022, NVAX trailed small-cap biopharma stocks after the company halved its full-year guidance following a sharp Q2 topline miss.
FDA authorizes updated bivalent COVID-19 booster for children aged 5 and older The booster was first rolled out for kids aged 12 and older in September. https://abcnews.go.com/Health/fda-a...t-covid-19-booster-children/story?id=91383649 The U.S. Food and Drug Administration authorized the updated bivalent COVID-19 booster for younger children Wednesday. The Pfizer booster has been authorized for children aged 5 and older and the Moderna booster for children aged 6 and older. When the new boosters were initially authorized in September, the Pfizer booster was only available for those aged 12 and older and the Moderna booster for those aged 18 and older. The FDA says children can receive the booster at least two months after completing their primary series or receiving a separate booster dose. "Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19," Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, said in a statement. "Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death. "While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease." The updated booster specifically protects against the omicron subvariants BA.4 and BA.5, which account for the majority of COVID-19 infections in the U.S. With the updated authorization from the FDA, this means more than 216 million Americans are now eligible to receive the bivalent booster. In its announcement, the FDA said it relied on data showing the original bivalent boosters -- which targeted the original variant from Wuhan and the original omicron variant BA.1 -- were safe and effective in adults. "The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages," the health agency wrote. Data from the Centers for Disease Control and Prevention shows 11.5 million Americans have received an updated booster since they were rolled out.
New data is out on COVID vaccine injury claims. What's to make of it? https://www.reuters.com/legal/litig...ccine-injury-claims-whats-make-it-2022-10-12/
Yes, human trails of the bivalent booster with BA.1/BA.2 were performed earlier prior approval and human trials with BA.4/BA.5 have now been completed. Pfizer, BioNTech find updated COVID booster protects against Omicron in trial https://www.reuters.com/business/he...tects-against-omicron-subvariants-2022-10-13/ Oct 13 (Reuters) - Pfizer (PFE.N) and its German partner BioNTech said their COVID-19 vaccine booster, adapted for the BA.4 and the BA.5 subvariants of Omicron, generated a strong immune response and was well-tolerated in testing on humans. With the results, which the companies described as consistent with preclinical data, the partners are following up with human trial data that had previously been missing from their successful filings for regulatory approval. In a joint statement on Thursday, the companies said data from roughly 80 adult patients showed the booster dose led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after one week. They did not disclose the levels of antibodies generated in the preliminary analysis of the study. Omicron-tailored shots made by Pfizer and Moderna Inc (MRNA.O) have already been given the green light by several countries, including in the United States for adults and, more recently, for children as young as 5 years. Healthcare regulators for the European Union and the United States had already approved the upgraded shot last month, even though trial data from testing on humans had at the time not been available. But they felt sufficiently encouraged from human study results on a similar shot targeting the BA.1 subvariant and on the established vaccine based on the original virus detected in China in late 2019. “While we expect more mature immune response data from the clinical trial of our Omicron BA.4/BA.5-adapted bivalent vaccine in the coming weeks, we are pleased to see encouraging responses just one week after vaccination in younger and older adults," said Pfizer Chief Executive Albert Bourla. While the European Medicines Agency has also cleared shots that address the BA.1 subvariant, the U.S. Food and Drug Administration has focused its response for immunity against the fast spreading Omicron variant only on BA.4/5-adapted shots. The preliminary data on Thursday also showed that, in the age group of adults older than 55, the new bivalent shot triggered a better neutralizing antibody response against the Omicron BA.4/5 subvariant than the established shot based on the initial form of the virus.
I was scheduled for my 5th shot tomorrow, but subsequently learned that the bivalent booster vaccine will only be available next week here where I live. Therefore, I postponed and rescheduled to ensure I get it.
I got my bivalent booster two weeks ago here in North Carolina. At this point the bivalent booster has been demonstrated to protect against the new BQ.1.1 Omicron variant in the U.K., but no data is available yet regarding the XBB variant in Singapore since bivalent boosters will only be rolled out on October 17th there.
Lol, I just came down here to ask you about that Singapore virus. FWIW.... my scanners flagged some huge put buying last Tuesday on both Cinemark and Imax. I even pm'd a few people here about it.... because these trades were out of the blue. Here:
The recent three posts in this thread provide much more detail about the new variants in Singapore and the U.K. https://www.elitetrader.com/et/threads/meet-the-covid-variants.361711/page-28https://www.elitetrader.com/et/threads/meet-the-covid-variants.361711/page-28
Hmmm. Well, not my wheelhouse... but I have always wondered if I had these scanners back in 2001, if I'd have spotted those airline trades before 9-11. That's why I pay attention to these type of things.
If those theater stocks are set to fall because there is a belief that the new Omicron variants will arrive in the U.S. this winter and stop people from going to the theaters -- hence tanking their revenue --- then these three articles provide insight on how risky these new variants are --- and if the scenario of much lower theater attendance holds water or not. Just due diligence to get a complete view on the matter.